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

• Status: Completed
• Trial end date: 2016-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InteKrin Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Signed informed consent before any study procedures

2. Male and female subjects aged 18-50

3. Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis

4. At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart

Exclusion Criteria:

1. Subjects with a history or presence of chronic disease of the immune system other than RRMS

2. Subjects with a diagnosis of primary or secondary progressive multiple sclerosis

3. Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2