Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis

NCT ID: NCT07286058

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-27
• Study Completion Date: 2029-12-18

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Zasocitinib

Intervention Type: DRUG

Zasocitinib oral tablets.

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.

Group Type: EXPERIMENTAL

Zasocitinib

Intervention Type: DRUG

Zasocitinib oral tablets.

Interventions

Zasocitinib

Zasocitinib oral tablets.

Intervention Type: DRUG

Other Intervention Names

TAK- 279; NDI-034858

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Central Contacts

Takeda Contact

Role: CONTACT

medinfoUS@takeda.com

+1-877-825-3327

Other Identifiers

2025-522586-30-00

Identifier Type: CTIS

Identifier Source: secondary_id

TAK-279-PsA-3003

Identifier Type: -

Identifier Source: org_study_id