Actively Recruiting
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-88545223 for Active Psoriatic Arthritis
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
240
Participants Needed
68
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug JNJ-88545223 compared with a placebo in adults with active psoriatic arthritis (PsA). The study aims to determine if JNJ-88545223 can help reduce PsA signs and symptoms and improve joint and skin health. This is a Phase 2b, randomized, double-blind, placebo-controlled study sponsored by Janssen Research & Development, LLC. Participants will be randomly assigned to one of four groups: a placebo group or one of three different dose groups of JNJ-88545223. Treatment will be given from Week 0 to Week 16. The study is designed to test different doses to evaluate their effects on PsA symptoms and skin condition. The intervention involves administration of the study drug or placebo during this 16-week period. During the study, participants will be closely monitored with regular assessments, including joint and skin evaluations. Researchers will measure how many participants achieve an American College of Rheumatology (ACR) 50 response at Week 16 as the primary outcome. Secondary outcomes include skin improvement scores and physical function assessments. Safety and treatment effects will be tracked throughout the 16 weeks of treatment.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 defined by at least 3 swollen joints and 3 tender joints at screening and at baseline based on the 66/68 joint assessment
- Have C-reactive protein (CRP) greater than or equal to 0.1 mg/dL at screening from the central laboratory
- Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis without rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- Have active plaque psoriasis with at least one psoriatic plaque of 2 cm diameter or nail changes consistent with psoriasis
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to study intervention
You will not qualify if you...
- Have a nonplaque form of psoriasis such as erythrodermic, guttate, or pustular psoriasis
- Have a history or signs of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances
- Have suspected or known allergies, hypersensitivity, or intolerance to JNJ-88545223, excipients in the investigational product, or placebo
- Have a history of severe allergic reactions, angioedema, or anaphylaxis to drugs or food
- Have fibromyalgia or osteoarthritis symptoms that could interfere with efficacy assessments
- Currently have a malignancy or history of malignancy within 5 years prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Week 0 to Week 16
Participants receive JNJ-88545223 or placebo treatment for active psoriatic arthritis.
Visits occur periodically during the 16-week treatment period
Trial Site Locations
Total: 68 locations
1
Unity Health-White County Medical Center
Searcy, Arkansas, United States, 72143
Actively Recruiting
2
Newport Huntington Medical Group
Huntington Beach, California, United States, 92648
Actively Recruiting
3
Rheumatology Center of San Diego
San Diego, California, United States, 92128
Actively Recruiting
4
American Research, LLC
Cutler Bay, Florida, United States, 33157
Actively Recruiting
5
Innovation Medical Research Center
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
6
Integral Rheumatology And Immunology Specialists
Plantation, Florida, United States, 33324
Actively Recruiting
7
Clinical Research of West Florida
Tampa, Florida, United States, 33606
Actively Recruiting
8
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
9
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States, 30060
Actively Recruiting
10
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States, 60527
Actively Recruiting
11
Qualmedica Research
Evansville, Indiana, United States, 47715
Actively Recruiting
12
Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
13
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
14
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
15
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
16
Arthritis and Rheumatology Research Institute
Allen, Texas, United States, 75013
Actively Recruiting
17
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
18
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
19
Xiangya Hospital Central South University
Changsha, China, 410008
Actively Recruiting
20
Changzhou No 2 Peoples Hospital
Changzhou, China, 213003
Actively Recruiting
21
West China Hospital Sichuan University
Chengdu, China, 610093
Actively Recruiting
22
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400016
Actively Recruiting
23
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China, 310009
Actively Recruiting
24
Ningbo medical center lihuili hospital
Ningbo, China, 315041
Actively Recruiting
25
RHEUMA s r o
Břeclav, Czechia, 690 02
Actively Recruiting
26
L K N Arthrocentrum
Hlučín, Czechia, 748 01
Actively Recruiting
27
Revmatologicka ambulance
Karvina Frystat, Czechia, 733 01
Actively Recruiting
28
Pratia Czech A S
Pardubice, Czechia, 53002
Actively Recruiting
29
Clintrial s r o
Prague, Czechia, 100 00
Actively Recruiting
30
Medical Plus Research S R O
Uherské Hradiště, Czechia, 68601
Actively Recruiting
31
Fachklinik Bad Bentheim
Bad Bentheim, Germany, 48455
Actively Recruiting
32
Charite Universitaetsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
33
Rheumatologische Schwerpunktpraxis
Berlin, Germany, 12161
Actively Recruiting
34
Hamburger Rheuma Forschungszentrum II
Hamburg, Germany, 20095
Actively Recruiting
35
CAIR Heidelberg
Heidelberg, Germany, 69121
Actively Recruiting
36
Gemeinschaftspraxis Dres. Quist
Mainz, Germany, 55128
Actively Recruiting
37
Hautarztpraxis Mortazawi
Remscheid, Germany, 42897
Actively Recruiting
38
Hautarztpraxis
Witten, Germany, 58453
Actively Recruiting
39
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
Budapest, Hungary, 1023
Actively Recruiting
40
Obudai Egeszsegugyi Centrum Kft
Budapest, Hungary, 1036
Actively Recruiting
41
Qualiclinic Kft
Budapest, Hungary, 1134
Actively Recruiting
42
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely, Hungary, 6800
Actively Recruiting
43
Complex Rendelo Med Zrt
Székesfehérvár, Hungary, 8000
Actively Recruiting
44
Tokyo Metropolitan Tama Medical Center
Fuchū, Japan, 183 8524
Actively Recruiting
45
Imamura General Hospital
Kagoshima, Japan, 890-0064
Actively Recruiting
46
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Japan, 807-8556
Actively Recruiting
47
Osaka Metropolitan University Hospital
Osaka, Japan, 545 8586
Actively Recruiting
48
Sanuki Municipal Hospital
Sanuki, Japan, 769-2393
Actively Recruiting
49
Tokito Clinic Rheumatology and Orthopaedic Surgery
Shimonoseki, Japan, 752 0976
Actively Recruiting
50
Nzoz Osteo Medic
Bialystok, Poland, 15 351
Actively Recruiting
51
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85 168
Actively Recruiting
52
Centrum Kliniczno Badawcze
Elblag, Poland, 82-300
Actively Recruiting
53
Malopolskie Badania Kliniczne Sp z o o
Krakow, Poland, 30-002
Actively Recruiting
54
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
55
ETG Lublin
Lublin, Poland, 20 412
Actively Recruiting
56
NZOZ Lecznica MAK MED S C
Nadarzyn, Poland, 05-830
Actively Recruiting
57
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
Olsztyn, Poland, 10 117
Actively Recruiting
58
MICS Centrum Medyczne Torun
Torun, Poland, 87-100
Actively Recruiting
59
MICS Centrum Medyczne Warszawa
Warsaw, Poland, 00 874
Actively Recruiting
60
MICS Centrum Medyczne Warszawa 1
Warsaw, Poland, 00-872
Actively Recruiting
61
Rheuma Medicus Sp z o o
Warsaw, Poland, 02 118
Actively Recruiting
62
Centrum Medyczne Reuma Park
Warsaw, Poland, 02 665
Actively Recruiting
63
FutureMeds Targowek
Warsaw, Poland, 03 291
Actively Recruiting
64
Hosp Univ A Coruna
A Coruña, Spain, 15006
Actively Recruiting
65
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
66
Hosp. Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
67
Hosp. Infanta Luisa
Seville, Spain, 41010
Actively Recruiting
68
Hosp. Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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