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NCT07321873 | RECRUITING | Arthritis, Psoriatic

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)
Sponsor:

Janssen Research & Development, LLC

Brief Summary:

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.

Condition or disease

Arthritis, Psoriatic

Intervention/treatment

JNJ-88545223

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-01-30
Estimated Primary Completion Date : 2027-06-28
Estimated Study Completion Date : 2027-08-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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)

Location Details

NCT07321873

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Rheumatology Center of San Diego

San Diego, California, United States, 92128

RECRUITING

United States, North Carolina

Joint and Muscle Research Institute

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, Ohio

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Pennsylvania

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States, 19114