A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
← catalyst calendarNCT07047144 · readout ≤ 833 d
Sponsored by Scholar Rock, Inc. (industry) · SRRK — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
52estimated
Sites
25
Countries
Belgium, France, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-09-15 | actual | When the study began enrolling |
| Primary completion | Nov 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Spinal Muscular Atrophy
- SMA
- Spinal Muscular Atrophy Type 2
- Spinal Muscular Atrophy Type 3
- Neuromuscular Manifestations
- Anti-myostatin
Interventions
- Drug: Apitegromab — also filed as SRK-015
- Drug: Nusinersen — also filed as Spinraza
- Drug: Risdiplam — also filed as Evrysdi
Primary outcomes
what the primary-completion date above is the date OFEvaluate the PK of apitegromab in subjects <2 years old with SMA
measured 52 Weeks
Evaluate the PD of apitegromab in subjects <2 years old with SMA
measured 52 Weeks
Evaluate the motor function outcomes (ie, efficacy) due to apitegromab treatment
measured 48 Weeks
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