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Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

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)
  • 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 multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (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

  • University of Alabama MS Center-Site Number:8400013
  • University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
  • University of Colorado-Site Number:8400012
  • Georgetown University Medical Center-Site Number:8400119
  • Beth Israel Deaconess Medical Center-Site Number:8400064
  • Axiom Clinical Research of Florida-Site Number:8400001
  • University of South Florida-Site Number:8400006
  • Meridian Clinical Research-Site Number:8400003
  • Consultants In Neurology-Site Number:8400011
  • Tufts Medical Center-Site Number:8400072
  • Michigan Institute For Neurological Disorders-Site Number:8400058
  • The Memorial Hospital-Site Number:8400033
  • Sharlin Health & Neurology-Site Number:8400093
  • Missouri Baptist Medical Center-Site Number:8400019
  • Meridian Clinical Research, LLC-Site Number:8400005
  • Wake Forest University Baptist Medical Center-Site Number:8400116
  • The Ohio State University Wexner Medical Center-Site Number:8400150
  • Optimed Research, LTD-Site Number:8400147
  • Columbus Neuroscience-Site Number:8400010
  • Oklahoma Medical Research Foundation-Site Number:8400018
  • Providence Multiple Sclerosis Center-Site Number:8400020
  • University of Texas Southwestern Medical Center-Site Number:8400077
  • Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121
  • Investigational Site Number :0400004
  • Investigational Site Number :1120005
  • Investigational Site Number :1120004
  • Investigational Site Number :1000002
  • Investigational Site Number :1000005
  • Investigational Site Number :1000004
  • Investigational Site Number :1000008
  • Investigational Site Number :1000001
  • Investigational Site Number :1000006
  • Investigational Site Number :1000009
  • Investigational Site Number :1240016
  • Investigational Site Number :1240003
  • Investigational Site Number :1240013
  • Investigational Site Number :1240006
  • Investigational Site Number :1560022
  • Investigational Site Number :1560006
  • Investigational Site Number :1560010
  • Investigational Site Number :1560012
  • Investigational Site Number :1560023
  • Investigational Site Number :1560001
  • Investigational Site Number :1560009
  • Investigational Site Number :1560025
  • Investigational Site Number :1560021
  • Investigational Site Number :1560004
  • Investigational Site Number :1560015
  • Investigational Site Number :1560005
  • Investigational Site Number :1560019
  • Investigational Site Number :1560035
  • Investigational Site Number :1560016
  • Investigational Site Number :1560028
  • Investigational Site Number :1560002
  • Investigational Site Number :1560027
  • Investigational Site Number :1560044
  • Investigational Site Number :1560042
  • Investigational Site Number :1560003
  • Investigational Site Number :1560018
  • Investigational Site Number :1560014
  • Investigational Site Number :1560008
  • Investigational Site Number :1560020
  • Investigational Site Number :1560011
  • Investigational Site Number :1560017
  • Investigational Site Number :1560033
  • Investigational Site Number :2030004
  • Investigational Site Number :2030009
  • Investigational Site Number :2030003
  • Investigational Site Number :2030007
  • Investigational Site Number :2080001
  • Investigational Site Number :2080005
  • Investigational Site Number :2330001
  • Investigational Site Number :2330002
  • Investigational Site Number :2460003
  • Investigational Site Number :2460001
  • Investigational Site Number :2460002
  • Investigational Site Number :2760001
  • Investigational Site Number :2760019
  • Investigational Site Number :2760016
  • Investigational Site Number :2760008
  • Investigational Site Number :2760004
  • Investigational Site Number :2760011
  • Investigational Site Number :3800002
  • Investigational Site Number :3800007
  • Investigational Site Number :3800011
  • Investigational Site Number :3800015
  • Investigational Site Number :3800012
  • Investigational Site Number :3800014
  • Investigational Site Number :3800001
  • Investigational Site Number :3800010
  • Investigational Site Number :3800003
  • Investigational Site Number :3800006
  • Investigational Site Number :3800008
  • Investigational Site Number :3800005
  • Investigational Site Number :3800009
  • Investigational Site Number :3800013
  • Investigational Site Number :3920016
  • Investigational Site Number :3920008
  • Investigational Site Number :3920012
  • Investigational Site Number :3920022
  • Investigational Site Number :3920005
  • Investigational Site Number :3920004
  • Investigational Site Number :3920001
  • Investigational Site Number :3920018
  • Investigational Site Number :3920014
  • Investigational Site Number :3920003
  • Investigational Site Number :3920010
  • Investigational Site Number :3920013
  • Investigational Site Number :3920009
  • Investigational Site Number :3920023
  • Investigational Site Number :4400003
  • Investigational Site Number :4400002
  • Investigational Site Number :4400004
  • Investigational Site Number :4400001
  • Investigational Site Number :4840002
  • Investigational Site Number :4840001
  • Investigational Site Number :4840003
  • Investigational Site Number :6160003
  • Investigational Site Number :6160005
  • Investigational Site Number :6160006
  • Investigational Site Number :6160009
  • Investigational Site Number :6160002
  • Investigational Site Number :6160004
  • Investigational Site Number :6160008
  • Investigational Site Number :6160001
  • Investigational Site Number :6420015
  • Investigational Site Number :6420008
  • Investigational Site Number :6420004
  • Investigational Site Number :6420003
  • Investigational Site Number :6420010
  • Investigational Site Number :6420005
  • Investigational Site Number :6420001
  • Investigational Site Number :6420002
  • Investigational Site Number :6430014
  • Investigational Site Number :6430002
  • Investigational Site Number :6430008
  • Investigational Site Number :6430011
  • Investigational Site Number :6430003
  • Investigational Site Number :6430007
  • Investigational Site Number :6430012
  • Investigational Site Number :6430005
  • Investigational Site Number :6430009
  • Investigational Site Number :6430001
  • Investigational Site Number :6430006
  • Investigational Site Number :6430004
  • Investigational Site Number :7240003
  • Investigational Site Number :7240009
  • Investigational Site Number :7240001
  • Investigational Site Number :7240008
  • Investigational Site Number :7240004
  • Investigational Site Number :7240006
  • Investigational Site Number :7240005
  • Investigational Site Number :7240007
  • Investigational Site Number :7520001
  • Investigational Site Number :7520002
  • Investigational Site Number :1580007
  • Investigational Site Number :1580005
  • Investigational Site Number :1580003
  • Investigational Site Number :1580002
  • Investigational Site Number :1580006
  • Investigational Site Number :7920005
  • Investigational Site Number :7920011
  • Investigational Site Number :7920002
  • Investigational Site Number :7920009
  • Investigational Site Number :7920007
  • Investigational Site Number :7920003
  • Investigational Site Number :7920008
  • Investigational Site Number :7920010
  • Investigational Site Number :7920001
  • Investigational Site Number :7920006
  • Investigational Site Number :8040011
  • Investigational Site Number :8040016
  • Investigational Site Number :8040013
  • Investigational Site Number :8040008
  • Investigational Site Number :8040014
  • Investigational Site Number :8040010
  • Investigational Site Number :8040001
  • Investigational Site Number :8040009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAR442168

Teriflunomide

Arm Description

Dose 1 of oral SAR442168 + 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 adjudicated protocol defined relapses
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses

Secondary Outcome Measures

Time to onset of confirmed disability worsening confirmed over at least 6 months
Time 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 (EOS)
Total of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the EOS
Change in cognitive function
Change in cognitive function from baseline to the end of study (EOS) as assessed by SDMT and by 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 (BVL)
Brain volume loss (BVL) rate as detected by brain MRI from Month 6 to the EOS
Change in Multiple Sclerosis Quality of Life
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)
Population Pharmacokinetics - Concentration SAR442168 and relevant metabolites at 6 months
Plasma concentration of SAR442168 (population PK assessment) at 6 Months
Population Pharmacokinetics Concentration of SAR442168 and relevant metabolites at 9 Months
Plasma concentration of SAR442168 (population PK assessment) at 9 Months
Population Pharmacokinetics - Concentration of SAR442168 and relevant metabolites at 12 Months
Plasma concentration of SAR442168 (population PK assessment) at 12 Months
Change in plasma NfL
Change in plasma neurofilament light chain (NfL) levels at the EOS compared to baseline
Change in lymphocyte Phenotype
Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
Changes in plasma Immunoglobulin levels
Changes in serum immunoglobulin level at the EOS compared to baseline
Change in CHI3L1 levels
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
NCT04410978
Brief Title
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Acronym
GEMINI 1
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 30, 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 population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety 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 + 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 adjudicated protocol defined relapses
Description
Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined 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
Time 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 approximately 36 months
Title
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from Month 6 through the end of study (EOS)
Time Frame
From 6 months up to approximately 36 months
Title
Total of Gd-enhancing T1 hyperintense lesions as detected by MRI from 6 months through the 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 end of study (EOS) as assessed by SDMT and by CVLT-II where available
Time Frame
From Baseline up to approximately 36 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 (BVL)
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
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
Population Pharmacokinetics - Concentration SAR442168 and relevant metabolites at 6 months
Description
Plasma concentration of SAR442168 (population PK assessment) at 6 Months
Time Frame
6 Months
Title
Population Pharmacokinetics Concentration of SAR442168 and relevant metabolites at 9 Months
Description
Plasma concentration of SAR442168 (population PK assessment) at 9 Months
Time Frame
9 Months
Title
Population Pharmacokinetics - Concentration of SAR442168 and relevant metabolites at 12 Months
Description
Plasma concentration of SAR442168 (population PK assessment) at 12 Months
Time Frame
12 Months
Title
Change in plasma NfL
Description
Change in plasma neurofilament light chain (NfL) levels at the EOS compared to baseline
Time Frame
From Baseline until end of study approximately 36 months
Title
Change in lymphocyte Phenotype
Description
Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
Time Frame
From Baseline until end of study approximately 36 months
Title
Changes in plasma Immunoglobulin levels
Description
Changes in serum immunoglobulin level at the EOS compared to baseline
Time Frame
From Baseline until end of study (up to 36 months)
Title
Change in CHI3L1 levels
Description
Change in serum Chi3L1 levels at the EOS compared to baseline
Time Frame
From Baseline until end of study 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) 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 multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (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
University of Alabama MS Center-Site Number:8400013
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado-Site Number:8400012
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center-Site Number:8400119
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Beth Israel Deaconess Medical Center-Site Number:8400064
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Axiom Clinical Research of Florida-Site Number:8400001
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4052
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
Tufts Medical Center-Site Number:8400072
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Michigan Institute For Neurological Disorders-Site Number:8400058
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
The Memorial Hospital-Site Number:8400033
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Facility Name
Sharlin Health & Neurology-Site Number:8400093
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Facility Name
Missouri Baptist Medical Center-Site Number:8400019
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
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
Wake Forest University Baptist Medical Center-Site Number:8400116
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University Wexner Medical Center-Site Number:8400150
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Optimed Research, LTD-Site Number:8400147
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Columbus Neuroscience-Site Number:8400010
City
Westerville
State/Province
Ohio
ZIP/Postal Code
40382
Country
United States
Facility Name
Oklahoma Medical Research Foundation-Site Number:8400018
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Multiple Sclerosis Center-Site Number:8400020
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Texas Southwestern Medical Center-Site Number:8400077
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Investigational Site Number :0400004
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Investigational Site Number :1120005
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Facility Name
Investigational Site Number :1120004
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Investigational Site Number :1000002
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Investigational Site Number :1000005
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Investigational Site Number :1000004
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Investigational Site Number :1000008
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigational Site Number :1000006
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigational Site Number :1000009
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Investigational Site Number :1240016
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Investigational Site Number :1240003
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Investigational Site Number :1240013
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Investigational Site Number :1240006
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Investigational Site Number :1560022
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Investigational Site Number :1560006
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number :1560010
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Investigational Site Number :1560012
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Investigational Site Number :1560023
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site Number :1560001
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number :1560009
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number :1560025
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number :1560021
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Investigational Site Number :1560004
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number :1560015
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Investigational Site Number :1560005
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site Number :1560019
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Investigational Site Number :1560035
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Investigational Site Number :1560016
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number :1560028
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Investigational Site Number :1560002
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Investigational Site Number :1560027
City
Hohhot
ZIP/Postal Code
010050
Country
China
Facility Name
Investigational Site Number :1560044
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Investigational Site Number :1560042
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Investigational Site Number :1560003
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Investigational Site Number :1560018
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Investigational Site Number :1560014
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Investigational Site Number :1560008
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Investigational Site Number :1560020
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Investigational Site Number :1560011
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Investigational Site Number :1560017
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
Investigational Site Number :1560033
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Investigational Site Number :2030004
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number :2030009
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Investigational Site Number :2030003
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Investigational Site Number :2030007
City
Zlin
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Investigational Site Number :2080001
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number :2080005
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Investigational Site Number :2330001
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
Investigational Site Number :2330002
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Investigational Site Number :2460003
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Investigational Site Number :2460001
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Investigational Site Number :2460002
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Investigational Site Number :2760001
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number :2760019
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Investigational Site Number :2760016
City
Hamburg
ZIP/Postal Code
22179
Country
Germany
Facility Name
Investigational Site Number :2760008
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site Number :2760004
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Facility Name
Investigational Site Number :2760011
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Investigational Site Number :3800002
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86077
Country
Italy
Facility Name
Investigational Site Number :3800007
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Investigational Site Number :3800011
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number :3800015
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site Number :3800012
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Investigational Site Number :3800014
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number :3800001
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number :3800010
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Investigational Site Number :3800003
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number :3800006
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number :3800008
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number :3800005
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Investigational Site Number :3800009
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Investigational Site Number :3800013
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Investigational Site Number :3920016
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Investigational Site Number :3920008
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Investigational Site Number :3920012
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
305-0005
Country
Japan
Facility Name
Investigational Site Number :3920022
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Investigational Site Number :3920005
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Investigational Site Number :3920004
City
Moriguchi-shi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
556-0016
Country
Japan
Facility Name
Investigational Site Number :3920018
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Investigational Site Number :3920014
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Investigational Site Number :3920003
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Investigational Site Number :3920010
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
146-0065
Country
Japan
Facility Name
Investigational Site Number :3920013
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Investigational Site Number :3920009
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Investigational Site Number :3920023
City
Sagamihara-shi
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Investigational Site Number :4400003
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigational Site Number :4400002
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Investigational Site Number :4400004
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Investigational Site Number :4400001
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number :4840002
City
Mexico
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Investigational Site Number :4840001
City
Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Investigational Site Number :4840003
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Investigational Site Number :6160003
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Investigational Site Number :6160005
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Investigational Site Number :6160006
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Investigational Site Number :6160009
City
Glogow Mlp.
State/Province
Podkarpackie
ZIP/Postal Code
36-060
Country
Poland
Facility Name
Investigational Site Number :6160002
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Investigational Site Number :6160004
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-686
Country
Poland
Facility Name
Investigational Site Number :6160008
City
Plewiska
State/Province
Wielkopolskie
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Investigational Site Number :6160001
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Investigational Site Number :6420015
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Investigational Site Number :6420008
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Investigational Site Number :6420004
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Investigational Site Number :6420003
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Investigational Site Number :6420010
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number :6420005
City
Sibiu
ZIP/Postal Code
550052
Country
Romania
Facility Name
Investigational Site Number :6420001
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Investigational Site Number :6420002
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Investigational Site Number :6430014
City
Krasnoyarsk
ZIP/Postal Code
660029
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Investigational Site Number :6430011
City
Nizhny Novgorod
ZIP/Postal Code
603137
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Investigational Site Number :6430007
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Investigational Site Number :6430012
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Investigational Site Number :6430009
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
St-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Investigational Site Number :7240003
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Donostia
State/Province
Pais Vasco
ZIP/Postal Code
20014
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site Number :7520001
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Investigational Site Number :7520002
City
Stockholm
ZIP/Postal Code
113 65
Country
Sweden
Facility Name
Investigational Site Number :1580007
City
Hsinchu City
ZIP/Postal Code
30059
Country
Taiwan
Facility Name
Investigational Site Number :1580005
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Investigational Site Number :1580003
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Investigational Site Number :1580002
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Investigational Site Number :1580006
City
Taoyuang
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Investigational Site Number :7920005
City
Eskisehir
Country
Turkey
Facility Name
Investigational Site Number :7920011
City
Hatay
Country
Turkey
Facility Name
Investigational Site Number :7920002
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Investigational Site Number :7920009
City
Istanbul
ZIP/Postal Code
34688
Country
Turkey
Facility Name
Investigational Site Number :7920007
City
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Istanbul
Country
Turkey
Facility Name
Investigational Site Number :7920008
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Investigational Site Number :7920010
City
Izmir
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Investigational Site Number :7920006
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Facility Name
Investigational Site Number :8040011
City
Ivano-Frankivsk
ZIP/Postal Code
76493
Country
Ukraine
Facility Name
Investigational Site Number :8040016
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Investigational Site Number :8040013
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040008
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Investigational Site Number :8040014
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Investigational Site Number :8040010
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Investigational Site Number :8040009
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine

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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