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

NCT02398461 — Phase 1, Completed, 27 participants, Acorda Therapeutics

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

Registry	NCT02398461
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, single group, masking: quadruple, treatment
Enrollment	27 (Actual)
Sponsor	Acorda Therapeutics (Industry); collaborators: PRA Health Sciences
Conditions	Multiple Sclerosis, Acute Relapsing
Interventions	rHIgM22, Placebo (Drug)
Dates	start 2015-04-01, primary completion 2017-09-01, completion 2017-09-21, first posted 2015-03-25, last updated 2018-08-22
Locations	12 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
rHIgM22	Experimental	Drug: 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).
Placebo	Placebo comparator	Drug: 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).

rHIgM22 (Drug), also known as M22: Administered via IV infusion
Placebo (Drug)

+Outcome measures

Primary outcomes

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) [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

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 [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.
The Expanded Disability Status Scale (EDSS) [Screening, specified time points up to 180 days post treatment]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (12)

Facility	City	Country
Acorda Site #12	Long Beach, California	United States
Acorda Site #3	Sacramento, California	United States
Acorda Site #7	San Francisco, California	United States
Acorda Site #11	Aurora, Colorado	United States
Acorda Site #16	Centennial, Colorado	United States
Acorda Site #22	Chicago, Illinois	United States
Acorda Site #14	St Louis, Missouri	United States
Acorda Site #19	Teaneck, New Jersey	United States
Acorda Site #10	Rochester, New York	United States
Acorda Site #18	Dallas, Texas	United States
Acorda Site #2	Seattle, Washington	United States
Acorda Site #6	Seattle, Washington	United States

+Publications

Results publication: 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. PMID 35496758