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

InteKrin Therapeutics, Inc.228 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

228

Conditions

Multiple Sclerosis, Relapsing Remitting

Interventions

INT131DRUG

INT- 131

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: asline to 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.