About 213 people with ALS will participate in this study. There will be locations in North and South America. During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3: - 2 will get the study drug - 1 will get a look-alike with no drug in it (placebo) During the second part, everyone will get the study drug. Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.
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.
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