A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521381-10-00

Acronym

77242113UCO3001

Enrollment

391

Registered

2025-12-01

Start date

2025-12-03

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Ulcerative Colitis

Brief summary

Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission at Week M-40

Interventions

DRUGJNJ-77242113-AAC Placebo tablet

DRUGIcotrokinra

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Induction study (adult): Clinical remission at Week I-12 Maintenance study (adult): Clinical remission at Week M-40 Adolescent study: Clinical remission at Week M-40	—

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026