An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Acute Relapsing
• Intervention / Treatment: Drug: Placebo; Drug: rHIgM22

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Acorda Site #12
    • Sacramento, California, United States, 95817
      • Acorda Site #3
    • San Francisco, California, United States, 94158
      • Acorda Site #7
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Acorda Site #11
    • Centennial, Colorado, United States, 80112
      • Acorda Site #16
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Acorda Site #22
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Acorda Site #14
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Acorda Site #19
  • New York
    • Rochester, New York, United States, 14642
      • Acorda Site #10
  • Texas
    • Dallas, Texas, United States, 75390-8508
      • Acorda Site #18
  • Washington
    • Seattle, Washington, United States, 98101
      • Acorda Site #2
    • Seattle, Washington, United States, 98122
      • Acorda Site #6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females (18-70 years of age; < 104 kg)
• Capable of giving informed consent
• Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
• Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
• Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.

Exclusion Criteria:

• Certain specified co-morbidities (including pregnancy)
• Taking certain proscribed medications
• A medical regimen that has changed in the month prior to screening
• Inability to undergo requisite MRI evaluations
• Drug or alcohol abuse
• Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rHIgM22; Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).	Drug: rHIgM22; Administered via IV infusion; Other Names: M22
Placebo Comparator: Placebo; Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs)	Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).	Up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Half-life (T1/2) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22		Pre-dose (day 1), specified time points up to 48 hours post treatment
Immunogenicity profile of single ascending doses of rHIgM22	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.	Specified time points up to 180 days post treatment
The Expanded Disability Status Scale (EDSS)		Screening, specified time points up to 180 days post treatment

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Collaborators: PRA Health Sciences

Publications and helpful links

General Publications

• Greenberg BM, Bowen JD, Alvarez E, Rodriguez M, Caggiano AO, Warrington AE, Zhao P, Eisen A. A double-blind, placebo-controlled, single-ascending-dose intravenous infusion study of rHIgM22 in subjects with multiple sclerosis immediately following a relapse. Mult Scler J Exp Transl Clin. 2022 Apr 26;8(2):20552173221091475. doi: 10.1177/20552173221091475. eCollection 2022 Apr-Jun.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 21, 2017

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: IM22-MS-1033