A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Plaque Psoriasis
Спонсор: Janssen Research & Development, LLC
Налично на:
БГ
Обобщение
The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.
Кой може да участва
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
Места на провеждане
16
Argentina (1)
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires
Австралия (1)
Dr Rodney Sinclair Pty Ltd
East Melbourne
Канада (1)
Dermatology Research Institute Inc
Calgary , Alberta
Китай (1)
China Japan Friendship Hospital
Beijing
Франция (1)
Hopital Prive d'Antony
Antony
Германия (1)
Fachklinik Bad Bentheim
Bad Bentheim
Унгария (1)
Pecsi Tudomanyegyetem
Borgyogyaszati Klinika
Италия (1)
Azienda Di Rilievo Nazionale E Di Alta Specializzazione