Inclusion Criteria: 1. Is 18-75 years of age at Screening 2. Has ALS symptom onset within 2 years prior to Screening 3. Has forced vital capacity (FVC) no higher than 60% at screening 4. If taking riluzole, is on a stable dose for 4 weeks before Screening Exclusion Criteria: 1. Has tracheostomy, diaphragm pacing, or an ongoing need for assisted ventilation of any type 2. Has used any medication within a time period not allowed per protocol 3. Has history of Type 1 or Type 2 diabetes mellitus, or any clinically significant infection 4. Used edaravone less than 1 week before Screening 5. Received any stem cell replacement therapy 6. Used steroids within a time period not allowed per protocol

This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled. Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units [U]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper. Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.

• Mallinckrodt

NCT03068754 (First Published: 2/23/2017)