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JNJ-88545223

Phase 2

Arthritis, Psoriatic | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07321873A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic ArthritisPHASE2 RECRUITING 240Jan 15, 2026Aug 2, 2027Jun 5, 202668 United States, China +6
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Study Endpoints
Primary Endpoints
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
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).

Secondary Endpoints
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 (%)
Week 16
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3%
Week 16
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3%
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
Arm 2: JNJ-88545223 Dose 1EXPERIMENTALParticipants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
Arm 3: JNJ-88545223 Dose 2EXPERIMENTALParticipants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
Arm 4: JNJ-88545223 Dose 3EXPERIMENTALParticipants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
Interventions
NameTypeDescription
JNJ-88545223DRUGJNJ-88545223 will be administered.
PlaceboDRUGPlacebo will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites68

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 ...

Countries:United StatesChinaCzechiaGermanyHungaryJapanPolandSpain
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07321873lastUpdatePostDate: changed
LOWJun 5, 2026NCT07321873lastUpdatePostDate: changed
LOWJun 5, 2026NCT07321873lastUpdatePostDate: changed
LOWJun 5, 2026NCT07321873lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT07321873lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT07321873lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT07321873lastUpdatePostDate: changed
LOWMay 26, 2026NCT07321873primaryCompletionDate: changed
LOWMay 24, 2026NCT07321873studyFirstPostDate: changed