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Active (not recruiting) Phase 3 NCT06934226

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

Phase 3 – large-scale trial before approval
Conditions: Plaque Psoriasis

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
Who can participate
Inclusion Criteria: * Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention * Total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline * Total psoriasis area and severity index (PASI) \>=12 at screening and baseline * Total investigator global assessment (IGA) \>=3 at screening and baseline * Candidate for phototherapy or systemic treatment for plaque psoriasis Exclusion Criteria: * Nonplaque form of psoriasis (for example \[e.g.\], erythrodermic, guttate, or pustular) * Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients * 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 * Transplanted organ (with exception of a corneal transplant greater than \[\>\] 12 weeks before the first administration of study intervention)
Locations 10
Argentina (1)
Consultora Integral de Salud SRL
Barrio Gral Paz Cba Capital
Australia (1)
Monash Medical Centre
Clayton
Belgium (1)
UZ Brussel
Brussels
Canada (1)
Skincare Studio Inc Dermatology Clinical Trials
St. John's , Newfoundland and Labrador
Denmark (1)
Aalborg Sygehus Syd
Aalborg
Hungary (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Poland (1)
Specderm Poznanska sp j
Bialystok
Spain (1)
Hosp. Gral. Univ. Dr. Balmis
Alicante
United Kingdom (1)
Dudley Group NHS Foundation Trust
Dudley
United States (1)
Cahaba Research Inc
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
15.04.2025
Completion date
20.08.2027
Registry ID
NCT06934226
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.