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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02638038

Enrollment

228

Registered

2015-12-22

Start date

2015-02-28

Completion date

2016-12-12

Last updated

2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing Remitting

Brief summary

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.

Interventions

DRUGINT131

INT- 131

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind

Intervention model description

A randomized double blind parallel group study with 3mg, 1mg or placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The number of new gadolinium CE T1 weighted lesions	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026