NCT07047144 - A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

March 31, 2029

Conditions

Spinal Muscular AtrophySMASpinal Muscular Atrophy Type 2Spinal Muscular Atrophy Type 3Neuromuscular ManifestationsAnti-myostatin

Interventions

DRUG

Apitegromab

Apitegromab is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that specifically binds to human pro/latent myostatin with high affinity inhibiting myostatin activation. SRK-015 will be administered every 4 weeks by intravenous (IV) infusion.

DRUG

Nusinersen

Nusinersen is a current standard-of-care SMN therapy that targets the SMN2 gene. It will be administered intrathecally per the prescribing information.

DRUG

Risdiplam

Risdiplam is a current standard-of-care SMN therapy that targets the SMN2 gene. It will be administered orally per the prescribing information.

Trial Locations (2)

27157

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

76208

RECRUITING

Neurology Rare Disease Center, Denton

All Listed Sponsors

lead

Scholar Rock, Inc.

INDUSTRY