Status:
ACTIVE_NOT_RECRUITING
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 includ...
Eligibility Criteria
Inclusion
- Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Participant meets the following disease activity criteria:
- Moderate to severe CD as assessed by CDAI
- Endoscopic evidence of mucosal inflammation as documented by a SES-CD
- Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
Exclusion
- Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participants with unstable doses of concomitant Crohn's disease therapy.
- Participants with prior exposure to p19 inhibitors.
- Participants with complications of Crohn's disease.
- Participants having an ostomy or ileoanal pouch.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT06063967
Start Date
November 15 2023
End Date
March 1 2027
Last Update
September 9 2025
Active Locations (179)
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1
Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
Sun City, Arizona, United States, 85351
2
Kindred Medical Institute - Corona /ID# 262075
Corona, California, United States, 92879-3104
3
Southern California Res. Ctr. /ID# 256612
Coronado, California, United States, 92118-1408
4
Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
Covina, California, United States, 91723