Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis
This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.
- Relapsing, Remitting Multiple Sclerosis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subjects must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald criteria.
- 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.
- 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.
- Subjects must have an EDSS score of 2.0 to 6.5 (inclusive) at the Baseline Visit.
- Subject has a history of use of Acthar for the treatment of multiple sclerosis (MS).
- Subject has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated with the most recent relapse.
- Subject has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or to porcine protein products.
- 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.
- 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.
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Repository Corticotropin Injection 1 mL (80U) subcutaneously administered QD for 14 consecutive days||
|Placebo 1 mL subcutaneously administered QD for 14 consecutive days.||
- NCT ID
Study ContactStudy Manager
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.