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

NCT06671483 · tracked via the Priya Life Science USA tracker

Sponsor

Takeda

Phase

Phase 3

Started

2025-03-03

Last updated

2026-09-17

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

Zasocitinib →Active ComparatorPlacebo

Zasocitinib: Zasocitinib over-encapsulated tablets.

Active Comparator: Active comparator capsule.

Placebo: Zasocitinib or active comparator matching placebo.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Age: 1. 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: 2. The participant has a diagnosis of PsA. 3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening. 4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria). 5. 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. 6. 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: 7. The participant has had at least one of the following: 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD). Exclusion Criteria: PsA and PsO: 1. 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. 2. 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).

Primary outcome measure(s)

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo — At Week 16
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

Trial sites (188)

Facility	City	Region	Status
AARR- Chandler AZ	Chandler	Arizona	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Phoenix	Arizona	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Phoenix	Arizona	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Phoenix	Arizona	Completed
First OC Dermatology Research Inc.	Fountain Valley	California	Recruiting
Purushotham & Akther Kotha MD	La Mesa	California	Recruiting
Triwest Research Associates LLC	La Mesa	California	Recruiting
The Cohen Medical Centers	Thousand Oaks	California	Recruiting
Foothill Arthritis Clinic	Tujunga	California	Recruiting
Medvin Clinical Research	Whittier	California	Completed
Denver Arthritis Clinic \| Denver, CO	Denver	Colorado	Recruiting
Arthritis & Rheumatic Disease Specialties (AARDS)	Aventura	Florida	Recruiting
RASF- Clinical Research Center	Boca Raton	Florida	Recruiting
Clinical Research of West Florida \| Clearwater, FL	Clearwater	Florida	Recruiting
GNP Research, LLC \| Hollywood, FL	Cooper City	Florida	Recruiting
Driven Research LLC	Coral Gables	Florida	Completed
Tectum Medical Research	Davie	Florida	Recruiting
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research	Hialeah	Florida	Recruiting
Bioresearch Partners	Miami	Florida	Recruiting
HMD Research LLC	Orlando	Florida	Completed
Millennium Research \| Ormond Beach, FL	Ormond Beach	Florida	Recruiting
IRIS Research and Development \| Plantation, FL	Plantation	Florida	Recruiting
Sarasota Arthritis Research Center	Sarasota	Florida	Recruiting
West Broward Rheumatology Associates, Inc.	Tamarac	Florida	Recruiting
Clinical Research of West Florida \| Tampa, FL	Tampa	Florida	Recruiting
Marietta Rheumatology Associates	Marietta	Georgia	Recruiting
GSCP/CIS	Orland Park	Illinois	Recruiting
Greater Chicago Specialty Physicians LLC/CIS	Schaumburg	Illinois	Recruiting
Accurate Clinical Research, Inc. \| Lake Charles	Lake Charles	Louisiana	Recruiting
Klein & Associates, M.D., P.A.	Hagerstown	Maryland	Recruiting
Henry Ford Health System-Rheumatology Department	Detroit	Michigan	Withdrawn
Michigan Rheumatology Group, P.C. - Grand Blanc Office	Grand Blanc	Michigan	Recruiting
Ash Research Clinic - Howell	Howell	Michigan	Recruiting
June DO, PC Private Practice - Dr. Justus Fiechtner	Lansing	Michigan	Recruiting
Clinical Research Institute of Michigan	Saint Clair Shores	Michigan	Recruiting
Saint Louis Rheumatology	St Louis	Missouri	Recruiting
Albuquerque Center for Rheumatology PC	Albuquerque	New Mexico	Recruiting
Santa Fe Rheumatology	Santa Fe	New Mexico	Recruiting
NYU Langone Health \| Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department	Brooklyn	New York	Recruiting
Accellacare of Hickory	Hickory	North Carolina	Recruiting

+ 148 more sites — see the full list on the official registry below.

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A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA) Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06671483 on ClinicalTrials.gov ↗ ← All trials in the USA