Arthritis, PsoriaticPhase 2VELOTANCT07321873
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
A Phase 2 study testing JNJ-88545223 in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 75 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- JNJ-88545223
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 75 sitesin 8 countries
- Study dates
- 15 Jan 2026to 2 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
75 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
75 sites in 8 countries
United States18 sites, 18 recruiting
- Recruiting
Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico, 87102
- Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
- Recruiting
Clinical Research of West Florida 1
Clearwater, Florida, 33765
- Recruiting
American Research, LLC
Cutler Bay, Florida, 33157
- Recruiting
Qualmedica Research
Evansville, Indiana, 47715
- Recruiting
Arthritis and Rheumatology Research Institute
Frisco, Texas, 75035
- Recruiting
Newport Huntington Medical Group
Huntington Beach, California, 92648
- Recruiting
Atlanta Research Center for Rheumatology
Marietta, Georgia, 30060
- Recruiting
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, 44130
- Recruiting
Innovation Medical Research Center
Palmetto Bay, Florida, 33157
- Recruiting
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114
- Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324
- Recruiting
Onsite Clinical Solutions
Salisbury, North Carolina, 28144
- Recruiting
Rheumatology Center of San Diego
San Diego, California, 92128
- Recruiting
Unity Health-White County Medical Center
Searcy, Arkansas, 72143
- Recruiting
Clinical Research of West Florida
Tampa, Florida, 33606
- Recruiting
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Poland14 sites, 14 recruiting
- Recruiting
Nzoz Osteo Medic
Bialystok, 15 351
- Recruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168
- Recruiting
Centrum Kliniczno Badawcze
Elblag, 82-300
- Recruiting
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30-002
- Recruiting
Pratia MCM Krakow
Krakow, 30-727
- Recruiting
ETG Lublin
Lublin, 20 412
- Recruiting
NZOZ Lecznica MAK MED S C
Nadarzyn, 05-830
- Recruiting
Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A
Olsztyn, 10 117
- Recruiting
MICS Centrum Medyczne Torun
Torun, 87-100
- Recruiting
MICS Centrum Medyczne Warszawa
Warsaw, 00 874
- Recruiting
MICS Centrum Medyczne Warszawa 1
Warsaw, 00-872
- Recruiting
Rheuma Medicus Sp z o o
Warsaw, 02 118
- Recruiting
Centrum Medyczne Reuma Park
Warsaw, 02 665
- Recruiting
FutureMeds Targowek
Warsaw, 03 291
China10 sites, 10 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, 102218
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
- Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, 213003
- Recruiting
West China Hospital Sichuan University
Chengdu, 610093
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, 310009
- Recruiting
Ningbo medical center lihuili hospital
Ningbo, 315041
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Germany9 sites, 9 recruiting
- Recruiting
Fachklinik Bad Bentheim
Bad Bentheim, 48455
- Recruiting
Charite Universitaetsmedizin Berlin
Berlin, 10117
- Recruiting
Rheumatologische Schwerpunktpraxis
Berlin, 10777
- Recruiting
Praxis Mario Sutowicz
Cottbus, 3042
- Recruiting
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095
- Recruiting
CAIR Heidelberg
Heidelberg, 69121
- Recruiting
Gemeinschaftspraxis Dres. Quist
Mainz, 55128
- Recruiting
Hautarztpraxis Mortazawi
Remscheid, 42897
- Recruiting
Hautarztpraxis
Witten, 58453
Hungary7 sites, 7 recruiting
- Recruiting
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika
Budapest, 1023
- Recruiting
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036
- Recruiting
Qualiclinic Kft
Budapest, 1134
- Recruiting
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
- Recruiting
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
Hódmezővásárhely, 6800
- Recruiting
Complex Rendelo Med Zrt
Székesfehérvár, 8000
- Recruiting
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, 8200
Czechia6 sites, 6 recruiting
- Recruiting
RHEUMA s r o
Břeclav, 690 02
- Recruiting
L K N Arthrocentrum
Hlučín, 748 01
- Recruiting
Revmatologicka ambulance
Karvina Frystat, 733 01
- Recruiting
Pratia Czech A S
Pardubice, 53002
- Recruiting
Clintrial s r o
Prague, 100 00
- Recruiting
Medical Plus Research S R O
Uherské Hradiště, 68601
Japan6 sites, 6 recruiting
- Recruiting
Tokyo Metropolitan Tama Medical Center
Fuchū, 183 8524
- Recruiting
Imamura General Hospital
Kagoshima, 890-0064
- Recruiting
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, 807-8556
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545 8586
- Recruiting
Sanuki Municipal Hospital
Sanuki, 769-2393
- Recruiting
Tokito Clinic Rheumatology and Orthopaedic Surgery
Shimonoseki, 752 0976
Spain5 sites, 5 recruiting
- Recruiting
Hosp Univ A Coruna
A Coruña, 15006
- Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
- Recruiting
Hosp. Virgen Macarena
Seville, 41009
- Recruiting
Hosp. Infanta Luisa
Seville, 41010
- Recruiting
Hosp. Virgen Del Rocio
Seville, 41013
About this study
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
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.
- Conditions
- Arthritis, Psoriatic
- Being tested
- JNJ-88545223, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-88545223Drug
JNJ-88545223 will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo | Placebo comparator | Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16. Receives: Drug: Placebo |
| Arm 2: JNJ-88545223 Dose 1 | Experimental | Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16. Receives: Drug: JNJ-88545223 |
| Arm 3: JNJ-88545223 Dose 2 | Experimental | Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16. Receives: Drug: JNJ-88545223 |
| Arm 4: JNJ-88545223 Dose 3 | Experimental | Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16. Receives: Drug: JNJ-88545223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 16
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Week 16
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Jan 2026
- Primary completion28 Jun 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321873
- Sponsor's protocol ID
- 88545223PSA2001
- Other IDs
- 2025-523141-10-00, 2025
- Acronym
- VELOTA
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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