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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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 more

Awards & 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.

Do I qualify?Apply below to find out