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The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg RPC1063 | Experimental | 1 mg RPC1063 oral capsule daily |
|
| 0.5 mg RPC1063 | Experimental | 0.5 mg RPC1063 oral capsule daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPC1063 | Drug | Oral capsule daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) | 24 hours after the last RPC1063 dose on Day 85 |
| Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration-time curve (AUC) | Approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with treatment-emergent adverse events | Up to 28 days after the last RPC1063 dose |
| EDSS (Expanded Disability Status Scale) | Changes from baseline in EDSS |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breastlink Medical Group, Inc. | Long Beach | California | 90806 | United States | ||
| Multiple Sclerosis Center at UCSF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32737072 | Derived | Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| Up to the last RPC1036 dose on Day 85 |
| Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count | Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %) | Up to 28 days after the last RPC1063 dose |
| San Francisco |
| California |
| 94158 |
| United States |
| Raleigh Neurology Associates PA | Raleigh | North Carolina | 27607 | United States |
| Neurology and Neuroscience Associates Inc. | Akron | Ohio | 44320 | United States |
| Hope Neurology MS Center | Knoxville | Tennessee | 37922 | United States |
| Central Texas Neurology Consultants PA | Round Rock | Texas | 78681 | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |