Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing remitting
Treatment int131
Phase phase 2
Sponsor InteKrin Therapeutics, Inc.
Start date February 2015
End date May 2016
Trial identifier NCT02638038, INT131-RU01-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
The number of new gadolinium CE T1 weighted lesions
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by InteKrin Therapeutics, Inc..