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

NCT ID: NCT02638038

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-12-12

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.

Conditions

Multiple Sclerosis, Relapsing Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral INT 131 3 mg

Oral INT-131 Double blind study

Group Type: EXPERIMENTAL

INT131

Intervention Type: DRUG

INT- 131

Oral INT-131 1 mg

Oral INT-131 Double blind

Group Type: EXPERIMENTAL

INT131

Intervention Type: DRUG

INT- 131

Placebo

Oral placebo Double blind

Group Type: PLACEBO_COMPARATOR

INT131

Intervention Type: DRUG

INT- 131

Interventions

INT131

INT- 131

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InteKrin Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara K. Finck, M.D

Role: STUDY_CHAIR

Coherus BioSciences (parent company for Zao InteKrin)

Other Identifiers

INT131-RU01-2

Identifier Type: -

Identifier Source: org_study_id