Recruiting
Phase 3

Zasocitinib

Sponsor:

Takeda

Code:

NCT07286058

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zasocitinib

Study Details

Brief summary:

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.

Conditions

Psoriatic Arthritis

Study ID

NCT07286058

Start date

Mar 11, 2026

Status verified date

Jul, 2026

Completion date

Dec 18, 2029

Anticipated

Primary completion date

Dec 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Zasocitinib

Zasocitinib oral tablets.

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Locations

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

Denver Arthritis Clinic - Lowry

Recruiting

Denver, Colorado, United States, 80230

Contacts

Principal Investigator:

Christopher Antolini

Direct Helpers Research Center

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Principal Investigator:

Frank Don

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

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Site Contact

csesin1979@aol.com

Principal Investigator:

Carlos Sesin

IRIS Research and Development

Recruiting

Plantation, Florida, United States, 33324

Contacts

Principal Investigator:

Guillermo Valenzuela

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

Recruiting

Hagerstown, Maryland, United States, 21740-6138

Contacts

Principal Investigator:

Okechukwu Okoye

Paramount Medical Research & Consulting, LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

Principal Investigator:

Isam Diab

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 LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Principal Investigator:

Wajeeha Yousaf

Novel Research | Abigail Neiman - Houston, TX

Recruiting

Houston, Texas, United States, 77024

Contacts

Principal Investigator:

Abigail Neiman

Northwest Houston Arthritis Center

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

Advanced Rheumatology of Houston

Recruiting

The Woodlands, Texas, United States, 77382united

Contacts

Principal Investigator:

Tamar Brionez

More Information

Sponsor

Takeda

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Drug Therapy
  • Latitude PsA
  • Latitude PsA-3003

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 2026-08-03.