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

Conditions

• Ulcerative Colitis (UC)

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• risankizumab — DRUG
  subcutaneous (SC) injection
• placebo for risankizumab — DRUG
  subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date

Aug 28, 2018

Status verified

Jan 2026

Primary completion

Sep 30, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

1,242 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score [ Time Frame: Week 52 ]

Locations (78)

Find similar trials in Coronado, CA

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