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.
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Full eligibility criteria for NCT02638038
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Signed informed consent before any study procedures
Male and female subjects aged 18-50
Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart
Subjects with a history or presence of chronic disease of the immune system other than RRMS
Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
All locations for NCT02638038
View full eligibility
Tris trial is registered with FDA with number: NCT02638038. The sponsor of the trial is InteKrin Therapeutics, Inc. and it is looking for 228 volunteers for the current phase.
Official trial 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
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