Recruitment difficulties and COVID-19 logistical challenges; no safety concerns

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

Key Inclusion Criteria:

• Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
• Had a relapse with onset ≤42 days prior to the Baseline Visit
• Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
• Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
• Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.