Back to resultsThis 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
Primary Purpose
Multiple Sclerosis, Relapsing Remitting
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
INT131
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing Remitting
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Oral INT 131 3 mg
Oral INT-131 1 mg
Placebo
Arm Description
Oral INT-131 Double blind study
Oral INT-131 Double blind
Oral placebo Double blind
Outcomes
Primary Outcome Measures
The number of new gadolinium CE T1 weighted lesions
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02638038
First Posted
December 16, 2015
Last Updated
February 27, 2018
Sponsor
InteKrin Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02638038
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InteKrin Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing Remitting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized double blind parallel group study with 3mg, 1mg or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral INT 131 3 mg
Arm Type
Experimental
Arm Description
Oral INT-131 Double blind study
Arm Title
Oral INT-131 1 mg
Arm Type
Experimental
Arm Description
Oral INT-131 Double blind
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo Double blind
Intervention Type
Drug
Intervention Name(s)
INT131
Intervention Description
INT- 131
Primary Outcome Measure Information:
Title
The number of new gadolinium CE T1 weighted lesions
Description
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.
Time Frame
asline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara K. Finck, M.D
Organizational Affiliation
Coherus BioSciences (parent company for Zao InteKrin)
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
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
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