Status:
ACTIVE_NOT_RECRUITING
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a pr...
Eligibility Criteria
Inclusion
- \- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Exclusion
- Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
- Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2029
Estimated Enrollment :
1242 Patients enrolled
Trial Details
Trial ID
NCT03398135
Start Date
August 28 2018
End Date
February 1 2029
Last Update
January 5 2026
Active Locations (426)
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1
Southern California Res. Ctr. /ID# 169659
Coronado, California, United States, 92118-1408
2
Hoag Memorial Hosp Presbyterian /ID# 218347
Irvine, California, United States, 92618
3
UC San Diego Health System /ID# 160430
La Jolla, California, United States, 92037
4
United Medical Doctors /ID# 158574
Los Alamitos, California, United States, 90720-3309