drugset
drugset / Trial / NCT04768062

Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)

NCT04768062 ↗

Phase 3 Unknown 74 enrolled NS Pharma, Inc. Nippon Shinyaku Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 3, multi-center, open-label extension study in ambulant boys with DMD who have completed the 48-week treatment period of either viltolarsen or placebo in Study NS-065/NCNP-01-301.

Timeline

Start
2021-04-13
Primary completion
2025-10
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Viltolarsen Unknown 80 mg/kg Intravenous

Indications

Duchenne muscular dystrophy