EAP of Apitegromab for Patients With Spinal Muscular Atrophy
- Conditions
- SMA
- Registration Number
- NCT06877689
- Lead Sponsor
- Scholar Rock, Inc.
- 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 medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- ≥2 years of age.
- Documented diagnosis of 5q SMA.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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