An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

NCT01803867 | Completed Phase 1 DMC

• 1 other identifier: IM22-MS-1004
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Multiple Sclerosis

Keywords

MS; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22

  Day 1 through Day 180

• Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS)

  Day 1 through Day 180

Study Arms (1)

rHIgM22

PLACEBO COMPARATOR

Cohorts 1-5: In each dosing cohort, the first 2 eligible patients will be enrolled and randomized 1:1 to receive rHIgM22 or placebo, and monitored for safety for a minimum of 7 days before the remaining 8 patients in the cohort are randomized (7 active: 1 placebo) and dosed. Expanded Cohort: Upon establishment of a Maximally Tolerated Dose (MTD), a new group of 21 patients will be enrolled in an Expansion Cohort. Randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: placebo, Investigational Product (IP) at MTD, or IP at one full dose level lower than MTD.

Drug: rHIgM22

Interventions

rHIgM22 DRUG

Administered via IV infusion

Also known as: M22

rHIgM22

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead
• PRA Health Sciences: collaborator

Study Sites (17)

Acorda Investigational Site

Long Beach, California, 90806, United States

Location

Acorda Investigational Site

Palo Alto, California, 04158, United States

Location

Acorda Investigational Site

Sacramento, California, 95817, United States

Location

Acorda Investigational Site

Stanford, California, 94305-5235, United States

Location

Acorda Investigational Site

Aurora, Colorado, 80045, United States

Location

Acorda Investigational Site

Centennial, Colorado, 80112, United States

Location

Acorda Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Acorda Investigational Site

Kansas City, Kansas, 66160, United States

Location

Acorda Investigational Site

Baltimore, Maryland, 22125, United States

Location

Acorda Investigational Site

St Louis, Missouri, 63131, United States

Location

Acorda Investigational Site

Rochester, New York, 14642, United States

Location

Acorda Investigational Site

Providence, Rhode Island, 02905, United States

Location

Acorda Investigational Site

Knoxville, Tennessee, 37920, United States

Location

Acorda Investigational Site

Dallas, Texas, 75390-9036, United States

Location

Acorda Investigational Site

Burlington, Vermont, 05401, United States

Location

Acorda Investigational Site

Seattle, Washington, 98101, United States

Location

Acorda Investigational Site

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Enrique Carrazana, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 27, 2015

Record last verified: 2015-02

Locations

US (17)