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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Unity Health-White County Medical Center
RECRUITING
Searcy
California
Newport Huntington Medical Group
RECRUITING
Huntington Beach
Rheumatology Center of San Diego
RECRUITING
San Diego
Florida
American Research, LLC
RECRUITING
Cutler Bay
Innovation Medical Research Center
RECRUITING
Palmetto Bay
Clinical Research of West Florida
RECRUITING
Tampa
Conquest Research
RECRUITING
Winter Park
Georgia
Atlanta Research Center for Rheumatology
RECRUITING
Marietta
Illinois
Willow Rheumatology and Wellness PLLC
RECRUITING
Willowbrook
Indiana
Qualmedica Research
RECRUITING
Evansville
North Carolina
Joint and Muscle Research Institute
RECRUITING
Charlotte
Ohio
Paramount Medical Research & Consulting
RECRUITING
Middleburg Heights
Pennsylvania
Clinical Research Philadelphia
RECRUITING
Philadelphia
Texas
Arthritis and Rheumatology Research Institute
RECRUITING
Allen
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
West China Hospital Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
Germany
Hamburger Rheuma Forschungszentrum II
RECRUITING
Hamburg
CAIR Heidelberg
RECRUITING
Heidelberg
Hautarztpraxis Mortazawi
RECRUITING
Remscheid
Hautarztpraxis
RECRUITING
Witten
Japan
Imamura General Hospital
RECRUITING
Kagoshima
Hospital of the University of Occupational and Environmental Health
RECRUITING
Kitakyushu-shi
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Sanuki Municipal Hospital
RECRUITING
Sanuki
Tokito Clinic Rheumatology and Orthopaedic Surgery
RECRUITING
Shimonoseki
Poland
Nzoz Osteo Medic
RECRUITING
Bialystok
Centrum Kliniczno Badawcze
RECRUITING
Elblag
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
Pratia MCM Krakow
RECRUITING
Krakow
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
RECRUITING
Olsztyn
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
FutureMeds Targowek
RECRUITING
Warsaw
MICS Centrum Medyczne Warszawa 1
RECRUITING
Warsaw
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
Hosp. Virgen Del Rocio
RECRUITING
Seville
Hosp. Virgen Macarena
RECRUITING
Seville
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2026-01-15
Estimated Completion Date:2027-08-02
Participants
Target number of participants:240
Treatments
Placebo_comparator: Arm 1: Placebo
Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
Experimental: Arm 2: JNJ-88545223 Dose 1
Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
Experimental: Arm 3: JNJ-88545223 Dose 2
Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
Experimental: Arm 4: JNJ-88545223 Dose 3
Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.