A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Recruiting · NCT06671483 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
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 who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, 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). In South Korea, the age requirement for adult participants is \>=19 years of age.
- 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).
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 18 US states.
- AARR- Chandler AZ - Chandler, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Phoenix, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Phoenix, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ - Phoenix, Arizona, United States
- First OC Dermatology Research Inc. - Fountain Valley, California, United States
- Purushotham & Akther Kotha MD - La Mesa, California, United States
- Triwest Research Associates LLC - La Mesa, California, United States
- The Cohen Medical Centers - Thousand Oaks, California, United States
- Foothill Arthritis Clinic - Tujunga, California, United States
- Medvin Clinical Research - Whittier, California, United States
- Denver Arthritis Clinic | Denver, CO - Denver, Colorado, United States
- Arthritis & Rheumatic Disease Specialties (AARDS) - Aventura, Florida, United States
- RASF- Clinical Research Center - Boca Raton, Florida, United States
- Clinical Research of West Florida | Clearwater, FL - Clearwater, Florida, United States
- GNP Research, LLC | Hollywood, FL - Cooper City, Florida, United States
- Driven Research LLC - Coral Gables, Florida, United States
- Tectum Medical Research - Davie, Florida, United States
- Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research - Hialeah, Florida, United States
- Bioresearch Partners - Miami, Florida, United States
- HMD Research LLC - Orlando, Florida, United States
- Millennium Research | Ormond Beach, FL - Ormond Beach, Florida, United States
- IRIS Research and Development | Plantation, FL - Plantation, Florida, United States
- Sarasota Arthritis Research Center - Sarasota, Florida, United States
- West Broward Rheumatology Associates, Inc. - Tamarac, Florida, United States
- Clinical Research of West Florida | Tampa, FL - Tampa, Florida, United States
- Marietta Rheumatology Associates - Marietta, Georgia, United States
- GSCP/CIS - Orland Park, Illinois, United States
- Greater Chicago Specialty Physicians LLC/CIS - Schaumburg, Illinois, United States
- Accurate Clinical Research, Inc. | Lake Charles - Lake Charles, Louisiana, United States
- Klein & Associates, M.D., P.A. - Hagerstown, Maryland, United States
- Henry Ford Health System-Rheumatology Department - Detroit, Michigan, United States
- Michigan Rheumatology Group, P.C. - Grand Blanc Office - Grand Blanc, Michigan, United States
- Ash Research Clinic - Howell - Howell, Michigan, United States
- June DO, PC Private Practice - Dr. Justus Fiechtner - Lansing, Michigan, United States
- Clinical Research Institute of Michigan - Saint Clair Shores, Michigan, United States
- Saint Louis Rheumatology - St Louis, Missouri, United States
- Albuquerque Center for Rheumatology PC - Albuquerque, New Mexico, United States
- Santa Fe Rheumatology - Santa Fe, New Mexico, United States
- NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department - Brooklyn, New York, United States
- Accellacare of Hickory - Hickory, 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
- PA Regional Center for Arthritis and Osteoporosis Research - Wyomissing, Pennsylvania, United States
- West Tennessee Research Institute - Jackson, Tennessee, United States
- Accurate Clinical Research - Baytown, Texas, United States
- Novel Research | Bellaire Location - Bellaire, Texas, United States
- Novel Research | Bellaire Location - Bellaire, Texas, United States
- Accurate Clinical Research - Houston, Texas, United States
- Introscience Research | Northwest Houston Arthritis Center - Houston, TX - Houston, Texas, United States
- West Texas Clinical Research - Lubbock, Texas, United States
- Southwest Rheumatology Research, LLC | Mesquite, TX - Mesquite, Texas, United States
- Clinical Investigations of Texas - Plano, Texas, United States
- Arthritis Northwest, PLLC | Spokane, WA - Spokane, Washington, United States
- Hospital Garcia de Orta - Almada, Portugal
- Barzilai Medical Center | Rheumatology Department - Ashkelon, Israel
- Rheumatologische Schwerpunktpraxis | Berlin, Germany - Berlin, Germany
- St Pierre Brussels - Brussels, Belgium
- Qualiclinic | Budapest, Hungary - Budapest, Hungary
- Centro Reumatologico de Caguas | Caguas, PR - Caguas, Puerto Rico
- Office of Cesar F. Pacheco-Tena, MD - Chihuahua City, Mexico
Showing 60 of 188 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →