A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002) (LATITUDE-PsA-3002)

Takeda Pharmaceutical Company Limited0 个研究点目标入组 600 人开始时间: 2025年3月10日最近更新: 2025年4月28日

适应症

试验速览

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•The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
•Disease Characteristics:
•The participant has had signs and symptoms consistent with PsA for at least 3 months.
•The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
•The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
•The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.
•Medications for PsA:
•The participant has had at least one of the following:
•a) Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
•b) Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
•c) Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.

•PsA and PsO:
•The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
•The participant has 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).

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