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

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis, Relapsing Remitting

Treatments: Drug: INT131

Study type: Interventional

Funder types: Industry

Identifiers

NCT02638038

INT131-RU01-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

228 participants in 3 patient groups, including a placebo group

Oral INT 131 3 mg

Experimental group

Description:

Oral INT-131 Double blind study

Treatment:

Drug: INT131

Oral INT-131 1 mg

Experimental group

Description:

Oral INT-131 Double blind

Treatment:

Drug: INT131

Placebo

Placebo Comparator group

Description:

Oral placebo Double blind

Treatment:

Drug: INT131