Relapsing-remitting Multiple SclerosisPhase 2NCT02306811
Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
A Phase 2 study testing Vatelizumab in people with Relapsing-remitting Multiple Sclerosis, run by Genzyme, a Sanofi Company at 18 sites in 4 countries.
Trial summary
Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Feb 2015to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed the 12-week treatment period in DRI13839.
Who cannot join
- 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 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
18 sites in 4 countries.
18 sites in 4 countries
Russia7 sites
Investigational Site Number 643010
Kazan', 420021
Investigational Site Number 643009
Moscow, 107150
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 643001
Saint Petersburg, 197376
United States6 sites
Investigational Site Number 840004
Cullman, Alabama, 35058
Investigational Site Number 840005
Fort Collins, Colorado, 80528
Investigational Site Number 840001
Latham, New York, 12210
Investigational Site Number 840007
Ormond Beach, Florida, 32174
Investigational Site Number 840003
Round Rock, Texas, 78681
Investigational Site Number 840016
San Antonio, Texas, 78258
Poland4 sites
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, 70-215
About this study
Official title: A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
Primary Objective:
To assess the long-term safety of vatelizumab in MS patients
Secondary Objective:
To assess the long-term efficacy of vatelizumab
Read the 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.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- 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
| Study group | Role | What they receive |
|---|---|---|
| Vatelizumab Dose 1 | Experimental | Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks Receives: Drug: Vatelizumab |
| Vatelizumab Dose 2 | Experimental | Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks Receives: Drug: Vatelizumab |
| Vatelizumab Dose 3 | Experimental | Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks Receives: Drug: Vatelizumab |
| Vatelizumab Dose 4 | Experimental | Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks Receives: Drug: Vatelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing adverse events
Measured: from Week 0 to Week 192
Secondary outcomes (2)
Change in total volume of T2 lesions
Measured: from Week 0 to Week 84
Change in number of T1 hypointense lesions
Measured: from Week 0 to Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startFeb 2015
- 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
- 62 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
- NCT02306811
- Sponsor's protocol ID
- LTS13840
- Other IDs
- 2014-003265-19, U1111-1160-6120, 2014
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 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 Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
- ClinicalTrials.gov ID
- NCT02306811
- Acronym / sponsor ID
- LTS13840
- 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
- 62 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Dec 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vatelizumab Dose 1 | Experimental | Drug: VatelizumabVatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks |
| Vatelizumab Dose 2 | Experimental | Drug: VatelizumabVatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks |
| Vatelizumab Dose 3 | Experimental | Drug: VatelizumabVatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks |
| Vatelizumab Dose 4 | Experimental | Drug: VatelizumabVatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who completed the 12-week treatment period in DRI13839.
Key exclusion criteria (5 listed)
- 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 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 |
Primary outcome
Proportion of patients experiencing adverse events
Time frame: from Week 0 to Week 192
2 secondary outcomes
Change in total volume of T2 lesions
Time frame: from Week 0 to Week 84
Change in number of T1 hypointense lesions
Time frame: from Week 0 to Week 84
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
18 sites in 4 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 18 sites in 4 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 1 inclusion and 5 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 18 sites in Russia, United States, Poland, Canada. 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. 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?
Proportion of patients experiencing adverse events (time frame: from Week 0 to Week 192). 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.