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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 October 2023
• Main ID: NCT03398135
• Date of registration: 08/01/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
• Scientific title: 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
• Date of first enrolment: August 28, 2018
• Target sample size: 1242
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03398135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

American Samoa, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: placebo for risankizumab

Drug: risankizumab

Primary Outcome(s)

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

Percentage of Participants with Adverse Events (AE) [Time Frame: Up to Week 300]

Secondary Outcome(s)

Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [Time Frame: Week 0 to Week 52]

Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization [Time Frame: Through Week 52]

Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 [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 [Time Frame: Week 52]

Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: Baseline (Week 0) to Week 52]

Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain [Time Frame: Week 52]

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

Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement [Time Frame: Week 52]

Sub-Study 1: 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: Change in Number of Fecal Incontinence Episodes per Week [Time Frame: Baseline (Week 0) to Week 52]

Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement [Time Frame: Week 52]

Sub-Study 1: Percentage of Participants Achieving No Tenesmus [Time Frame: Week 52]

Secondary ID(s)

2016-004676-22

2023-506994-36-00

M16-066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors