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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06052059
Registration number
NCT06052059
Ethics application status
Date submitted
18/09/2023
Date registered
25/09/2023
Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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PR200-301
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Secondary ID [2]
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7240-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IV Tulisokibart
Treatment: Drugs - IV Placebo
Treatment: Drugs - SC Tulisokibart
Treatment: Drugs - SC Placebo
Experimental: Study 1: High Dose Induction, High Dose Maintenance - Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Experimental: Study 1: High Dose Induction, Low Dose Maintenance - Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Experimental: Study 1: Low Dose Induction, Low Dose Maintenance - Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Placebo comparator: Study 1: Placebo - Participants receive IV placebo, followed by an SC placebo regimen.
Experimental: Study 1: High Dose Extension - Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 1: Low Dose Extension - Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 2: High Dose Induction - Participants receive high dose IV tulisokibart.
Experimental: Study 2: Low Dose Induction - Participants receive low dose IV tulisokibart.
Placebo comparator: Study 2: Placebo - Participants receive IV placebo.
Experimental: Study 2: High Dose Extension - Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 2: Low Dose Extension - Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Treatment: Drugs: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
Treatment: Drugs: IV Placebo
Placebo matching IV tulisokibart
Treatment: Drugs: SC Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Treatment: Drugs: SC Placebo
Placebo matching SC tulisokibart
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
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Assessment method [1]
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The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
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Assessment method [2]
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The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [2]
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Week 52
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Primary outcome [3]
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Study 1: Percentage of Participants With One or More Adverse Events (AEs)
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Assessment method [3]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.
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Timepoint [3]
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Up to approximately 52 weeks
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Primary outcome [4]
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Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE
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Assessment method [4]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [4]
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Up to approximately 52 weeks
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Primary outcome [5]
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Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12
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Assessment method [5]
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The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [5]
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Week 12
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Primary outcome [6]
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Study 2: Percentage of Participants With One or More AEs
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Assessment method [6]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
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Timepoint [6]
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Up to approximately 12 weeks
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Primary outcome [7]
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Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE
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Assessment method [7]
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0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [7]
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Up to approximately 12 weeks
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Secondary outcome [1]
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Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2
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Assessment method [1]
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The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
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Timepoint [1]
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Week 2
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Secondary outcome [2]
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Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
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Assessment method [2]
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Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
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Assessment method [3]
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0
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
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Assessment method [4]
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HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
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Assessment method [5]
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0
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1.
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Timepoint [5]
0
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Week 12
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Secondary outcome [6]
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Study 1: Percentage of Participants With Endoscopic Remission at Week 12
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Assessment method [6]
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0
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
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Timepoint [6]
0
0
Week 12
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Secondary outcome [7]
0
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Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12
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Assessment method [7]
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Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
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Timepoint [7]
0
0
Week 12
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Secondary outcome [8]
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Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12
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Assessment method [8]
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Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
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Timepoint [8]
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Week 12
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Secondary outcome [9]
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Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
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Assessment method [9]
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The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
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Timepoint [9]
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0
Week 12
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Secondary outcome [10]
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Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
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Assessment method [10]
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The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12
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Assessment method [11]
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Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [11]
0
0
Week 12
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Secondary outcome [12]
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Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
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Assessment method [12]
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Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [12]
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Week 12
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Secondary outcome [13]
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Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12
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Assessment method [13]
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HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
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Timepoint [13]
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Week 12
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Secondary outcome [14]
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Study 1: Percentage of Participants with Endoscopic Improvement at Week 52
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Assessment method [14]
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Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [14]
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Week 52
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Secondary outcome [15]
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Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52
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Assessment method [15]
0
0
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for =90 days before Week 52.
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Timepoint [15]
0
0
Week 52
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Secondary outcome [16]
0
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Study 1: Percentage of Participants Achieving HEMI at Week 52
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Assessment method [16]
0
0
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
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Timepoint [16]
0
0
Week 52
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Secondary outcome [17]
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0
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52
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Assessment method [17]
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0
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1.
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Timepoint [17]
0
0
Week 52
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Secondary outcome [18]
0
0
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52
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Assessment method [18]
0
0
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.
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Timepoint [18]
0
0
Week 12 and Week 52
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Secondary outcome [19]
0
0
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52
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Assessment method [19]
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0
Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
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Timepoint [19]
0
0
Week 52
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Secondary outcome [20]
0
0
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52
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Assessment method [20]
0
0
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
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Timepoint [20]
0
0
Week 52
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Secondary outcome [21]
0
0
Study 1: Percentage of Participants With Endoscopic Remission at Week 52
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Assessment method [21]
0
0
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
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Timepoint [21]
0
0
Week 52
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Secondary outcome [22]
0
0
Study 1: Percentage of Participants with Sustained Clinical Response Per MMS at Both Week 12 and Week 52
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Assessment method [22]
0
0
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1, at both Week 12 and Week 52.
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Timepoint [22]
0
0
Week 12, and Week 52
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Secondary outcome [23]
0
0
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52
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Assessment method [23]
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0
Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [23]
0
0
Week 12 and Week 52
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Secondary outcome [24]
0
0
Study 1: Percentage of Participants Achieving HER at Week 52
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Assessment method [24]
0
0
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
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Timepoint [24]
0
0
Week 52
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Secondary outcome [25]
0
0
Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52
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Assessment method [25]
0
0
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
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Timepoint [25]
0
0
Week 52
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Secondary outcome [26]
0
0
Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52
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Assessment method [26]
0
0
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
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Timepoint [26]
0
0
Baseline and Week 52
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Secondary outcome [27]
0
0
Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52
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Assessment method [27]
0
0
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [27]
0
0
Week 52
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Secondary outcome [28]
0
0
Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52
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Assessment method [28]
0
0
Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [28]
0
0
Week 52
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Secondary outcome [29]
0
0
Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2
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Assessment method [29]
0
0
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
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Timepoint [29]
0
0
Week 2
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Secondary outcome [30]
0
0
Study 2: Percentage of Participants With Endoscopic Improvement at Week 12
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Assessment method [30]
0
0
Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
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Timepoint [30]
0
0
Week 12
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Secondary outcome [31]
0
0
Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
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Assessment method [31]
0
0
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Query!
Timepoint [31]
0
0
Week 12
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Secondary outcome [32]
0
0
Study 2: Percentage of Participants Achieving HEMI at Week 12
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Assessment method [32]
0
0
HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Query!
Timepoint [32]
0
0
Week 12
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Secondary outcome [33]
0
0
Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
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Assessment method [33]
0
0
pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of =1.
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Timepoint [33]
0
0
Week 12
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Secondary outcome [34]
0
0
Study 2: Percentage of Participants With Endoscopic Remission at Week 12
Query!
Assessment method [34]
0
0
ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Query!
Timepoint [34]
0
0
Week 12
Query!
Secondary outcome [35]
0
0
Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12
Query!
Assessment method [35]
0
0
Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.
Query!
Timepoint [35]
0
0
Week 12
Query!
Secondary outcome [36]
0
0
Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12
Query!
Assessment method [36]
0
0
Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Query!
Timepoint [36]
0
0
Week 12
Query!
Secondary outcome [37]
0
0
Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12
Query!
Assessment method [37]
0
0
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Query!
Timepoint [37]
0
0
Week 12
Query!
Secondary outcome [38]
0
0
Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12
Query!
Assessment method [38]
0
0
The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Query!
Timepoint [38]
0
0
Baseline and Week 12
Query!
Secondary outcome [39]
0
0
Study 2: Percentage of Participants Achieving HER at Week 12
Query!
Assessment method [39]
0
0
HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation.
Query!
Timepoint [39]
0
0
Week 12
Query!
Eligibility
Key inclusion criteria
* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
* Has moderately to severely active UC
* Weight =40 kg
* Satisfies at least 1 of the following criteria:
* Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
* Protocol specified corticosteroid dependence
* Has been intolerant to 1 or more protocol-specified UC treatments
* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
* Adolescent participants =16 and <18 years of age can participate if approved by the country or regulatory/health authority
* Participant assigned male sex at birth, if capable of producing sperm, agrees to abstain from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent; or uses prescribed contraception unless azoospermic
* A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
* Has a current diagnosis of fulminant colitis and/or toxic megacolon
* Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
* Has a current or impending need for colostomy or ileostomy
* Has had a total proctocolectomy or partial colectomy
* Has received fecal microbial transplantation within 4 weeks before randomization
* Has been hospitalized for the treatment of UC within 2 weeks before screening
* Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the Screening colonoscopy that has not been completely removed
* Has any active or serious infections without resolution after adequate treatment
* Has had a herpes zoster reactivation or cytomegalovirus that resolved less than 8 weeks before screening
* Has a transplanted organ which requires continued immunosuppression
* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
* Has confirmed or suspected COVID-19 infection
* Has a history of drug or alcohol abuse within 6 months prior to screening
* Has had major surgery within 3 months before screening or has a major surgery (i.e, requiring general anesthesia) planned during the study
* Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
* Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
* Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
* Has received protocol-specified prohibited medications
* Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
Query!
Phase
Phase 3
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Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
17/12/2029
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Actual
Query!
Sample size
Target
1020
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Mater Misericordiae Limited-Gastroenterology ( Site 2506) - Brisbane
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Recruitment postcode(s) [1]
0
0
4101 - Brisbane
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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0
0
United States of America
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0
0
Arizona
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0
0
United States of America
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0
0
California
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0
0
United States of America
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0
0
Colorado
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0
0
United States of America
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0
0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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0
0
Georgia
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0
0
United States of America
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0
0
Illinois
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0
0
United States of America
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0
0
Iowa
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0
0
United States of America
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0
0
Louisiana
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0
0
United States of America
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0
0
Michigan
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0
0
United States of America
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0
0
New York
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0
0
United States of America
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0
0
North Carolina
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0
0
United States of America
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0
0
Rhode Island
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0
0
United States of America
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0
0
South Carolina
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0
0
United States of America
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0
0
Tennessee
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0
0
United States of America
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0
0
Texas
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0
0
United States of America
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0
0
Utah
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0
0
United States of America
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0
0
Washington
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0
0
Argentina
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0
0
Buenos Aires
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0
0
Argentina
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0
0
Caba
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0
0
Argentina
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0
0
Tucuman
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0
0
Canada
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0
0
Ontario
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0
0
Chile
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0
0
Los Rios
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0
Chile
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0
0
Region M. De Santiago
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0
0
China
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0
0
Beijing
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0
0
China
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0
0
Chongqing
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0
0
China
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0
0
Guangdong
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0
0
China
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0
0
Hebei
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0
0
China
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0
0
Henan
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0
0
China
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0
0
Hubei
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0
0
China
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0
0
Hunan
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0
0
China
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0
0
Jiangsu
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0
0
China
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0
0
Shandong
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0
0
China
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0
0
Shanghai
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0
0
China
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0
0
Xinjiang
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0
0
China
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0
0
Yunnan
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0
0
China
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0
0
Zhejiang
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0
0
Croatia
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State/province [39]
0
0
Grad Zagreb
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0
0
Dominican Republic
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State/province [40]
0
0
Distrito Nacional
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0
0
Greece
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State/province [41]
0
0
Attiki
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0
0
Greece
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0
0
Kentriki Makedonia
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0
0
Greece
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0
0
Kriti
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0
0
Hungary
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0
0
Budapest
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0
0
Israel
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0
0
Ashkelon
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0
0
Israel
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0
0
Haifa
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0
0
Israel
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0
0
Holon
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Country [48]
0
0
Israel
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State/province [48]
0
0
Jerusalem
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Country [49]
0
0
Israel
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State/province [49]
0
0
Kfar Saba
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Country [50]
0
0
Israel
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State/province [50]
0
0
Petah Tikva
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Country [51]
0
0
Israel
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State/province [51]
0
0
Ramat Gan
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Country [52]
0
0
Italy
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State/province [52]
0
0
Foggia
Query!
Country [53]
0
0
Italy
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State/province [53]
0
0
Lazio
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Country [54]
0
0
Italy
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State/province [54]
0
0
Lombardia
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Country [55]
0
0
Italy
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State/province [55]
0
0
Roma
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Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Sicilia
Query!
Country [57]
0
0
Italy
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State/province [57]
0
0
Verona
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Country [58]
0
0
Italy
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State/province [58]
0
0
Milano
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Country [59]
0
0
Italy
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State/province [59]
0
0
Pavia
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Country [60]
0
0
Japan
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State/province [60]
0
0
Aichi
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Country [61]
0
0
Japan
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State/province [61]
0
0
Chiba
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Country [62]
0
0
Japan
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State/province [62]
0
0
Fukuoka
Query!
Country [63]
0
0
Japan
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State/province [63]
0
0
Hiroshima
Query!
Country [64]
0
0
Japan
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State/province [64]
0
0
Hokkaido
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0
0
Japan
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State/province [65]
0
0
Hyogo
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0
0
Japan
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State/province [66]
0
0
Ishikawa
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0
0
Japan
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State/province [67]
0
0
Iwate
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0
0
Japan
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State/province [68]
0
0
Kanagawa
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Country [69]
0
0
Japan
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State/province [69]
0
0
Mie
Query!
Country [70]
0
0
Japan
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State/province [70]
0
0
Osaka
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0
0
Japan
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State/province [71]
0
0
Shizuoka
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0
0
Japan
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State/province [72]
0
0
Tokyo
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0
0
Japan
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State/province [73]
0
0
Yamanashi
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0
0
Japan
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State/province [74]
0
0
Fukui
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0
0
Japan
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State/province [75]
0
0
Kagoshima
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0
0
Japan
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State/province [76]
0
0
Kyoto
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0
0
Japan
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State/province [77]
0
0
Oita
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Country [78]
0
0
Japan
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State/province [78]
0
0
Saga
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Country [79]
0
0
Japan
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State/province [79]
0
0
Saitama
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Country [80]
0
0
Japan
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State/province [80]
0
0
Toyama
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Country [81]
0
0
Korea, Republic of
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State/province [81]
0
0
Kang-won-do
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Country [82]
0
0
Korea, Republic of
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State/province [82]
0
0
Kyonggi-do
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Country [83]
0
0
Korea, Republic of
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State/province [83]
0
0
Pusan-Kwangyokshi
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0
0
Korea, Republic of
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State/province [84]
0
0
Seoul
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0
0
Korea, Republic of
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State/province [85]
0
0
Taegu-Kwangyokshi
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Country [86]
0
0
Korea, Republic of
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State/province [86]
0
0
Taejon-Kwangyokshi
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Country [87]
0
0
Netherlands
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State/province [87]
0
0
Gelderland
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0
0
Netherlands
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State/province [88]
0
0
Noord-Brabant
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0
0
Netherlands
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State/province [89]
0
0
Noord-Holland
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0
0
Netherlands
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State/province [90]
0
0
Utrecht
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0
0
Poland
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State/province [91]
0
0
Dolnoslaskie
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0
0
Portugal
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0
0
Braga
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0
0
Portugal
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0
0
Lisboa
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0
0
Portugal
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State/province [94]
0
0
Viana do Castelo
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0
0
Switzerland
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0
0
Berne
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0
0
Switzerland
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0
0
Sankt Gallen
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0
0
Switzerland
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0
0
Zurich
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0
0
Taiwan
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0
0
Changhua
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0
0
Taiwan
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0
0
Hsinchu
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0
0
Taiwan
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0
0
Taipei
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0
0
Taiwan
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0
0
Taoyuan
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0
0
Turkey
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0
0
Ankara
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0
0
United Kingdom
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State/province [103]
0
0
England
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
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Address
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Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
PPD, Part of Thermo Fisher Scientific
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06052059
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Toll Free Number
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06052059