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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03126760
• Date of registration: 04/04/2017
• Prospective Registration: Yes
• Primary sponsor: Mallinckrodt
• Public title: Pilot Study to Assess the Efficacy & Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis OPTIONS
• Scientific title: 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
• Date of first enrolment: May 22, 2017
• Target sample size: 35
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03126760
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Clinical Team Leader
• Affiliation: Mallinckrodt

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing, Remitting Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: Repository Corticotropin Injection

Primary Outcome(s)

Change from Baseline in body temperature [Time Frame: Baseline and Up to Day 42]

Change from Baseline in heart rate [Time Frame: Baseline and Up to Day 42]

Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry [Time Frame: Baseline and Up to Day 42]

Response rate on Expanded Disability Status Scale (EDSS) at Day 42 [Time Frame: Day 42]

Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis [Time Frame: Baseline and Up to Day 42]

Change from Baseline in respiratory rate [Time Frame: Baseline and Up to Day 42]

Change from Baseline in diastolic/systolic blood pressures [Time Frame: Baseline and Up to Day 42]

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Day 42]

Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology [Time Frame: Baseline and Up to Day 42]

Secondary Outcome(s)

Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs [Time Frame: Days 7, 21 and 42]

The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs) [Time Frame: Days 7, 14, 21 and 42]

The response rates on EDSS and 90% CIs on Day 7 and Day 21 [Time Frame: Days 7 and 21]

Secondary ID(s)

MNK14274069

Source(s) of Monetary Support

Please refer to primary and secondary sponsors