Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remittin
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)
What it found
The trial was stopped early because the treatment was not working.
Reason given: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Vatelizumab
Integrin alpha-2 antagonist
Placebo
- Placebo (for Vatelizumab)
What it measured
Main measures
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
from Week 4 to Week 12
MRI lesionsReduction in the cumulative number of new CELs on MRI compared to placebo
MRI lesions
Other measures (2)
Safety: proportion of patients experiencing adverse events
up to Week 104
SafetyPharmacokinetics: serum concentrations of vatelizumab
up to Week 32
How the body handles the medicine
Who could take part
Relapsing MS · 18 to 55
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Sept 2014
Main results due
Apr 2016
Finished
Jul 2016