VELOTANCT07321873
A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History
All 13 versions: 12 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Minor Enrollment closed, study ongoing
- Final enrollment: 157 participants (planned 240)
- Site details revised at 75 of 75 sites
- Minor Study sites: 73 to 75
- Eligibility criteria expanded, about 10 words
- Secondary endpoints: details revised at 7 of 7 entries
- Minor Study sites: 72 to 73v10
- Minor Trial sites expanded: 68 → 72 locationsv9
- Minor Trial sites expanded: 63 → 68 locationsv8
- Minor Trial sites expanded: 40 → 63 locations
- Eligibility criteria expanded, about 10 words
- Secondary endpoints: 9 to 7
- Minor Trial sites expanded: 19 → 40 locationsv6
- Minor Study sites: 10 to 19v5
- Minor Study sites: 4 to 10v4
- Minor Start date changed from estimate of Jan 30, 2026 to Jan 15, 2026
- Secondary endpoints revised (9)
- Study title shortened, about 5 words
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 4
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
Timeframe: Week 16
Secondary (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 (%)
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3%
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3%
Proportion of Participants who Achieved an ACR 20 Response at Week 16
Proportion of Participants who Achieved an ACR 70 Response at Week 16
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Arms and interventions
Arm 1: PlaceboPlacebo comparator
Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
Arm 2: JNJ-88545223 Dose 1Experimental
Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
Arm 3: JNJ-88545223 Dose 2Experimental
Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
Arm 4: JNJ-88545223 Dose 3Experimental
Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
Drugs: JNJ-88545223, Placebo
Sites
75 sites in 8 countries
United States 18, Poland 14, China 10, Germany 9, Hungary 7, Czechia 6, Japan 6, Spain 5