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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638038
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
InteKrin Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing Remitting Drug: INT131 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized double blind parallel group study with 3mg, 1mg or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
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
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 12, 2016
Actual Study Completion Date : December 12, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral INT 131 3 mg
Oral INT-131 Double blind study
 Drug: INT131
INT- 131
Experimental: Oral INT-131 1 mg
Oral INT-131 Double blind
 Drug: INT131
INT- 131
Placebo Comparator: Placebo
Oral placebo Double blind
 Drug: INT131
INT- 131


Outcome Measures
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Primary Outcome Measures :
  1. The number of new gadolinium CE T1 weighted lesions [ Time Frame: asline to 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638038


Sponsors and Collaborators
InteKrin Therapeutics, Inc.
Investigators
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Study Chair: Barbara K. Finck, M.D Coherus BioSciences (parent company for Zao InteKrin)
More Information
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Responsible Party: InteKrin Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02638038    
Other Study ID Numbers: INT131-RU01-2
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases