Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis

Subjects with RRMS who have experienced a relapse and who will receive 3 to 5 (given over a
period of up to 7 days) days of treatment with high dose steroids (oral or IV) within 14 days
of the onset of relapse symptoms are candidates for the current study. At 14 (± 1) days
following the initiation of high dose steroids, subjects will be re-assessed with the
Expanded Disability Status Scale/Functional Systems Score (EDSS/FSS) and subjects who do not
improve by at least 1 point on the FSS will be randomized on a 1:1 basis to receive
subcutaneous (SC) Acthar 1 mL (80 U) once a day (QD) or SC matching placebo 1 mL QD for 14
days. Follow-up visits then occur at 14, 28 and 42 days.

Inclusion Criteria:

1. Subjects must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS)
according to the revised McDonald criteria.

2. Subjects must have had a relapse with onset ≤25 days prior to the Baseline Visit.
Relapse is defined as new neurological symptom(s) persisting for ≥24 hours, and
accompanied by an objective change in neurological examination.

3. Subject must have started treatment with 3 to 5 days of high dose corticosteroids
within 14 days of the onset of the first relapse symptom.

4. Subjects must have an EDSS score of 2.0 to 6.5 (inclusive) at the Baseline Visit.

Exclusion Criteria:

1. Subject has a history of use of Acthar for the treatment of multiple sclerosis (MS).

2. Subject has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated
with the most recent relapse.

3. Subject has a history of sensitivity to adrenocorticotropic hormone (ACTH)
preparations or to porcine protein products.

4. Subject has been treated with natalizumab, ocrelizumab, daclizumab or any
immunosuppressants (including but not limited to cyclophosphamide, mitoxantrone, or
rituximab) in the 6 months prior to the Screening Visit or throughout the study.
Subjects treated with natalizumab will be excluded if they are not currently negative
for JC virus based on a negative John Cunningham (JC) virus test result in the 6
months prior to the Screening Visit.

5. Subjects receiving any disease modifying treatments (including beta-interferons,
glatiramer acetate, fingolimod, teriflunomide, and dimethyl fumarate) must have been
on a stable dose(s) for 30 days prior to the Baseline Visit, and plan to remain on
that dose(s) throughout the study.