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

Genzyme

Status and phase: Terminated; Phase 2

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: Vatelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02306811

U1111-1160-6120 (Other Identifier)

2014-003265-19 (EudraCT Number)

LTS13840

Details and patient eligibility

About

Primary Objective:

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

Secondary Objective:

To assess the long-term efficacy of vatelizumab

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who completed the 12-week treatment period in DRI13839.

Exclusion criteria

• Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study.
• Confirmed platelet count below the lower limit of normal at any time during DRI13839.
• Pregnancy or breast-feeding.
• Other protocol defined 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

62 participants in 4 patient groups

Vatelizumab Dose 1

Experimental group

Description:

Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks

Treatment:

Drug: Vatelizumab

Vatelizumab Dose 2

Experimental group

Description:

Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks

Treatment:

Drug: Vatelizumab

Vatelizumab Dose 3

Experimental group

Description:

Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks

Treatment:

Drug: Vatelizumab

Vatelizumab Dose 4

Experimental group

Description:

Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks

Treatment:

Drug: Vatelizumab