A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ulcerative Colitis (UC)

Intervention / Treatment
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* Drug: risankizumab
* Drug: placebo for risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol. 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Substudy 1: Double-blind Placebo<br>Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection. | Drug: placebo for risankizumab<br>* subcutaneous (SC) injection<br>|
| Experimental: Substudy 1: Double-blind Risankizumab Dose 1<br>Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: Substudy 1: Double-blind Risankizumab Dose 2<br>Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: Substudy 2: Open-label (OL) Clinical Assessment Risankizumab<br>Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: Substudy 2: OL Therapeutic Drug Monitoring Risankizumab<br>Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: Substudy 3: OL Extension Risankizumab<br>Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: OL Continuous Treatment Extension - Dose 1<br>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. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|
| Experimental: OL Continuous Treatment Extension - Dose 2<br>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. | Drug: risankizumab<br>* subcutaneous (SC) injection<br>* Other names: SKYRIZI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score | Clinical remission per Adapted Mayo Score. | Week 52 | 
| Percentage of Participants with Adverse Events (AE) | 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. | Up to Week 300 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement per endoscopy subscore. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement | Percentage of participants achieving histologic-endoscopic mucosal improvement. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission per endoscopy subscore. | Week 52 | 
| Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days | Clinical remission per Adapted Mayo Score. | Week 52 | 
| Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 | Clinical remission per Adapted Mayo Score. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency | Percentage of participants achieving no bowel urgency. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain | Percentage of participants achieving no abdominal pain. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission | Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 | Endoscopic improvement per endoscopy subscore. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score | Clinical response per Adapted Mayo Score. | Week 52 | 
| Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week. | Week 0 to Week 52 | 
| Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease. | Baseline (Week 0) to Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements | Percentage of participants achieving no nocturnal bowel movements. | Week 52 | 
| Sub-Study 1: Percentage of Participants Achieving No Tenesmus | Percentage of participants achieving no tenesmus. | Week 52 | 
| Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week | Change in number of fecal incontinence episodes per week. | Baseline (Week 0) to Week 52 | 
| Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms | Change in number of days per week with sleep interrupted due to UC symptoms. | Baseline (Week 0) to Week 52 | 
| Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization | Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital. | Through Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-066, BI 655066