Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839

Phase 2

Terminated

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: Vatelizumab

• Registration Number: NCT02306811
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

Primary Objective:

To assess the long-term safety of vatelizumab in MS patients

Secondary Objective:

To assess the long-term efficacy of vatelizumab

Detailed Description

The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Study Start: 2015-02
• 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: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vatelizumab Dose 2	Vatelizumab	Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks
Vatelizumab Dose 1	Vatelizumab	Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks
Vatelizumab Dose 4	Vatelizumab	Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks
Vatelizumab Dose 3	Vatelizumab	Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing adverse events	from Week 0 to Week 192

Secondary Outcome Measures

Name	Time	Method
Change in total volume of T2 lesions	from Week 0 to Week 84
Change in number of T1 hypointense lesions	from Week 0 to Week 84

Trial Locations

Locations (18)

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

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

Investigational Site Number 643009; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 616001; 🇵🇱 Lodz, Poland

Investigational Site Number 616004; 🇵🇱 Lublin, Poland

Investigational Site Number 616003; 🇵🇱 Lublin, Poland

Investigational Site Number 616002; 🇵🇱 Szczecin, Poland

Investigational Site Number 643010; 🇷🇺 Kazan, Russian Federation

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

Investigational Site Number 643008; 🇷🇺 Novosibirsk, Russian Federation

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

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

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

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

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

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

Investigational Site Number 124001; 🇨🇦 Greenfield Park, Canada

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