A phase 3 multicentre, randomised, 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 randomised withdrawal and retreatment ICONIC-LEAD

Janssen-Cilag International N.V.0 个研究点目标入组 684 人开始时间: 2023年11月8日最近更新: 2024年5月6日

研究概览

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•1. Diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention
•2. Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
•3. Total psoriasis area and severity index (PASI) >=12 at screening and baseline
•4. Total investigator global assessment (IGA) >=3 at screening and baseline
•5. Candidate for phototherapy or systemic treatment for plaque psoriasis
•6. 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

•1. Non-plaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
•2. Current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
•3. A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances
•4. Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
•5. Major surgical procedures, (for example, requiring general anaesthesia) 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.

发起方