A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation (ATLAS)

Amyotrophic Lateral Sclerosis (ALS) associated with SOD1 gene mutation

Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 24 Months of Part B Baseline. [Time Frame: Up to 24 months]

Parts B and C: Time to Emergence of Clinically Manifest ALS. [Time Frame: Up to 5.6 years]., Parts B and C: Change in ALS Functional Rating Scale (ALSFRS-R) Total Score. The ALSFRS-R measures 4 functional domains: respiratory, bulbar function, gross motor skills, and fine motor skills. There are 12 questions, each scored from 0 to 4, for a total possible score of 48, with higher scores representing better function. [Time Frame: Up to 5.6 years]., Parts B and C: Change from Baseline in Percent Predicted Slow Vital Capacity (SVC). [Time Frame: Up to 5.6 years]., Parts B and C: Percentage of Participants with Outcome as Death or Permanent Ventilation Based on time to Death or Permanent Ventilation Analysis. Permanent ventilation is defined as ≥22 hours of invasive or non-invasive mechanical ventilation per day for ≥21 consecutive days. [Time Frame: Up to 5.6 years]., Parts B and C: Percentage of Participants with Outcome as Deaths Based on Time to Death Analysis. [Time Frame: Up to 5.6 years]., Parts B, C and D: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the Treatment Period. [Time Frame: Parts B and C: Up to 5.6 years and Part D: Up to 2 years]., Parts B, C and D: Change from Baseline in Plasma NfL Concentrations. [Time Frame: Parts B and C: Up to 5.6 years and Part D: Up to 2 years]., Parts B, C and D: Change in Total Cerebrospinal Fluid (CSF) SOD1 Concentrations. [Time Frame: Parts B and C: Up to 5.6 years and Part D: Up to 2 years].

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