Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Inclusion Criteria:

1. Male and female patients ≥18 years of age with Sporadic or familial ALS
2. If taking riluzole and/or edaravone, must be on a stable dose prior to Screening.

Exclusion Criteria:

1. History of a clinically significant non-ALS neurologic disorder
2. Inability to swallow capsules.
3. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus
4. Women who are pregnant, planning to become pregnant, or are breastfeeding.
5. Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
6. Current or anticipated need of a diaphragm pacing system (DPS).
7. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
8. Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.