Overview

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

Status:
Recruiting

Trial end date:
2023-03-23

Target enrollment:

Participant gender:

Summary

The primary purpose of this study is to assess the efficacy and safety profiles of investigational product RPH-104 (R-Pharm Overseas, Inc., USA) for treatment of Familial Mediterranean Fever (FMF) in adult patients resistant/intolerant to colchicine (crFMF). Pharmacokinetic and pharmacodynamic parameters of RPH-104 single or multiple doses in this patient population will be assessed as well.

Phase:

Phase 2

Details

Lead Sponsor:

R-Pharm International, LLC

Collaborators:

Atlant Clinical LLC
Center of Pharmaceutical Analytics LLC
Data Management 365 LLC
R-Pharm
Unimed Laboratories CJSC