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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523141-10-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Placebo | Placebo Comparator | Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16. |
|
| Arm 2: JNJ-88545223 Dose 1 | Experimental | Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16. |
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| Arm 3: JNJ-88545223 Dose 2 | Experimental | Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16. |
|
| Arm 4: JNJ-88545223 Dose 3 | Experimental | Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-88545223 | Drug | JNJ-88545223 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | The ACR 50 responders are participants with an improvement of greater than or equal to (>=) 50 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale [VAS], patient's global assessment of disease activity [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%) | A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unity Health-White County Medical Center | Recruiting | Searcy | Arkansas | 72143 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Placebo | Drug | Placebo will be administered. |
|
| Week 16 |
| Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% | A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. | Week 16 |
| Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% | A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. | Week 16 |
| Proportion of Participants who Achieved an ACR 20 Response at Week 16 | The ACR 20 responders are participants with an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein). | Week 16 |
| Proportion of Participants who Achieved an ACR 70 Response at Week 16 | The ACR 70 responders are participants with an improvement of >= 70% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). | Week 16 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 | The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Baseline up to Week 16 |
| Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 | SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). | Baseline up to Week 16 |
| Up to Week 20 |
| Number of Participants With Change from Baseline in the Laboratory Parameters | Participants with change from baseline in the laboratory parameters (hematology and serum chemistry) will be reported. | Baseline up to Week 20 |
| Newport Huntington Medical Group |
| Recruiting |
| Huntington Beach |
| California |
| 92648 |
| United States |
| Rheumatology Center of San Diego | Recruiting | San Diego | California | 92128 | United States |
| American Research, LLC | Recruiting | Cutler Bay | Florida | 33157 | United States |
| Innovation Medical Research Center | Recruiting | Palmetto Bay | Florida | 33157 | United States |
| Integral Rheumatology And Immunology Specialists | Recruiting | Plantation | Florida | 33324 | United States |
| Clinical Research of West Florida | Recruiting | Tampa | Florida | 33606 | United States |
| Conquest Research | Recruiting | Winter Park | Florida | 32789 | United States |
| Atlanta Research Center for Rheumatology | Recruiting | Marietta | Georgia | 30060 | United States |
| Willow Rheumatology and Wellness PLLC | Recruiting | Willowbrook | Illinois | 60527 | United States |
| Qualmedica Research | Recruiting | Evansville | Indiana | 47715 | United States |
| Albuquerque Rehabilitation and Rheumatology | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Joint and Muscle Research Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Paramount Medical Research & Consulting | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Research Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19114 | United States |
| Arthritis and Rheumatology Research Institute | Recruiting | Allen | Texas | 75013 | United States |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | 102218 | China |
| Xiangya Hospital Central South University | Recruiting | Changsha | 410008 | China |
| Changzhou No 2 Peoples Hospital | Recruiting | Changzhou | 213003 | China |
| West China Hospital Sichuan University | Recruiting | Chengdu | 610093 | China |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| The Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | 310009 | China |
| Ningbo medical center lihuili hospital | Recruiting | Ningbo | 315041 | China |
| RHEUMA s r o | Recruiting | Břeclav | 690 02 | Czechia |
| L K N Arthrocentrum | Recruiting | Hlučín | 748 01 | Czechia |
| Revmatologicka ambulance | Recruiting | Karvina Frystat | 733 01 | Czechia |
| Pratia Czech A S | Recruiting | Pardubice | 53002 | Czechia |
| Clintrial s r o | Recruiting | Prague | 100 00 | Czechia |
| Medical Plus Research S R O | Recruiting | Uherské Hradiště | 68601 | Czechia |
| Fachklinik Bad Bentheim | Recruiting | Bad Bentheim | 48455 | Germany |
| Charite Universitaetsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
| Rheumatologische Schwerpunktpraxis | Recruiting | Berlin | 12161 | Germany |
| Praxis Mario Sutowicz | Recruiting | Cottbus | 3042 | Germany |
| Hamburger Rheuma Forschungszentrum II | Recruiting | Hamburg | 20095 | Germany |
| CAIR Heidelberg | Recruiting | Heidelberg | 69121 | Germany |
| Gemeinschaftspraxis Dres. Quist | Recruiting | Mainz | 55128 | Germany |
| Hautarztpraxis Mortazawi | Recruiting | Remscheid | 42897 | Germany |
| Hautarztpraxis | Recruiting | Witten | 58453 | Germany |
| Semmelweis Egyetem Reumatologiai es Immunologiai Klinika | Recruiting | Budapest | 1023 | Hungary |
| Obudai Egeszsegugyi Centrum Kft | Recruiting | Budapest | 1036 | Hungary |
| Qualiclinic Kft | Recruiting | Budapest | 1134 | Hungary |
| Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz | Recruiting | Gyula | 5700 | Hungary |
| Porcika Klinika - Vasarhelyi Sarkanyfu Kft. | Recruiting | Hódmezővásárhely | 6800 | Hungary |
| Complex Rendelo Med Zrt | Recruiting | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center Orvosi es Fogaszati Kozpont | Recruiting | Veszprém | 8200 | Hungary |
| Tokyo Metropolitan Tama Medical Center | Recruiting | Fuchū | 183 8524 | Japan |
| Imamura General Hospital | Recruiting | Kagoshima | 890-0064 | Japan |
| Hospital of the University of Occupational and Environmental Health | Recruiting | Kitakyushu-shi | 807-8556 | Japan |
| Osaka Metropolitan University Hospital | Recruiting | Osaka | 545 8586 | Japan |
| Sanuki Municipal Hospital | Recruiting | Sanuki | 769-2393 | Japan |
| Tokito Clinic Rheumatology and Orthopaedic Surgery | Recruiting | Shimonoseki | 752 0976 | Japan |
| Nzoz Osteo Medic | Recruiting | Bialystok | 15 351 | Poland |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Recruiting | Bydgoszcz | 85 168 | Poland |
| Centrum Kliniczno Badawcze | Recruiting | Elblag | 82-300 | Poland |
| Malopolskie Badania Kliniczne Sp z o o | Recruiting | Krakow | 30-002 | Poland |
| Pratia MCM Krakow | Recruiting | Krakow | 30-727 | Poland |
| ETG Lublin | Recruiting | Lublin | 20 412 | Poland |
| NZOZ Lecznica MAK MED S C | Recruiting | Nadarzyn | 05-830 | Poland |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S K A | Recruiting | Olsztyn | 10 117 | Poland |
| MICS Centrum Medyczne Torun | Recruiting | Torun | 87-100 | Poland |
| MICS Centrum Medyczne Warszawa | Recruiting | Warsaw | 00 874 | Poland |
| MICS Centrum Medyczne Warszawa 1 | Recruiting | Warsaw | 00-872 | Poland |
| Rheuma Medicus Sp z o o | Recruiting | Warsaw | 02 118 | Poland |
| Centrum Medyczne Reuma Park | Recruiting | Warsaw | 02 665 | Poland |
| FutureMeds Targowek | Recruiting | Warsaw | 03 291 | Poland |
| Hosp Univ A Coruna | Recruiting | A Coruña | 15006 | Spain |
| Hosp. Clinico Univ. de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hosp. Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| Hosp. Infanta Luisa | Recruiting | Seville | 41010 | Spain |
| Hosp. Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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