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
Phase 2
Recruiting
60 enrolled
R-Pharm International, LLC
Atlant Clinical Ltd. · collabData Management 365 · collabExacte Labs LLC · collabKeystat, LLC · collabR-Pharm JSC · collabTRPharm İlaç Sanayi Ticaret Anonim Şirketi and ASCOT SCIENCE Education and Consulting Ltd. · collabUnimed Laboratories · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Subcutaneous |