RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-03-10
Study Completion:2028-01-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06671496

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
  2. 2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
  3. 3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
  4. 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. 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. 6. The participant has had at least one of the following:
  7. 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
  8. 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
  9. 3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.
  1. 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. 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).

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Mesa, Arizona, 85210
United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Phoenix, Arizona, 85032
United States
Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ
Tucson, Arizona, 85748
United States
Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA
Covina, California, 91722
United States
Direct Helpers Medical Center
Hialeah, Florida, 33012
United States
IRIS Research and Development | Plantation, FL
Plantation, Florida, 33324
United States
BayCare Medical Group
Saint Petersburg, Florida, 33705
United States
North Georgia Rheumatology Group PC
Lawrenceville, Georgia, 30046
United States
Clinic of Robert Hozman
Skokie, Illinois, 60076
United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205
United States
Advanced Rheumatology PC | Lansing, MI
Lansing, Michigan, 48910-5894
United States
AARR- Kansas City Physician Partners
Kansas City, Missouri, 85032
United States
DJL Clinical Research | Charlotte, NC
Charlotte, North Carolina, 28210
United States
University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division
Cleveland, Ohio, 44106
United States
Altoona Center for Clinical Research | Ducansville, PA
Duncansville, Pennsylvania, 16635
United States
AARR- Lone Star Arthritis & Rheumatology Associates
Fort Worth, Texas, 76109
United States
Biopharma Informatic | Hassan
Houston, Texas, 77089
United States
Advanced Rheumatology of Houston - The Woodlands
The Woodlands, Texas, 77382
United States
Swedish Rheumatology Research
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2028-01-26

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2028-01-26

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy
  • Latitude Research Program
  • Latitude PsA
  • Latitude PsA-3002

Additional Relevant MeSH Terms

  • Psoriatic Arthritis