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

NCT06671496 · tracked via the Priya Life Science UK tracker

Sponsor

Takeda

Phase

Phase 3

Started

2025-03-10

Last updated

2026-09-09

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

ZasocitinibPlacebo

Zasocitinib: Zasocitinib tablets.

Placebo: Zasocitinib 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 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.

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). 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), OR 3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs. 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 (123)

Facility	City	Region	Status
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Mesa	Arizona	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Phoenix	Arizona	Recruiting
Arizona Arthritis & Rheumatology Research, PLLC \| Phoenix, AZ	Tucson	Arizona	Recruiting
Biovin Enterprises LLC dba Medvin Clinical Research \| Covina, CA	Covina	California	Recruiting
RASF- Clinical Research Center	Boca Raton	Florida	Recruiting
Direct Helpers Medical Center	Hialeah	Florida	Recruiting
IRIS Research and Development \| Plantation, FL	Plantation	Florida	Recruiting
BayCare Medical Group	St. Petersburg	Florida	Recruiting
North Georgia Rheumatology Group PC	Lawrenceville	Georgia	Recruiting
Clinic of Robert Hozman	Skokie	Illinois	Completed
Graves Gilbert Clinic	Bowling Green	Kentucky	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	Recruiting
Advanced Rheumatology PC \| Lansing, MI	Lansing	Michigan	Recruiting
AARR- Kansas City Physician Partners	Kansas City	Missouri	Recruiting
DJL Clinical Research \| Charlotte, NC	Charlotte	North Carolina	Recruiting
University Hospitals \| UH Cleveland Medical Center - Department of Medicine - Rheumatology Division	Cleveland	Ohio	Recruiting
Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio	Recruiting
Altoona Center for Clinical Research \| Ducansville, PA	Duncansville	Pennsylvania	Recruiting
AARR- Lone Star Arthritis & Rheumatology Associates	Fort Worth	Texas	Recruiting
Biopharma Informatic \| Hassan	Houston	Texas	Recruiting
Advanced Rheumatology of Houston - The Woodlands	The Woodlands	Texas	Recruiting
Swedish Rheumatology Research	Seattle	Washington	Recruiting
Instituto de Investigaciones Clinicas Quilmes	Quilmes	Buenos Aires	Recruiting
Clinica Regional del Sud S.A.	Río Cuarto	Córdoba Province	Recruiting
Centro de Investigaciones Reumatologicas	San Miguel de Tucumán	Tucumán Province	Recruiting
CIMER	San Miguel de Tucumán	Tucumán Province	Recruiting
Hospital General de Agudo Jose Maria Ramos Mejia	Buenos Aires	Argentina	Withdrawn
APRILLUS Asistencia e Investigacion Clinica	Buenos Aires	Argentina	Recruiting
Consultora Integral de Salud Centro Medico Privado SRL \| Cordoba, Argentina	Córdoba	Argentina	Recruiting
CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica	San Juan	Argentina	Recruiting
Royal Prince Alfred Hospital	Camperdown	New South Wales	Recruiting
Westmead Hospital	Westmead	New South Wales	Recruiting
Sunshine Coast University Private Hospital \| Clinical Trials	Sippy Downs	Queensland	Recruiting
The Queen Elizabeth Hospital \| Rheumatology Department	Woodville South	South Australia	Recruiting
Fiona Stanley Hospital	Palmyra Dc	Western Australia	Recruiting
Colin Bayliss Research and Teaching Unit	Victoria Park	Western Australia	Recruiting
CMIP-Centro Mineiro de Pesquisa Ltda	Juiz de Fora	Minas Gerais	Recruiting
Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica	Uberlândia	Minas Gerais	Recruiting
EDUMED - Educacao em Saude SS Ltda	Curitiba	Paraná	Recruiting
LMK Servicos Medicos Sociedade Simples	Porto Alegre	Rio Grande do Sul	Recruiting

+ 83 more sites — see the full list on the official registry below.

More Takeda trials in the UK

An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease Active, not recruiting

A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib Recruiting

A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein Recruiting

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis Active, not recruiting

Other trials for the same condition

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Active, not recruiting

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs Active, not recruiting

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment Active, not recruiting

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 NCT06671496 on ClinicalTrials.gov ↗ ← All trials in the UK