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

Phase 2

Terminated

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Vatelizumab; Drug: Placebo (for Vatelizumab)

• Registration Number: NCT02222948
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Study Timeline

• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-22
• Study Start: 2014-09
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Status Verified: 2016-12
• Disposition First Submitted: 2016-12-20
• Disposition First Submitted QC: 2016-12-20
• Last Update Submitted: 2016-12-20
• Disposition First Posted: 2016-12-21
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vatelizumab Dose 3	Vatelizumab	Vatelizumab dose 3 at Weeks 0, 2, 4 and 8
Vatelizumab Dose 2	Vatelizumab	Vatelizumab dose 2 at Weeks 0, 2, 4 and 8
Vatelizumab Dose 1	Vatelizumab	Vatelizumab dose 1 at Weeks 0, 2, 4 and 8
Placebo	Placebo (for Vatelizumab)	Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8
Vatelizumab Dose 4	Vatelizumab	Vatelizumab dose 4 at Weeks 0, 2, 4 and 8

Primary Outcome Measures

Name	Time	Method
Reduction in the cumulative number of new contrast-enhancing lesions on MRI	from Week 4 to Week 12

Secondary Outcome Measures

Name	Time	Method
Safety: proportion of patients experiencing adverse events	up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab	up to Week 32

Trial Locations

Locations (32)

Investigational Site Number 840004; 🇺🇸 Cullman, Alabama, United States

Investigational Site Number 840005; 🇺🇸 Fort Collins, Colorado, United States

Investigational Site Number 840001; 🇺🇸 Latham, New York, United States

Investigational Site Number 840003; 🇺🇸 Round Rock, Texas, United States

Investigational Site Number 840016; 🇺🇸 San Antonio, Texas, United States

Investigational Site Number 124001; 🇨🇦 Greenfield Park, Canada

Investigational Site Number 840008; 🇺🇸 Seattle, Washington, United States

Investigational Site Number 616001; 🇵🇱 Lodz, Poland

Investigational Site Number 616002; 🇵🇱 Szczecin, Poland

Investigational Site Number 616006; 🇵🇱 Warszawa, Poland

Investigational Site Number 643010; 🇷🇺 Kazan, Russian Federation

Investigational Site Number 643009; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 643003; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 643006; 🇷🇺 Nizhny Novgorod, Russian Federation

Investigational Site Number 643002; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number 643008; 🇷🇺 Novosibirsk, Russian Federation

Investigational Site Number 643011; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number 752002; 🇸🇪 Göteborg, Sweden

Investigational Site Number 752001; 🇸🇪 Stockholm, Sweden

Investigational Site Number 616003; 🇵🇱 Lublin, Poland

Investigational Site Number 616008; 🇵🇱 Bydgoszcz, Poland

Investigational Site Number 616007; 🇵🇱 Lodz, Poland

Investigational Site Number 643001; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number 124002; 🇨🇦 QuebeC, Canada

Investigational Site Number 840009; 🇺🇸 Phoenix, Arizona, United States

Investigational Site Number 840014; 🇺🇸 Washington, District of Columbia, United States

Investigational Site Number 840012; 🇺🇸 Tampa, Florida, United States

Investigational Site Number 616004; 🇵🇱 Lublin, Poland

Investigational Site Number 840015; 🇺🇸 Knoxville, Tennessee, United States

Investigational Site Number 840007; 🇺🇸 Ormond Beach, Florida, United States

Investigational Site Number 840002; 🇺🇸 Salt Lake City, Utah, United States

Investigational Site Number 643005; 🇷🇺 Nizhniy Novgorod, Russian Federation