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Monoclonal Antibodies
Risankizumab for Crohn's Disease (AFFIRM Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Pivotal Trial
Summary
This trial will assess the efficacy and safety of risankizumab SC treatment for adults with Crohn's disease, a long-lasting illness causing severe inflammation in the digestive tract.
Who is the study for?
Adults with moderately to severely active Crohn's Disease who haven't responded well to other treatments can join this study. They must have a confirmed diagnosis for at least 3 months and show clear signs of inflammation in their bowels.
What is being tested?
The trial is testing Risankizumab, an approved drug for Crohn's Disease, given as a subcutaneous injection. Participants are randomly assigned to get either the real drug or a placebo during two periods, totaling about 49 weeks.
What are the potential side effects?
Risankizumab may cause side effects such as infections, allergic reactions, headache, fatigue, skin problems like itching or rash, and potential injection site reactions.
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
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)
Percentage of Participants With Endoscopic Response
Secondary study objectives
Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Percentage of Participants With Clinical Remission
Percentage of Participants With Endoscopic Remission
+2 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: Period C: Open-Label Risankizumab Dose DExperimental Treatment1 Intervention
Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
Group II: Period B: Risankizumab Dose CExperimental Treatment1 Intervention
Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
Group III: Period B: Risankizumab Dose BExperimental Treatment1 Intervention
Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.
Group IV: Period A: Risankizumab Dose AExperimental Treatment1 Intervention
Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
Group V: Period B: PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.
Group VI: Period A: PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
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Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,303 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,088 Total Patients Enrolled