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Completed

NCT Number: NCT02638038

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 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.

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Key information

Conditions

Multiple Sclerosis, Relapsing Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INT131

Drug

INT- 131

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

InteKrin Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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