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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03398135
Registration number
NCT03398135
Ethics application status
Date submitted
8/01/2018
Date registered
12/01/2018
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
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Secondary ID [1]
0
0
2016-004676-22
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Secondary ID [2]
0
0
M16-066
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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 (UC)
0
0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
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
0
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 - risankizumab
Treatment: Drugs - placebo for risankizumab
Placebo comparator: Substudy 1: Double-blind Placebo - Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
Experimental: Substudy 1: Double-blind Risankizumab Dose 1 - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Experimental: Substudy 1: Double-blind Risankizumab Dose 2 - Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab - Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
Experimental: Substudy 3: OL Extension Risankizumab - Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
Experimental: OL Continuous Treatment Extension - Dose 1 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection.
Experimental: OL Continuous Treatment Extension - Dose 2 - Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection.
Treatment: Drugs: risankizumab
subcutaneous (SC) injection
Treatment: Drugs: placebo for risankizumab
subcutaneous (SC) injection
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Intervention code [1]
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0
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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0
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
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Assessment method [1]
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Clinical remission per Adapted Mayo Score.
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Percentage of Participants with Adverse Events (AE)
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Assessment method [2]
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0
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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Up to Week 300
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Secondary outcome [1]
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Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement
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Assessment method [1]
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Endoscopic improvement per endoscopy subscore.
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Timepoint [1]
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0
Week 52
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Secondary outcome [2]
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Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
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Assessment method [2]
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Percentage of participants achieving histologic-endoscopic mucosal improvement.
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Timepoint [2]
0
0
Week 52
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Secondary outcome [3]
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0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission
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Assessment method [3]
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Endoscopic remission per endoscopy subscore.
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Timepoint [3]
0
0
Week 52
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Secondary outcome [4]
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0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days
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Assessment method [4]
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Clinical remission per Adapted Mayo Score.
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Timepoint [4]
0
0
Week 52
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Secondary outcome [5]
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0
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0
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Assessment method [5]
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Clinical remission per Adapted Mayo Score.
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Timepoint [5]
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0
Week 52
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Secondary outcome [6]
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Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency
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Assessment method [6]
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Percentage of participants achieving no bowel urgency.
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Timepoint [6]
0
0
Week 52
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Secondary outcome [7]
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Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain
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Assessment method [7]
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0
Percentage of participants achieving no abdominal pain.
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Timepoint [7]
0
0
Week 52
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Secondary outcome [8]
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Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission
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Assessment method [8]
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0
Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.
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Timepoint [8]
0
0
Week 52
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Secondary outcome [9]
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0
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0
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Assessment method [9]
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0
Endoscopic improvement per endoscopy subscore.
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Timepoint [9]
0
0
Week 52
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Secondary outcome [10]
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0
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
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Assessment method [10]
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0
Clinical response per Adapted Mayo Score.
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Timepoint [10]
0
0
Week 52
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Secondary outcome [11]
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Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
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Assessment method [11]
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0
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
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Timepoint [11]
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Week 0 to Week 52
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Secondary outcome [12]
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Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
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Assessment method [12]
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The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
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Timepoint [12]
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Baseline (Week 0) to Week 52
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Secondary outcome [13]
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Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements
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Assessment method [13]
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Percentage of participants achieving no nocturnal bowel movements.
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Timepoint [13]
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0
Week 52
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Secondary outcome [14]
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Sub-Study 1: Percentage of Participants Achieving No Tenesmus
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Assessment method [14]
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0
Percentage of participants achieving no tenesmus.
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Timepoint [14]
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0
Week 52
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Secondary outcome [15]
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0
Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week
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Assessment method [15]
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Change in number of fecal incontinence episodes per week.
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Timepoint [15]
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0
Baseline (Week 0) to Week 52
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Secondary outcome [16]
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Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
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Assessment method [16]
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0
Change in number of days per week with sleep interrupted due to UC symptoms.
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Timepoint [16]
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0
Baseline (Week 0) to Week 52
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Secondary outcome [17]
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0
Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization
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Assessment method [17]
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0
Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.
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Timepoint [17]
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0
Through Week 52
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Eligibility
Key inclusion criteria
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
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Minimum age
16
Years
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Maximum age
80
Years
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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
* Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
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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 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 3
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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
28/08/2018
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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
25/09/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
1242
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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0
United States of America
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California
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United States of America
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0
Colorado
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0
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0
0
Connecticut
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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
Indiana
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0
0
United States of America
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0
0
Kansas
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0
0
United States of America
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State/province [9]
0
0
Kentucky
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0
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United States of America
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0
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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South Carolina
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Argentina
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Ciudad Autonoma De Buenos Aires
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Argentina
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Santa Fe
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Tucuman
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Cordoba
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Austria
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Niederoesterreich
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Wien
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Austria
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Salzburg
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Belgium
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Namur
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Bonheiden
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Goias
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Brazil
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Brazil
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Rio Grande Do Sul
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Brazil
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Sliven
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Canada
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Ontario
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Montreal
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Region Metropolitana Santiago
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Concepción
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Talcahuano
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China
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Anhui
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China
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Beijing
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China
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Guangdong
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China
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China
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Ningxia
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China
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Shaanxi
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China
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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China
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Changsha
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China
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Shenyang
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Colombia
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Colombia
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Medellin
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Croatia
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Grad Zagreb
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Croatia
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Osjecko-baranjska Zupanija
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Croatia
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Brno
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Czechia
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Denmark
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Egypt
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France
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France
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Loire
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France
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Meurthe-et-Moselle
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France
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Somme
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France
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Nantes
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Berlin
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Braunschweig
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Germany
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Leipzig
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Gyeonggido
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Seoul Teugbyeolsi
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Busan
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Seoul
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Del. Benito Juárez
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Amsterdam
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Braga
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Ponce
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Romania
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Cluj
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Bucharest
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Pushkin
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Russian Federation
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St. Petersburg
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Russian Federation
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Ulyanovsk
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Serbia
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Beograd
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Serbia
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Belgrade
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Leskovac
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Nitra
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Nove Zamky
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Slovakia
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Presov
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Ljubljana
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Free State
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Gauteng
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South Africa
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Stockholm
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Zuerich
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Bern
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Kyiv
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United Kingdom
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United Kingdom
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Barnsley
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United Kingdom
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Tooting
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.
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Trial website
https://clinicaltrials.gov/study/NCT03398135
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
0
0
AbbVie
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Country
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0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
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Country
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0
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Phone
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Fax
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Email
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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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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/NCT03398135