drugset / Trial / NCT05432960
Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)
Phase 3
Withdrawn
R-Pharm International, LLC
Data Management 365 · collabExacte Labs LLC · collabMinistry of Health, Russian Federation · collabScientific Center EFiS · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the study is to evaluate the efficacy of RPH-104 when administered at a dose of 160 mg on Day 0, Day 7, Day 21 and then once every 2 weeks (Q2W) subcutaneous (SC) in patients with Adult Onset Still's Disease (AOSD). Furthermore, the study is scheduled to investigate pharmacokinetic (PK) and pharmacodynamic (PD) parameters of RPH-104.
Timeline
- Start
- 2023-12
- Primary completion
- 2025-08
- Completion
- 2025-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Subcutaneous |