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

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001643-20-DE

Enrollment

168

Registered

2014-08-18

Start date

2015-02-10

Completion date

Unknown

Last updated

2017-02-13

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

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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 ;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 ;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

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. ;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. ;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.

Design outcomes

Primary

Measure	Time frame
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. ;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;Timepoint(s) of evaluation of this end point: from Week 4 to Week 12 ;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. ;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;Timepoint(s) of evaluation of this end point: from Week 4 to Week 12 ;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. ;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;Timepoint(s) of evaluation of this end point: from Week 4 to Week 12	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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 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 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	—

Measure

Time frame

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 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 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

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Countries

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

Contacts

Public ContactMedical Information Genzyme Europe;Medical Information Genzyme Europe;Medical Information Genzyme Europe ;;

Genzyme Europe B.V.;Genzyme Europe B.V.;Genzyme Europe B.V.

eumedinfo@genzyme.com;eumedinfo@genzyme.com;eumedinfo@genzyme.com;;

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026