Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
NCT05626855 · ONYX Phase 3Active, not recruiting
- Lead sponsor
- Scholar Rock, Inc. (Industry)
- Enrollment
- 238 (actual)
- Start date
- 17 Apr 2023
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 2 May 2029
- Last update posted
- 1 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Apitegromab Drug
Conditions and primary outcome
- Spinal Muscular Atrophy
- Spinal Muscular Atrophy Type 3
- Spinal Muscular Atrophy Type 2
- SMA
- Neuromuscular Diseases
- Muscular Atrophy
- Atrophy
- Muscular Atrophy, Spinal
- Neuromuscular Manifestations
- Anti-myostatin
Primary outcome
Evaluate the long-term safety and tolerability of apitegromab in patients with Type 2 and Type 3 SMA (Up to 6 years)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT05626855.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05626855 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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