Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
R-Pharm International, LLC
Collaborators:
Data Management 365 LLC Federal State Budgetary Educational Institution for Higher Education FSPbSMU n. a. I.P. Pavlov of the Ministry of Health of the Russian Federation Pharmaceutical Analytics Center LLC Scientific Center EFiS LLC