A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT06671496

Run by

Takeda

People needed

600

Starts

2025-03-10

Expected to finish

2028-01-26

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Mesa, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Tucson, Arizona, United States (enrolling)
• Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA — Covina, California, United States (enrolling)
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
• Direct Helpers Medical Center — Hialeah, Florida, United States (enrolling)
• IRIS Research and Development | Plantation, FL — Plantation, Florida, United States (enrolling)
• BayCare Medical Group — St. Petersburg, Florida, United States (enrolling)
• North Georgia Rheumatology Group PC — Lawrenceville, Georgia, United States (enrolling)
• RASF- Clinical Research Center — Boca Raton, Florida, United States (enrolling)
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States (enrolling)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Advanced Rheumatology PC | Lansing, MI — Lansing, Michigan, United States (enrolling)
• AARR- Kansas City Physician Partners — Kansas City, Missouri, United States (enrolling)
• DJL Clinical Research | Charlotte, NC — Charlotte, North Carolina, United States (enrolling)
• University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division — Cleveland, Ohio, United States (enrolling)
• Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States (enrolling)
• Altoona Center for Clinical Research | Ducansville, PA — Duncansville, Pennsylvania, United States (enrolling)
• AARR- Lone Star Arthritis & Rheumatology Associates — Fort Worth, Texas, United States (enrolling)
• Biopharma Informatic | Hassan — Houston, Texas, United States (enrolling)
• Advanced Rheumatology of Houston - The Woodlands — The Woodlands, Texas, United States (enrolling)
• Swedish Rheumatology Research — Seattle, Washington, United States (enrolling)
• Instituto de Investigaciones Clinicas Quilmes — Quilmes, Buenos Aires, Argentina (enrolling)
• Clinica Regional del Sud S.A. — Río Cuarto, Córdoba Province, Argentina (enrolling)
• Centro de Investigaciones Reumatologicas — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• CIMER — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)

Full record on ClinicalTrials.gov

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