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

Purpose

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.

Condition

  • Relapsing, Remitting Multiple Sclerosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acthar
Repository Corticotropin Injection 1 mL (80U) subcutaneously administered QD for 14 consecutive days
  • Drug: Repository Corticotropin Injection
    Administered subcutaneously once a day for 14 consecutive days
    Other names:
    • H.P. Acthar® Gel
Placebo Comparator
Placebo
Placebo 1 mL subcutaneously administered QD for 14 consecutive days.
  • Drug: Placebo
    Administered subcutaneously once a day for 14 consecutive days

Recruiting Locations

More Details

NCT ID
NCT03126760
Status
Recruiting
Sponsor
Mallinckrodt

Study Contact

Study Manager
800-556-3314
clinicaltrials@mnk.com

Detailed Description

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.