Your session is about to expire
← Back to Search
Monoclonal Antibodies
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Pivotal Trial
Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Eligible Conditions
- Crohn's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Global Outside of US: Percentage of Participants With Endoscopic Response
US Specific: Percentage of Participants With Endoscopic Response
Secondary study objectives
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
+24 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Risankizumab Dose 3 (Induction period 2)Experimental Treatment1 Intervention
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Group II: Risankizumab Dose 2 (Induction Period 2)Experimental Treatment1 Intervention
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Group III: Risankizumab Dose 2 (Induction Period 1)Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 2 in Induction Period 1.
Group IV: Risankizumab Dose 1 (Induction Period 2)Experimental Treatment1 Intervention
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Group V: Risankizumab Dose 1 (Induction Period 1)Experimental Treatment1 Intervention
Participants randomized to receive risankizumab dose 1 in Induction Period 1.
Group VI: Placebo (Induction Period 1)Placebo Group1 Intervention
Participants randomized to receive placebo for risankizumab in Induction Period 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
risankizumab SC
2017
Completed Phase 3
~3230
risankizumab IV
2017
Completed Phase 3
~3230
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
522,961 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
163,746 Total Patients Enrolled