A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521382-27-00

Acronym

77242113CRD3001

Enrollment

433

Registered

2025-12-01

Start date

2025-12-04

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 Crohn's Disease

Brief summary

Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response at Week M-40

Interventions

DRUGIcotrokinra

DRUGJNJ-77242113

DRUGJNJ-77242113-AAC Placebo tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2b Induction: clinical response at Week I-12 Phase 3 Induction: Co-primary endpoints - Clinical remission at Week I-12 - Endoscopic response at Week I-12 Phase 3 Maintenance: co-primary endpoints: - Clinical remission at Week M-40 - Endoscopic response 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