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

Purpose

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

  • Arthritis, Psoriatic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 (Week 0/Day 1) based on the 66/68 joint assessment; AND (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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1: Placebo 		Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
  • Drug: Placebo
    Placebo will be administered.
Experimental
Arm 2: JNJ-88545223 Dose 1 		Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
  • Drug: JNJ-88545223
    JNJ-88545223 will be administered.
Experimental
Arm 3: JNJ-88545223 Dose 2 		Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
  • Drug: JNJ-88545223
    JNJ-88545223 will be administered.
Experimental
Arm 4: JNJ-88545223 Dose 3 		Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
  • Drug: JNJ-88545223
    JNJ-88545223 will be administered.

Recruiting Locations

Unity Health-White County Medical Center
Searcy, Arkansas 72143

Newport Huntington Medical Group
Huntington Beach, California 92648

Rheumatology Center of San Diego
San Diego, California 92128

American Research, LLC
Cutler Bay, Florida 33157

Innovation Medical Research Center
Palmetto Bay, Florida 33157

Integral Rheumatology And Immunology Specialists
Plantation, Florida 33324

Clinical Research of West Florida
Tampa, Florida 33606

Conquest Research
Winter Park, Florida 32789

Atlanta Research Center for Rheumatology
Marietta, Georgia 30060

Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois 60527

Qualmedica Research
Evansville, Indiana 47715

Albuquerque Rehabilitation and Rheumatology
Albuquerque, New Mexico 87102

Joint and Muscle Research Institute
Charlotte, North Carolina 28204

Paramount Medical Research & Consulting
Middleburg Heights, Ohio 44130

Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114

Arthritis and Rheumatology Research Institute
Allen, Texas 75013

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com