Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
16-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), ...
Eligibility Criteria
Inclusion
- Male or female aged \>=18 to \<= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to \< 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
- Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
- Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
- Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.
Exclusion
- Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
- Participant receiving prohibited medications and treatment.
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- Participant with currently known complications of UC (e.g., megacolon).
- No known active Coronavirus Disease - 2019 (COVID-19) infection.
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
1558 Patients enrolled
Trial Details
Trial ID
NCT03398148
Start Date
March 7 2018
End Date
May 11 2023
Last Update
January 16 2025
Active Locations (430)
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1
Southern California Res. Ctr. /ID# 169660
Coronado, California, United States, 92118-1408
2
Hoag Memorial Hosp Presbyterian /ID# 218348
Irvine, California, United States, 92618
3
UC San Diego Health System /ID# 160452
La Jolla, California, United States, 92037
4
United Medical Doctors /ID# 158528
Los Alamitos, California, United States, 90720-3309