A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- Registration Number
- NCT03398135
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1242
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Substudy 1: Double-blind Placebo placebo for risankizumab Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection. Substudy 1: Double-blind Risankizumab Dose 1 risankizumab Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. Substudy 1: Double-blind Risankizumab Dose 2 risankizumab Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection. Substudy 2: Open-label (OL) Clinical Assessment Risankizumab risankizumab Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. Substudy 3: OL Extension Risankizumab risankizumab Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3. Substudy 2: OL Therapeutic Drug Monitoring Risankizumab risankizumab Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. OL Continuous Treatment Extension - Dose 1 risankizumab 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. OL Continuous Treatment Extension - Dose 2 risankizumab 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.
- Primary Outcome Measures
Name Time Method Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score Week 52 Clinical remission per Adapted Mayo Score.
Percentage of Participants with Adverse Events (AE) Up to Week 300 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.
- Secondary Outcome Measures
Name Time Method Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Baseline (Week 0) to Week 52 The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements Week 52 Percentage of participants achieving no nocturnal bowel movements.
Sub-Study 1: Percentage of Participants Achieving No Tenesmus Week 52 Percentage of participants achieving no tenesmus.
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement Week 52 Endoscopic improvement per endoscopy subscore.
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement Week 52 Percentage of participants achieving histologic-endoscopic mucosal improvement.
Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission Week 52 Endoscopic remission per endoscopy subscore.
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days Week 52 Clinical remission per Adapted Mayo Score.
Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score Week 52 Clinical response per Adapted Mayo Score.
Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 Week 52 Clinical remission per Adapted Mayo Score.
Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency Week 52 Percentage of participants achieving no bowel urgency.
Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain Week 52 Percentage of participants achieving no abdominal pain.
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 Week 52 Endoscopic improvement per endoscopy subscore.
Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week Baseline (Week 0) to Week 52 Change in number of fecal incontinence episodes per week.
Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission Week 52 Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Week 0 to Week 52 The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms Baseline (Week 0) to Week 52 Change in number of days per week with sleep interrupted due to UC symptoms.
Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization Through Week 52 Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.
Trial Locations
- Locations (425)
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128
🇺🇸North Massapequa, New York, United States
Umbal Kaspela /ID# 200795
🇧🇬Plovdiv, Bulgaria
Toronto Digestive Disease Associates /ID# 169120
🇨🇦Vaughan, Ontario, Canada
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 211229
🇨🇳Guangzhou, Guangdong, China
Duplicate_Fakultni nemocnice u sv. Anny v Brne /ID# 239158
🇨🇿Brno, Brno-mesto, Czechia
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 155627
🇮🇹Bologna, Italy
Daido Clinic - Nagoya /ID# 211478
🇯🇵Nagoya-shi, Aichi, Japan
Hamamatsu University School Of Medicine University Hospital /ID# 226729
🇯🇵Hamamatsu, Shizuoka, Japan
Kyorin University Hospital - Mitaka Campus /ID# 164226
🇯🇵Mitaka-shi, Tokyo, Japan
Vivamed Sp. z o.o. /ID# 216308
🇵🇱Warszawa, Mazowieckie, Poland
Scroll for more (415 remaining)Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171128🇺🇸North Massapequa, New York, United States