Testing Zasocitinib for Psoriatic Arthritis in Adults
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
This study is testing a new medication called zasocitinib to see if it can help adults with active psoriatic arthritis who haven't tried biologic treatments before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1088 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | zasocitinib |
| Locations | 189 sites (Chandler, Arizona and 188 other locations) |
| Trial ID | NCT06671483 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of zasocitinib (TAK-279) in adults with active psoriatic arthritis (PsA) who have not previously received biologic treatments. Participants will be randomly assigned to receive either zasocitinib, an active comparator, or a placebo for up to 60 weeks. The study aims to assess improvements in joint and skin symptoms associated with PsA. Inclusion criteria include having active arthritis and meeting specific classification criteria for PsA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with active psoriatic arthritis and a history of inadequate response to NSAIDs or conventional DMARDs.
Not a fit: Patients who have previously been treated with biologic disease-modifying antirheumatic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with psoriatic arthritis who have not responded to traditional therapies.
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). 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).
Where this trial is running
Chandler, Arizona and 188 other locations
- AARR- Chandler AZ — Chandler, Arizona, United States (Recruiting)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (Recruiting)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (Recruiting)
- Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix, Arizona, United States (Recruiting)
- First OC Dermatology Research Inc. — Fountain Valley, California, United States (Recruiting)
- Purushotham & Akther Kotha MD — La Mesa, California, United States (Recruiting)
- Triwest Research Associates LLC — La Mesa, California, United States (Recruiting)
- The Cohen Medical Centers — Thousand Oaks, California, United States (Recruiting)
- Foothill Arthritis Clinic — Tujunga, California, United States (Recruiting)
- Medvin Clinical Research — Whittier, California, United States (Recruiting)
- Denver Arthritis Clinic | Denver, CO — Denver, Colorado, United States (Recruiting)
- Arthritis & Rheumatic Disease Specialties (AARDS) — Aventura, Florida, United States (Recruiting)
- RASF- Clinical Research Center — Boca Raton, Florida, United States (Recruiting)
- Clinical Research of West Florida | Clearwater, FL — Clearwater, Florida, United States (Recruiting)
- GNP Research, LLC | Hollywood, FL — Cooper City, Florida, United States (Recruiting)
- Driven Research LLC — Coral Gables, Florida, United States (Recruiting)
- Tectum Medical Research — Davie, Florida, United States (Recruiting)
- Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research — Hialeah, Florida, United States (Recruiting)
- Bioresearch Partners — Miami, Florida, United States (Recruiting)
- HMD Research LLC — Orlando, Florida, United States (Recruiting)
- Millennium Research | Ormond Beach, FL — Ormond Beach, Florida, United States (Recruiting)
- IRIS Research and Development | Plantation, FL — Plantation, Florida, United States (Recruiting)
- Sarasota Arthritis Research Center — Sarasota, Florida, United States (Recruiting)
- West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States (Recruiting)
- Clinical Research of West Florida | Tampa, FL — Tampa, Florida, United States (Recruiting)
- Marietta Rheumatology Associates — Marietta, Georgia, United States (Recruiting)
- Gscp/cis — Orland Park, Illinois, United States (Recruiting)
- Greater Chicago Specialty Physicians LLC/CIS — Schaumburg, Illinois, United States (Recruiting)
- Accurate Clinical Research, Inc. | Lake Charles — Lake Charles, Louisiana, United States (Recruiting)
- Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States (Recruiting)
- Henry Ford Health System-Rheumatology Department — Detroit, Michigan, United States (Not_yet_recruiting)
- Michigan Rheumatology Group, P.C. - Grand Blanc Office — Grand Blanc, Michigan, United States (Recruiting)
- Ash Research Clinic - Howell — Howell, Michigan, United States (Recruiting)
- June DO, PC Private Practice - Dr. Justus Fiechtner — Lansing, Michigan, United States (Recruiting)
- Clinical Research Institute of Michigan — Saint Clair Shores, Michigan, United States (Recruiting)
- Saint Louis Rheumatology — St Louis, Missouri, United States (Recruiting)
- Albuquerque Center for Rheumatology PC — Albuquerque, New Mexico, United States (Recruiting)
- Santa Fe Rheumatology — Santa Fe, New Mexico, United States (Recruiting)
- NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department — Brooklyn, New York, United States (Recruiting)
- Accellacare of Hickory — Hickory, North Carolina, United States (Recruiting)
- University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division — Cleveland, Ohio, United States (Recruiting)
- Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States (Recruiting)
- PA Regional Center for Arthritis and Osteoporosis Research — Wyomissing, Pennsylvania, United States (Recruiting)
- West Tennessee Research Institute — Jackson, Tennessee, United States (Recruiting)
- Accurate Clinical Research — Baytown, Texas, United States (Recruiting)
- Novel Research | Bellaire Location — Houston, Texas, United States (Recruiting)
- Novel Research | Bellaire Location — Houston, Texas, United States (Recruiting)
- Accurate Clinical Research — Houston, Texas, United States (Recruiting)
- Introscience Research | Northwest Houston Arthritis Center - Houston, TX — Houston, Texas, United States (Recruiting)
- West Texas Clinical Research — Lubbock, Texas, United States (Recruiting)
+139 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.