First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)
← catalyst calendarNCT06351592 · readout in 2,040 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
54estimated
Sites
20
Countries
Australia, Belgium, Canada +6
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 | 2024-08-28 | actual | When the study began enrolling |
| Primary completion | 2032-03-21 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-03-21 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Mutation in the Superoxide Dismutase-1 (SOD1) Gene
Interventions
- Drug: ALN-SOD
- Other: Diluent
- Drug: Placebo (PB)
Primary outcomes
what the primary-completion date above is the date OFIncidence of Treatment-Emergent Adverse Event (TEAEs) in participants treated with ALN-SOD
measured At week 4 and through week 228
Severity of TEAEs in participants treated with ALN-SOD
measured At week 4 and through week 228
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