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

Phase 3Active Not RecruitingNCT03398135

AbbVie1,242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,242

Conditions

Ulcerative Colitis (UC)

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (426)

Southern California Res. Ctr. /ID# 169659

Coronado, California, United States

Hoag Memorial Hosp Presbyterian /ID# 218347

Irvine, California, United States

UC San Diego Health System /ID# 160430

La Jolla, California, United States

United Medical Doctors /ID# 158574

Los Alamitos, California, United States

Cedars-Sinai Medical Center /ID# 163848

Los Angeles, California, United States

Outcomes

Primary Outcomes

Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

Clinical remission per Adapted Mayo Score.

Time frame: 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.

Time frame: Up to Week 300

Secondary Outcomes

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement

Endoscopic improvement per endoscopy subscore.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

Percentage of participants achieving histologic-endoscopic mucosal improvement.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission

Endoscopic remission per endoscopy subscore.

Time frame: 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.

Time frame: 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.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency

Percentage of participants achieving no bowel urgency.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain

Percentage of participants achieving no abdominal pain.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission

Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0

Endoscopic improvement per endoscopy subscore.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score

Clinical response per Adapted Mayo Score.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 52

Sub-Study 1: Percentage of Participants Achieving No Tenesmus

Percentage of participants achieving no tenesmus.

Time frame: Week 52

Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week

Change in number of fecal incontinence episodes per week.

Time frame: 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.

Time frame: 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.

Time frame: Through Week 52