Study evaluating the efficacy of Icotrokinra in Crohn’s disease
Research type
Research Study
Full title
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
IRAS ID
1012360
Contact name
Elena Bolanos Cascales
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2025-521382-27
ISRCTN Number
ISRCTN15911581
Research summary
Crohn’s Disease (CD) is a disease of the digestive system that causes inflammation and ulcers in the intestine (gut).
Although there are approved treatment options, participants either do not respond or may not tolerate them due to side effects. Hence, there is a need for better treatment options.
Icotrokinra (JNJ-77242113) targets interleukin-23 (IL-23R) to prevent IL-23* from binding to its receptor**. Blocking this protein helps to reduce inflammation.
*Protein involved in inflammation
**Protein that binds to a specific molecule
Researchers want to assess how well icotrokinra works when compared to placebo (treatment with no medical effect) in participants aged 18 years or older with moderate to severely active CD.
The study consists of:
Screening period (up to 6 weeks)
Induction Study periods: Daily dosing from Week I-0 to Week I-12 one of Icotrokinra dose 1, dose 2 or placebo
Induction Study 2: Icotrokinra: As per dose from induction study 1 or Placebo
Maintenance Study: Daily dosing from Week M-0 to Week M-40. Responder participants from induction study 1 and 2 will receive one of Icotrokinra dose 1, dose 2 or placebo
- Responder participants who show loss of response during the maintenance study will be eligible for dose adjustment to icotrokinra
- Non-responder participants will receive icotrokinra dose 2 and will be reassessed at week M-12 and continue in the study if in response.
Long term extension study period: Daily dosing up to Week M-248.
Safety follow-up period (up to 4 weeks after last dose of study treatment)
Patients undergo safety assessments including adverse events, physical examinations, vital signs, electrocardiogram, clinical laboratory tests, suicide assessments, and tuberculosis screening.
The duration of the study will be approximately 5 years.REC name
Wales REC 1
REC reference
25/WA/0249
Date of REC Opinion
1 Oct 2025
REC opinion
Further Information Favourable Opinion