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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rHIgM22 | Experimental | 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 | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rHIgM22 | Drug | Administered via IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Site #12 | Long Beach | California | 90806 | United States | ||
| Acorda Site #3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35496758 | Derived | 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. |
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| Placebo | Drug |
|
| 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 | Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies. | Specified time points up to 180 days post treatment |
| The Expanded Disability Status Scale (EDSS) | Screening, specified time points up to 180 days post treatment |
| 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 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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