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

Phase 2

Completed

• Conditions: Multiple Sclerosis, Relapsing Remitting
• Interventions: Drug: INT131

• Registration Number: NCT02638038
• Lead Sponsor: InteKrin Therapeutics, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-20
• Study First Posted: 2015-12-22
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral INT 131 3 mg	INT131	Oral INT-131 Double blind study
Oral INT-131 1 mg	INT131	Oral INT-131 Double blind
Placebo	INT131	Oral placebo Double blind

Primary Outcome Measures

Name	Time	Method
The number of new gadolinium CE T1 weighted lesions	asline to 6 months	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.