An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 9 March 2015
• Main ID: NCT01803867
• Date of registration: 26/02/2013
• Prospective Registration: Yes
• Primary sponsor: Acorda Therapeutics
• Public title: An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis M22
• Scientific title: A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)
• Date of first enrolment: March 2013
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01803867
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Enrique Carrazana, MD
• Affiliation: Acorda Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

- Able to give written informed consent, with adequate cognitive function to sign the
IRBapproved informed consent

- Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria

- Man or woman aged 18 to 70 years, inclusive

- Women of childbearing potential must have a negative serum pregnancy test at the
Screening Visit and

- Women of childbearing potential and engaged in heterosexual relations must agree to
practice adequate contraception for at least 60 days after study dosing. Women of
childbearing potential and not engaged in heterosexual relations or not practicing
adequate contraception must agree to remain abstinent for at least 60 days after
study dosing practice adequate contraception for the duration of the study

- Agree to remain in the hospital for the 48 hour post infusion observation period, and
can be contacted in case of an emergency once discharged

Exclusion Criteria:

- Serum creatinine =1.5 mg/dL

- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or alkaline
phosphatase =1.5 times the upper limit of normal

- Angina, uncontrolled hypertension, clinically significant cardiac arrhythmias
(including atrial fibrillation), any other clinically significant cardiovascular
abnormality or clinically significant abnormal ECG

- Immune-mediated disorder other than MS that in the Investigator's judgment, may
affect the interpretation of results or the patient's ability to safely complete the
study

- Any clinically significant cardiac, endocrinologic, hematologic, hepatic,
immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,
renal, allergic or anaphylactic reasons, or other major diseases (other than MS),
that in the Investigator's judgment, may affect the interpretation of results or
patient's ability to safely complete the study. This includes a suicide attempt
within the past 1 year or severe suicidal ideation within the past 6 months or
patients who in the opinion of the Investigator are at significant risk of suicidal
behavior

- MS relapse within 30 days prior to screening or treatment with systemic (oral, IV or
IM) corticosteroids, except for minimally absorbed topical or inhalational
preparations, within the 30 days prior to the Screening Visit

- Initiation of interferon-beta 1b (Betaseron,a extavia), interferon beta-1a (Avonex, a
Rebif a), glatiramer acetate (copaxone), natalizumab (Tysabri), or fingolimod
(Gilenya), or dimethyl fumarate (Tecfidera ®) within the 90 days prior to the
Screening Visit, or any change in the dosing regimen of these drugs within the 30
days prior to the Screening Visit. Initiation of teriflunomide (AUBAGIO®) or any
change in the dosing regimen of this drug within 90 days prior to the Screening
Visit.

- Treatment with any of the following medications within the 12 months prior to Day 1
of the study: daclizumab, azathioprine, methotrexate, IV immunoglobulin,
plasmaphoresis, or mycophenolate mofetil; or discontinuation of teriflunomide
(AUBAGIO®) within 12 months prior to Day 1.

- History of clinically significant infusion reactions with administration of
biologics, including plasma exchange, intravenous immunoglobulin, and other
monoclonal antibodies such as natalizumab (Tysabri)

- Prior treatment with total lymphoid irradiation, T cell or T-cell receptor
vaccination, alemtuzumab, mitoxantrone, cyclophosphamide, or rituximab

- Received any investigational agent or therapy up to 30 days or 4 pharmacokinetic
half-lives (whichever is longer) prior to Screening Visit or plans to enroll in
another investigational trial at any time during this study

- Contraindication to brain MRI or inability to tolerate brain MRI



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: rHIgM22

Primary Outcome(s)

Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS. [Time Frame: 90 Days]

Secondary Outcome(s)

Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22 [Time Frame: Day 1 through Day 180]

Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS) [Time Frame: Day 1 through Day 180]

Secondary ID(s)

IM22-MS-1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PRA Health Sciences