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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Placebo; Drug: JNJ-88545223

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Changsha, China, 410008
    • Recruiting
    • Xiangya Hospital Central South University
  • Changzhou, China, 213003
    • Recruiting
    • Changzhou No 2 Peoples Hospital
  • Chengdu, China, 610093
    • Recruiting
    • West China Hospital Sichuan University
  • Chongqing, China, 400016
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
  • Hangzhou, China, 310009
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
  • Ningbo, China, 315041
    • Recruiting
    • Ningbo Medical Center Lihuili Hospital
• Czechia
  • Břeclav, Czechia, 690 02
    • Recruiting
    • RHEUMA s r o
  • Hlučín, Czechia, 748 01
    • Recruiting
    • L K N Arthrocentrum
  • Karvina Frystat, Czechia, 733 01
    • Recruiting
    • Revmatologicka ambulance
  • Pardubice, Czechia, 53002
    • Recruiting
    • Pratia Czech A S
  • Prague, Czechia, 100 00
    • Recruiting
    • Clintrial s r o
  • Uherské Hradiště, Czechia, 68601
    • Recruiting
    • Medical Plus Research S R O
• Germany
  • Bad Bentheim, Germany, 48455
    • Recruiting
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 12161
    • Recruiting
    • Rheumatologische Schwerpunktpraxis
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitaetsmedizin Berlin
  • Hamburg, Germany, 20095
    • Recruiting
    • Hamburger Rheuma Forschungszentrum II
  • Heidelberg, Germany, 69121
    • Recruiting
    • CAIR Heidelberg
  • Mainz, Germany, 55128
    • Recruiting
    • Gemeinschaftspraxis Dres. Quist
  • Remscheid, Germany, 42897
    • Recruiting
    • Hautarztpraxis Mortazawi
  • Witten, Germany, 58453
    • Recruiting
    • Hautarztpraxis
• Hungary
  • Budapest, Hungary, 1036
    • Recruiting
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, 1023
    • Recruiting
    • Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
  • Budapest, Hungary, 1134
    • Recruiting
    • Qualiclinic Kft
  • Hódmezővásárhely, Hungary, 6800
    • Recruiting
    • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
  • Székesfehérvár, Hungary, 8000
    • Recruiting
    • Complex Rendelo Med Zrt
• Japan
  • Fuchū, Japan, 183 8524
    • Recruiting
    • Tokyo Metropolitan Tama Medical Center
  • Kagoshima, Japan, 890-0064
    • Recruiting
    • Imamura General Hospital
  • Kitakyushu-shi, Japan, 807-8556
    • Recruiting
    • Hospital of the University of Occupational and Environmental Health
  • Osaka, Japan, 545 8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Sanuki, Japan, 769-2393
    • Recruiting
    • Sanuki Municipal Hospital
  • Shimonoseki, Japan, 752 0976
    • Recruiting
    • Tokito Clinic Rheumatology and Orthopaedic Surgery
• Poland
  • Bialystok, Poland, 15 351
    • Recruiting
    • Nzoz Osteo Medic
  • Bydgoszcz, Poland, 85 168
    • Recruiting
    • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
  • Elblag, Poland, 82-300
    • Recruiting
    • Centrum Kliniczno Badawcze
  • Krakow, Poland, 30-727
    • Recruiting
    • Pratia MCM Krakow
  • Krakow, Poland, 30-002
    • Recruiting
    • Malopolskie Badania Kliniczne Sp z o o
  • Lublin, Poland, 20 412
    • Recruiting
    • ETG Lublin
  • Nadarzyn, Poland, 05-830
    • Recruiting
    • NZOZ Lecznica MAK MED S C
  • Olsztyn, Poland, 10 117
    • Recruiting
    • Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
  • Torun, Poland, 87-100
    • Recruiting
    • MICS Centrum Medyczne Torun
  • Warsaw, Poland, 03 291
    • Recruiting
    • FutureMeds Targowek
  • Warsaw, Poland, 00 874
    • Recruiting
    • MICS Centrum Medyczne Warszawa
  • Warsaw, Poland, 02 118
    • Recruiting
    • Rheuma Medicus Sp z o o
  • Warsaw, Poland, 02 665
    • Recruiting
    • Centrum Medyczne Reuma Park
  • Warsaw, Poland, 00-872
    • Recruiting
    • MICS Centrum Medyczne Warszawa 1
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Hosp Univ A Coruna
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
  • Seville, Spain, 41013
    • Recruiting
    • Hosp. Virgen Del Rocio
  • Seville, Spain, 41009
    • Recruiting
    • Hosp. Virgen Macarena
  • Seville, Spain, 41010
    • Recruiting
    • Hosp. Infanta Luisa
• United States
  • Arkansas
    • Searcy, Arkansas, United States, 72143
      • Recruiting
      • Unity Health-White County Medical Center
  • California
    • Huntington Beach, California, United States, 92648
      • Recruiting
      • Newport Huntington Medical Group
    • San Diego, California, United States, 92128
      • Recruiting
      • Rheumatology Center of San Diego
  • Florida
    • Cutler Bay, Florida, United States, 33157
      • Recruiting
      • American Research, LLC
    • Palmetto Bay, Florida, United States, 33157
      • Recruiting
      • Innovation Medical Research Center
    • Plantation, Florida, United States, 33324
      • Recruiting
      • Integral Rheumatology and Immunology Specialists
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Clinical Research of West Florida
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Conquest Research
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Atlanta Research Center for Rheumatology
  • Illinois
    • Willowbrook, Illinois, United States, 60527
      • Recruiting
      • Willow Rheumatology and Wellness PLLC
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Recruiting
      • Qualmedica Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • Albuquerque Rehabilitation and Rheumatology
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Joint and Muscle Research Institute
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Recruiting
      • Paramount Medical Research & Consulting
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Clinical Research Philadelphia
  • Texas
    • Allen, Texas, United States, 75013
      • Recruiting
      • Arthritis and Rheumatology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1: Placebo; Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.	Drug: Placebo; Placebo will be administered.
Experimental: Arm 2: JNJ-88545223 Dose 1; Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.	Drug: JNJ-88545223; JNJ-88545223 will be administered.
Experimental: Arm 3: JNJ-88545223 Dose 2; Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.	Drug: JNJ-88545223; JNJ-88545223 will be administered.
Experimental: Arm 4: JNJ-88545223 Dose 3; Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.	Drug: JNJ-88545223; JNJ-88545223 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at 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).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants who Achieved an ACR 20 Response at Week 16	The ACR 20 responders are participants with an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain 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).	Week 16
Proportion of Participants who Achieved an ACR 70 Response at Week 16	The ACR 70 responders are participants with an improvement of >= 70% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain 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).	Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16	The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline up to Week 16
Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).	Baseline up to Week 16
Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%)	A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3%	A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3%	A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.	Up to Week 20
Number of Participants With Change from Baseline in the Laboratory Parameters	Participants with change from baseline in the laboratory parameters (hematology and serum chemistry) will be reported.	Baseline up to Week 20

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): August 2, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic
• Other Study ID Numbers: 88545223PSA2001 (Janssen Research & Development, LLC); 2025-523141-10-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No