drugset / Trial / NCT05190991

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

NCT05190991

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2021-10-05
Primary completion
2028-12
Completion
2029-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Goflikicept Monoclonal antibody 80 mg Subcutaneous
Subject Goflikicept Monoclonal antibody 160 mg Subcutaneous