drugset
drugset / Trial / NCT05337553

A Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Participants With Spinal Muscular Atrophy

NCT05337553 ↗

Phase 3 Active not recruiting 269 enrolled Biohaven Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen and/or risdiplam and/or have a history of onasemnogene abeparvovec, compared to placebo.

Timeline

Start
2022-07-06
Primary completion
2024-09-25
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Taldefgrobep Alfa Protein / enzyme biologic 35 mg Subcutaneous
Subject Taldefgrobep Alfa Protein / enzyme biologic 50 mg Subcutaneous

Indications

spinal muscular atrophy