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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04996797
Registration number
NCT04996797
Ethics application status
Date submitted
2/08/2021
Date registered
9/08/2021
Titles & IDs
Public title
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
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Scientific title
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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0
MK-7240-005
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Secondary ID [2]
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PR200-102
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Universal Trial Number (UTN)
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Trial acronym
ARTEMIS-UC
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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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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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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
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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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 - Tulisokibart
Treatment: Devices - Companion Diagnostic (CDx) Testing
Other interventions - Placebo
Experimental: Cohort 1 Tulisokibart - Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Placebo comparator: Cohort 1 Placebo - Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Experimental: Cohort 2 Tulisokibart - Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Placebo comparator: Cohort 2 Placebo - Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Treatment: Drugs: Tulisokibart
Administered by IV infusion
Treatment: Devices: Companion Diagnostic (CDx) Testing
PRA023 CDx Genotyping Assay
Other interventions: Placebo
Placebo administered by IV infusion
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Intervention code [3]
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Other interventions
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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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Percentage of Participants in Cohort 1 Achieving Clinical Remission
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Assessment method [1]
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The 3-component Modified Mayo Score (MMS) ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding (RB), and stool frequency (SF) subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Percentage of Participants Who Experienced an Adverse Event (AE)
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Assessment method [2]
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An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who experienced at least one AE is reported.
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Timepoint [2]
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Up to ~14 weeks
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Primary outcome [3]
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Percentage of Participants Who Discontinued Due to an AE
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Assessment method [3]
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An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants who discontinued due to an AE is reported.
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Timepoint [3]
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Up to ~14 weeks
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Primary outcome [4]
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Percentage of Participants Who Had One or More Serious Adverse Events
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Assessment method [4]
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Reported adverse experiences used the Common Terminology for Adverse Events (CTCAE) Version 4.0. Serious adverse events are defined as: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Life-threatening consequences; urgent intervention indicated, and death. Per protocol, adverse events are reported by treatment with tulisokibart or placebo regardless of assigned cohort. Participants received identical treatment regiments regardless of cohort. The percentage of participants experiencing a serious AE are presented.
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Timepoint [4]
0
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Up to ~14 weeks
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Secondary outcome [1]
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Percentage of Participants in Cohort 1 With Endoscopic Improvement
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Assessment method [1]
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The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of the MMS of = 1 with no friability. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Percentage of Participants in Cohort 1 Achieving Clinical Response
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Assessment method [2]
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The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined as a reduction from Baseline = 2 points and = 30% in 3-component Modified Mayo Score, accompanied by a reduction = 1 in RB subscore or absolute RB subscore = 1. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [2]
0
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Baseline and Week 12
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Secondary outcome [3]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission
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Assessment method [3]
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The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical remission is defined as endoscopic subscore of 0 or 1, RB subscore of 0, and SF subscore of 0 or 1 and not greater than baseline. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Percentage of Participants in Cohort 1 With Symptomatic Remission
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Assessment method [4]
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RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [4]
0
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Baseline and Week 12
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Secondary outcome [5]
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Percentage of Participants in Cohort 1 With Histologic Improvement
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Assessment method [5]
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Histologic improvement is defined as Geboes score = 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement
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Assessment method [6]
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Histologic-endoscopic mucosal improvement is defined as a Geboes score = 3.1 and endoscopy subscore of the MMS = 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement
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Assessment method [7]
0
0
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Endoscopic improvement is defined by endoscopy subscore of MMS of = 1 with no friability. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
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Timepoint [7]
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0
Baseline and Week 12
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Secondary outcome [8]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response
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Assessment method [8]
0
0
The 3-component MMS ranges from 0 to 9 and is composed of endoscopic assessment, RB, and SF subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease. Clinical response is defined by reduction from Baseline = 2 points and = 30% in 3-component Modified Mayo Score, accompanied by a reduction = 1 in RB subscore or absolute RB subscore = 1. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
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Timepoint [8]
0
0
Baseline and Week 12
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Secondary outcome [9]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission
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Assessment method [9]
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RB, and SF subscores each range from 0 to 3, with higher scores indicating more severe disease. Symptomatic remission is defined as participants with SF subscore = 0 and RB subscore = 0. The percentage of participants who achieved symptomatic remission is presented. Per protocol participants who were CDx+ (Cohort 1 + Cohort 2) were analyzed for this outcome measure.
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Timepoint [9]
0
0
Baseline and Week 12
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Secondary outcome [10]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement
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Assessment method [10]
0
0
Histologic improvement is defined as Geboes score = 3.1. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. A higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
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Timepoint [10]
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0
Baseline and Week 12
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Secondary outcome [11]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement
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Assessment method [11]
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Histologic-endoscopic mucosal improvement is defined as a Geboes score = 3.1 and endoscopy subscore of the MMS = 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
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Timepoint [11]
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Baseline and Week 12
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Secondary outcome [12]
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Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing
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Assessment method [12]
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Histologic-endoscopic mucosal improvement is defined as Geboes score = 2B.1 and endoscopy subscore of MMS = 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [12]
0
0
Baseline and Week 12
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Secondary outcome [13]
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Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing
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Assessment method [13]
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0
Histologic-endoscopic mucosal improvement is defined as Geboes score = 2B.1 and endoscopy subscore of MMS = 1 with no friability. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. The endoscopic subscore of the MMS ranges from 0-3. For both scales a higher score indicates more severe disease. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
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Timepoint [13]
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Baseline and Week 12
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Secondary outcome [14]
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Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response
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Assessment method [14]
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IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by = 16-point increase from Baseline at Week 12. Per protocol participants in Cohort 1 were analyzed for this outcome measure.
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Timepoint [14]
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Baseline and Week 12
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Secondary outcome [15]
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Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response
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Assessment method [15]
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IBDQ is a self-administered, disease-specific Health-Related Quality of Life (HRQOL) instrument for subjects with IBD. The IBDQ covers 4 dimensions and 32 questions: bowel symptoms, systemic symptoms, emotional function, and social function. Items are scored on a 7-point Likert scale (1 = all of the time and 7 = none of the time), for a total global score in the range 32 to 224 (with higher scores indicating better HRQOL). IBDQ response, as defined by = 16-point increase from Baseline at Week 12. Per protocol participants who were CDx+ (Cohorts 1 + 2) were analyzed for this outcome measure.
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Timepoint [15]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:
* Confirmed diagnosis of ulcerative colitis (UC)
* Has moderately to severely active UC as defined by 3-component Modified Mayo score
* Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The main exclusion criteria include but are not limited to the following:
* Has diagnosis of Crohn's disease or indeterminate colitis
* Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
* Has current or impending need for colostomy or ileostomy
* Has had surgical bowel resection within 3 months before screening
* Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
178
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Recruitment in Australia
Recruitment state(s)
AdelaideNSW,QLD,SA,VIC
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Recruitment hospital [1]
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Prometheus Biosciences Selected Site - Woodville
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Recruitment hospital [2]
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Prometheus Biosciences Selected Site - Kingswood
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Recruitment hospital [3]
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Prometheus Biosciences Selected Site - Old Toongabbie
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Recruitment hospital [4]
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Prometheus Biosciences Selected Site - South Brisbane
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Recruitment hospital [5]
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Prometheus Biosciences Selected Site - Woolloongabba
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Recruitment hospital [6]
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Prometheus Biosciences Selected Site - Adelaide
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Recruitment hospital [7]
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Prometheus Biosciences Selected Site - Fitzroy
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Recruitment hospital [8]
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Prometheus Biosciences Selected Site - Melbourne
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Recruitment postcode(s) [1]
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- Woodville
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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NSW 2146 - Old Toongabbie
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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VIC 3065 - Fitzroy
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Recruitment postcode(s) [8]
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VIC 3065 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Georgia
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Illinois
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Kansas
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United States of America
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Louisiana
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Maryland
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Michigan
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New Hampshire
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New York
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Ohio
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Tennessee
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Texas
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Virginia
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Washington
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Belgium
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Leuven
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Belgium
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Liège
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Hradec Králové
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Czechia
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Olomouc
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Czechia
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Slaný
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Clichy
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France
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Lille
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France
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Nice
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France
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Pierre-Bénite
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France
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Saint-Priest-en-Jarez
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France
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Vandœuvre-lès-Nancy
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Georgia
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Tbilisi
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Hungary
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Gyor-Moson-Sopron
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Israel
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Afula
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Israel
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Be'er Sheva
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Israel
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H_olon
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Israel
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Jerusalem
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Israel
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Kraków
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Torun
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Lódz
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Merseyside
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT04996797
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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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
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT04996797/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/97/NCT04996797/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04996797