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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2027-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Psoriatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1: Placebo

Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Arm 2: JNJ-88545223 Dose 1

Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.

Group Type EXPERIMENTAL

JNJ-88545223

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

JNJ-88545223

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

JNJ-88545223

Intervention Type DRUG

JNJ-88545223 will be administered orally.

Interventions

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JNJ-88545223

JNJ-88545223 will be administered orally.

Intervention Type DRUG

Placebo

Placebo will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Joint and Muscle Research Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Contact

Role: CONTACT

844-434-4210

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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