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A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

NCT07321873

RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Arthritis, Psoriatic

Interventions: JNJ-88545223, Placebo

Countries: United States, China, Czechia, Germany, Hungary, Japan, Poland, Spain

The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 (Week 0/Day 1) based on the 66/68 joint assessment; AND (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

Exclusion Criteria:

* 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
Locations (73)
  • Searcy, Arkansas, United States
  • Huntington Beach, California, United States
  • San Diego, California, United States
  • Cutler Bay, Florida, United States
  • Palmetto Bay, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Winter Park, Florida, United States
  • Marietta, Georgia, United States
  • Willowbrook, Illinois, United States
  • Evansville, Indiana, United States
  • Albuquerque, New Mexico, United States
  • Charlotte, North Carolina, United States
  • Middleburg Heights, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Frisco, Texas, United States
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Changsha, China
  • Changzhou, China
  • Chengdu, China
  • Chongqing, China
  • Hangzhou, China
  • Ningbo, China
  • Shanghai, China
  • Břeclav, Czechia
  • Hlučín, Czechia
  • Karvina Frystat, Czechia
  • Pardubice, Czechia
  • + 43 more on CT.gov