Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Substudy 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Sub-study 1: Randomized, double-blind, placebo-controlled maintenance To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 and had a Baseline (of induction) eligibility SES-CD of = 6 (= 4 for isolated ileal disease). Sub-study 2: Randomized, exploratory maintenance To evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects with moderately to severely active CD who responded to induction treatment in Study M16-006 or Study M15-991. Sub-study 3: Open-label long term extension To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2 or M15-989, or subjects who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the coronavirus SARS-CoV-2 pandemic.;Secondary Objective: Not applicable;Primary end point(s): Proportion of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52. Proportion of participants with endoscopic response at Week 52.;Timepoint(s) of evaluation of this end point: Week 52 Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 52 2. Proportion of subjects with clinical remission at Week 52 among the subjects with clinical remission in Week 0 3. Proportion of subjects with ulcer-free endoscopy at Week 52 4. Proportion of subjects with endoscopic remission at Week 52 5. Mean change of IBDQ total score at Week 52 from baseline of induction 6. Mean change of FACIT fatigue at Week 52 from baseline of induction 7. Proportion of subjects who discontinued corticosteroid use for 90 days and achieved clinical remission at Week 52 in subjects taking steroids at baseline (of induction). 8. Proportion of subjects with CDAI clinical response at Week 52 9. Proportion of subjects with clinical remission and endoscopic response at Week 52 10. Proportion of subjects with enhanced clinical response at Week 52 11. Proportion of subjects with deep remission at Week 52 12. Proportion of subjects with resolution of EIMs at Week 52 in subjects with any EIMs at baseline of induction 13. Proportion of subjects with CD-related hospitalizations through Week 52 14. Proportion of subjects without draining fistulas at Week 52 in subjects with draining fistulas at baseline of induction 15.Proportion of subjects with CD-related surgeries through Week 52 ;Timepoint(s) of evaluation of this end point: All are Week 52 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed