Recruiting
Phase 3

Zasocitinib

Sponsor:

Takeda

Code:

NCT06671496

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zasocitinib

Placebo

Study Details

Brief summary:

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 ID

NCT06671496

Start date

Mar 10, 2025

Status verified date

Aug, 2026

Completion date

Jan 26, 2028

Anticipated

Primary completion date

May 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zasocitinib Dose A

Participants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.

experimental: Zasocitinib Dose B

Participants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.

experimental: Placebo + Zasoctinib

Participants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.

Interventions

Zasocitinib

Zasocitinib tablets.

Placebo

Zasocitinib matching placebo.

Primary outcome measure

  • Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [ Time Frame: At Week 16 ]

Central Contacts and Locations

Central contacts

Locations

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Mesa, Arizona, United States, 85210

Contacts

Principal Investigator:

Swati Bharadwaj

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Principal Investigator:

Joonhee Lim

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Tucson, Arizona, United States, 85748

Contacts

Principal Investigator:

Jeffrey Loomer

Biovin Enterprises LLC dba Medvin Clinical Research | Covina, CA

Recruiting

Covina, California, United States, 91722

Contacts

Principal Investigator:

Samy Metyas

RASF- Clinical Research Center

Recruiting

Boca Raton, Florida, United States, 33486-1390

Contacts

Principal Investigator:

Shawn Baca

Direct Helpers Medical Center

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Site Contact

Don@dhrtrials.com

Principal Investigator:

Frank Don

IRIS Research and Development | Plantation, FL

Recruiting

Plantation, Florida, United States, 33324

Contacts

Principal Investigator:

Guillermo Valenzuela

BayCare Medical Group

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Principal Investigator:

Sonialy Lugo Ruiz

North Georgia Rheumatology Group PC

Recruiting

Lawrenceville, Georgia, United States, 30046

Contacts

Site Contact

tolfmd@aol.com

Principal Investigator:

Theresa Lawrence Ford

Graves Gilbert Clinic

Recruiting

Bowling Green, Kentucky, United States, 42101

Contacts

Principal Investigator:

Asad Fraser

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Principal Investigator:

Ana-Maria Orbai

Advanced Rheumatology PC | Lansing, MI

Recruiting

Lansing, Michigan, United States, 48910-5894

Contacts

Principal Investigator:

Monika Mohan

AARR- Kansas City Physician Partners

Recruiting

Kansas City, Missouri, United States, 85032

Contacts

Principal Investigator:

Tina Shah

DJL Clinical Research | Charlotte, NC

Recruiting

Charlotte, North Carolina, United States, 28210

Contacts

Principal Investigator:

Emily Jane Herron Box

University Hospitals | UH Cleveland Medical Center - Department of Medicine - Rheumatology Division

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Marina Magrey

Paramount Medical Research & Consulting, LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Principal Investigator:

Isam Diab

Altoona Center for Clinical Research | Ducansville, PA

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Site Contact

ajkivitz@yahoo.com

Principal Investigator:

Alan Kivitz

AARR- Lone Star Arthritis & Rheumatology Associates

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

Principal Investigator:

Himabindu Reddy

Biopharma Informatic | Hassan

Recruiting

Houston, Texas, United States, 77089

Contacts

Principal Investigator:

Laila Hassan

Advanced Rheumatology of Houston - The Woodlands

Recruiting

The Woodlands, Texas, United States, 77382

Contacts

Principal Investigator:

Tamar Brionez

Swedish Rheumatology Research

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Philip Mease

Niagara Rheumatology Research Centre | Ontario, Canada

Recruiting

Niagara Falls, Ontario, Canada, L2E 6A6

Contacts

Principal Investigator:

Rajwinder Dhillon

G.R.M.O. Inc.

Recruiting

Québec, Quebec, Canada, G1V 3M7

Contacts

Principal Investigator:

Philippe Desaulniers

More Information

Sponsor

Takeda

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-08-11.