A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

CR109138

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

2022-02-03

2022-12-15

2022-12-15

Completed

Early phase I

255

Inclusion Criteria: * Participant has a diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), for at least 6 months prior to the first administration of study intervention * Participant be a candidate for phototherapy or systemic treatment for plaque psoriasis * Participant has a total body surface area (BSA) greater than or equal to (\>=)10 percent (%) at screening and baseline * Participant has a total Psoriasis area and severity index (PASI) \>=12 at screening and baseline * Participant has a total Investigator global assessment (IGA) \>=3 at screening and baseline Exclusion Criteria: * Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) * Participant has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * Participant have previously received any other therapeutic agent directly targeted to interleukin 23 receptor (IL-23R) (including but not limited to guselkumab, tildrakizumab, or risankizumab) * Participant has received any therapeutic agent directly targeted to interleukin 17 receptor (IL-17) or interleukin 12/23 receptor (IL-12/23) (including but not limited to secukinumab, ixekizumab, brodalumab, or ustekinumab) or has received anti-tumor necrosis factor \[TNF\]-alpha biologic therapy (including, but not limited to adalimumab) within 12 weeks or 5 half-lives, whichever is longer, of the first administration of study intervention * Participant has received agents that deplete B cells (including, but not limited to, rituximab, or alemtuzumab) within 26 weeks of the first administration of study intervention

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 255, 'type': 'ACTUAL'}}

2024-01-05