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NCT02222948

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

NCT ID: NCT02222948

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks.

Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.

Conditions

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Relapsing-remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vatelizumab Dose 1

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

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Vatelizumab Dose 2

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

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Vatelizumab Dose 3

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

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Vatelizumab Dose 4

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

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (for Vatelizumab)

Intervention Type DRUG

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Interventions

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Vatelizumab

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type DRUG

Placebo (for Vatelizumab)

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Intervention Type DRUG

Other Intervention Names

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SAR339658

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840004

Cullman, Alabama, United States

Site Status

Investigational Site Number 840009

Phoenix, Arizona, United States

Site Status

Investigational Site Number 840005

Fort Collins, Colorado, United States

Site Status

Investigational Site Number 840014

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

Site Status

Investigational Site Number 840007

Ormond Beach, Florida, United States

Site Status

Investigational Site Number 840012

Tampa, Florida, United States

Site Status

Investigational Site Number 840001

Latham, New York, United States

Site Status

Investigational Site Number 840015

Knoxville, Tennessee, United States

Site Status

Investigational Site Number 840003

Round Rock, Texas, United States

Site Status

Investigational Site Number 840016

San Antonio, Texas, United States

Site Status

Investigational Site Number 840002

Salt Lake City, Utah, United States

Site Status

Investigational Site Number 840008

Seattle, Washington, United States

Site Status

Investigational Site Number 124001

Greenfield Park, , Canada

Site Status

Investigational Site Number 124002

Québec, , Canada

Site Status

Investigational Site Number 616008

Bydgoszcz, , Poland

Site Status

Investigational Site Number 616007

Lodz, , Poland

Site Status

Investigational Site Number 616001

Lodz, , Poland

Site Status

Investigational Site Number 616004

Lublin, , Poland

Site Status

Investigational Site Number 616003

Lublin, , Poland

Site Status

Investigational Site Number 616002

Szczecin, , Poland

Site Status

Investigational Site Number 616006

Warsaw, , Poland

Site Status

Investigational Site Number 643010

Kazan', , Russia

Site Status

Investigational Site Number 643009

Moscow, , Russia

Site Status

Investigational Site Number 643003

Moscow, , Russia

Site Status

Investigational Site Number 643006

Nizhny Novgorod, , Russia

Site Status

Investigational Site Number 643005

Nizhny Novgorod, , Russia

Site Status

Investigational Site Number 643008

Novosibirsk, , Russia

Site Status

Investigational Site Number 643002

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643011

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643001

Saint Petersburg, , Russia

Site Status

Investigational Site Number 752002

Gothenburg, , Sweden

Site Status

Investigational Site Number 752001

Stockholm, , Sweden

Site Status

Countries

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United States Canada Poland Russia Sweden

Other Identifiers

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U1111-1153-3840

Identifier Type: OTHER

Identifier Source: secondary_id

2014-001643-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DRI13839

Identifier Type: -

Identifier Source: org_study_id