Clinical Trials List
2025-02-28 - 2028-08-30
Phase III
Recruiting5
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Apremilast
Dosage Form
030
Dosage
10mg, 20mg, 30mg
Endpoints
Inclution Criteria
Age:
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.
Disease Characteristics:
The participant has a diagnosis of PsA.
The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
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:
Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union [EU]/ European Economic Area [EEA]), OR
Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).
Exclusion Criteria
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).
The Estimated Number of Participants
-
Taiwan
15 participants
-
Global
1088 participants
