Clinical Trial

A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

Study acronym: ATLAS
Active, Not Recruiting Phase 3
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Summary
The primary objective of this study is to evaluate the efficacy of tofersen in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability tofersen and to evaluate the effect of tofersen on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).
Protocol Amendment History 38 amendments
This ClinicalTrials.gov record has been amended 38 times since 2021-04-20; most recent amendment 2026-03-27.
Status change: Recruiting → Active, Not Recruiting 2025-03-06
Status change: Not Yet Recruiting → Recruiting 2021-06-03
Trial Details
NCT Number NCT04856982
Lead Sponsor Biogen
Conditions Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
Enrollment 158 participants
Start Date 2021-05-17
Primary Completion 2027-08-07 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-30