77242113PSO3003: Study of Treatment for Plaque Psoriasis Involving Special Areas (ICONIC-TOTAL)
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas
IRAS ID
1008238
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V
Eudract number
2023-505122-34
Research summary
Plaque psoriasis is a skin disease that causes red, scaly, and sometimes painful and itchy patches on the skin.
Drugs that prevent interleukin IL-23 (a specific type of protein involved in inflammation) from binding to its receptor (a protein that binds to specific molecule) may be an effective way to disease control. The study drug, JNJ-77242113, is a medicine that targets the IL-23 receptor and blocks IL-23 from binding to it. By blocking the effects of IL-23, inflammation is reduced thus preventing disease from getting worse.
The purpose of this study is to see how effective JNJ-77242113 is in participants with at least moderate severity plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).
The participants will receive JNJ-77242113 or placebo in a 2:1 ratio which means in every 2 participants receive JNJ-77242113, 1 will receive placebo treatment. JNJ-77242113 will be administered in all treatment groups (JNJ-77242113, placebo). This is a double-blind study, which means that the participant and the study doctor will not know whether the participants are receiving JNJ-77242113 or placebo.
The study will be conducted in 3 periods:
1. Screening period (5 weeks): Participants will be screened to confirm if they can take part in the study.
2. Double-blind (156 weeks) treatment period: Participants will be randomly (like flip of a coin) divided into 2 groups, JNJ-77242113 or placebo.
Group 1: Participants will receive JNJ-77242113 from Weeks 0-156.
Group 2: Participants will receive matching placebo of JNJ-77242113 from Week 0-16 and then JNJ-77242113 to Week 156.
Participants will undergo study assessments such as questionnaires, blood tests, vital signs, and physical exams.
3. Follow-up period (4 weeks): Participants will be monitored for their health after the last dose of study drug until the study ends.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0268
Date of REC Opinion
20 Oct 2023
REC opinion
Further Information Favourable Opinion