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This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..
Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral INT 131 3 mg | Experimental | Oral INT-131 Double blind study |
|
| Oral INT-131 1 mg | Experimental | Oral INT-131 Double blind |
|
| Placebo | Placebo Comparator | Oral placebo Double blind |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INT131 | Drug | INT- 131 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of new gadolinium CE T1 weighted lesions | The mean number of new gadolinium CE T1-weighted lesions, on monthly MRI in subjects receiving INT131 compared to Placebo from baseline to 6 months. | asline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara K. Finck, M.D | Coherus BioSciences (parent company for Zao InteKrin) | Study Chair |
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A randomized double blind parallel group study with 3mg, 1mg or placebo
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Double blind
| 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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| ID | Term |
|---|---|
| C541917 | INT 131 |
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