drugset / Trial / NCT06666335
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with colchicine-resistand Familial Mediterranian Fever (FMF). The study consists of up to one month screening, to see if a patient is suitable to the study, 6 months of treatment with anakinra and one month safety follow up after last dose of anakinra. In total 3 patients, male and female from 2 years of age (minimum 10kg weight), will be enrolled to the study.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2027-08-30
- Completion
- 2027-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |
| Subject | Anakinra | Protein / enzyme biologic | 2 mg/kg | Subcutaneous |
| Subject | Anakinra | Protein / enzyme biologic | 4 mg/kg | Subcutaneous |
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Anakinra | Protein / enzyme biologic | 200 mg | Subcutaneous |