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

February 27, 2018 updated by: InteKrin Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
asline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InteKrin Therapeutics, Inc.

Investigators

  • Study Chair: Barbara K. Finck, M.D, Coherus BioSciences (parent company for Zao InteKrin)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

December 12, 2016

Study Completion (ACTUAL)

December 12, 2016

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (ESTIMATE)

December 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT131-RU01-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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