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
This trial is active, not recruiting.
|Condition||multiple sclerosis, relapsing remitting|
|Sponsor||InteKrin Therapeutics, Inc.|
|Start date||February 2015|
|End date||May 2016|
|Trial identifier||NCT02638038, INT131-RU01-2|
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.
The number of new gadolinium CE T1 weighted lesions
time frame: 6 months
Male or female participants from 18 years up to 50 years old.
- 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
|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.|
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