Relapsing-remitting Multiple SclerosisPhase 2EMPIRENCT02222948
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Vatelizumab in people with Relapsing-remitting Multiple Sclerosis, run by Genzyme, a Sanofi Company at 32 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Vatelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 32 sitesin 5 countries
- Study dates
- Sep 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
United States12 sites
Investigational Site Number 840004
Cullman, Alabama, 35058
Investigational Site Number 840005
Fort Collins, Colorado, 80528
Investigational Site Number 840015
Knoxville, Tennessee, 37922
Investigational Site Number 840001
Latham, New York, 12210
Investigational Site Number 840007
Ormond Beach, Florida, 32174
Investigational Site Number 840009
Phoenix, Arizona, 85060
Investigational Site Number 840003
Round Rock, Texas, 78681
Investigational Site Number 840002
Salt Lake City, Utah, 84103
Investigational Site Number 840016
San Antonio, Texas, 78258
Investigational Site Number 840008
Seattle, Washington, 98122
Investigational Site Number 840012
Tampa, Florida, 33612
Investigational Site Number 840014
Washington D.C., District of Columbia, 20037
Russia9 sites
Investigational Site Number 643010
Kazan', 420021
Investigational Site Number 643009
Moscow, 107150
Investigational Site Number 643003
Moscow, 127018
Investigational Site Number 643006
Nizhny Novgorod, 603076
Investigational Site Number 643005
Nizhny Novgorod, 603155
Investigational Site Number 643008
Novosibirsk, 630087
Investigational Site Number 643002
Saint Petersburg, 197089
Investigational Site Number 643011
Saint Petersburg, 197110
Investigational Site Number 643001
Saint Petersburg, 197376
Poland7 sites
Investigational Site Number 616008
Bydgoszcz, 85-079
Investigational Site Number 616007
Lodz, 90-549
Investigational Site Number 616001
Lodz, 93-121
Investigational Site Number 616004
Lublin, 20-090
Investigational Site Number 616003
Lublin, 20-718
Investigational Site Number 616002
Szczecin, 70-111
Investigational Site Number 616006
Warsaw, 02-653
Canada2 sites
Investigational Site Number 124001
Greenfield Park, J4V 2J2
Investigational Site Number 124002
Québec
Sweden2 sites
Investigational Site Number 752002
Gothenburg, 416 85
Investigational Site Number 752001
Stockholm, 171 76
About this study
Official 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)
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.
Read the detailed description
The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks.
Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Vatelizumab, Placebo (for Vatelizumab)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VatelizumabDrug
Also called SAR339658
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Placebo (for Vatelizumab)Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Vatelizumab Dose 1 | Experimental | Vatelizumab dose 1 at Weeks 0, 2, 4 and 8 Receives: Drug: Vatelizumab |
| Vatelizumab Dose 2 | Experimental | Vatelizumab dose 2 at Weeks 0, 2, 4 and 8 Receives: Drug: Vatelizumab |
| Vatelizumab Dose 3 | Experimental | Vatelizumab dose 3 at Weeks 0, 2, 4 and 8 Receives: Drug: Vatelizumab |
| Vatelizumab Dose 4 | Experimental | Vatelizumab dose 4 at Weeks 0, 2, 4 and 8 Receives: Drug: Vatelizumab |
| Placebo | Placebo comparator | Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8 Receives: Drug: Placebo (for Vatelizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
Measured: from Week 4 to Week 12
Secondary outcomes (2)
Safety: proportion of patients experiencing adverse events
Measured: up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab
Measured: up to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionJul 2016
Why it stopped: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222948
- Sponsor's protocol ID
- DRI13839
- Other IDs
- 2014-001643-20, U1111-1153-3840, 2014
- Acronym
- EMPIRE
- Status last verified
- Dec 2016
- First submitted
- 20 Aug 2014
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02222948
- Acronym / sponsor ID
- EMPIRE / DRI13839
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks.
Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vatelizumab Dose 1 | Experimental | Drug: VatelizumabVatelizumab dose 1 at Weeks 0, 2, 4 and 8 |
| Vatelizumab Dose 2 | Experimental | Drug: VatelizumabVatelizumab dose 2 at Weeks 0, 2, 4 and 8 |
| Vatelizumab Dose 3 | Experimental | Drug: VatelizumabVatelizumab dose 3 at Weeks 0, 2, 4 and 8 |
| Vatelizumab Dose 4 | Experimental | Drug: VatelizumabVatelizumab dose 4 at Weeks 0, 2, 4 and 8 |
| Placebo | Placebo comparator | Drug: Placebo (for Vatelizumab)Placebo (for Vatelizumab) at Weeks 0, 2, 4 and 8 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VatelizumabAlso: SAR339658Pharmaceutical form: solution for infusion Route of administration: intravenous | Drug | Vatelizumab Dose 1, Vatelizumab Dose 2, Vatelizumab Dose 3, Vatelizumab Dose 4 |
| Placebo (for Vatelizumab)Pharmaceutical form: solution for infusion Route of administration: intravenous | Drug | Placebo |
Primary outcome
Reduction in the cumulative number of new contrast-enhancing lesions on MRI
Time frame: from Week 4 to Week 12
2 secondary outcomes
Safety: proportion of patients experiencing adverse events
Time frame: up to Week 104
Pharmacokinetics: serum concentrations of vatelizumab
Time frame: up to Week 32
Results and safety
The study was stopped early (reason given: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vatelizumab in people with Relapsing-remitting Multiple Sclerosis, run by Genzyme, a Sanofi Company at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Russia, Poland, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the cumulative number of new contrast-enhancing lesions on MRI (time frame: from Week 4 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.