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Clinical Trials List

Protocol NumberTAK-279-PsA-3003
NCT Number(ClinicalTrials.gov Identfier)NCT07286058
Not yet recruiting

2026-07-01 - 2030-06-30

Phase III

Not yet recruiting2

Recruiting3

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

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/08

Investigators and Locations

Principal Investigator TSEN-FANG TSAI Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 魏正宗 Division of Rheumatology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 吳建陞醫師 Division of Rheumatology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宏安 風濕免疫科
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Meng-Yu Weng
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Psoriatic Arthritis

Objectives

這是一項第 3 期、多中心、長期延伸試驗，旨在評估 zasocitinib 在完成 TAK-279-PsA-3001 或 TAK-279-PsA-3002 兩項主試驗之一的 52 週雙盲治療期的活動性乾癬性關節炎 (PsA) 成年受試者中的長期安全性、耐受性和療效。

Test Drug

錠劑

Active Ingredient

Zasocitinib (TAK-279) 或安慰劑

Dosage Form

110

Dosage

15 mg

Endpoints

•治療引發不良事件的發生率。
•嚴重不良事件的發生率。
•特別關注不良事件的發生率。
•生命徵象和臨床檢驗值參數的變化。

Inclution Criteria

Inclusion Criteria:

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.

Exclusion Criteria

Exclusion Criteria:

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).

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    1182 participants

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