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drugset / Trial / NCT05626855

Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab

NCT05626855 ↗

Phase 3 Active not recruiting 238 enrolled Scholar Rock, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.

Timeline

Start
2023-04-17
Primary completion
2026-11-01
Completion
2029-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Apitegromab Monoclonal antibody 20 mg/kg Intravenous

Indications

muscular atrophy spinal muscular atrophy, type II spinal muscular atrophy, type III