EAP of Apitegromab for Patients With Spinal Muscular Atrophy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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SMA

Interventions

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Apitegromab

Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab will be administered every 4 weeks by intravenous (IV) infusion.

Intervention Type DRUG

Other Intervention Names

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SRK-015

Eligibility Criteria

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Inclusion Criteria

1. ≥2 years of age.
2. Documented diagnosis of 5q SMA.

Exclusion Criteria

1. 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.
2. Enrolled in a clinical study for any investigational drug.
3. Pregnant or breastfeeding.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No