A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn's Disease
M
Monika Fischer, MD
Primary Investigator
S
Sashidhar Sagi, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
3
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- This study comprises of a Period A and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC or Placebo.
- 49 weeks with a 35-day screening period, followed by a 24-week primary treatment period consisting of 2 periods, Period A (Weeks 0-12), Period B (Weeks 12-24) and a 140-day follow-up visit/call after the last dose of study drug.
- 11 study visits consisting of colonoscopies (3) , blood draws, fecal collections, drug administration, ECG, physical exam, daily patient diaries. All study visits take place at Indiana University Hospital, 550 N University Blvd, Indianapolis, IN 46202.
- The duration of the study will bey 49 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Moderate to severe Crohn’s Disease (CD)
- Must have AT LEAST one exposure to advanced therapy for CD
Exclusion Criteria:
- Previous Risankizumab exposure
- Active, chronic, or recurrent infections
- Organ transplant
- History of malignancy within last 5 years
- Ulcerative Colitis
- Ostomy or ileoanal pouch
- Pregnancy or plan to become pregnant
- Pednisone >20 mg currently
Updated on
28 Apr 2025.
Study ID: GI-ABBVIE-AFFIRM, 22400
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