CTIS2023-505120-59-00
Recruiting
Phase 1
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 Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment - 77242113PSO3001
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to Severe Plaque Psoriasis
- Sponsor
- Janssen - Cilag International
- Enrollment
- 600
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \=12 years of age at the screening visit., 2\. Diagnosis of plaque psoriasis, with or without psoriatic arthritis, 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 (eg, erythrodermic, guttate, or pustular)., 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 or its excipients., 5\. Major surgical procedures, within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
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 AreasCTIS2023-505122-34-00Janssen - Cilag International300
Active, not recruiting
Not Applicable
A Study of the Safety and Efficacy of Ustekinumab in Patients with Psoriatic Arthritis with and without Prior Exposure to Anti-TNF AgentsPsoriatic arthritisMedDRA version: 14.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2009-012265-60-DEJanssen Biologics B.V.300
Active, not recruiting
Not Applicable
This is a study of the safety and efficiacy of ustekinumab (CNTO1275) in adolescent patients with moderate to severe psoriasis.Moderate to Severe Plaque-type PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2009-014368-20-Outside-EU/EEAJanssen-Cilag International N.V.150
Active, not recruiting
Not Applicable
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial ofUstekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody,Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNFa Agent(s) - PSUMMIT IIMedDRA version: 12.1Level: LLTClassification code 10037160Term: Psoriatic arthritisEUCTR2009-012265-60-SEJanssen Biologics B.V.300
Active, not recruiting
Phase 1
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis Including Those Previously Treated with Biologic Anti-TNFa Agent(s) - PSUMMIT IIPsoriatic ArthritisMedDRA version: 12.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritisEUCTR2009-012265-60-GBJanssen Biologics B.V.