drugset / Trial / NCT05092776
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
Phase 2
Active not recruiting
84 enrolled
R-Pharm International, LLC
Ascot Eğitim ve Danışmanlık LTD. ŞTİ. · collabAtlant 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
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-04-29
- Primary completion
- 2025-01
- Completion
- 2025-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Subcutaneous |