A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)
NCT07221669 · STELLAR-1 Phase 3Recruiting
- Lead sponsor
- Biogen (Industry)
- Enrollment
- 30 (estimated)
- Start date
- 28 Apr 2026
- Primary completion
- 28 Nov 2028 (estimated)
- Study completion
- 29 May 2032
- Last update posted
- 23 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- Salanersen Drug
Conditions and primary outcome
- Muscular Atrophy, Spinal
Primary outcome
Part 1: Percentage of Participants with 2 Survival Motor Neuron 2 (SMN2) Copies Sitting Without Support (for at Least 10 Seconds) (At Month 12); Part 1: Percentage of Participants with 3 SMN2 Copies Walking Alone (for at Least 5 Steps) (At Month 18); Part 2: Percentage of Participants Attaining and Maintaining World Health Organization (WHO) Motor Milestones (Up to Day 1825)
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 NCT07221669.
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
- NCT07221669 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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