A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis

Phase 1

• Conditions: Moderate to Severe Plaque Type Psoriasis; MedDRA version: 20.0Level: PTClassification code: 10037153Term: Psoriasis Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-508424-34-00
• Lead Sponsor: Janssen Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 828

Inclusion Criteria

1. Male or female with at least 18 years of age., 2. Has a disease duration of plaque psoriasis of either =2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration =2 years., 3. Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) a DLQI score >10 at baseline (week 0)., 4. Is a candidate for systemic treatment for psoriasis., 5. Before first administration of study drug, a woman must be: a. Not of childbearing potential b. Of childbearing potential and practicing a highly effective method of contraception

Exclusion Criteria

1. clinical active psoriasis arthritis which needs systemic therapy beyond NSAIDs, 2. diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments, 3. unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject, 4. Has a transplanted organ, 5. history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced

Study & Design

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