A Phase 3 Multicenter, Randomized, 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

Phase 1

Recruiting

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

• Registration Number: CTIS2023-507039-39-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 698

Inclusion Criteria

1. =18 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. Total BSA =10% at screening and baseline., 4. Total PASI =12 at screening and baseline., 5. Total IGA =3 at screening and baseline.

Exclusion Criteria

1. Nonplaque form of psoriasis., 2. Current drug-induced psoriasis., 3. 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., 4. Known allergies, hypersensitivity, or intolerance to JNJ-77242113, deucravacitinib, or to any of the excipients or components of the study intervention., 5. Major surgical procedure, within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study.

Study & Design

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