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)
NCT ID: NCT07321873
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2026-01-30
2027-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: Placebo
Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
Placebo
Placebo will be administered orally.
Arm 2: JNJ-88545223 Dose 1
Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
JNJ-88545223
JNJ-88545223 will be administered orally.
Arm 3: JNJ-88545223 Dose 2
Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
JNJ-88545223
JNJ-88545223 will be administered orally.
Arm 4: JNJ-88545223 Dose 3
Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
JNJ-88545223
JNJ-88545223 will be administered orally.
Interventions
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JNJ-88545223
JNJ-88545223 will be administered orally.
Placebo
Placebo will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Rheumatology Center of San Diego
San Diego, California, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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88545223PSA2001
Identifier Type: OTHER
Identifier Source: secondary_id
2025-523141-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
88545223PSA2001
Identifier Type: -
Identifier Source: org_study_id
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