A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 For the Treatment of Participants With Active Psoriatic Arthritis ( VELOTA)

Not provided0 sites240 target enrollmentStarted: TBD

Overview

No summary available.

•Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
•Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
•Have >= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
•Have active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
•A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

•Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
•Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances
•Has suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223 or excipients used in the investigational medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
•Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments
•Currently has a malignancy or has a history of malignancy within 5 years prior to screening

Sponsor

Not provided