Status:
RECRUITING
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely ac...
Eligibility Criteria
Inclusion
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
- Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
- An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
- For adolescent participants \>=12 to less than (\<) 18 years of age, body weight must be \>=40 kilograms (kg) at baseline (Week I-0)
- Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
- Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy \[ADT\]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol
Exclusion
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
- Presence of a stoma
- Presence or history of a fistula
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 13 2032
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT07196748
Start Date
October 1 2025
End Date
January 13 2032
Last Update
December 19 2025
Active Locations (126)
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1
AZ Gastro Care
Chandler, Arizona, United States, 85206
2
Clinnova Research
Anaheim, California, United States, 92805
3
Southern California Research Center
Coronado, California, United States, 92118
4
Om Research LLC
Lancaster, California, United States, 93534