search
Back to results

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

Primary Purpose

Primary Progressive Multiple Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolebrutinib
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Multiple Sclerosis

Eligibility Criteria

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

Inclusion criteria :

  • 18 to 55 years of age inclusive
  • Diagnosis of PPMS according to the 2017 McDonald criteria
  • Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at screening
  • Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0.
  • Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history.
  • Contraceptive use consistent with local regulations for individuals participating in clinical studies
  • Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    • Is not a woman of child bearing potential (WOCBP) OR
    • Is a WOCBP and agrees to use an acceptable contraceptive method

Exclusion criteria:

  • Participant has conditions that would adversely affect study participation such as short life expectancy.
  • Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation.
  • Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator
  • History of malignancy within 5 years prior to screening.
  • History of alcohol or drug abuse within 1 year prior to Screening.
  • Hospitalized for psychiatric disease within 2 years prior to Screening.
  • Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
  • Bleeding disorder, known platelet dysfunction at any time prior to the screening visit
  • A platelet count <150 000/μL at the screening visit.
  • A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal
  • Lymphocyte count below the lower limit of normal at Screening.
  • Recent live (attenuated) vaccine within 2 months before the first treatment visit.
  • Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study.
  • The participant has received medications/treatments for MS within a specified time frame.
  • Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes.
  • Receiving anticoagulant or antiplatelet therapy (such as aspirin>81mg/day, clopidogrel, warfarin).
  • Contraindications to magnetic resonance imaging (MRI).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Arcadia Neurology Center-Site Number:8400070
  • UC San Diego ACTRI-Site Number:8400101
  • Collaborative Neuroscience Research-Site Number:8400045
  • Multiple Sclerosis Center of California-Site Number:8400135
  • University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
  • Harbor UCLA-Site Number:8400088
  • University of Colorado-Site Number:8400012
  • Advanced Neurosciences Research-Site Number:8400025
  • South Florida Neurology Associates-Site Number:8400029
  • University of Florida, Fixel Center for Neurology-Site Number:8400159
  • Neurology Associates, PA-Site Number:8400004
  • University of South Florida-Site Number:8400006
  • Meridian Clinical Research-Site Number:8400003
  • Hawaii Pacific Neuroscience-Site Number:8400103
  • Consultants In Neurology-Site Number:8400011
  • Prairie Education and Research Cooperative-Site Number:8400071
  • Methodist Hospital-Site Number:8400164
  • College Park Family Care Certer-Site Number:8400044
  • University of Kentucky-Site Number:8400106
  • Ochsner Baptist Clinical Trials Unit (CTU)-Site Number:8400107
  • International Neurorehabilitation Institute-Site Number:8400034
  • Tufts Medical Center-Site Number:8400072
  • Beth Israel Deaconess Medical Center-Site Number:8400143
  • University of Massachusetts-Site Number:8400014
  • Wayne State University-Site Number:8400046
  • Michigan Institute For Neurological Disorders-Site Number:8400058
  • The Memorial Hospital-Site Number:8400033
  • Mayo Clinic-Site Number:8400111
  • Saint Luke's Hospital-Site Number:8400153
  • Sharlin Health & Neurology-Site Number:8400093
  • University Of Nebraska-Site Number:8400129
  • Hackensack University Hospital-Site Number:8400047
  • Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038
  • Neurology Associates of Stony Brook-Site Number:8400042
  • Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120
  • Duke Neurological Disorders Clinic-Site Number:8400098
  • Meridian Clinical Research, LLC-Site Number:8400005
  • Wake Forest University Baptist Medical Center-Site Number:8400116
  • Cleveland Clinic-Site Number:8400125
  • The Ohio State University Wexner Medical Center-Site Number:8400150
  • Optimed Research, LTD-Site Number:8400147
  • Providence Multiple Sclerosis Center-Site Number:8400020
  • Jefferson Neurology Associates-Site Number:8400016
  • Mountain View Clinical Research-Site Number:8400024
  • Advanced Neuroscience Center-Site Number:8400035
  • Mt Olympus Medical Research-Site Number:8400163
  • Neurology Center of San Antonio-Site Number:8400036
  • Wheaton Franciscan Healthcare-Site Number:8400022
  • Medical College of Wisconsin-Site Number:8400028
  • Investigational Site Number :0320002Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :0320003Recruiting
  • Investigational Site Number :0360005Recruiting
  • Investigational Site Number :0360006Recruiting
  • Investigational Site Number :0360003
  • Investigational Site Number :0400004Recruiting
  • Investigational Site Number :0400002Recruiting
  • Investigational Site Number :1120004
  • Investigational Site Number :1120005
  • Investigational Site Number :0560009Recruiting
  • Investigational Site Number :0560007Recruiting
  • Investigational Site Number :0560003Recruiting
  • Investigational Site Number :0560004Recruiting
  • Investigational Site Number :0560006Recruiting
  • Investigational Site Number :0560008Recruiting
  • Investigational Site Number :0560002Recruiting
  • Investigational Site Number :0560001Recruiting
  • Investigational Site Number :1000002Recruiting
  • Investigational Site Number :1000004Recruiting
  • Investigational Site Number :1000008Recruiting
  • Investigational Site Number :1000001Recruiting
  • Investigational Site Number :1240002Recruiting
  • Investigational Site Number :1240003Recruiting
  • Investigational Site Number :1240013Recruiting
  • Investigational Site Number :1240004Recruiting
  • Investigational Site Number :1240015Recruiting
  • Investigational Site Number :1240007Recruiting
  • Investigational Site Number :1240001Recruiting
  • Investigational Site Number :1240021Recruiting
  • Investigational Site Number :1520006Recruiting
  • Investigational Site Number :1520002Recruiting
  • Investigational Site Number :1520001Recruiting
  • Investigational Site Number :1560012Recruiting
  • Investigational Site Number :1560021Recruiting
  • Investigational Site Number :1560003Recruiting
  • Investigational Site Number :1560009Recruiting
  • Investigational Site Number :1560025Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :1560015Recruiting
  • Investigational Site Number :1560005Recruiting
  • Investigational Site Number :1560035Recruiting
  • Investigational Site Number :1560002Recruiting
  • Investigational Site Number :1560027Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560008Recruiting
  • Investigational Site Number :1560020Recruiting
  • Investigational Site Number :1560026Recruiting
  • Investigational Site Number :1700001
  • Investigational Site Number :1700003Recruiting
  • Investigational Site Number :1910001Recruiting
  • Investigational Site Number :1910002Recruiting
  • Investigational Site Number :2030002Recruiting
  • Investigational Site Number :2030004Recruiting
  • Investigational Site Number :2030001Recruiting
  • Investigational Site Number :2030003Recruiting
  • Investigational Site Number :2080001Recruiting
  • Investigational Site Number :2080005Recruiting
  • Investigational Site Number :2330001Recruiting
  • Investigational Site Number :2500011Recruiting
  • Investigational Site Number :2500005Recruiting
  • Investigational Site Number :2500015Recruiting
  • Investigational Site Number :2500009Recruiting
  • Investigational Site Number :2500006Recruiting
  • Investigational Site Number :2500008Recruiting
  • Investigational Site Number :2500017Recruiting
  • Investigational Site Number :2500014Recruiting
  • Investigational Site Number :2500007Recruiting
  • Investigational Site Number :2500004Recruiting
  • Investigational Site Number :2500003Recruiting
  • Investigational Site Number :2500001Recruiting
  • Investigational Site Number :2500012Recruiting
  • Investigational Site Number :2680006Recruiting
  • Investigational Site Number :2680005Recruiting
  • Investigational Site Number :2680003Recruiting
  • Investigational Site Number :2680004Recruiting
  • Investigational Site Number :2760005Recruiting
  • Investigational Site Number :2760009Recruiting
  • Investigational Site Number :2760015Recruiting
  • Investigational Site Number :2760020Recruiting
  • Investigational Site Number :2760001Recruiting
  • Investigational Site Number :2760021Recruiting
  • Investigational Site Number :2760012Recruiting
  • Investigational Site Number :2760002Recruiting
  • Investigational Site Number :2760010
  • Investigational Site Number :2760006Recruiting
  • Investigational Site Number :2760018Recruiting
  • Investigational Site Number :2760008Recruiting
  • Investigational Site Number :2760004Recruiting
  • Investigational Site Number :2760011Recruiting
  • Investigational Site Number :3000001Recruiting
  • Investigational Site Number :3000006Recruiting
  • Investigational Site Number :3000002Recruiting
  • Investigational Site Number :3000007Recruiting
  • Investigational Site Number :3000004Recruiting
  • Investigational Site Number :3000003Recruiting
  • Investigational Site Number :3000009Recruiting
  • Investigational Site Number :3480202Recruiting
  • Investigational Site Number :3480205Recruiting
  • Investigational Site Number :3480204Recruiting
  • Investigational Site Number :3480203Recruiting
  • Investigational Site Number :3560007Recruiting
  • Investigational Site Number :3560003Recruiting
  • Investigational Site Number :3560004Recruiting
  • Investigational Site Number :3560005Recruiting
  • Investigational Site Number :3560002Recruiting
  • Investigational Site Number :3760002Recruiting
  • Investigational Site Number :3760008Recruiting
  • Investigational Site Number :3760001Recruiting
  • Investigational Site Number :3760004Recruiting
  • Investigational Site Number :3800002
  • Investigational Site Number :3800007
  • Investigational Site Number :3800015
  • Investigational Site Number :3800018
  • Investigational Site Number :3800016
  • Investigational Site Number :3800001
  • Investigational Site Number :3800003
  • Investigational Site Number :3800006
  • Investigational Site Number :3800004
  • Investigational Site Number :3800013
  • Investigational Site Number :3920016
  • Investigational Site Number :3920008
  • Investigational Site Number :3920022
  • Investigational Site Number :3920011
  • Investigational Site Number :3920020
  • 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 :3920017
  • Investigational Site Number :3920015
  • Investigational Site Number :3920023
  • Investigational Site Number :4280002Recruiting
  • Investigational Site Number :4280003Recruiting
  • Investigational Site Number :4840004Recruiting
  • Investigational Site Number :4840001Recruiting
  • Investigational Site Number :4840005Recruiting
  • Investigational Site Number :4840007Recruiting
  • Investigational Site Number :4840003Recruiting
  • Investigational Site Number :5280003Recruiting
  • Investigational Site Number :5280006Recruiting
  • Investigational Site Number :5280002Recruiting
  • Investigational Site Number :5780003Recruiting
  • Investigational Site Number :5780005Recruiting
  • Investigational Site Number :6040004Recruiting
  • Investigational Site Number :6160003Recruiting
  • Investigational Site Number :6160001Recruiting
  • Investigational Site Number :6160005Recruiting
  • Investigational Site Number :6160006Recruiting
  • Investigational Site Number :6160002Recruiting
  • Investigational Site Number :6160007
  • Investigational Site Number :6160004Recruiting
  • Investigational Site Number :6200001Recruiting
  • Investigational Site Number :6200016Recruiting
  • Investigational Site Number :6200007Recruiting
  • Investigational Site Number :6200012Recruiting
  • Investigational Site Number :6200002Recruiting
  • Investigational Site Number :6200010Recruiting
  • Investigational Site Number :6200004Recruiting
  • Investigational Site Number :6420008Recruiting
  • Investigational Site Number :6420004Recruiting
  • Investigational Site Number :6420003Recruiting
  • Investigational Site Number :6420013Recruiting
  • Investigational Site Number :6420001Recruiting
  • Investigational Site Number :6420002Recruiting
  • Investigational Site Number :6430018
  • Investigational Site Number :6430022
  • Investigational Site Number :6430023
  • Investigational Site Number :6430004
  • Investigational Site Number :6430021
  • Investigational Site Number :6430013
  • Investigational Site Number :6430011
  • Investigational Site Number :6430014
  • Investigational Site Number :6430008
  • Investigational Site Number :6430015
  • Investigational Site Number :6430017
  • Investigational Site Number :6430009
  • Investigational Site Number :6430020
  • Investigational Site Number :6430007
  • Investigational Site Number :6430006
  • Investigational Site Number :6880001Recruiting
  • Investigational Site Number :6880002Recruiting
  • Investigational Site Number :6880004Recruiting
  • Investigational Site Number :7100001Recruiting
  • Investigational Site Number :7240012Recruiting
  • Investigational Site Number :7240015Recruiting
  • Investigational Site Number :7240007Recruiting
  • Investigational Site Number :7240010Recruiting
  • Investigational Site Number :7240013Recruiting
  • Investigational Site Number :7240011Recruiting
  • Investigational Site Number :7240016Recruiting
  • Investigational Site Number :7240002Recruiting
  • Investigational Site Number :7240001Recruiting
  • Investigational Site Number :7240004Recruiting
  • Investigational Site Number :7240003Recruiting
  • Investigational Site Number :7240005Recruiting
  • Investigational Site Number :7240006Recruiting
  • Investigational Site Number :7240014Recruiting
  • Investigational Site Number :7240008Recruiting
  • Investigational Site Number :7520001Recruiting
  • Investigational Site Number :7520005Recruiting
  • Investigational Site Number :7560003Recruiting
  • Investigational Site Number :7560002Recruiting
  • Investigational Site Number :7920009Recruiting
  • Investigational Site Number :7920014Recruiting
  • Investigational Site Number :7920005Recruiting
  • Investigational Site Number :7920010Recruiting
  • Investigational Site Number :7920016Recruiting
  • Investigational Site Number :7920002Recruiting
  • Investigational Site Number :7920007Recruiting
  • Investigational Site Number :7920006Recruiting
  • Investigational Site Number :7920003Recruiting
  • Investigational Site Number :7920015Recruiting
  • Investigational Site Number :7920001Recruiting
  • Investigational Site Number :7920011Recruiting
  • Investigational Site Number :7920012Recruiting
  • Investigational Site Number :7920013Recruiting
  • Investigational Site Number :7920008Recruiting
  • Investigational Site Number :8040020
  • Investigational Site Number :8040022
  • Investigational Site Number :8040012
  • Investigational Site Number :8040017
  • Investigational Site Number :8040025
  • Investigational Site Number :8040014
  • Investigational Site Number :8040023
  • Investigational Site Number :8040013
  • Investigational Site Number :8040015
  • Investigational Site Number :8040011
  • Investigational Site Number :8040002
  • Investigational Site Number :8040007
  • Investigational Site Number :8040010
  • Investigational Site Number :8040004
  • Investigational Site Number :8040024
  • Investigational Site Number :8040008
  • Investigational Site Number :8260006Recruiting
  • Investigational Site Number :8260005Recruiting
  • Investigational Site Number :8260010Recruiting
  • Investigational Site Number :8260012Recruiting
  • Investigational Site Number :8260013Recruiting
  • Investigational Site Number :8260001Recruiting
  • Investigational Site Number :8260019Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR442168

Placebo

Arm Description

Dose 1 of oral SAR442168 daily

Placebo to match the SAR442168 daily

Outcomes

Primary Outcome Measures

6 month Confirmed Disability Progression (CDP)
Time to onset of 6 month CDP defined as follows: Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or Increase of ≥0.5 points when the baseline EDSS score is >5.5

Secondary Outcome Measures

3-month confirmed disability progression (CDP)
Time to onset of 3-month CDP as assessed by EDSS score
3-month change in 9-hole peg test (9-HPT)
Time to onset of sustained 20% increase in the 9-HPT test confirmed over at least 3 months
3-month change in timed 25 foot walk (T25-FW)
Time to onset of sustained 20% increase in the T25-FW confirmed over at least 3 months
Change in T2 hyperintense lesions by MRI
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
Time to onset of confirmed disability improvement (CDI)
Time to onset of CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months
Percent change in Brain volume loss (BVL)
Percent change in brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6
Change in cognitive function as assessed by the Symbol Digit Modalities Test (SDMT)
Change in cognitive function at the EOS compared to baseline as assessed by the SDMT
Change in cognitive function as assessed by the California Verbal Learning Test II (CVLT-II)
Change in cognitive function at the EOS compared to baseline as assessed by the CVLT-II
Change in Multiple Sclerosis Quality of Life
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
Safety and Tolerability
Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
Population pharmacokinetics
Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
Change in plasma neurofilament light chain (NfL)
Change in NfL levels from at the EOS compared to baseline
Change in lymphocyte phenotype subsets
Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
Changes in serum 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 chitinase-3 like protein 1 (Chi3L1) from baseline to EOS

Full Information

First Posted
July 1, 2020
Last Updated
August 15, 2023
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT04458051
Brief Title
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Acronym
PERSEUS
Official Title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 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 determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Detailed Description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SAR442168
Arm Type
Experimental
Arm Description
Dose 1 of oral SAR442168 daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match the SAR442168 daily
Intervention Type
Drug
Intervention Name(s)
Tolebrutinib
Other Intervention Name(s)
SAR442168
Intervention Description
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Film-coated Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
6 month Confirmed Disability Progression (CDP)
Description
Time to onset of 6 month CDP defined as follows: Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.5, or Increase of ≥0.5 points when the baseline EDSS score is >5.5
Time Frame
Up to approximately 48 months
Secondary Outcome Measure Information:
Title
3-month confirmed disability progression (CDP)
Description
Time to onset of 3-month CDP as assessed by EDSS score
Time Frame
Up to approximately 48 months
Title
3-month change in 9-hole peg test (9-HPT)
Description
Time to onset of sustained 20% increase in the 9-HPT test confirmed over at least 3 months
Time Frame
Up to approximately 48 months
Title
3-month change in timed 25 foot walk (T25-FW)
Description
Time to onset of sustained 20% increase in the T25-FW confirmed over at least 3 months
Time Frame
Up to approximately 48 months
Title
Change in T2 hyperintense lesions by MRI
Description
Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI after baseline up to and including the end of study (EOS)
Time Frame
From Baseline up to 48 approximately months
Title
Time to onset of confirmed disability improvement (CDI)
Description
Time to onset of CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months
Time Frame
From Baseline up to 48 approximately months
Title
Percent change in Brain volume loss (BVL)
Description
Percent change in brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6
Time Frame
From 6 months up to approximately 48 months -
Title
Change in cognitive function as assessed by the Symbol Digit Modalities Test (SDMT)
Description
Change in cognitive function at the EOS compared to baseline as assessed by the SDMT
Time Frame
From Baseline up to approximately 48 months
Title
Change in cognitive function as assessed by the California Verbal Learning Test II (CVLT-II)
Description
Change in cognitive function at the EOS compared to baseline as assessed by the CVLT-II
Time Frame
From Baseline up to approximately 48 months
Title
Change in Multiple Sclerosis Quality of Life
Description
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) at the EOS compared to baseline
Time Frame
From Baseline up to approximately 48 months
Title
Safety and Tolerability
Description
Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)
Time Frame
From screening up to approximately 48 months
Title
Population pharmacokinetics
Description
Plasma concentration of SAR442168 (population PK assessment) at Months 6, 9, and 12
Time Frame
Months 6, 9 and 12
Title
Change in plasma neurofilament light chain (NfL)
Description
Change in NfL levels from at the EOS compared to baseline
Time Frame
From Baseline up to approximately 48 months
Title
Change in lymphocyte phenotype subsets
Description
Change in lymphocyte phenotype subsets in whole blood at the EOS compared to baseline in a subset of participants
Time Frame
From Baseline up to approximately 48 months
Title
Changes in serum Immunoglobulin level
Description
Changes in serum Immunoglobulin level at the EOS compared to baseline
Time Frame
From Baseline up to approximately 48 months
Title
Change in serum chitinase-3 like protein 1 (Chi3L1)
Description
Change in serum chitinase-3 like protein 1 (Chi3L1) from baseline to EOS
Time Frame
From Baseline up to approximately 48 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 : 18 to 55 years of age inclusive Diagnosis of PPMS according to the 2017 McDonald criteria Expanded disability status scale (EDSS) between 2.0 to 6.5 points, inclusive at screening Disease duration from the onset of MS symptoms of <15 years if screening EDSS score of >5.0 OR <10 years if screening EDSS score of ≤5.0. Positive cerebrospinal fluid oligoclonal bands and/or elevated Immunoglobulin G (IgG) index either during screening or documented previous history. Contraceptive use consistent with local regulations for individuals participating in clinical studies Participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP) OR Is a WOCBP and agrees to use an acceptable contraceptive method Exclusion criteria: Participant has conditions that would adversely affect study participation such as short life expectancy. Evidence of infection with human immunodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infection that would adversely affect study participation. Persistent chronic or active or recurring system infection that may adversely affect participation or IMP administration in this study as judged by the investigator History of malignancy within 5 years prior to screening. History of alcohol or drug abuse within 1 year prior to Screening. Hospitalized for psychiatric disease within 2 years prior to Screening. Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening. Bleeding disorder, known platelet dysfunction at any time prior to the screening visit A platelet count <150 000/μL at the screening visit. A history of significant bleeding event within 6 months prior to screening, according to the Investigator's judgment such as, but not limited to cerebral or gastrointestinal Lymphocyte count below the lower limit of normal at Screening. Recent live (attenuated) vaccine within 2 months before the first treatment visit. Recent major surgery (within 4 weeks of Screening) or planned major surgery during the study. The participant has received medications/treatments for MS within a specified time frame. Receiving potent and moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes. Receiving anticoagulant or antiplatelet therapy (such as aspirin>81mg/day, clopidogrel, warfarin). Contraindications to magnetic resonance imaging (MRI). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
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
Arcadia Neurology Center-Site Number:8400070
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UC San Diego ACTRI-Site Number:8400101
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Collaborative Neuroscience Research-Site Number:8400045
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Multiple Sclerosis Center of California-Site Number:8400135
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Active, not recruiting
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
Individual Site Status
Active, not recruiting
Facility Name
Harbor UCLA-Site Number:8400088
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Colorado-Site Number:8400012
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Advanced Neurosciences Research-Site Number:8400025
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
South Florida Neurology Associates-Site Number:8400029
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Florida, Fixel Center for Neurology-Site Number:8400159
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neurology Associates, PA-Site Number:8400004
City
Maitland
State/Province
Florida
ZIP/Postal Code
32761
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of South Florida-Site Number:8400006
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Meridian Clinical Research-Site Number:8400003
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hawaii Pacific Neuroscience-Site Number:8400103
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Consultants In Neurology-Site Number:8400011
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Prairie Education and Research Cooperative-Site Number:8400071
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Methodist Hospital-Site Number:8400164
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
College Park Family Care Certer-Site Number:8400044
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kentucky-Site Number:8400106
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ochsner Baptist Clinical Trials Unit (CTU)-Site Number:8400107
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
International Neurorehabilitation Institute-Site Number:8400034
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tufts Medical Center-Site Number:8400072
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Beth Israel Deaconess Medical Center-Site Number:8400143
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Massachusetts-Site Number:8400014
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wayne State University-Site Number:8400046
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Michigan Institute For Neurological Disorders-Site Number:8400058
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Memorial Hospital-Site Number:8400033
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic-Site Number:8400111
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Luke's Hospital-Site Number:8400153
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sharlin Health & Neurology-Site Number:8400093
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Of Nebraska-Site Number:8400129
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hackensack University Hospital-Site Number:8400047
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038
City
New York
State/Province
New York
ZIP/Postal Code
10029-6501
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neurology Associates of Stony Brook-Site Number:8400042
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Active, not recruiting
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
Individual Site Status
Active, not recruiting
Facility Name
Duke Neurological Disorders Clinic-Site Number:8400098
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Completed
Facility Name
Meridian Clinical Research, LLC-Site Number:8400005
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Active, not recruiting
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
Individual Site Status
Active, not recruiting
Facility Name
Cleveland Clinic-Site Number:8400125
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Ohio State University Wexner Medical Center-Site Number:8400150
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Optimed Research, LTD-Site Number:8400147
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Providence Multiple Sclerosis Center-Site Number:8400020
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Jefferson Neurology Associates-Site Number:8400016
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mountain View Clinical Research-Site Number:8400024
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651-1817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Advanced Neuroscience Center-Site Number:8400035
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mt Olympus Medical Research-Site Number:8400163
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Neurology Center of San Antonio-Site Number:8400036
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wheaton Franciscan Healthcare-Site Number:8400022
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical College of Wisconsin-Site Number:8400028
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360005
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360006
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360003
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0400004
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0400002
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1120004
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :1120005
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0560009
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560007
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560003
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560004
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560006
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560008
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560002
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0560001
City
Pelt
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000002
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000004
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000008
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240002
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240013
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240015
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240007
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240021
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520006
City
Concepcion
State/Province
Biobío
ZIP/Postal Code
4070038
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7650568
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560012
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560021
City
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560025
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560015
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560005
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560035
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560002
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560027
City
Hohhot
ZIP/Postal Code
010050
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560008
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560020
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560026
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1700001
City
Bogota
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :1700003
City
Bogotá
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1910001
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1910002
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2030002
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2030004
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2030001
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2030003
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2080001
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2080005
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2330001
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500011
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500005
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500015
City
Gonesse
ZIP/Postal Code
95500
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500009
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500006
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500008
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500017
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500014
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500007
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500004
City
Poissy
ZIP/Postal Code
78300
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500012
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680006
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680005
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680003
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680004
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760005
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760009
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760015
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760020
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760021
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760012
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760002
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760010
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :2760006
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760018
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760008
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760004
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760011
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000006
City
Athens
ZIP/Postal Code
11535
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000002
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000007
City
Athens
ZIP/Postal Code
15125
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000004
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000003
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000009
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480202
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480205
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480204
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480203
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560007
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560003
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560004
City
Mangaluru
ZIP/Postal Code
575018
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560005
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560002
City
New Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760002
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760008
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760001
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760004
City
Safed
ZIP/Postal Code
13100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800002
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800007
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800015
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800018
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800016
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800001
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800003
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800006
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800004
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3800013
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920016
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920008
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920022
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920011
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920020
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920005
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920004
City
Moriguchi-shi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920001
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
556-0016
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920018
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920014
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920003
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920010
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
146-0065
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920017
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920015
City
Toyama-shi
State/Province
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :3920023
City
Sagamihara-shi
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :4280002
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4280003
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840001
City
Cdmx
State/Province
México
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840005
City
Cdmx
State/Province
México
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840007
City
Tlalnepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840003
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280003
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280006
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280002
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5780003
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5780005
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6040004
City
Lima
ZIP/Postal Code
15084
Country
Peru
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160003
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
90-549
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160005
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-211
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160006
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160002
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-571
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160007
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-684
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6160004
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-686
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200001
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200016
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200007
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200012
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200002
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200010
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200004
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420008
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420004
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420003
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420013
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420001
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420002
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430018
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430022
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430023
City
Kaliningrad
ZIP/Postal Code
236035
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430004
City
Kazan
ZIP/Postal Code
420032
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430021
City
Krasnoyarsk
ZIP/Postal Code
660029
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430013
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430011
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430014
City
Nizhny Novgorod
ZIP/Postal Code
603137
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430008
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430015
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430017
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430009
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430020
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430007
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6430006
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :6880001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6880002
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6880004
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100001
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240012
City
La Coruña
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240015
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240007
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240010
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240013
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240011
City
Salt
State/Province
Girona [Gerona]
ZIP/Postal Code
17190
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240016
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240014
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7520001
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7520005
City
Motala
ZIP/Postal Code
591 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7560003
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7560002
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920009
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920014
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920005
City
Eskisehir
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920010
City
Hatay
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920016
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920002
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920007
City
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920006
City
Istanbul
ZIP/Postal Code
34896
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920003
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920015
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920001
City
Izmit
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920011
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920012
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920013
City
Samsun
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7920008
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8040020
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040022
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040012
City
Ivano-Frankivsk
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040017
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040025
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040014
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040023
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040013
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040015
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040011
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040002
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040007
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040010
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040004
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040024
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040008
City
Zhytormyr
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8260006
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260005
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260010
City
Swansea
State/Province
Neath Port Talbot
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260012
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260013
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260001
City
Cardiff
State/Province
Vale Of Glamorgan, The
ZIP/Postal Code
CF4 4XY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260019
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting

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

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

We'll reach out to this number within 24 hrs