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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.

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE December 22, 2015
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2015)
The number of new gadolinium CE T1 weighted lesions [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis, Relapsing Remitting
Intervention  ICMJE Drug: INT131
INT- 131
Study Arms  ICMJE
  • Experimental: Oral INT 131 3 mg
    Oral INT-131 Double blind study
    Intervention: Drug: INT131
  • Experimental: Oral INT-131 1 mg
    Oral INT-131 Double blind
    Intervention: Drug: INT131
  • Placebo Comparator: Placebo
    Oral placebo Double blind
    Intervention: Drug: INT131
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
228
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 12, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638038
Other Study ID Numbers  ICMJE INT131-RU01-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InteKrin Therapeutics, Inc.
Study Sponsor  ICMJE InteKrin Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Barbara K. Finck, M.D Coherus BioSciences (parent company for Zao InteKrin)
PRS Account InteKrin Therapeutics, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP