Colitis, Ulcerative
Conditions
Interventions
Experimental: Double-blind (DB) Induction Study: Icotrokinra
Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all part
Sponsors
Kano Yuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 (=40 kilograms (kg) at baseline (Week I-0) - A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-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]-naive) 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 criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [Time Frame: At Week I-12] Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. 2. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 [Time Frame: At Week M-40] Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. 3. Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 [Time Frame: At Week M-40] Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed