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
概览
- 阶段
- 3 期
- 干预措施
- placebo for risankizumab
- 疾病 / 适应症
- Ulcerative Colitis (UC)
- 发起方
- AbbVie
- 入组人数
- 1242
- 试验地点
- 850
- 主要终点
- Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •\- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
排除标准
- •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.
研究组 & 干预措施
Substudy 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
干预措施: placebo for risankizumab
Substudy 3: OL Extension Risankizumab
Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
干预措施: risankizumab
Substudy 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
干预措施: risankizumab
Substudy 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
干预措施: risankizumab
Substudy 2: Open-label (OL) Clinical Assessment Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
干预措施: risankizumab
Substudy 2: OL Therapeutic Drug Monitoring Risankizumab
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
干预措施: risankizumab
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.
干预措施: risankizumab
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.
干预措施: risankizumab
结局指标
主要结局
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
时间窗: Week 52
Clinical remission per Adapted Mayo Score.
Percentage of Participants with Adverse Events (AE)
时间窗: 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.
次要结局
- Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements(Week 52)
- Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)(Baseline (Week 0) to Week 52)
- Sub-Study 1: Percentage of Participants Achieving No Tenesmus(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement(Week 52)
- Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Clinical Response 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(Week 52)
- Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency(Week 52)
- Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain(Week 52)
- Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0(Week 52)
- Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week(Baseline (Week 0) to Week 52)
- Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission(Week 52)
- Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)(Week 0 to Week 52)
- Sub-Study 1: 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(Through Week 52)