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
NCT02638038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228
Last updated 2018-02-28
Summary
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.
Conditions
- Multiple Sclerosis, Relapsing Remitting
Interventions
- DRUG
-
INT131
INT- 131
Sponsors & Collaborators
-
InteKrin Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Barbara K. Finck, M.D · Coherus BioSciences (parent company for Zao InteKrin)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2016-12-12
- Completion
- 2016-12-12
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