Clinical trial
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular…
NCT05156320 · Scholar Rock, Inc., Industry · Completed
Key facts
| NCT number | NCT05156320 |
|---|---|
| Title | Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam |
| 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 |
| Acronym | SAPPHIRE |
| Lead sponsor | Scholar Rock, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, Spinal Muscular Atrophy Type 2, SMA, Neuromuscular Diseases, Muscular Atrophy, Atrophy, Spinal, Neuromuscular Manifestations, Anti-myostatin |
| Intervention type | Drug |
| Interventions | Apitegromab, Placebo |
| Enrollment | 188 |
| Start date | Apr 14, 2022 |
| Primary completion | Dec 18, 2024 |
| Completion | Dec 18, 2024 |
| First posted | Dec 14, 2021 |
| Last update posted | Jan 22, 2026 |
| Countries | Belgium, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: