NCT02306811

Brief Summary

Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
4 countries

18 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 1, 2014

Last Update Submit

December 20, 2016

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients experiencing adverse events

    from Week 0 to Week 192

Secondary Outcomes (2)

  • Change in total volume of T2 lesions

    from Week 0 to Week 84

  • Change in number of T1 hypointense lesions

    from Week 0 to Week 84

Study Arms (4)

Vatelizumab Dose 1

EXPERIMENTAL

Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks

Drug: Vatelizumab

Vatelizumab Dose 2

EXPERIMENTAL

Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks

Drug: Vatelizumab

Vatelizumab Dose 3

EXPERIMENTAL

Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks

Drug: Vatelizumab

Vatelizumab Dose 4

EXPERIMENTAL

Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks

Drug: Vatelizumab

Interventions

VatelizumabDRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

Also known as: SAR339658
Vatelizumab Dose 1Vatelizumab Dose 2Vatelizumab Dose 3Vatelizumab Dose 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who completed the 12-week treatment period in DRI13839.

You may not qualify if:

  • Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study.
  • Confirmed platelet count below the lower limit of normal at any time during DRI13839.
  • Pregnancy or breast-feeding.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Investigational Site Number 840004

Cullman, Alabama, 35058, United States

Location

Investigational Site Number 840005

Fort Collins, Colorado, 80528, United States

Location

Investigational Site Number 840007

Ormond Beach, Florida, 32174, United States

Location

Investigational Site Number 840001

Latham, New York, 12210, United States

Location

Investigational Site Number 840003

Round Rock, Texas, 78681, United States

Location

Investigational Site Number 840016

San Antonio, Texas, 78258, United States

Location

Investigational Site Number 124001

Greenfield Park, J4V 2J2, Canada

Location

Investigational Site Number 616001

Lodz, 93-121, Poland

Location

Investigational Site Number 616004

Lublin, 20-090, Poland

Location

Investigational Site Number 616003

Lublin, 20-718, Poland

Location

Investigational Site Number 616002

Szczecin, 70-215, Poland

Location

Investigational Site Number 643010

Kazan', 420021, Russia

Location

Investigational Site Number 643009

Moscow, 107150, Russia

Location

Investigational Site Number 643006

Nizhny Novgorod, 603076, Russia

Location

Investigational Site Number 643005

Nizhny Novgorod, 603155, Russia

Location

Investigational Site Number 643008

Novosibirsk, 630087, Russia

Location

Investigational Site Number 643002

Saint Petersburg, 197089, Russia

Location

Investigational Site Number 643001

Saint Petersburg, 197376, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

PL(4)US(6)CA(1)RU(7)