A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken 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 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.

Key facts

Study ID

NCT06671483

Run by

Takeda

People needed

1088

Starts

2025-03-03

Expected to finish

2028-01-28

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). 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).

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 — Phoenix, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
• First OC Dermatology Research Inc. — Fountain Valley, California, United States (enrolling)
• Purushotham & Akther Kotha MD — La Mesa, California, United States (enrolling)
• Triwest Research Associates LLC — La Mesa, California, United States (enrolling)
• The Cohen Medical Centers — Thousand Oaks, California, United States (enrolling)
• Foothill Arthritis Clinic — Tujunga, California, United States (enrolling)
• Medvin Clinical Research — Whittier, California, United States (enrolling)
• Denver Arthritis Clinic | Denver, CO — Denver, Colorado, United States (enrolling)
• Arthritis & Rheumatic Disease Specialties (AARDS) — Aventura, Florida, United States (enrolling)
• RASF- Clinical Research Center — Boca Raton, Florida, United States (enrolling)
• Clinical Research of West Florida | Clearwater, FL — Clearwater, Florida, United States (enrolling)
• GNP Research, LLC | Hollywood, FL — Cooper City, Florida, United States (enrolling)
• Driven Research LLC — Coral Gables, Florida, United States (enrolling)
• Tectum Medical Research — Davie, Florida, United States (enrolling)
• Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research — Hialeah, Florida, United States (enrolling)
• Bioresearch Partners — Miami, Florida, United States (enrolling)
• HMD Research LLC — Orlando, Florida, United States (enrolling)
• Millennium Research | Ormond Beach, FL — Ormond Beach, Florida, United States (enrolling)
• IRIS Research and Development | Plantation, FL — Plantation, Florida, United States (enrolling)
• Sarasota Arthritis Research Center — Sarasota, Florida, United States (enrolling)
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States (enrolling)
• Clinical Research of West Florida | Tampa, FL — Tampa, Florida, United States (enrolling)
• AARR- Chandler AZ — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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