A Phase 1b, Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)

What this Trial Is About

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes the drug JTE-162 in adults with Cryopyrin-associated Periodic Syndrome (CAPS). This phase 1b, open-label study focuses on individuals diagnosed with familial cold autoinflammatory syndrome or Muckle-Wells syndrome, both forms of CAPS, to better understand the treatment's impact on this rare condition. The study is sponsored by Akros Pharma Inc. and aims to collect detailed information on inflammation markers and symptom changes. Participants will receive JTE-162 tablets once daily for two weeks. The study does not include a comparison group or placebo and is designed as a single-arm trial. During the treatment period, participants will take the study drug daily, and various blood tests and symptom assessments will be conducted to monitor response and drug levels in the body. Throughout the study, participants will undergo regular evaluations including measurements of inflammation markers such as high-sensitivity C-reactive protein, serum amyloid A, and interleukin-6. Symptom scores and global disease activity assessments will also be recorded. Adverse events will be monitored for four weeks to assess safety. The total study duration includes treatment and follow-up assessments, with detailed pharmacokinetic sampling on several days during the two-week period.

Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)