Clinical trial NCT02398461: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis, Acute Relapsing
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2015-03-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: Up to 180 days
Secondary outcomes:
measure: Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22
timeFrame: Pre-dose (day 1), specified time points up to 48 hours post treatment
measure: Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
timeFrame: Pre-dose (day 1), specified time points up to 48 hours post treatment
measure: Half-life (T1/2) of single ascending doses of rHIgM22
timeFrame: Pre-dose (day 1), specified time points up to 48 hours post treatment
measure: Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22
timeFrame: Pre-dose (day 1), specified time points up to 48 hours post treatment
measure: Immunogenicity profile of single ascending doses of rHIgM22
timeFrame: Specified time points up to 180 days post treatment
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Screening, specified time points up to 180 days post treatment
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Acorda Site #12
state: California
city: Sacramento
country: United States
facility: Acorda Site #3
state: California
city: San Francisco
country: United States
facility: Acorda Site #7
state: California
city: Aurora
country: United States
facility: Acorda Site #11
state: Colorado
city: Centennial
country: United States
facility: Acorda Site #16
state: Colorado
city: Chicago
country: United States
facility: Acorda Site #22
state: Illinois
city: Saint Louis
country: United States
facility: Acorda Site #14
state: Missouri
city: Teaneck
country: United States
facility: Acorda Site #19
state: New Jersey
city: Rochester
country: United States
facility: Acorda Site #10
state: New York
city: Dallas
country: United States
facility: Acorda Site #18
state: Texas
city: Seattle
country: United States
facility: Acorda Site #2
state: Washington
city: Seattle
country: United States
facility: Acorda Site #6
state: Washington
Study officials:
References:
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.