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

• Sponsor: InteKrin Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02638038
• Collaborator: (none)
• Enrollment: 228
• Arms: 3
• Actual Duration (Months): 22.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing Remitting	Drug: INT131	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized double blind parallel group study with 3mg, 1mg or placeboA randomized double blind parallel group study with 3mg, 1mg or placebo
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blind
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 12, 2016
• Actual Study Completion Date: Dec 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral INT 131 3 mg Oral INT-131 Double blind study	Drug: INT131; INT- 131
Experimental: Oral INT-131 1 mg Oral INT-131 Double blind	Drug: INT131; INT- 131
Placebo Comparator: Placebo Oral placebo Double blind	Drug: INT131; INT- 131

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• InteKrin Therapeutics, Inc.

Investigators

• Study Chair: Barbara K. Finck, M.D, Coherus BioSciences (parent company for Zao InteKrin)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: InteKrin Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02638038
• Other Study ID Numbers: INT131-RU01-2
• First Posted: Dec 22, 2015
• Last Update Posted: Feb 28, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis

Study Results

No Results Posted as of Feb 28, 2018