Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 13 February 2017
• Main ID: EUCTR2014-001643-20-DE
• Date of registration: 18/08/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme Corporation
• Public title: Efficacy and Safety of Vatelizumab in Patients with Relapsing Remitting Multiple Sclerosis
• Scientific title: 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)
• Date of first enrolment: 10/02/2015
• Target sample size: 168
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001643-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Germany, Italy, Mexico, Poland, Russian Federation, Sweden, Switzerland, United States

Contacts

• Name: Medical Information Genzyme Europe
• Affiliation: Genzyme Europe B.V.

• Name: Medical Information Genzyme Europe
• Affiliation: Genzyme Europe B.V.

Key inclusion & exclusion 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 month and / or at screening.
At least 3 T2 lesions on screening MRI.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Nervous System Diseases
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Code: SAR339658
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vatelizumab
CAS Number: 1238217-55-4
Current Sponsor code: SAR339658
Other descriptive name: CHR-1103 / GBR500
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Secondary Objective: To evaluate the safety and tolerability of vatelizumab compared to placebo
To evaluate the pharmacokinetics (PK) of vatelizumab

Primary end point(s): Reduction in the cumulative number of new CELs on MRI compared to placebo

Main Objective: To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in RRMS patients
To evaluate mutiple doses of vatelizumab for a dose-response.

Timepoint(s) of evaluation of this end point: from Week 4 to Week 12

Secondary Outcome(s)

Secondary end point(s): Safety: proportion of patients experiencing adverse events
Pharmacokinetics: serum concentrations of vatelizumab

Timepoint(s) of evaluation of this end point: Safety: proportion of patients experiencing adverse events: up to 32 weeks
Pharmacokinetics: serum concentrations of vatelizumab: up to 32 weeks

Secondary ID(s)

DRI13839

Source(s) of Monetary Support

Genzyme Corporation