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: Subjects who have completed Study M16-006 or Study M15-991 and have achieved clinical response or completion of M15-989. Main entry criteria for Study M16-006 and Study M15-991: • Males and females 18 to 80 years of age, and 16 to =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 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. 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;Secondary Objective: Not applicable;Primary end point(s): Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 52. Percentage of participants with endoscopic response at Week 52.;Timepoint(s) of evaluation of this end point: 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 participants who discontinued corticosteroid use for 90 days and achieved clinical remission per average daily SF and average daily AP score at Week 52 3. Proportion of participants who discontinued corticosteroid use at Week 52 4. Proportion of participants with sustained clinical remission 5. Proportion of participants with enhanced clinical response at Week 52 6. Proportion of participants with clinical remission and endoscopic response at Week 52 7. Proportion of participants with endoscopic healing at Week 52 8. Proportion of participants with endoscopic remission at Week 52 9. Proportion of subjects with resolution of EIMs at Week 52 10. Proportion of subjects with deep remission at Week 52 11. Proportion of participants with hospitalizations through Week 52 12. Proportion of participants with draining fistulas at Week 52 in subjects with draining fistulas at baseline of the induction study 13. Change from Week 0 in FACIT-Fatigue at Week 52 14. Change from Week 0 in short form-36 at Week 52 15. Proportion of subjects with CD-related surgeries through Week 52 16. Crohn's Symptoms Severity (CSS): Change from week 0 to week 52;Timepoint(s) of evaluation of this end point: All are Week 52 unless noted: sustained clinical remission and CSS are at Week 0 and Week 52 and the FACIT and SF-36 are from Baseline of induction study and Week 52 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, 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, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed