77242113PSO3002: Study Comparing Different Treatments in Moderate to Severe Plaque Psoriasis
Research type
Research Study
Full title
A Phase 3 Multicentre, Randomised, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis - ICONIC-ADVANCE 1
IRAS ID
1008235
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2023-505121-14
ISRCTN Number
ISRCTN69978417
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 see how effective JNJ-77242113 is compared to placebo (looks like JNJ-77242113 but it does not contain any active medication) and deucravacitinib in participants with moderate to severe plaque psoriasis.
This 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 randomly (like flip of a coin) divided into 3 groups: JNJ-77242113, placebo, and deucravacitinib.
Group 1: JNJ-77242113 for 52 weeks
Group 2: JNJ-77242113 matching placebo from Week 0 to Week 16, and then JNJ-77242113 from Week 16 to Week 52.
Group 3: Deucravacitinib from Week 0 to Week 24 and then JNJ-77242113 from Week 24 to Week 52
3. Treatment Period 2 (104 weeks): everyone receives JNJ-77242113.
4. Follow-up Period (4 weeks)
This is a double-blind study, which means that the participant and the study doctor/team will not know whether the participants are receiving JNJ-77242113, placebo or deucravacitinib during Treatment Period 1.
During the study, participants will undergo assessments and tests, such as questionnaires, blood tests, vital signs, and physical examinations.
The study includes participants aged 18 years or older with moderate to severe plaque psoriasis and the total study duration is approximately 3 years and 2 months.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0227
Date of REC Opinion
25 Oct 2023
REC opinion
Further Information Favourable Opinion