An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— M22  

Official title:

A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803867
• Other study ID #: IM22-MS-1004
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2013
• Last updated: February 26, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• rHIgM22
Administered via IV infusion

Locations

Country	Name	City	State
United States	Acorda Investigational Site	Aurora	Colorado
United States	Acorda Investigational Site	Baltimore	Maryland
United States	Acorda Investigational Site	Burlington	Vermont
United States	Acorda Investigational Site	Centennial	Colorado
United States	Acorda Investigational Site	Dallas	Texas
United States	Acorda Investigational Site	Indianapolis	Indiana
United States	Acorda Investigational Site	Kansas City	Kansas
United States	Acorda Investigational Site	Knoxville	Tennessee
United States	Acorda Investigational Site	Long Beach	California
United States	Acorda Investigational Site	Palo Alto	California
United States	Acorda Investigational Site	Providence	Rhode Island
United States	Acorda Investigational Site	Rochester	New York
United States	Acorda Investigational Site	Sacramento	California
United States	Acorda Investigational Site	Seattle	Washington
United States	Acorda Investigational Site	Seattle	Washington
United States	Acorda Investigational Site	St. Louis	Missouri
United States	Acorda Investigational Site	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Acorda Therapeutics	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS.	Monitoring of adverse events (AEs) will be conducted throughout the study. Adverse events, including serious adverse events will be recorded in the case report forms (CRFs).	90 Days	No
Secondary	Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22	PK parameters will include; The maximum measured plasma concentration (Cmax), time to maximum plasma concentration (Tmax), half-life (T1/2), and the area under the concentration curve from time 0 to the concentration at last time point (AUC (0-last)).	Day 1 through Day 180	No
Secondary	Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS)		Day 1 through Day 180	No