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Completed

NCT Number: NCT02398461

An 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.

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Key information

Conditions

Multiple Sclerosis, Acute Relapsing Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acorda Site #12, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rHIgM22

Drug

Administered via IV infusion

Other names: M22

Placebo

Drug

Primary outcomes

  1. 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)

    Time frame: Up to 180 days

    Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Immunogenicity profile of single ascending doses of rHIgM22

    Time frame: Specified time points up to 180 days post treatment

    Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

  6. The Expanded Disability Status Scale (EDSS)

    Time frame: Screening, specified time points up to 180 days post treatment

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Collaborators

  • PRA Health Sciences

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2015
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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