NCT02638038

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2016

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

December 16, 2015

Last Update Submit

February 27, 2018

Conditions

Multiple Sclerosis, Relapsing Remitting

Outcome Measures

Primary Outcomes (1)

  • 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.

    asline to 6 months

Study Arms (3)

Oral INT 131 3 mg

EXPERIMENTAL

Oral INT-131 Double blind study

Drug: INT131

Oral INT-131 1 mg

EXPERIMENTAL

Oral INT-131 Double blind

Drug: INT131

Placebo

PLACEBO COMPARATOR

Oral placebo Double blind

Drug: INT131

Interventions

INT131DRUG

INT- 131

Oral INT 131 3 mgOral INT-131 1 mgPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

INT 131

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Barbara K. Finck, M.D

    Coherus BioSciences (parent company for Zao InteKrin)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized double blind parallel group study with 3mg, 1mg or placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

February 1, 2015

Primary Completion

December 12, 2016

Study Completion

December 12, 2016

Last Updated

February 28, 2018

Record last verified: 2018-02