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A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
NCT07321873 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 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 (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
Study design
Enrollment target: 240 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-01-15
Estimated completion: 2027-08-02
Last updated: 2026-04-13
Interventions
Drug: JNJ-88545223Drug: Placebo
Primary outcomes
- • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 (Week 16)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (40)
Unity Health-White County Medical CenterRecruiting
Searcy, Arkansas, United States
Newport Huntington Medical GroupRecruiting
Huntington Beach, California, United States
Rheumatology Center of San DiegoRecruiting
San Diego, California, United States
American Research, LLCRecruiting
Cutler Bay, Florida, United States
Innovation Medical Research CenterRecruiting
Palmetto Bay, Florida, United States
Clinical Research of West FloridaRecruiting
Tampa, Florida, United States
Conquest ResearchRecruiting
Winter Park, Florida, United States
Atlanta Research Center for RheumatologyRecruiting
Marietta, Georgia, United States
Willow Rheumatology and Wellness PLLCRecruiting
Willowbrook, Illinois, United States
Qualmedica ResearchRecruiting
Evansville, Indiana, United States
Joint and Muscle Research InstituteRecruiting
Charlotte, North Carolina, United States
Paramount Medical Research & ConsultingRecruiting
Middleburg Heights, Ohio, United States
Clinical Research PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Arthritis and Rheumatology Research InstituteRecruiting
Allen, Texas, United States
Peking University People's HospitalRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
Changzhou No 2 Peoples HospitalRecruiting
Changzhou, China
West China Hospital Sichuan UniversityRecruiting
Chengdu, China
The Second Affiliated Hospital of Zhejiang UniversityRecruiting
Hangzhou, China
Ningbo medical center lihuili hospitalRecruiting
Ningbo, China
Hamburger Rheuma Forschungszentrum IIRecruiting
Hamburg, Germany
CAIR HeidelbergRecruiting
Heidelberg, Germany
Hautarztpraxis MortazawiRecruiting
Remscheid, Germany
HautarztpraxisRecruiting
Witten, Germany
Imamura General HospitalRecruiting
Kagoshima, Japan
Hospital of the University of Occupational and Environmental HealthRecruiting
Kitakyushu-shi, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Sanuki Municipal HospitalRecruiting
Sanuki, Japan
Tokito Clinic Rheumatology and Orthopaedic SurgeryRecruiting
Shimonoseki, Japan
Nzoz Osteo MedicRecruiting
Bialystok, Poland
Centrum Kliniczno BadawczeRecruiting
Elblag, Poland
Malopolskie Badania Kliniczne Sp z o oRecruiting
Krakow, Poland
Pratia MCM KrakowRecruiting
Krakow, Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K ARecruiting
Olsztyn, Poland
MICS Centrum Medyczne Warszawa 1Recruiting
Warsaw, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Poland
FutureMeds TargowekRecruiting
Warsaw, Poland
Hosp Univ A CorunaRecruiting
A Coruña, Spain
Hosp. Virgen MacarenaRecruiting
Seville, Spain
Hosp. Virgen Del RocioRecruiting
Seville, Spain