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

Description

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.

Conditions

Psoriatic Arthritis

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Psoriatic Arthritis
Intervention / Treatment

-

Contacts and Locations

Mesa

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ, Mesa, Arizona, United States, 85210

Phoenix

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ, Phoenix, Arizona, United States, 85032

Tucson

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ, Tucson, Arizona, United States, 85748

Covina

Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA, Covina, California, United States, 91722

Hialeah

Direct Helpers Medical Center, Hialeah, Florida, United States, 33012

Plantation

IRIS Research and Development | Plantation, FL, Plantation, Florida, United States, 33324

Saint Petersburg

BayCare Medical Group, Saint Petersburg, Florida, United States, 33705

Lawrenceville

North Georgia Rheumatology Group PC, Lawrenceville, Georgia, United States, 30046

Skokie

Clinic of Robert Hozman, Skokie, Illinois, United States, 60076

Bowling Green

Graves Gilbert Clinic, Bowling Green, Kentucky, United States, 42101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
  • 2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
  • 3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
  • 4. 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.
  • 5. 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.
  • 6. The participant has had at least one of the following:
  • 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), 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.
  • 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2028-01-26