Clinical trial NCT02222948: Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in the cumulative number of new contrast-enhancing lesions on MRI
timeFrame: from Week 4 to Week 12
Secondary outcomes:
measure: Safety: proportion of patients experiencing adverse events
timeFrame: up to Week 104
measure: Pharmacokinetics: serum concentrations of vatelizumab
timeFrame: up to Week 32
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Investigational Site Number 840004
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 840009
state: Arizona
city: Fort Collins
country: United States
facility: Investigational Site Number 840005
state: Colorado
city: Washington
country: United States
facility: Investigational Site Number 840014
state: District of Columbia
city: Ormond Beach
country: United States
facility: Investigational Site Number 840007
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840012
state: Florida
city: Latham
country: United States
facility: Investigational Site Number 840001
state: New York
city: Knoxville
country: United States
facility: Investigational Site Number 840015
state: Tennessee
city: Round Rock
country: United States
facility: Investigational Site Number 840003
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840016
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site Number 840002
state: Utah
city: Seattle
country: United States
facility: Investigational Site Number 840008
state: Washington
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124001
city: QuebeC
country: Canada
facility: Investigational Site Number 124002
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616008
city: Lodz
country: Poland
facility: Investigational Site Number 616007
city: Lodz
country: Poland
facility: Investigational Site Number 616001
city: Lublin
country: Poland
facility: Investigational Site Number 616004
city: Lublin
country: Poland
facility: Investigational Site Number 616003
city: Szczecin
country: Poland
facility: Investigational Site Number 616002
city: Warszawa
country: Poland
facility: Investigational Site Number 616006
city: Kazan
country: Russian Federation
facility: Investigational Site Number 643010
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643009
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigational Site Number 643005
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 643006
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643008
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643002
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643011
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643001
city: Göteborg
country: Sweden
facility: Investigational Site Number 752002
city: Stockholm
country: Sweden
facility: Investigational Site Number 752001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: