A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis
Recruiting · NCT07321873 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
JNJ-88545223Placebo
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 11 US states.
- 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
- Integral Rheumatology And Immunology Specialists - Plantation, 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
- Albuquerque Rehabilitation and Rheumatology - Albuquerque, New Mexico, 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 - Frisco, Texas, United States
- Hosp Univ A Coruna - A Coruña, Spain
- Fachklinik Bad Bentheim - Bad Bentheim, Germany
- Peking University People's Hospital - Beijing, China
- Peking University Third Hospital - Beijing, China
- Beijing Tsinghua Changgung Hospital - Beijing, China
- Charite Universitaetsmedizin Berlin - Berlin, Germany
- Rheumatologische Schwerpunktpraxis - Berlin, Germany
- Nzoz Osteo Medic - Bialystok, Poland
- Semmelweis Egyetem Reumatologiai es Immunologiai Klinika - Budapest, Hungary
- Obudai Egeszsegugyi Centrum Kft - Budapest, Hungary
- Qualiclinic Kft - Budapest, Hungary
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy - Bydgoszcz, Poland
- RHEUMA s r o - Břeclav, Czechia
- Xiangya Hospital Central South University - Changsha, China
- Changzhou No 2 Peoples Hospital - Changzhou, China
- West China Hospital Sichuan University - Chengdu, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, China
- Praxis Mario Sutowicz - Cottbus, Germany
- Centrum Kliniczno Badawcze - Elblag, Poland
- Tokyo Metropolitan Tama Medical Center - Fuchū, Japan
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz - Gyula, Hungary
- Hamburger Rheuma Forschungszentrum II - Hamburg, Germany
- The Second Affiliated Hospital of Zhejiang University - Hangzhou, China
- CAIR Heidelberg - Heidelberg, Germany
- L K N Arthrocentrum - Hlučín, Czechia
- Porcika Klinika - Vasarhelyi Sarkanyfu Kft. - Hódmezővásárhely, Hungary
- Imamura General Hospital - Kagoshima, Japan
- Revmatologicka ambulance - Karvina Frystat, Czechia
- Hospital of the University of Occupational and Environmental Health - Kitakyushu-shi, Japan
- Malopolskie Badania Kliniczne Sp z o o - Krakow, Poland
- Pratia MCM Krakow - Krakow, Poland
- ETG Lublin - Lublin, Poland
- Gemeinschaftspraxis Dres. Quist - Mainz, Germany
- NZOZ Lecznica MAK MED S C - Nadarzyn, Poland
- Ningbo medical center lihuili hospital - Ningbo, China
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A - Olsztyn, Poland
- Osaka Metropolitan University Hospital - Osaka, Japan
- Pratia Czech A S - Pardubice, Czechia
- Clintrial s r o - Prague, Czechia
- Hautarztpraxis Mortazawi - Remscheid, Germany
- Hosp. Clinico Univ. de Santiago - Santiago de Compostela, Spain
- Sanuki Municipal Hospital - Sanuki, Japan
- Hosp. Virgen Macarena - Seville, Spain
- Hosp. Infanta Luisa - Seville, Spain
Showing 60 of 73 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →