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Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

Primary Purpose

Relapsing Multiple Sclerosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolebrutinib
Teriflunomide HMR1726
Placebo to match Tolebrutinib
Placebo to match Teriflunomide
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

  • The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
  • The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
  • The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit

  • The participant must have at least 1 of the following prior to screening:

    • ≥1 documented relapse within the previous year OR
    • ≥2 documented relapses within the previous 2 years, OR
    • ≥1 documented Gd enhancing lesion on an MRI scan within the previous year
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

  • Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:

    • Refrain from donating sperm

Plus either:

  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
  • Must agree to use contraception/barrier as detailed below

  • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant

    - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply:

  • Is not a WOCBP OR

  • Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time.

    • A WOCBP must have a negative highly sensitive pregnancy test at screening and within 24hours before the first dose of study intervention.
    • If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    • The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative

Exclusion criteria:

  • The participant has been diagnosed with primary progressive multiplesclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiplesclerosis (SPMS)
  • The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection
  • Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.

  • The participant has conditions or situations that would adversely affect participation in this study, including but not limited to:

    • A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist
    • Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator
    • A requirement for concomitant treatment that could bias the primary evaluation
  • The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
  • At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody

  • The participant has any of the following:

    • A bleeding disorder or known platelet dysfunction at any time prior to the screening visit
    • A platelet count <150 000/μL at the screening visit
  • The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit
  • The presence of psychiatric disturbance or substance abuse
  • Prior/concomitant therapy
  • The participant is receiving potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes
  • The participant is receiving anticoagulant/antiplatelet therapies
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Sites / Locations

  • North Central Neurology Associates, PC-Site Number:8400009
  • Center for Neurology and Spine-Site Number:8400089
  • Arcadia Neurology Center-Site Number:8400070
  • Multiple Sclerosis Center of California-Site Number:8400135
  • Harbor UCLA-Site Number:8400088
  • Mountain Neurological Research Center, Inc.-Site Number:8400128
  • Advanced Neurosciences Research-Site Number:8400025
  • South Florida Neurology Associates-Site Number:8400029
  • University of Florida Health-Site Number:8400159
  • Neurology Associates, PA-Site Number:8400004
  • University of Miami-Site Number:8400063
  • Infinity Clinical Research-Site Number:8400008
  • University of South Florida-Site Number:8400006
  • Meridian Clinical Research-Site Number:8400003
  • Consultants In Neurology-Site Number:8400011
  • Prairie Education and Research Cooperative-Site Number:8400071
  • Fort Wayne Neurological Center-Site Number:8400039
  • CHI Saint Joseph Medical Group Neurology-Site Number:8400110
  • University of Kentucky-Site Number:8400106
  • Norton Neurology MS Services-Site Number:8400127
  • The NeuroMedical Center-Site Number:8400057
  • International Neurorehabilitation Institute-Site Number:8400034
  • Wayne State University-Site Number:8400046
  • Minneapolis Clinic of Neurology-Site Number:8400051
  • Saint Luke's Hospital-Site Number:8400153
  • West Omaha Family Physicians-Site Number:8400139
  • University Of Nebraska-Site Number:8400129
  • Hackensack University Hospital-Site Number:8400047
  • University of New Mexico-Site Number:8400032
  • South Shore Neurologic Associates-Site Number:8400100
  • Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120
  • Meridian Clinical Research, LLC-Site Number:8400005
  • Sanford Brain & Spine Center-Site Number:8400126
  • Dayton Center for Neurological Disorders-Site Number:8400081
  • Jefferson Neurology Associates-Site Number:8400016
  • Premier Neurology-Site Number:8400069
  • Advanced Neuroscience Center-Site Number:8400035
  • Sibyl Wray, MD, Neurology, PC-Site Number:8400007
  • Mt Olympus Medical Research-Site Number:8400163
  • Neurology Center of San Antonio-Site Number:8400036
  • Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151
  • Neurological Associates-Site Number:8400097
  • Wheaton Franciscan Healthcare-Site Number:8400022
  • Investigational Site Number :0320004
  • Investigational Site Number :0320002
  • Investigational Site Number :0320001
  • Investigational Site Number :0320003
  • Investigational Site Number :0320005
  • Investigational Site Number :0560005
  • Investigational Site Number :0560004
  • Investigational Site Number :0560002
  • Investigational Site Number :0560001
  • Investigational Site Number :0760001
  • Investigational Site Number :0760002
  • Investigational Site Number :0760007
  • Investigational Site Number :1240002
  • Investigational Site Number :1240014
  • Investigational Site Number :1240005
  • Investigational Site Number :1240006
  • Investigational Site Number :1240021
  • Investigational Site Number :1520002
  • Investigational Site Number :1520005
  • Investigational Site Number :1520001
  • Investigational Site Number :1520003
  • Investigational Site Number :1520006
  • Investigational Site Number :1520004
  • Investigational Site Number :1910001
  • Investigational Site Number :1910002
  • Investigational Site Number :1910003
  • Investigational Site Number :2030002
  • Investigational Site Number :2030011
  • Investigational Site Number :2030001
  • Investigational Site Number :2030008
  • Investigational Site Number :2030005
  • Investigational Site Number :2500019
  • Investigational Site Number :2500018
  • Investigational Site Number :2500011
  • Investigational Site Number :2500005
  • Investigational Site Number :2500006
  • Investigational Site Number :2500010
  • Investigational Site Number :2500002
  • Investigational Site Number :2500017
  • Investigational Site Number :2500007
  • Investigational Site Number :2500004
  • Investigational Site Number :2500003
  • Investigational Site Number :2500001
  • Investigational Site Number :2760005
  • Investigational Site Number :2760015
  • Investigational Site Number :2760014
  • Investigational Site Number :2760020
  • Investigational Site Number :2760012
  • Investigational Site Number :2760003
  • Investigational Site Number :3000001
  • Investigational Site Number :3000006
  • Investigational Site Number :3000002
  • Investigational Site Number :3000007
  • Investigational Site Number :3000009
  • Investigational Site Number :3000004
  • Investigational Site Number :3000003
  • Investigational Site Number :3480105
  • Investigational Site Number :3480102
  • Investigational Site Number :3480106
  • Investigational Site Number :3480103
  • Investigational Site Number :3560005
  • Investigational Site Number :3560007
  • Investigational Site Number :3560008
  • Investigational Site Number :3560002
  • Investigational Site Number :3560004
  • Investigational Site Number :3760002
  • Investigational Site Number :3760003
  • Investigational Site Number :3760006
  • Investigational Site Number :3760004
  • Investigational Site Number :3760001
  • Investigational Site Number :4100001
  • Investigational Site Number :4100003
  • Investigational Site Number :4100006
  • Investigational Site Number :4100002
  • Investigational Site Number :4280002
  • Investigational Site Number :4280003
  • Investigational Site Number :5280001
  • Investigational Site Number :5780002
  • Investigational Site Number :5780001
  • Investigational Site Number :6200001
  • Investigational Site Number :6200005
  • Investigational Site Number :6200011
  • Investigational Site Number :6200006
  • Investigational Site Number :6200002
  • Investigational Site Number :6200010
  • Investigational Site Number :6200004
  • San Juan MS Center-Site Number:8400015
  • Investigational Site Number :6430006
  • Investigational Site Number :6430013
  • Investigational Site Number :6430012
  • Investigational Site Number :6430001
  • Investigational Site Number :6430010
  • Investigational Site Number :6430007
  • Investigational Site Number :6430005
  • Investigational Site Number :6430003
  • Investigational Site Number :6430014
  • Investigational Site Number :6430002
  • Investigational Site Number :6430011
  • Investigational Site Number :6430004
  • Investigational Site Number :6880001
  • Investigational Site Number :6880003
  • Investigational Site Number :6880006
  • Investigational Site Number :6880002
  • Investigational Site Number :6880004
  • Investigational Site Number :6880005
  • Investigational Site Number :7030001
  • Investigational Site Number :7030002
  • Investigational Site Number :7030004
  • Investigational Site Number :7240011
  • Investigational Site Number :7240006
  • Investigational Site Number :7240009
  • Investigational Site Number :7240004
  • Investigational Site Number :7240013
  • Investigational Site Number :7240007
  • Investigational Site Number :7240008
  • Investigational Site Number :7240005
  • Investigational Site Number :7240003
  • Investigational Site Number :7240001
  • Investigational Site Number :7240002
  • Investigational Site Number :7240010
  • Investigational Site Number :7240012
  • Investigational Site Number :7560003
  • Investigational Site Number :7560002
  • Investigational Site Number :7560004
  • Investigational Site Number :7920002
  • Investigational Site Number :7920005
  • Investigational Site Number :7920006
  • Investigational Site Number :7920004
  • Investigational Site Number :7920001
  • Investigational Site Number :7920003
  • Investigational Site Number :8040020
  • Investigational Site Number :8040002
  • Investigational Site Number :8040019
  • Investigational Site Number :8040005
  • Investigational Site Number :8040022
  • Investigational Site Number :8040018
  • Investigational Site Number :8040007
  • Investigational Site Number :8040006
  • Investigational Site Number :8040003
  • Investigational Site Number :8260003
  • Investigational Site Number :8260016
  • Investigational Site Number :8260009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAR442168

Teriflunomide

Arm Description

Dose 1 of oral SAR442168 daily + placebo to match the teriflunomide tablet once daily

Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily

Outcomes

Primary Outcome Measures

Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses
Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses

Secondary Outcome Measures

Time to onset of confirmed disability worsening confirmed over at least 6 months
ime to onset of confirmed disability worsening (CDW), confirmed over at least 6 months, defined as follows: increase of ≥1.5 points from the baseline expanded disability status scale (EDSS) score when the baseline score is 0 OR increase of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 OR increase of ≥0.5 point from the baseline EDSS score when the baseline score is >5.5 - 5.
Time to onset of CDW, assessed by the EDSS score and confirmed over at least 3 months
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from Month 6 through the end of study
Total Number of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the End of study (EOS)
Change in cognitive function
Change in cognitive function from baseline to the EOS as assessed by the SDMT and CVLT-II where available
Time to confirmed disability improvement
Time to confirmed disability improvement (CDI), defined as a ≥1.0 point decrease on the EDSS from the baseline EDSS score confirmed over at least 6 months
Percent change in Brain volume Loss as detected by brain MRI
Brain volume loss (BVL) rate as detected by brain MRI from Month 6 to the EOS
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS
Number of participants with adverse events A(Es) leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
Change in plasma neurofilament light chain (NfL)
Change in plasma neurofilament light chain (NfL) levels at the EOS compared to baselineC
Changes in plasma Immunoglobulin level
Changes in serum immunoglobulin level at the EOS compared to baseline
Change in serum chitinase-3 like protein 1 (Chi3L1) -
Change in serum Chi3L1 levels at the EOS compared to baseline -

Full Information

First Posted
May 28, 2020
Last Updated
August 4, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04410991
Brief Title
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Acronym
GEMINI 2
Official Title
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
Detailed Description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAR442168
Arm Type
Experimental
Arm Description
Dose 1 of oral SAR442168 daily + placebo to match the teriflunomide tablet once daily
Arm Title
Teriflunomide
Arm Type
Active Comparator
Arm Description
Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily
Intervention Type
Drug
Intervention Name(s)
Tolebrutinib
Other Intervention Name(s)
SAR442168
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Teriflunomide HMR1726
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Placebo to match Tolebrutinib
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Placebo to match Teriflunomide
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses
Description
Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses
Time Frame
Up to approximately 36 months
Secondary Outcome Measure Information:
Title
Time to onset of confirmed disability worsening confirmed over at least 6 months
Description
ime to onset of confirmed disability worsening (CDW), confirmed over at least 6 months, defined as follows: increase of ≥1.5 points from the baseline expanded disability status scale (EDSS) score when the baseline score is 0 OR increase of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 OR increase of ≥0.5 point from the baseline EDSS score when the baseline score is >5.5 - 5.
Time Frame
Up to approximately 36 months
Title
Time to onset of CDW, assessed by the EDSS score and confirmed over at least 3 months
Time Frame
Up to 36 approximately months
Title
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from Month 6 through the end of study
Time Frame
From 6 months up to approximately 36 months
Title
Total Number of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the End of study (EOS)
Time Frame
From 6 months up to approximately 36 months
Title
Change in cognitive function
Description
Change in cognitive function from baseline to the EOS as assessed by the SDMT and CVLT-II where available
Time Frame
From Baseline up to 36 approximately months
Title
Time to confirmed disability improvement
Description
Time to confirmed disability improvement (CDI), defined as a ≥1.0 point decrease on the EDSS from the baseline EDSS score confirmed over at least 6 months
Time Frame
From Baseline up to approximately 36 months
Title
Percent change in Brain volume Loss as detected by brain MRI
Description
Brain volume loss (BVL) rate as detected by brain MRI from Month 6 to the EOS
Time Frame
From 6 months up to approximately 36 months
Title
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Description
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS
Time Frame
From Baseline up to approximately 36 months
Title
Number of participants with adverse events A(Es) leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
Time Frame
From screening until end of study approximately 36 months
Title
Change in plasma neurofilament light chain (NfL)
Description
Change in plasma neurofilament light chain (NfL) levels at the EOS compared to baselineC
Time Frame
From Baseline until end of study up to approximately 36 months -
Title
Changes in plasma Immunoglobulin level
Description
Changes in serum immunoglobulin level at the EOS compared to baseline
Time Frame
From Baseline until end of study up to 36 approximately months
Title
Change in serum chitinase-3 like protein 1 (Chi3L1) -
Description
Change in serum Chi3L1 levels at the EOS compared to baseline -
Time Frame
From Baseline until end of study up to approximately 36 months -

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit The participant must have at least 1 of the following prior to screening: ≥1 documented relapse within the previous year OR ≥2 documented relapses within the previous 2 years, OR ≥1 documented Gd enhancing lesion on an MRI scan within the previous year Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure: Refrain from donating sperm Plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions apply: Is not a WOCBP OR Is a WOCBP and agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and until accelerated elimination procedure is completed (or for at least 10 days after the last dose of SAR442168, if the case was unblinded) and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for the same period of time. A WOCBP must have a negative highly sensitive pregnancy test at screening and within 24hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. The participant must have given written informed consent prior to undertaking any study related procedure. This includes consent to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where the legal age of maturity is greater than 18 years, a specific ICF for such legally minor participants must also be signed by the participant's legally authorized representative Exclusion criteria: The participant has been diagnosed with primary progressive multiplesclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiplesclerosis (SPMS) The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, hepatitis B or C, any persistent chronic or active recurring infection Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening. The participant has conditions or situations that would adversely affect participation in this study, including but not limited to: A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator A requirement for concomitant treatment that could bias the primary evaluation The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody The participant has any of the following: A bleeding disorder or known platelet dysfunction at any time prior to the screening visit A platelet count <150 000/μL at the screening visit The participant has a lymphocyte count below the lower limit of normal (LLN) at the screening visit The presence of psychiatric disturbance or substance abuse Prior/concomitant therapy The participant is receiving potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes The participant is receiving anticoagulant/antiplatelet therapies The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates, PC-Site Number:8400009
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Center for Neurology and Spine-Site Number:8400089
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
84018
Country
United States
Facility Name
Arcadia Neurology Center-Site Number:8400070
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
Multiple Sclerosis Center of California-Site Number:8400135
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Harbor UCLA-Site Number:8400088
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Mountain Neurological Research Center, Inc.-Site Number:8400128
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
Advanced Neurosciences Research-Site Number:8400025
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
South Florida Neurology Associates-Site Number:8400029
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
University of Florida Health-Site Number:8400159
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Neurology Associates, PA-Site Number:8400004
City
Maitland
State/Province
Florida
ZIP/Postal Code
32761
Country
United States
Facility Name
University of Miami-Site Number:8400063
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Infinity Clinical Research-Site Number:8400008
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
University of South Florida-Site Number:8400006
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Meridian Clinical Research-Site Number:8400003
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Consultants In Neurology-Site Number:8400011
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Prairie Education and Research Cooperative-Site Number:8400071
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Neurological Center-Site Number:8400039
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
CHI Saint Joseph Medical Group Neurology-Site Number:8400110
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Kentucky-Site Number:8400106
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Neurology MS Services-Site Number:8400127
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
The NeuroMedical Center-Site Number:8400057
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
International Neurorehabilitation Institute-Site Number:8400034
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Wayne State University-Site Number:8400046
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minneapolis Clinic of Neurology-Site Number:8400051
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Saint Luke's Hospital-Site Number:8400153
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
West Omaha Family Physicians-Site Number:8400139
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
University Of Nebraska-Site Number:8400129
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hackensack University Hospital-Site Number:8400047
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico-Site Number:8400032
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
South Shore Neurologic Associates-Site Number:8400100
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Meridian Clinical Research, LLC-Site Number:8400005
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Sanford Brain & Spine Center-Site Number:8400126
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Dayton Center for Neurological Disorders-Site Number:8400081
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Jefferson Neurology Associates-Site Number:8400016
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Premier Neurology-Site Number:8400069
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Advanced Neuroscience Center-Site Number:8400035
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Sibyl Wray, MD, Neurology, PC-Site Number:8400007
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Mt Olympus Medical Research-Site Number:8400163
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Neurology Center of San Antonio-Site Number:8400036
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Neurological Associates-Site Number:8400097
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Wheaton Franciscan Healthcare-Site Number:8400022
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Investigational Site Number :0320004
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Facility Name
Investigational Site Number :0320002
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
C1061
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Investigational Site Number :0560005
City
Brugge
ZIP/Postal Code
B-8000
Country
Belgium
Facility Name
Investigational Site Number :0560004
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number :0560002
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Investigational Site Number :0560001
City
Pelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Investigational Site Number :0760001
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Investigational Site Number :0760002
City
Curitiba
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Investigational Site Number :0760007
City
Sao Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Investigational Site Number :1240002
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Investigational Site Number :1240014
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Investigational Site Number :1240006
City
Gatineau
ZIP/Postal Code
J8Y1W2
Country
Canada
Facility Name
Investigational Site Number :1240021
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7650568
Country
Chile
Facility Name
Investigational Site Number :1520005
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
833-0024
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8431657
Country
Chile
Facility Name
Investigational Site Number :1520006
City
Concepción
Country
Chile
Facility Name
Investigational Site Number :1520004
City
Valdivia
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Investigational Site Number :1910001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number :1910002
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number :1910003
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Investigational Site Number :2030002
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Investigational Site Number :2030011
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Investigational Site Number :2030008
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Investigational Site Number :2030005
City
Praha 5 - Motol
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Investigational Site Number :2500019
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Investigational Site Number :2500018
City
Bordeaux
Country
France
Facility Name
Investigational Site Number :2500011
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Investigational Site Number :2500005
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Investigational Site Number :2500006
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number :2500010
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500002
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Investigational Site Number :2500017
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number :2500007
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Investigational Site Number :2500004
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Investigational Site Number :2500003
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number :2500001
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Investigational Site Number :2760005
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Investigational Site Number :2760015
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Investigational Site Number :2760014
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Investigational Site Number :2760020
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigational Site Number :2760012
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Investigational Site Number :2760003
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Investigational Site Number :3000006
City
Athens
ZIP/Postal Code
11535
Country
Greece
Facility Name
Investigational Site Number :3000002
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigational Site Number :3000007
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
Investigational Site Number :3000009
City
Athens
Country
Greece
Facility Name
Investigational Site Number :3000004
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Investigational Site Number :3000003
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Investigational Site Number :3480105
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Investigational Site Number :3480102
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Investigational Site Number :3480106
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Investigational Site Number :3480103
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Investigational Site Number :3560005
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Investigational Site Number :3560007
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Investigational Site Number :3560008
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Facility Name
Investigational Site Number :3560002
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Investigational Site Number :3560004
City
Thiruvananthapuram
ZIP/Postal Code
695004
Country
India
Facility Name
Investigational Site Number :3760002
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number :3760003
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigational Site Number :3760006
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number :3760004
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigational Site Number :3760001
City
Tel HaShomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number :4100001
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100006
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site Number :4280002
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number :4280003
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Investigational Site Number :5280001
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Investigational Site Number :5780002
City
Namsos
ZIP/Postal Code
7800
Country
Norway
Facility Name
Investigational Site Number :5780001
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Investigational Site Number :6200001
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Investigational Site Number :6200005
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number :6200011
City
Lisboa
ZIP/Postal Code
1162-050
Country
Portugal
Facility Name
Investigational Site Number :6200006
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number :6200002
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Investigational Site Number :6200010
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Investigational Site Number :6200004
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
San Juan MS Center-Site Number:8400015
City
Guaynabo
ZIP/Postal Code
00969
Country
Puerto Rico
Facility Name
Investigational Site Number :6430006
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Investigational Site Number :6430013
City
Bryansk
ZIP/Postal Code
241033
Country
Russian Federation
Facility Name
Investigational Site Number :6430012
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Investigational Site Number :6430010
City
Kirov
ZIP/Postal Code
610998
Country
Russian Federation
Facility Name
Investigational Site Number :6430007
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Investigational Site Number :6430014
City
Saint-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number :6430011
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6880001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880003
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880006
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880002
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigational Site Number :6880004
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Investigational Site Number :6880005
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Investigational Site Number :7030001
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Investigational Site Number :7030002
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Investigational Site Number :7030004
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Investigational Site Number :7240011
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Salt
State/Province
Girona [Gerona]
ZIP/Postal Code
17190
Country
Spain
Facility Name
Investigational Site Number :7240013
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number :7240008
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number :7240010
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240012
City
Pozuelo De Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Investigational Site Number :7560003
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Investigational Site Number :7560002
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Investigational Site Number :7560004
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Investigational Site Number :7920002
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Investigational Site Number :7920005
City
Besevler / Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Investigational Site Number :7920006
City
Istanbul
ZIP/Postal Code
34896
Country
Turkey
Facility Name
Investigational Site Number :7920004
City
Kuttahta
ZIP/Postal Code
43100
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Samsun
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Investigational Site Number :8040020
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Investigational Site Number :8040019
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Facility Name
Investigational Site Number :8040005
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Investigational Site Number :8040022
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040018
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Investigational Site Number :8040006
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Investigational Site Number :8040003
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Investigational Site Number :8260003
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Investigational Site Number :8260016
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Investigational Site Number :8260009
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

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