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

Phase 1

• Conditions: Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code: 10071117Term: Plaque psoriasis Class: 10040785; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-505122-34-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. =12 years of age at the screening visit., 2. Diagnosis of plaque psoriasis, with or without PsA, for at least 26 weeks prior to the first administration of study intervention., 3. Candidate for phototherapy or systemic treatment for plaque psoriasis., 4. Need to meet criteria (a) and/or (b) a. Total BSA =1% at screening and baseline, AND IGA (overall) =2 at screening and baseline AND at least one of the following: - ss-IGA score =3 at screening and baseline, and/or - sPGA-G =3 at screening and baseline, and/or - hf-PGA score =3 at screening and baseline., 5. Failed to respond to at least 1 topical therapy used for treatment of psoriasis.

Exclusion Criteria

1. Nonplaque form of psoriasis., 2. Dermatoses other than plaque psoriasis or palmoplantar pustulosis of the palmoplantar area., 3. Current drug-induced psoriasis., 4. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances., 5. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified