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RECRUITINGPhase 3INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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 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.

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). 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). 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). 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).

Treatments Being Tested

DRUG

Zasocitinib

Zasocitinib over-encapsulated tablets.

DRUG

Active Comparator

Active comparator capsule.

DRUG

Placebo

Zasocitinib or active comparator matching placebo.

Locations (20)

AARR- Chandler AZ
Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, United States
First OC Dermatology Research Inc.
Fountain Valley, California, United States
Purushotham & Akther Kotha MD
La Mesa, California, United States
Triwest Research Associates LLC
La Mesa, California, United States
The Cohen Medical Centers
Thousand Oaks, California, United States
Foothill Arthritis Clinic
Tujunga, California, United States
Medvin Clinical Research
Whittier, California, United States
Denver Arthritis Clinic | Denver, CO
Denver, Colorado, United States
Arthritis & Rheumatic Disease Specialties (AARDS)
Aventura, Florida, United States
RASF- Clinical Research Center
Boca Raton, Florida, United States
Clinical Research of West Florida | Clearwater, FL
Clearwater, Florida, United States
GNP Research, LLC | Hollywood, FL
Cooper City, Florida, United States
Driven Research LLC
Coral Gables, Florida, United States
Tectum Medical Research
Davie, Florida, United States
Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
Hialeah, Florida, United States
Bioresearch Partners
Miami, Florida, United States
HMD Research LLC
Orlando, Florida, United States