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
1 other identifier
interventional
27
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2015
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2017
CompletedAugust 22, 2018
May 1, 2017
2.4 years
March 13, 2015
August 21, 2018
Conditions
Outcome Measures
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)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
rHIgM22
EXPERIMENTALPatients 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 COMPARATORPatients 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acorda Therapeuticslead
- PRA Health Sciencescollaborator
Study Sites (12)
Acorda Site #12
Long Beach, California, 90806, United States
Acorda Site #3
Sacramento, California, 95817, United States
Acorda Site #7
San Francisco, California, 94158, United States
Acorda Site #11
Aurora, Colorado, 80045, United States
Acorda Site #16
Centennial, Colorado, 80112, United States
Acorda Site #22
Chicago, Illinois, 60612, United States
Acorda Site #14
St Louis, Missouri, 63131, United States
Acorda Site #19
Teaneck, New Jersey, 07666, United States
Acorda Site #10
Rochester, New York, 14642, United States
Acorda Site #18
Dallas, Texas, 75390-8508, United States
Acorda Site #2
Seattle, Washington, 98101, United States
Acorda Site #6
Seattle, Washington, 98122, United States
Related Publications (1)
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: 35496758DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 25, 2015
Study Start
April 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 21, 2017
Last Updated
August 22, 2018
Record last verified: 2017-05