A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines

Launched by TAKEDA · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called zasocitinib (also known as TAK-279) to see how well it works for adults with psoriatic arthritis (PsA). PsA is a long-term condition that causes pain and swelling in the joints and can also affect the skin. The trial is looking for participants who have experienced symptoms of PsA for at least three months and have had trouble managing their condition with previous treatments. Participants must be 18 years or older and have specific signs of active arthritis and skin issues related to psoriasis.

If you join this study, you will receive either the new medication or a placebo (a harmless pill with no active ingredients) for up to 60 weeks. This means that some people will receive the actual treatment, while others will receive a placebo to help researchers understand the medication's effects better. The study is currently recruiting participants, and it’s important to note that certain health conditions may make you ineligible for participation. If you're interested, talk to your doctor about whether this trial might be a good option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Age:
• • 1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).
• Disease Characteristics:
• • 2. The participant has had signs and symptoms consistent with PsA for at least 3 months.
• • 3. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
• • 4. 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.
• • 5. 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:
• 6. The participant has had at least one of the following:
• • 1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID), OR
• • 2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR
• • 3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.
• Exclusion Criteria:
• PsA and PsO:
• • 1. 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.
• • 2. 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).