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

Multiple Sclerosis, Relapsing Remitting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638038
• Other study ID #: INT131-RU01-2
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2015
• Last updated: February 27, 2018
• Start date: February 2015
• Est. completion date: December 12, 2016

Study information

• Verified date: February 2018
• Source: InteKrin Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 12, 2016
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing Remitting
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• INT131
INT- 131

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InteKrin Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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