A Multicenter Randomized Double Blind Placebo Controlled Parallel Group Pilot Study to Assess the Efficacy and Safety of H.P. Acthar Gel in Subjects with Relapsing-remitting Multiple Sclerosis

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to examine the safety, tolerability and response rate of Acthar in subjects with RRMS who have not responded to high dose intravenous methylprednisolone (IVMP), oral prednisone, or oral methylprednisolone.

Detailed description of study

The purpose of this study is to examine the safety, tolerability and response rate of Acthar in subjects with Relapsing-remitting multiple sclerosis (RRMS) who have not responded to high dose intravenous methylprednisolone, oral prednisone, or oral methylprednisolone.
Participants will be compensated for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: relapsing-remitting multiple sclerosis
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
Must have a diagnosis of RRMS
Must have had a relapse with onset less than or equal to 25 days prior to the Baseline Visit
Must have started treatment with 3 tp 5 days of 1 g per day of IVMP, 1,250 mg per day or oral prednisone, or 1,000 mg per day or oral methylprenisolone within 10 days of the onset of the first relapse symptom
Exclusion Criteria
History of use of Acthar for the treatment of MS
Has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated with the most recent relapse
Unwilling to receive, or is intolerant of, SC injections
History of sensitivity to ACTH preparations or to porcine protein products
Has been treated with ocrelizumab, daclizumab, natalizumab, alemtuzumab, or any immunosuppressants in the 6 months prior to the Screening Visit or throughout the study
History of chronic active hepatitis
History of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection
Has type 1 or type 2 diabetes mellitus

Updated on 04 Aug 2024. Study ID: 1706802372

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