This is a Randomized 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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.. 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.

Official Title
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A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing Remitting

Intervention / Treatment
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* Drug: INT131


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent before any study procedures Male and female subjects aged 18-50 Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart Exclusion Criteria: Subjects with a history or presence of chronic disease of the immune system other than RRMS Subjects with a diagnosis of primary or secondary progressive multiple sclerosis Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized double blind parallel group study with 3mg, 1mg or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral INT 131 3 mg<br>Oral INT-131 Double blind study | Drug: INT131<br>* INT- 131<br>|
| Experimental: Oral INT-131 1 mg<br>Oral INT-131 Double blind | Drug: INT131<br>* INT- 131<br>|
| Placebo Comparator: Placebo<br>Oral placebo Double blind | Drug: INT131<br>* INT- 131<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |