Status:
AVAILABLE
EAP of Apitegromab for Patients With Spinal Muscular Atrophy
Lead Sponsor:
Scholar Rock, Inc.
Conditions:
SMA
Eligibility:
All Genders
2+ years
Brief Summary
The purpose of this expanded access program (EAP) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (SMA) prior to approval by the local regulatory agency . A medi...
Eligibility Criteria
Inclusion
- ≥2 years of age.
- Documented diagnosis of 5q SMA.
Exclusion
- Previous history of a hypersensitivity reaction to a monoclonal antibody or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab.
- Enrolled in a clinical study for any investigational drug.
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06877689
Last Update
March 14 2025
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