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Active (not recruiting) Phase 3 NCT06095115

A Study of JNJ-77242113 in Adolescent and Adult 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 purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
Who can participate
Inclusion Criteria: * Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks 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 * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention Exclusion Criteria: * Nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) * Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * 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 * Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients * Major surgical procedures, (for example, requiring general anesthesia) 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
Locations 16
Argentina (1)
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires
Australia (1)
Dr Rodney Sinclair Pty Ltd
East Melbourne
Canada (1)
Dermatology Research Institute Inc
Calgary , Alberta
China (1)
China Japan Friendship Hospital
Beijing
France (1)
Hopital Prive d'Antony
Antony
Germany (1)
Fachklinik Bad Bentheim
Bad Bentheim
Hungary (1)
Pecsi Tudomanyegyetem
Borgyogyaszati Klinika
Italy (1)
Azienda Di Rilievo Nazionale E Di Alta Specializzazione
Palermo
Japan (1)
Teikyo University Hospital
Itabashi Ku
Poland (1)
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok
South Korea (1)
Korea University Ansan Hospital
Ansan-si
Spain (1)
Hosp. Univ. Fundacion Alcorcon
Alcorcón
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Turkey (1)
Hacettepe University Medical Faculty
Ankara
United Kingdom (1)
London North West University Healthcare NHS Trust
Harrow
United States (1)
Medical Dermatology Specialists
Phoenix , Arizona
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
12.10.2023
Completion date
06.04.2027
Registry ID
NCT06095115
Source
anzctr
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