clinical trial · NCT05156320
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
Scholar Rock, Inc.·phase3·completed·n = 188
Spinal Muscular AtrophySpinal Muscular Atrophy Type 3Spinal Muscular Atrophy Type 2SMANeuromuscular DiseasesMuscular AtrophyAtrophyMuscular Atrophy, SpinalApitegromabPlacebo
brief summary
This Phase 3 trial (Study SRK-015-003) was conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and were receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.
started
Apr 14, 2022
primary completion
Dec 18, 2024
completion
Dec 18, 2024
last updated
Jan 22, 2026
official title
Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients With Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol