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RECRUITINGPhase 2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

JNJ-88545223

JNJ-88545223 will be administered orally.

DRUG

Placebo

Placebo will be administered orally.

Locations (19)

Unity Health-White County Medical Center
Searcy, Arkansas, United States
Newport Huntington Medical Group
Huntington Beach, California, United States
Rheumatology Center of San Diego
San Diego, California, United States
American Research, LLC
Cutler Bay, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Qualmedica Research
Evansville, Indiana, 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
Arthritis and Rheumatology Research Institute
Allen, Texas, United States
Peking University People's Hospital
Beijing, China
Ningbo medical center lihuili hospital
Ningbo, China
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Sanuki Municipal Hospital
Sanuki, Japan