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
This trial is active, not recruiting.
|Condition||multiple sclerosis, relapsing remitting|
|Sponsor||InteKrin Therapeutics, Inc.|
|Start date||February 2015|
|End date||April 2017|
|Trial size||228 participants|
|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.
|Intervention model||parallel assignment|
|Intervention model description||a randomized double blind parallel group study with 3mg, 1mg or placebo|
|Masking||participant, care provider, investigator, outcomes assessor|
|Masking description||double blind|
Oral INT-131 Double blind study
Oral INT-131 Double blind
Oral placebo Double blind
The number of new gadolinium CE T1 weighted lesions
time frame: asline to 6 months
All 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
|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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