Recruiting
Phase 3

Zasocitinib

Sponsor:

Takeda

Code:

NCT06671483

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zasocitinib

Active Comparator

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 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.

Conditions

Psoriatic Arthritis

Study ID

NCT06671483

Start date

Mar 3, 2025

Status verified date

Aug, 2026

Completion date

Jan 28, 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). 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).

Study Design

Enrollment

1088 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.

active comparator: Active Comparator Dose C

Participants will receive active comparator Dose C, capsules, orally, twice daily (BID) 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 over-encapsulated tablets.

Active Comparator

Active comparator capsule.

Placebo

Zasocitinib or active comparator 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

AARR- Chandler AZ

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Principal Investigator:

Amer Al-Khoudari

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Principal Investigator:

Nehad Soloman

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Principal Investigator:

Saima Chohan

Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ

Recruiting

Phoenix, Arizona, United States, 85306

Contacts

Principal Investigator:

Andrew Sharobeem

First OC Dermatology Research Inc.

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Vivian Laquer

Purushotham & Akther Kotha MD

Recruiting

La Mesa, California, United States, 91942

Contacts

Principal Investigator:

Roshan Kotha

Triwest Research Associates LLC

Recruiting

La Mesa, California, United States, 91942

Contacts

Principal Investigator:

Arthur Ray Mabaquiao

The Cohen Medical Centers

Recruiting

Thousand Oaks, California, United States, 91360-3967

Contacts

Principal Investigator:

Shariar Cohen-Gadol

Foothill Arthritis Clinic

Recruiting

Tujunga, California, United States, 91042

Contacts

Principal Investigator:

Dan La

Medvin Clinical Research

Recruiting

Whittier, California, United States, 90602-1005

Contacts

Principal Investigator:

Tien-I Karleen Su

Denver Arthritis Clinic | Denver, CO

Recruiting

Denver, Colorado, United States, 80230

Contacts

Principal Investigator:

Christopher Antolini

Arthritis & Rheumatic Disease Specialties (AARDS)

Recruiting

Aventura, Florida, United States, 33180

Contacts

Principal Investigator:

Norman Gaylis

RASF- Clinical Research Center

Recruiting

Boca Raton, Florida, United States, 33486-1390

Contacts

Principal Investigator:

Shawn Baca

Clinical Research of West Florida | Clearwater, FL

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Principal Investigator:

Robert Levin

GNP Research, LLC | Hollywood, FL

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Principal Investigator:

Mark Jaffe

Driven Research LLC

Recruiting

Coral Gables, Florida, United States, 33134-3901

Contacts

Principal Investigator:

Javier Alonso-Llamazares

Tectum Medical Research

Recruiting

Davie, Florida, United States, 33024

Contacts

Principal Investigator:

Lilliam Miranda

Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Principal Investigator:

Carlos Sesin

Bioresearch Partners

Recruiting

Miami, Florida, United States, 33143

Contacts

Principal Investigator:

Olga Kromo

HMD Research LLC

Recruiting

Orlando, Florida, United States, 32819

Contacts

Principal Investigator:

Marvin Heuer

Millennium Research | Ormond Beach, FL

Recruiting

Ormond Beach, Florida, United States, 32174

Contacts

Principal Investigator:

Michael Kohen

IRIS Research and Development | Plantation, FL

Recruiting

Plantation, Florida, United States, 33324

Contacts

Principal Investigator:

Guillermo Valenzuela

Sarasota Arthritis Research Center

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Principal Investigator:

Jesse Boodoo

West Broward Rheumatology Associates, Inc.

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Principal Investigator:

Laurie Ramrattan

Clinical Research of West Florida | Tampa, FL

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

John Carter

Marietta Rheumatology Associates

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Principal Investigator:

Roel Querubin

GSCP/CIS

Recruiting

Orland Park, Illinois, United States, 60467

Contacts

Principal Investigator:

Cory Conniff

Greater Chicago Specialty Physicians LLC/CIS

Recruiting

Schaumburg, Illinois, United States, 60195

Contacts

Principal Investigator:

Kamran Chaudhary

Accurate Clinical Research, Inc. | Lake Charles

Recruiting

Lake Charles, Louisiana, United States, 70605

Contacts

Principal Investigator:

Enrique Mendez

Klein & Associates, M.D., P.A.

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Principal Investigator:

Mary Howell

Michigan Rheumatology Group, P.C. - Grand Blanc Office

Recruiting

Grand Blanc, Michigan, United States, 48439-2451

Contacts

Principal Investigator:

Ali Karrar

Ash Research Clinic - Howell

Recruiting

Howell, Michigan, United States, 48843

Contacts

Principal Investigator:

Mir M Asghar

June DO, PC Private Practice - Dr. Justus Fiechtner

Recruiting

Lansing, Michigan, United States, 48911-4285

Contacts

Principal Investigator:

Joshua June

Clinical Research Institute of Michigan

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Contacts

Principal Investigator:

Andrew Sulich

Saint Louis Rheumatology

Recruiting

St Louis, Missouri, United States, 63119

Contacts

Principal Investigator:

Chad Ronholm

Albuquerque Center for Rheumatology PC

Recruiting

Albuquerque, New Mexico, United States, 87102-1710

Contacts

Principal Investigator:

Leroy Pacheco

Santa Fe Rheumatology

Recruiting

Santa Fe, New Mexico, United States, 87505-1102

Contacts

Principal Investigator:

Hillary Norton

NYU Langone Health | Joseph S. and Diane H. Steinberg Ambulatory Care Center - Rheumatology Department

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Principal Investigator:

David Goddard

Accellacare of Hickory

Recruiting

Hickory, North Carolina, United States, 28602

Contacts

Principal Investigator:

Ronald Caldwell

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

PA Regional Center for Arthritis and Osteoporosis Research

Recruiting

Wyomissing, Pennsylvania, United States, 19610-3206

Contacts

Principal Investigator:

Gregory Emkey

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

Principal Investigator:

Jacob Aelion

Accurate Clinical Research

Recruiting

Baytown, Texas, United States, 77521

Contacts

Principal Investigator:

Sabeen Najam

Novel Research | Bellaire Location

Recruiting

Houston, Texas, United States, 77024

Contacts

Principal Investigator:

Wajeeha Yousaf

Novel Research | Bellaire Location

Recruiting

Houston, Texas, United States, 77024

Contacts

Principal Investigator:

Abigail Neiman

Accurate Clinical Research

Recruiting

Houston, Texas, United States, 77089

Contacts

Principal Investigator:

Philip Waller

Introscience Research | Northwest Houston Arthritis Center - Houston, TX

Recruiting

Houston, Texas, United States, 77090

Contacts

Principal Investigator:

Adnan Peer

West Texas Clinical Research

Recruiting

Lubbock, Texas, United States, 79424

Contacts

Principal Investigator:

Jitendra Vasandani

Southwest Rheumatology Research, LLC | Mesquite, TX

Recruiting

Mesquite, Texas, United States, 75150

Contacts

Principal Investigator:

Atul Singhal

Clinical Investigations of Texas

Recruiting

Plano, Texas, United States, 75075

Contacts

Principal Investigator:

Fehmida Zahabi

Arthritis Northwest, PLLC | Spokane, WA

Recruiting

Spokane, Washington, United States, 99204

Contacts

Principal Investigator:

Michael Coan

More Information

Sponsor

Takeda

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Drug Therapy
  • Latitude Research Program
  • Latitude PsA
  • Latitude PsA-3001

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