An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Scl
A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- rHIgM22
Placebo
- Placebo
What it measured
Main 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)
Up to 180 days
RelapsesSafety
Other measures (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
How the body handles the medicineTime to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22
Pre-dose (day 1), specified time points up to 48 hours post treatment
How the body handles the medicineHalf-life (T1/2) of single ascending doses of rHIgM22
Pre-dose (day 1), specified time points up to 48 hours post treatment
MRI lesionsHow the body handles the medicineArea 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
Immune responseThe Expanded Disability Status Scale (EDSS)
Screening, specified time points up to 180 days post treatment
Disability progression
Who could take part
MS (type not specified) · 18 to 70
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Apr 2015
Main results due
Sept 2017
Finished
Sept 2017