A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
Recruiting · NCT06671496 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboZasocitinib
What this trial is about
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments. The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.
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 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age:
- The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
- Disease Characteristics:
- The participant has a diagnosis of PsA.
- The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
- The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
- The participant has active arthritis as shown by a minimum of \>=3 tender joints in TJC68 and \>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
- The participant has at least 1 active lesion of plaque PsO \>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
- Medications for PsA:
- The participant has had at least one of the following:
- Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
- Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
- Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.
Exclusion criteria
- PsA and PsO:
- The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
- The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).
Where it is running
60 locations listed across 14 US states.
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Mesa, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Phoenix, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Tucson, Arizona, United States
- Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA - Covina, California, United States
- RASF- Clinical Research Center - Boca Raton, Florida, United States
- Direct Helpers Medical Center - Hialeah, Florida, United States
- IRIS Research and Development | Plantation, FL - Plantation, Florida, United States
- BayCare Medical Group - St. Petersburg, Florida, United States
- North Georgia Rheumatology Group PC - Lawrenceville, Georgia, United States
- Clinic of Robert Hozman - Skokie, Illinois, United States
- Graves Gilbert Clinic - Bowling Green, Kentucky, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Advanced Rheumatology PC | Lansing, MI - Lansing, Michigan, United States
- AARR- Kansas City Physician Partners - Kansas City, Missouri, United States
- DJL Clinical Research | Charlotte, NC - Charlotte, North Carolina, United States
- University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division - Cleveland, Ohio, United States
- Paramount Medical Research & Consulting, LLC - Middleburg Heights, Ohio, United States
- Altoona Center for Clinical Research | Ducansville, PA - Duncansville, Pennsylvania, United States
- AARR- Lone Star Arthritis & Rheumatology Associates - Fort Worth, Texas, United States
- Biopharma Informatic | Hassan - Houston, Texas, United States
- Advanced Rheumatology of Houston - The Woodlands - The Woodlands, Texas, United States
- Swedish Rheumatology Research - Seattle, Washington, United States
- ISA - Interdisciplinary Study Association - Berlin, Germany
- Hospital General de Agudo Jose Maria Ramos Mejia - Buenos Aires, Argentina
- APRILLUS Asistencia e Investigacion Clinica - Buenos Aires, Argentina
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital - Chengdu, China
- Consultora Integral de Salud Centro Medico Privado SRL | Cordoba, Argentina - Córdoba, Argentina
- Sun Yat-sen University - The Third Affiliated Hospital (Third Affiliated Hospital of Zhongshan Medical University) - Guangzhou, China
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH - Hamburg - Hamburg, Germany
- The Princess Alexandra Hospital NHS Trust - Harlow, United Kingdom
- Rheumazentrum Ruhrgebiet - Herne, Germany
- Zespol Poradni Specjalistycznych Reumed - Lublin, Poland
- Hospital Universitario La Paz - Madrid, Spain
- Oxford University Hospitals NHS Trust - Oxford, United Kingdom
- Hopital Nord - Saint-Etienne, France
- CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica - San Juan, Argentina
- Hospital Universitario de Canarias - Santa Cruz de Tenerife, Spain
- Hospital Quirónsalud Sagrado Corazón - Seville, Spain
- Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine - Shanghai, China
- Haywood Hospital - Stoke-on-Trent, United Kingdom
- CEPIC - Centro Paulista de Investigacao Clinica - São Paulo, Brazil
- Wenzhou Medical University (WMU) - The First Affiliated Hospital - Wenzhou, China
- The Royal Wolverhampton NHS Trust - Wolverhampton, United Kingdom
- Kojunkai Social Medical Corporation Daido Clinic - Minami-ku, Nagoya-shi, Aichi-ken, Japan
- Nagoya City University Hospital - Nagoya, Aichi-ken, Japan
- The First Affiliated Hospital Of Bengbu Medical College - Bengbu, Anhui, China
- Clinique de l'Infirmerie Protestante - Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
- Hospital Universitario Araba - Sede Hospital Txagorritxu - Vitoria-Gasteiz, Basque Country, Spain
- Xuanwu Hospital Capital Medical University - Beijing, Beijing Municipality, China
- Peking University Third Hospital - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- Instituto de Investigaciones Clinicas Quilmes - Quilmes, Buenos Aires, Argentina
- Hospital Universitario Marques de Valdecilla | Rheumatology Department - Santander, Cantabria, Spain
- Clinica Regional del Sud S.A. - Río Cuarto, Córdoba Province, Argentina
- The First Affiliated Hospital of Xiamen University - Xiamen, Fujian, China
- King's College Hospital - London, Greater London, United Kingdom
- Guangzhou First People's Hospital - Guangzhou, Guandong, China
- Shenzhen People's Hospital - Shenzhen, Guangdong, China
- CHU Toulouse - Toulouse, Haute Garonne, France
- The First Affiliated Hospital of Henan University of Science and Technology - Luoyang, Henan, China
Showing 60 of 123 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →