A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989
- Conditions
- Crohn's diseaseMedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-003191-50-HR
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1250
1. Entry and completion of Study M16-006, Study M15-991 or Study M15-989. The final endoscopy for studies M16-006 and M15-991 may be missing during the coronavirus SARS-CoV-2 pandemic due to local regulations prohibiting endoscopy and subjects may be allowed to enroll in Sub-study 3 should they meet clinical response.
2. Achieved clinical response, defined as = 30% decrease in average daily SF and/or = 30% decrease in average daily AP score, and both not worse than Baseline of the induction study, at the last visit of Study M16-006 or Study M15-991. This is not applicable for subjects enrolling from Study M15 989.
3. If female, subject must meet the criteria as stated in protocol Contraception Recommendations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. Subjects should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991 or during Study M15-989 if the final endoscopy was performed prior to enter M16-000.
Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16 006 , M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method