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

A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02306811

Enrollment

Registered

2014-12-03

Start date

2015-02-28

Completion date

2016-07-31

Last updated

2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting Multiple Sclerosis

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.

Interventions

DRUGVatelizumab

Pharmaceutical form:solution for infusion Route of administration: intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients experiencing adverse events	from Week 0 to Week 192

Secondary

Measure	Time frame
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

Countries

Canada, Poland, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026