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 ( VELOTA)
A Study to Find Out How Effective and Safe JNJ-88545223 is for the Treatment of Participants With Active Psoriatic Arthritis (a Long-term Inflammatory Arthritis) (VELOTA)
Okubo Yusuke
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Medical Information Center
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Pending
Mar. 23, 2026
240
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
- 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
- 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
18age old over
No limit
Both
Arthritis, Psoriatic
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 orally.
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 orally.
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 orally.
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 orally.
1. 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).
[Time Frame: Week 16]
2. 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 (%) and With Baseline IGA Score of >=2
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.
[Time Frame: Week 16]
3. Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
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.
[Time Frame: Week 16]
4. Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
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.
[Time Frame: Week 16]
5. 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).
[Time Frame: Week 16]
6. 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).
[Time Frame: Week 16]
7. 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.
[Time Frame: Baseline up to Week 16]
8. 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).
[Time Frame: Baseline up to Week 16]
Janssen Pharmaceutical K.K.
Hillside Clinic Jingumae IRB
4-22-11 Jingumae, Sibuya-ku,Tokyo, Tokyo
+81-3-3470-1188
chi-pr-cirb-hillside@cmicgroup.com
Approval
Jan. 08, 2026
Yes
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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
