NCT02222948

Brief Summary

Primary Objectives:

  • To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients.
  • To evaluate multiple doses of vatelizumab for a dose-response. Secondary Objectives:
  • To evaluate the safety and tolerability of vatelizumab compared to placebo.
  • To evaluate the pharmacokinetics (PK) of vatelizumab.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Geographic Reach
5 countries

32 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

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.6 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

1.6 years

First QC Date

August 20, 2014

Last Update Submit

December 20, 2016

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Reduction in the cumulative number of new contrast-enhancing lesions on MRI

    from Week 4 to Week 12

Secondary Outcomes (2)

  • Safety: proportion of patients experiencing adverse events

    up to Week 104

  • Pharmacokinetics: serum concentrations of vatelizumab

    up to Week 32

Study Arms (5)

Vatelizumab Dose 1

EXPERIMENTAL

Vatelizumab dose 1 at Weeks 0, 2, 4 and 8

Drug: Vatelizumab

Vatelizumab Dose 2

EXPERIMENTAL

Vatelizumab dose 2 at Weeks 0, 2, 4 and 8

Drug: Vatelizumab

Vatelizumab Dose 3

EXPERIMENTAL

Vatelizumab dose 3 at Weeks 0, 2, 4 and 8

Drug: Vatelizumab

Vatelizumab Dose 4

EXPERIMENTAL

Vatelizumab dose 4 at Weeks 0, 2, 4 and 8

Drug: Vatelizumab

Placebo

PLACEBO COMPARATOR

Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8

Drug: Placebo (for 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
Placebo (for Vatelizumab)DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance imaging (MRI) in the past 12 months and/or at screening.
  • At least 3 T2 lesions on screening MRI.

You may not qualify if:

  • Diagnosis of primary progressive or secondary progressive MS. Expanded disability status scale (EDSS) score \>5.5. Relapse within 30 days prior to enrollment. Prior immunosuppressive treatment within protocol-specified time periods. Prior treatment with natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain infections as defined in the protocol, or any other past or current medical conditions that would adversely affect the patient's participation in the study.
  • 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 (32)

Investigational Site Number 840004

Cullman, Alabama, 35058, United States

Location

Investigational Site Number 840009

Phoenix, Arizona, 85060, United States

Location

Investigational Site Number 840005

Fort Collins, Colorado, 80528, United States

Location

Investigational Site Number 840014

Washington D.C., District of Columbia, 20037, United States

Location

Investigational Site Number 840007

Ormond Beach, Florida, 32174, United States

Location

Investigational Site Number 840012

Tampa, Florida, 33612, United States

Location

Investigational Site Number 840001

Latham, New York, 12210, United States

Location

Investigational Site Number 840015

Knoxville, Tennessee, 37922, 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 840002

Salt Lake City, Utah, 84103, United States

Location

Investigational Site Number 840008

Seattle, Washington, 98122, United States

Location

Investigational Site Number 124001

Greenfield Park, J4V 2J2, Canada

Location

Investigational Site Number 124002

Québec, Canada

Location

Investigational Site Number 616008

Bydgoszcz, 85-079, Poland

Location

Investigational Site Number 616007

Lodz, 90-549, Poland

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, 70-111, Poland

Location

Investigational Site Number 616006

Warsaw, 02-653, Poland

Location

Investigational Site Number 643010

Kazan', 420021, Russia

Location

Investigational Site Number 643009

Moscow, 107150, Russia

Location

Investigational Site Number 643003

Moscow, 127018, 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 643011

Saint Petersburg, 197110, Russia

Location

Investigational Site Number 643001

Saint Petersburg, 197376, Russia

Location

Investigational Site Number 752002

Gothenburg, 416 85, Sweden

Location

Investigational Site Number 752001

Stockholm, 171 76, Sweden

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

August 20, 2014

First Posted

August 22, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

US(12)CA(2)SE(2)RU(9)PL(7)