Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

July 31, 2026 updated by: Takeda

A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs

Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.

The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.

Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).

Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Victoria Park, Western Australia, Australia, 6100
        • Recruiting
        • R.K. Will Pty Ltd
        • Principal Investigator:
          • Robert Will
        • Contact:
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Xiaofeng Zeng
        • Contact:
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Rong MU
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoyan Cai
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Recruiting
        • Central South University - Xiangya School of Medicine - Zhuzhou Central Hospital
        • Principal Investigator:
          • Jing-yang Li
        • Contact:
    • Shandong
      • Linyi Shi, Shandong, China, 276000
        • Recruiting
        • Linyi People's Hospital
        • Principal Investigator:
          • Zunzhong Li
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Zili Fu
  • Czechia
      • Uherské Hradiště, Czechia, 68601
        • Recruiting
        • MEDICAL Plus s.r.o.
        • Principal Investigator:
          • Eva Dokoupilova
        • Contact:
      • Zlín, Czechia, 760 01
        • Recruiting
        • Pv Medical Services
        • Principal Investigator:
          • Petr Vitek
        • Contact:
  • Estonia
      • Tallinn, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre Foundation
        • Principal Investigator:
          • Eve-Kai Raussi
        • Contact:
      • Tartu, Estonia, 50708
  • Germany
      • Hamburg, Germany, 20095
        • Recruiting
        • Hamburger Rheuma Forschungszentrum (HRF II) II
        • Principal Investigator:
          • Andrea Everding
        • Contact:
  • Israel
      • Nahariya, Israel, 2210001
        • Recruiting
        • Galilee Medical Center
        • Contact:
        • Principal Investigator:
          • Mohammad E. Naffaa
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital
        • Principal Investigator:
          • Akimichi Morita
        • Contact:
    • Mie-ken
      • Tsu, Mie, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Principal Investigator:
          • Keiichi Yamanaka
        • Contact:
    • Osaka
      • Osaka, Osaka, Japan, 550-0006
        • Recruiting
        • Nippon Life Hospital
        • Principal Investigator:
          • Shigeyoshi Tsuji
        • Contact:
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital
        • Principal Investigator:
          • Satoshi Kawaai
        • Contact:
      • Meguro-Ku, Tokyo, Japan, 152-8902
        • Recruiting
        • National Hospital Organization Tokyo Medical Center
        • Principal Investigator:
          • Katsuya Suzuki
        • Contact:
    • Tokyo-To
      • Mitaka-shi, Tokyo-To, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital
        • Principal Investigator:
          • Mitsumasa Kishimoto
        • Contact:
  • Poland
      • Bialystok, Poland, 15-077
        • Recruiting
        • INTER CLINIC Piotr Adrian Klimiuk
        • Contact:
        • Principal Investigator:
          • Piotr Klimiuk
      • Krakow, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Mariusz Korkosz
        • Contact:
      • Poznan, Poland, 61-397
        • Recruiting
        • Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
        • Principal Investigator:
          • Pawel Hrycaj
        • Contact:
      • Torun, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun
        • Principal Investigator:
          • Slawomir Jeka
        • Contact:
          • Site Contact
          • Phone Number: 48 606453300
          • Email: s.jeka@wp.pl
      • Warsaw, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
        • Principal Investigator:
          • Janusz Jaworski
        • Contact:
      • Warsaw, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by PRATIA - PPDS
        • Principal Investigator:
          • Robert Rupinski
        • Contact:
      • Warsaw, Poland, 02-677
        • Recruiting
        • ETG Warszawa Sp. z o.o.
        • Principal Investigator:
          • Anna Rowinska-Osuch
        • Contact:
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Centro Reumatologico de Caguas
        • Principal Investigator:
          • Amarilis Perez De Jesus
        • Contact:
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • GCM Medical Group, PSC
        • Principal Investigator:
          • Karina Vila-Rivera
        • Contact:
  • United States
    • California
      • Fountain Valley, California, United States, 92708
      • La Mesa, California, United States, 91942
        • Recruiting
        • Purushotham & Akther Kotha MD
        • Principal Investigator:
          • Roshan Kotha
        • Contact:
      • La Mesa, California, United States, 91942
        • Recruiting
        • Triwest Research Associates LLC
        • Principal Investigator:
          • Arthur Ray Mabaquiao
        • Contact:
      • Thousand Oaks, California, United States, 91360-3967
        • Recruiting
        • The Cohen Medical Centers
        • Principal Investigator:
          • Shariar Cohen-Gadol
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic - Lowry
        • Principal Investigator:
          • Christopher Antolini
        • Contact:
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Research Center
        • Principal Investigator:
          • Frank Don
        • Contact:
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
        • Principal Investigator:
          • Carlos Sesin
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development
        • Principal Investigator:
          • Guillermo Valenzuela
        • Contact:
    • Maryland
      • Hagerstown, Maryland, United States, 21740-6138
        • Recruiting
        • Klein and Associates, M.D., P.A.
        • Principal Investigator:
          • Okechukwu Okoye
        • Contact:
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Principal Investigator:
          • Isam Diab
        • Contact:
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Principal Investigator:
          • Jacob Aelion
        • Contact:
    • Texas
      • Baytown, Texas, United States, 77521
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Novel Research LLC
        • Principal Investigator:
          • Wajeeha Yousaf
        • Contact:
      • Houston, Texas, United States, 77090
        • Recruiting
        • Northwest Houston Arthritis Center
        • Contact:
        • Principal Investigator:
          • Adnan Peer
      • Houston, Texas, United States, 77024
        • Recruiting
        • Novel Research | Abigail Neiman - Houston, TX
        • Principal Investigator:
          • Abigail Neiman
        • Contact:
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • West Texas Clinical Research
        • Principal Investigator:
          • Jitendra Vasandani
        • Contact:
      • The Woodlands, Texas, United States, 77382united
        • Recruiting
        • Advanced Rheumatology of Houston
        • Principal Investigator:
          • Tamar Brionez
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.
  2. The participant has completed the 52-week treatment period in one of the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002) independent of treatment assignment, and without meeting the criteria for permanent discontinuation of trial intervention defined in the parent studies.
  3. The participant must be deemed by the investigator to benefit from continued or newly initiated (that is, for participants randomized to active comparator in parent study TAK-279-PsA-3001) zasocitinib therapy.

Exclusion Criteria:

  1. Any participant who is deemed by the investigator to be not benefiting from the trial intervention based upon lack of improvement or worsening of their symptoms in the respective parent study.
  2. Any participant who met the criteria for permanent discontinuation of trial intervention defined in the parent studies (TAK-279-PsA-3001 or TAK-279-PsA-3002).
  3. The participant has developed any disease(s) that might confound the evaluations of benefit of zasocitinib therapy since enrollment in the respective parent study, including but not limited to rheumatoid arthritis, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
  4. The participant has developed evidence of 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zasocitinib Dose A or Dose B
Participants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 [NCT06671483] or TAK-279-PsA-3002 [NCT06671496]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.
Drug: Zasocitinib
Zasocitinib oral tablets.
Other Names:
  • NDI-034858
  • TAK- 279
Experimental: Re-randomized Participants - Zasocitinib Dose A or Dose B
Participants assigned to active comparator in the parent study (TAK-279-PsA-3001 [NCT06671483]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.
Drug: Zasocitinib
Zasocitinib oral tablets.
Other Names:
  • NDI-034858
  • TAK- 279

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: From start of study drug administration up to follow-up (up to Week 108)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Adverse Events of Special Interest (AESI)
Time Frame: From start of study drug administration up to follow-up (up to Week 108)
An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time Frame: From start of study drug administration up to follow-up (up to Week 108)
Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
From start of study drug administration up to follow-up (up to Week 108)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Time Frame: From start of study drug administration up to follow-up (up to Week 108)
Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.
From start of study drug administration up to follow-up (up to Week 108)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104
Time Frame: At Weeks 24, 48, and 104
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as greater than or equal to (>=) 20 percentage (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and >=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of PsA pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP).
At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104
Time Frame: At Weeks 24, 48, and 104
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs) and PROs. An ACR50 response is defined as >=50% improvement from baseline in both SJC66 and TJC68, and >=50% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP.
At Weeks 24, 48, and 104
Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104
Time Frame: At Weeks 24, 48, and 104
ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite COA measure that includes both ClinROs) and PROs. An ACR70 response is defined as >=70% improvement from baseline in both SJC66 and TJC68, and >=70% improvement from baseline in 3 of the following 5 assessments: PtGA of PsA pain; PtGA of PsA; PGA of PsA; participant's assessment of physical function as measured by HAQ-DI; hsCRP.
At Weeks 24, 48, and 104
Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104
Time Frame: At Weeks 24, 48, and 104
The MDA is defined as a composite outcome measure of 7 ClinROs and PROs used in PsA. Participants are classified as achieving MDA if they fulfil 5 of 7 outcome measures: TJC68 less than or equal to (<=) 1, SJC66 <=1, psoriasis area and severity index (PASI) score <=1 or body surface area (BSA) affected by psoriasis (PsO) <=3%, PtGA of PsA Pain score <=15, PtGA of PsA score <=20, HAQ-DI <=0.5, and Leeds Enthesitis Index (LEI) <=1.
At Weeks 24, 48, and 104
Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104
Time Frame: At Weeks 24, 48, and 104
A PASI-75 response is defined as >=75% improvement in the PASI score from baseline. It is a ClinRO used to measure PsO severity, combining the percentage of surface area of skin affected with the severity of erythema, induration, and desquamation across four body regions: head, upper extremities, trunk, and lower extremities. Severity is scored on a 0-4 scale, with 0 indicating a complete lack of cutaneous involvement and 4 indicating the severest possible involvement. PASI scores range from 0 to 72, with <=3 representing mild disease, >=3 to 15 representing moderate disease, and >=15 indicating severe disease.
At Weeks 24, 48, and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

December 18, 2029

Study Completion (Estimated)

December 18, 2029

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-279-PsA-3003
  • 2025-522586-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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