Multiple Sclerosis, Acute Relapsing
Conditions
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.
Interventions
DRUGrHIgM22
Administered via IV infusion
DRUGPlacebo
Sponsors
PRA Health Sciences
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maximum measured plasma concentration (Cmax) 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed