Evaluating Zasocitinib for Psoriatic Arthritis Treatment
A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)
PHASE3 · Takeda · NCT06671496
This study is testing a new drug called zasocitinib to see if it helps adults with active psoriatic arthritis feel better, no matter what treatments they've tried before.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda (industry) |
| Drugs / interventions | zasocitinib |
| Locations | 122 sites (Mesa, Arizona and 121 other locations) |
| Trial ID | NCT06671496 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of zasocitinib (TAK-279) in adults with active psoriatic arthritis (PsA), regardless of their previous treatment history with biologic medicines. Participants will receive either the drug or a placebo over a period of up to 60 weeks. The study aims to assess how well the treatment works based on the participants' prior experiences with other therapies. The trial includes individuals who meet specific criteria related to their disease characteristics and treatment responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with active psoriatic arthritis and a history of inadequate response to previous treatments.
Not a fit: Patients who do not have active psoriatic arthritis or have not previously tried any treatments for the condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from psoriatic arthritis.
How similar studies have performed: Other studies have shown promise with similar drug therapies for psoriatic arthritis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Mesa, Arizona and 121 other locations
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Mesa, Arizona, United States (RECRUITING)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (RECRUITING)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Tucson, Arizona, United States (RECRUITING)
- Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA — Covina, California, United States (RECRUITING)
- RASF- Clinical Research Center — Boca Raton, Florida, United States (RECRUITING)
- Direct Helpers Medical Center — Hialeah, Florida, United States (RECRUITING)
- IRIS Research and Development | Plantation, FL — Plantation, Florida, United States (RECRUITING)
- BayCare Medical Group — St. Petersburg, Florida, United States (RECRUITING)
- North Georgia Rheumatology Group PC — Lawrenceville, Georgia, United States (RECRUITING)
- Clinic of Robert Hozman — Skokie, Illinois, United States (RECRUITING)
- Graves Gilbert Clinic — Bowling Green, Kentucky, United States (RECRUITING)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
- Advanced Rheumatology PC | Lansing, MI — Lansing, Michigan, United States (RECRUITING)
- AARR- Kansas City Physician Partners — Kansas City, Missouri, United States (RECRUITING)
- DJL Clinical Research | Charlotte, NC — Charlotte, North Carolina, United States (RECRUITING)
- University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division — Cleveland, Ohio, United States (RECRUITING)
- Altoona Center for Clinical Research | Ducansville, PA — Duncansville, Pennsylvania, United States (RECRUITING)
- AARR- Lone Star Arthritis & Rheumatology Associates — Fort Worth, Texas, United States (RECRUITING)
- Biopharma Informatic | Hassan — Houston, Texas, United States (RECRUITING)
- Advanced Rheumatology of Houston - The Woodlands — The Woodlands, Texas, United States (RECRUITING)
- Swedish Rheumatology Research — Seattle, Washington, United States (RECRUITING)
- Instituto de Investigaciones Clinicas Quilmes — Quilmes, Buenos Aires, Argentina (RECRUITING)
- Clinica Regional del Sud S.A. — Río Cuarto, Córdoba Province, Argentina (RECRUITING)
- Centro de Investigaciones Reumatologicas — San Miguel de Tucumán, Tucumán Province, Argentina (RECRUITING)
- CIMER — San Miguel de Tucumán, Tucumán Province, Argentina (RECRUITING)
- Hospital General de Agudo Jose Maria Ramos Mejia — Buenos Aires, Argentina (NOT_YET_RECRUITING)
- 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, Australia (RECRUITING)
- Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
- Sunshine Coast University Private Hospital | Clinical Trials — Sippy Downs, Queensland, Australia (RECRUITING)
- The Queen Elizabeth Hospital | Rheumatology Department — Woodville South, South Australia, Australia (RECRUITING)
- Fiona Stanley Hospital — Palmyra Dc, Western Australia, Australia (RECRUITING)
- Colin Bayliss Research and Teaching Unit — Victoria Park, Western Australia, Australia (RECRUITING)
- CMIP-Centro Mineiro de Pesquisa Ltda — Juiz de Fora, Minas Gerais, Brazil (RECRUITING)
- Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica — Uberlândia, Minas Gerais, Brazil (RECRUITING)
- EDUMED - Educacao em Saude SS Ltda — Curitiba, Paraná, Brazil (RECRUITING)
- LMK Servicos Medicos Sociedade Simples — Porto Alegre, Rio Grande do Sul, Brazil (RECRUITING)
- Hospital de Base | Centro Integrado de Pesquisa Funfarme - Rheumatology Department — São José do Rio Preto, São Paulo, Brazil (RECRUITING)
- CEPIC - Centro Paulista de Investigacao Clinica — São Paulo, Brazil (RECRUITING)
- Niagara Rheumatology Research Centre | Ontario, Canada — Niagara Falls, Ontario, Canada (RECRUITING)
- University Health Network (UHN) - Toronto Western Hospital (TWH) - Centre for Prognosis Studies in the Rheumatic Diseases — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
- G.R.M.O. Inc. — Québec, Quebec, Canada (RECRUITING)
- The First Affiliated Hospital Of Bengbu Medical College — Bengbu, Anhui, China (RECRUITING)
- Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (RECRUITING)
- Guangzhou First People's Hospital — Guangzhou, Guandong, China (RECRUITING)
+72 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psoriatic Arthritis, Drug Therapy, Latitude Research Program, Latitude PsA, Latitude PsA-3002