ICONIC-UC
Research type
Research Study
Full title
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
IRAS ID
1012594
Contact name
Elena Bolanos Cascales
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2025-521381-10
ISRCTN Number
ISRCTN13017615
Clinicaltrials.gov Identifier
NCT0719674
Research summary
Ulcerative colitis (UC) is a chronic disease of large intestine in which lining of the colon becomes inflamed and develops tiny open ulcers. Although there are approved treatment options, many people do not either respond or may be not able to tolerate them due to their side effects. Hence, there is still a need for better therapies. The study treatment, icotrokinra (JNJ-77242113) targets interleukin-23 (IL-23R) to prevent IL-23* from binding to its receptor**. Blocking this protein helps to reduce the inflammation which causes many of the symptoms of UC. *A specific type of protein involved in inflammation. **A protein that binds to specific molecule. In this study, researchers want to evaluate how well icotrokinra works in inducing and maintaining clinical remission*** when compared to placebo in adult participants with moderate to severely active UC and how well icotrokinra works in inducing and maintaining clinical remission in adolescent participants (more than or equal to [>=] 12 years old) with moderate to severely active UC. ***Time when the disease is not active and there is a decrease of signs and symptoms.
The protocol will be conducted as 3 separate studies below:
• A 12-week Double-blind Induction Study in Adults
• A 40-week Double-blind Maintenance Study in Adults
• A 52-week Open label Induction and Maintenance Study in Adolescents
The overall program is comprised of the following:
1. Screening: Up to 6 weeks
2. Induction: 12 weeks (daily dosing from induction Week 0 (Week I-0) to Week I-12)
3. Maintenance: 40 weeks (daily dosing from maintenance Week 0 (Week M-0) to Week M-40)
4. Long-term Extension: Up to 4 years (daily dosing up to Week M-248)
5. Safety follow-up: 4 weeks after the last dose of study treatment
Safety assessments will include adverse events, physical examinations, vital signs, ECG , clinical laboratory testing, suicide assessments, and TB screening. The overall duration of the study is approximately 5 years.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0265
Date of REC Opinion
23 Oct 2025
REC opinion
Further Information Favourable Opinion