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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— EMPIRE  

Official title:

A Phase 2a/2b Double-Blind, Randomized, Placebo-Controlled Study Assessing Efficacy, Safety, and Dose-Response of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02222948
• Other study ID #: DRI13839
• Secondary ID: 2014-001643-20U1
• Status: Terminated
• Phase: Phase 2
• First received: August 20, 2014
• Last updated: December 20, 2016
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Pregnancy or breast-feeding. Other protocol-defined inclusion/exclusion criteria may apply.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Vatelizumab
Pharmaceutical form: solution for infusion Route of administration: intravenous
• Placebo (for Vatelizumab)
Pharmaceutical form: solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Canada	Investigational Site Number 124001	Greenfield Park
Canada	Investigational Site Number 124002	QuebeC
Poland	Investigational Site Number 616008	Bydgoszcz
Poland	Investigational Site Number 616001	Lodz
Poland	Investigational Site Number 616007	Lodz
Poland	Investigational Site Number 616003	Lublin
Poland	Investigational Site Number 616004	Lublin
Poland	Investigational Site Number 616002	Szczecin
Poland	Investigational Site Number 616006	Warszawa
Russian Federation	Investigational Site Number 643010	Kazan
Russian Federation	Investigational Site Number 643003	Moscow
Russian Federation	Investigational Site Number 643009	Moscow
Russian Federation	Investigational Site Number 643005	Nizhniy Novgorod
Russian Federation	Investigational Site Number 643006	Nizhny Novgorod
Russian Federation	Investigational Site Number 643008	Novosibirsk
Russian Federation	Investigational Site Number 643001	St-Petersburg
Russian Federation	Investigational Site Number 643002	St-Petersburg
Russian Federation	Investigational Site Number 643011	St-Petersburg
Sweden	Investigational Site Number 752002	Göteborg
Sweden	Investigational Site Number 752001	Stockholm
United States	Investigational Site Number 840004	Cullman	Alabama
United States	Investigational Site Number 840005	Fort Collins	Colorado
United States	Investigational Site Number 840015	Knoxville	Tennessee
United States	Investigational Site Number 840001	Latham	New York
United States	Investigational Site Number 840007	Ormond Beach	Florida
United States	Investigational Site Number 840009	Phoenix	Arizona
United States	Investigational Site Number 840003	Round Rock	Texas
United States	Investigational Site Number 840002	Salt Lake City	Utah
United States	Investigational Site Number 840016	San Antonio	Texas
United States	Investigational Site Number 840008	Seattle	Washington
United States	Investigational Site Number 840012	Tampa	Florida
United States	Investigational Site Number 840014	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the cumulative number of new contrast-enhancing lesions on MRI		from Week 4 to Week 12	No
Secondary	Safety: proportion of patients experiencing adverse events		up to Week 104	Yes
Secondary	Pharmacokinetics: serum concentrations of vatelizumab		up to Week 32	No