Clinical Trial

Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever

Recruiting Phase 2
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Summary
The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance or intolerance (i.e. colchicine resistant, crFMF), who completed the core study, during which they received at least one dose of RPH-104 (i.e. study patient population).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-01-12; most recent amendment 2024-12-10.
Trial Details
NCT Number NCT05190991
Lead Sponsor R-Pharm International, LLC
Collaborators: Atlant Clinical LLC, Unimed Laboratories, Data Management 365, R-Pharm JSC, TRPharm İlaç Sanayi Ticaret Anonim Şirketi and ASCOT SCIENCE Education and Consulting Ltd., Exacte Labs LLC, Key Stat LLC
Conditions Familial Mediterranean Fever, FMF
Enrollment 60 participants
Start Date 2021-10-05
Primary Completion 2028-12 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-16