Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

NCT07286058 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: TAK-279-PsA-30032025-522586-30-00
• Study Type: interventional
• Target: 1,182
• Locations: 1 country
• Sites: 1

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

Keywords

Drug Therapy; Latitude PsA; Latitude PsA-3003

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  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)

  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

  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

  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 Outcomes (5)

• Percentage of Participants Achieving American College of Rheumatology (ACR20) Response at Weeks 24, 48, and 104

  At Weeks 24, 48, and 104

• Percentage of Participants Achieving ACR50 at Weeks 24, 48, and 104

  At Weeks 24, 48, and 104

• Percentage of Participants Achieving ACR70 at Weeks 24, 48, and 104

  At Weeks 24, 48, and 104

• Percentage of Participants Achieving Minimal Disease Activity (MDA) Status at Weeks 24, 48, and 104

  At Weeks 24, 48, and 104

• Percentage of Participants Achieving >=75 % Improvement From Baseline in PASI Score at Weeks 24, 48, and 104

  At Weeks 24, 48, and 104

Study Arms (2)

Zasocitinib Dose A or Dose B

EXPERIMENTAL

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

Re-randomized Participants - Zasocitinib Dose A or Dose B

EXPERIMENTAL

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

Interventions

Zasocitinib DRUG

Zasocitinib oral tablets.

Also known as: TAK- 279, NDI-034858

Re-randomized Participants - Zasocitinib Dose A or Dose B; Zasocitinib Dose A or Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 16, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 18, 2029
• Study Completion (Estimated): December 18, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)