Ireland
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Active, not recruiting Phase 2

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

NCT07321873 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-01-15
Last updated
2026-11-03

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

JNJ-88545223Placebo

JNJ-88545223: JNJ-88545223 will be administered.

Placebo: Placebo will be administered.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 — Week 16
    The ACR 50 responders are participants with an improvement of greater than or equal to (\>=) 50 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale \[VAS\], patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

Trial sites (75)

FacilityCityRegionStatus
Unity Health-White County Medical Center Searcy Arkansas
Newport Huntington Medical Group Huntington Beach California
Rheumatology Center of San Diego San Diego California
Clinical Research of West Florida 1 Clearwater Florida
American Research, LLC Cutler Bay Florida
Innovation Medical Research Center Palmetto Bay Florida
Integral Rheumatology And Immunology Specialists Plantation Florida
Clinical Research of West Florida Tampa Florida
Conquest Research Winter Park Florida
Atlanta Research Center for Rheumatology Marietta Georgia
Willow Rheumatology and Wellness PLLC Willowbrook Illinois
Qualmedica Research Evansville Indiana
Albuquerque Rehabilitation and Rheumatology Albuquerque New Mexico
Joint and Muscle Research Institute Charlotte North Carolina
Onsite Clinical Solutions Salisbury North Carolina
Paramount Medical Research & Consulting Middleburg Heights Ohio
Clinical Research Philadelphia Philadelphia Pennsylvania
Arthritis and Rheumatology Research Institute Frisco Texas
Peking University People's Hospital Beijing China
Peking University Third Hospital Beijing China
Beijing Tsinghua Changgung Hospital Beijing China
Xiangya Hospital Central South University Changsha China
Changzhou No 2 Peoples Hospital Changzhou China
West China Hospital Sichuan University Chengdu China
The First Affiliated Hospital of Chongqing Medical University Chongqing China
The Second Affiliated Hospital of Zhejiang University Hangzhou China
Ningbo medical center lihuili hospital Ningbo China
Shanghai Sixth People's Hospital Shanghai China
RHEUMA s r o Břeclav Czechia
L K N Arthrocentrum Hlučín Czechia
Revmatologicka ambulance Karvina Frystat Czechia
Pratia Czech A S Pardubice Czechia
Clintrial s r o Prague Czechia
Medical Plus Research S R O Uherské Hradiště Czechia
Fachklinik Bad Bentheim Bad Bentheim Germany
Charite Universitaetsmedizin Berlin Berlin Germany
Rheumatologische Schwerpunktpraxis Berlin Germany
Praxis Mario Sutowicz Cottbus Germany
Hamburger Rheuma Forschungszentrum II Hamburg Germany
CAIR Heidelberg Heidelberg Germany

+ 35 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321873 on ClinicalTrials.gov ↗ ← All trials in China