JNJ-88545223 for adults 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
This trial will test whether the medicine JNJ-88545223 can reduce joint and skin symptoms in adults with active psoriatic arthritis compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 40 sites (Searcy, Arkansas and 39 other locations) |
| Trial ID | NCT07321873 on ClinicalTrials.gov |
What this trial studies
This is a phase 2, placebo-controlled interventional trial of JNJ-88545223 in adults with active psoriatic arthritis. Enrolled participants must have had PsA for at least 3 months, meet CASPAR criteria, have at least 3 swollen and 3 tender joints, and a CRP ≥ 0.1 mg/dL; they must also have active plaque psoriasis or nail changes. Participants will receive either JNJ-88545223 or a matching placebo and will be monitored for changes in joint and skin signs and symptoms and for safety. The study is being conducted at multiple U.S. clinical sites.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of psoriatic arthritis meeting CASPAR, active disease with ≥3 swollen and ≥3 tender joints, CRP ≥0.1 mg/dL, and at least one qualifying psoriasis feature (≥2 cm plaque or nail changes) are ideal candidates.
Not a fit: People without active PsA by the study criteria, pregnant women, or those who do not meet the joint-count or laboratory requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, JNJ-88545223 could reduce joint pain and swelling and improve skin symptoms for people with active PsA.
How similar studies have performed: Other randomized, placebo-controlled trials of targeted therapies for psoriatic arthritis have produced meaningful symptom improvements, but the specific effects of JNJ-88545223 are still being tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Searcy, Arkansas and 39 other locations
- Unity Health-White County Medical Center — Searcy, Arkansas, United States (Recruiting)
- Newport Huntington Medical Group — Huntington Beach, California, United States (Recruiting)
- Rheumatology Center of San Diego — San Diego, California, United States (Recruiting)
- American Research, LLC — Cutler Bay, Florida, United States (Recruiting)
- Innovation Medical Research Center — Palmetto Bay, Florida, United States (Recruiting)
- Clinical Research of West Florida — Tampa, Florida, United States (Recruiting)
- Conquest Research — Winter Park, Florida, United States (Recruiting)
- Atlanta Research Center for Rheumatology — Marietta, Georgia, United States (Recruiting)
- Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States (Recruiting)
- Qualmedica Research — Evansville, Indiana, United States (Recruiting)
- Joint and Muscle Research Institute — Charlotte, North Carolina, United States (Recruiting)
- Paramount Medical Research & Consulting — Middleburg Heights, Ohio, United States (Recruiting)
- Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Arthritis and Rheumatology Research Institute — Allen, Texas, United States (Recruiting)
- Peking University People's Hospital — Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Changzhou No 2 Peoples Hospital — Changzhou, China (Recruiting)
- West China Hospital Sichuan University — Chengdu, China (Recruiting)
- The Second Affiliated Hospital of Zhejiang University — Hangzhou, China (Recruiting)
- Ningbo medical center lihuili hospital — Ningbo, China (Recruiting)
- Hamburger Rheuma Forschungszentrum II — Hamburg, Germany (Recruiting)
- CAIR Heidelberg — Heidelberg, Germany (Recruiting)
- Hautarztpraxis Mortazawi — Remscheid, Germany (Recruiting)
- Hautarztpraxis — Witten, Germany (Recruiting)
- Imamura General Hospital — Kagoshima, Japan (Recruiting)
- Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi, Japan (Recruiting)
- Osaka Metropolitan University Hospital — Osaka, Japan (Recruiting)
- Sanuki Municipal Hospital — Sanuki, Japan (Recruiting)
- Tokito Clinic Rheumatology and Orthopaedic Surgery — Shimonoseki, Japan (Recruiting)
- Nzoz Osteo Medic — Bialystok, Poland (Recruiting)
- Centrum Kliniczno Badawcze — Elblag, Poland (Recruiting)
- Malopolskie Badania Kliniczne Sp z o o — Krakow, Poland (Recruiting)
- Pratia MCM Krakow — Krakow, Poland (Recruiting)
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A — Olsztyn, Poland (Recruiting)
- MICS Centrum Medyczne Warszawa 1 — Warsaw, Poland (Recruiting)
- Centrum Medyczne Reuma Park — Warsaw, Poland (Recruiting)
- FutureMeds Targowek — Warsaw, Poland (Recruiting)
- Hosp Univ A Coruna — A Coruña, Spain (Recruiting)
- Hosp. Virgen Macarena — Seville, Spain (Recruiting)
- Hosp. Virgen Del Rocio — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.