Clinical Trial

Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine

Active, Not Recruiting Phase 2
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Record status
This record was last updated December 6, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
Study purpose is an evaluation of efficacy and safety of RPH-104 in the population of subjects with Familial Mediterranean Fever (FMF) with colchicine resistance or intolerance(i.e. colchicine resistant (crFMF).. Primary objective is to determine proportion of subjects with complete response to treatment with RPH-104 compared to placebo among FMF subjects with colchicine resistance or intolerance.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-10-12; most recent amendment 2024-12-03.
Status change: Recruiting → Active, Not Recruiting 2024-12-03
Trial Details
NCT Number NCT05092776
Lead Sponsor R-Pharm International, LLC
Collaborators: Data Management 365, Atlant Clinical LLC, R-Pharm JSC, Unimed Laboratories, Exacte Labs LLC, Key Stat LLC, TRPharm İlaç Sanayi Ticaret Anonim Şirketi and ASCOT SCIENCE Education and Consulting Ltd., Ascot Eğitim ve Danışmanlık LTD. ŞTİ.
Conditions Familial Mediterranean Fever, FMF
Enrollment 84 participants
Start Date 2021-04-29
Primary Completion 2025-01 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-06