search
Back to results

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

Primary Purpose

Multiple Sclerosis, Acute Relapsing

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rHIgM22
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Acute Relapsing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Acorda Site #12
  • Acorda Site #3
  • Acorda Site #7
  • Acorda Site #11
  • Acorda Site #16
  • Acorda Site #22
  • Acorda Site #14
  • Acorda Site #19
  • Acorda Site #10
  • Acorda Site #18
  • Acorda Site #2
  • Acorda Site #6

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rHIgM22

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
Half-life (T1/2) of single ascending doses of rHIgM22
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22
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.
The Expanded Disability Status Scale (EDSS)

Full Information

First Posted
March 13, 2015
Last Updated
August 21, 2018
Sponsor
Acorda Therapeutics
Collaborators
PRA Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02398461
Brief Title
An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Official Title
A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Acute Relapsing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rHIgM22
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
rHIgM22
Other Intervention Name(s)
M22
Intervention Description
Administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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)
Description
Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).
Time Frame
Up to 180 days
Secondary Outcome Measure Information:
Title
Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22
Time Frame
Pre-dose (day 1), specified time points up to 48 hours post treatment
Title
Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
Time Frame
Pre-dose (day 1), specified time points up to 48 hours post treatment
Title
Half-life (T1/2) of single ascending doses of rHIgM22
Time Frame
Pre-dose (day 1), specified time points up to 48 hours post treatment
Title
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22
Time Frame
Pre-dose (day 1), specified time points up to 48 hours post treatment
Title
Immunogenicity profile of single ascending doses of rHIgM22
Description
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Time Frame
Specified time points up to 180 days post treatment
Title
The Expanded Disability Status Scale (EDSS)
Time Frame
Screening, specified time points up to 180 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Acorda Site #12
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Acorda Site #3
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Acorda Site #7
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Acorda Site #11
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Acorda Site #16
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Acorda Site #22
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Acorda Site #14
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Acorda Site #19
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Acorda Site #10
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Acorda Site #18
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8508
Country
United States
Facility Name
Acorda Site #2
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Acorda Site #6
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35496758
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs