77242113PSO3001: Study of treatment, withdrawal & re-treatment in plaque psoriasis
Research type
Research Study
Full title
A Phase 3 Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomised Withdrawal and Retreatment ICONIC-LEAD
IRAS ID
1008234
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2023-505120-59
ISRCTN Number
ISRCTN21453767
Clinicaltrials.gov Identifier
Research summary
Plaque psoriasis is a disease that causes red, scaly, and sometimes painful and itchy patches on the skin. Drugs that prevent interleukin 23 (a protein involved in inflammation) from binding to its receptor (a protein that binds to a specific molecule) may be an effective way to control psoriasis. The study drug, JNJ-77242113, is a medicine that targets the IL-23 receptor and blocks IL-23 from binding to it.
The purpose of this study is to compare JNJ-77242113 to a placebo (dummy drug) in participants with moderate to severe plaque psoriasis.
The study will be done in 4 periods:
1. Screening Period (5 weeks): participants will be screened to confirm if they can take part in the study.
2. Treatment Period 1 (52 weeks): participants will be divided into 2 groups:
Group 1: Participants will receive JNJ-77242113 from Week 0 to 24 then psoriasis area and severity index (PASI) 75 responders will be re-randomised to continue JNJ-77242113 or to take placebo. PASI 75 non-responders will continue to receive JNJ-77242113 until Week 52.
Group 2: Participants will receive placebo from Weeks 0 to 16 then JNJ-77242113 from Weeks 16 to 52.
3. Treatment Period 2 (104 weeks): everyone receives JNJ-77242113.
4. Follow-up Period (4 weeks)
During the study, participants will undergo assessments and tests, such as questionnaires, blood tests, vital signs, and physical examinations.REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0790
Date of REC Opinion
25 Oct 2023
REC opinion
Further Information Favourable Opinion