RECRUITINGPhase 3INTERVENTIONAL
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
Age:
1. The participant is aged 18 years or older at the time of signing the willing to sign a consent form 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.
Who Should NOT Join This Trial:
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).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
DRUG
Zasocitinib
Zasocitinib tablets.
DRUG
Placebo
Zasocitinib matching placebo.
Locations (20)
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Tucson, Arizona, United States
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
Covina, California, United States
RASF- Clinical Research Center
Boca Raton, Florida, United States
Direct Helpers Medical Center
Hialeah, Florida, United States
IRIS Research and Development | Plantation, FL
Plantation, Florida, United States
BayCare Medical Group
St. Petersburg, Florida, United States
North Georgia Rheumatology Group PC
Lawrenceville, Georgia, United States
Clinic of Robert Hozman
Skokie, Illinois, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Advanced Rheumatology PC | Lansing, MI
Lansing, Michigan, United States
AARR- Kansas City Physician Partners
Kansas City, Missouri, United States
DJL Clinical Research | Charlotte, NC
Charlotte, North Carolina, United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
Cleveland, Ohio, United States
Altoona Center for Clinical Research | Ducansville, PA
Duncansville, Pennsylvania, United States
AARR- Lone Star Arthritis & Rheumatology Associates
Fort Worth, Texas, United States
Biopharma Informatic | Hassan
Houston, Texas, United States
Advanced Rheumatology of Houston - The Woodlands
The Woodlands, Texas, United States