Back to resultsNonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
Primary Purpose
Secondary Progressive Multiple Sclerosis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tolebrutinib
Placebo to match Tolebrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis
Eligibility Criteria
Inclusion criteria :
- 18 to 60 years of age inclusive
- Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
- Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
- The participant must have documented evidence of disability progression observed during the 12 months before screening
- Absence of clinical relapses for at least 24 months
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a WOCBP OR
- Is a WOCBP and agrees to use an acceptable contraceptive method
Exclusion criteria:
- The participant has conditions that would adversely affect study participation such as short life expectancy.
- History of organ transplant.
- Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections 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 dysfunctionat 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 bleeding.
- 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
- University of Alabama MS Center-Site Number:8400013
- Center for Neurology and Spine-Site Number:8400089
- Arcadia Neurology Center-Site Number:8400070
- UC San Diego ACTRI-Site Number:8400101
- Collaborative Neuroscience Research-Site Number:8400045
- Multiple Sclerosis Center-Site Number:8400143
- University of San Francisco, Sandler Neurosciences Center-Site Number:8400137
- Harbor UCLA-Site Number:8400088
- Regina Berkovich, MD, PhD-Site Number:8400059
- Mountain Neurological Research Center, Inc.-Site Number:8400128
- University of Colorado-Site Number:8400012
- Advanced Neurosciences Research-Site Number:8400025
- South Florida Neurology Associates-Site Number:8400029
- Neurology Associates, PA-Site Number:8400004
- Aqualane Clinical Research-Site Number:8400027
- 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
- University of Kansas Medical Center-Site Number:8400023
- CHI Saint Joseph Medical Group Neurology-Site Number:8400110
- Tufts Medical Center-Site Number:8400072
- University of Massachusetts-Site Number:8400014
- Wayne State University-Site Number:8400046
- The Memorial Hospital-Site Number:8400033
- Minneapolis Clinic of Neurology-Site Number:8400051
- Mayo Clinic-Site Number:8400111
- Missouri Baptist Medical Center-Site Number:8400019
- Lou Ruvo Center for Brain Health-Site Number:8400117
- Holy Name Hospital-Site Number:8400104
- University of New Mexico-Site Number:8400032
- Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038
- Neurology Associates of Stony Brook-Site Number:8400042
- Meridian Clinical Research, LLC-Site Number:8400005
- Sanford Brain & Spine Center-Site Number:8400126
- University Hospitals CMC-Site Number:8400083
- Cleveland Clinic-Site Number:8400125
- Optimed Research, LTD-Site Number:8400147
- Neurology Specialists-Site Number:8400002
- Columbus Neuroscience-Site Number:8400010
- Providence Multiple Sclerosis Center-Site Number:8400020
- Perelman Center for Advanced Medicine-Site Number:8400142
- Jefferson Neurology Associates-Site Number:8400016
- Premier Neurology-Site Number:8400069
- Mountain View Clinical Research-Site Number:8400024
- Neurology Clinic, PC-Site Number:8400087
- Advanced Neuroscience Center-Site Number:8400035
- Baylor College of Medicine-Site Number:8400136
- Neurology Center of San Antonio-Site Number:8400036
- University Of Vermont College Of Medicine-Site Number:8400130
- Medical College of Wisconsin-Site Number:8400028
- Investigational Site Number :0320002
- Investigational Site Number :0320001
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- Investigational Site Number :8260019
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAR442168
Placebo
Arm Description
Dose 1 of oral SAR442168 once daily
Placebo tablet to match SAR442168 once daily
Outcomes
Primary Outcome Measures
6-month confirmed disability progression (CDP)
Time to onset of 6 months CDP defined as follows:
-Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.0, or -Increase of ≥0.5 point when the baseline EDSS score is >5.0 -
Secondary Outcome Measures
3-months change in T25-FW and 9-HPT
Time to onset of composite CDP, confirmed over at least 3 months (3-month CCDP), by the EDSS Plus composite (EDSS score increase, or 20% increase in the T25 FW test, or 20% increase in the 9 hole peg test (9 HPT)
3-month CDP
Time to onset of 3-month CDP as assessed by EDSS score
New and enlarging T2 hyperintense lesions by MRI
Total number of new or enlarging T2 hyperintense lesions as detected by MRI
Time to onset of confirmed disability improvement (CDI)
Time to CDI defined as ≥1.0 point decrease on the EDSS score from baseline confirmed over at least 6 months
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
Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT) and by the California Verbal Learning Test (CVLT-II)
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS
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 and relevant metabolites (population PK assessment) at Months 6, 9, and 12
Change in plasma neurofilament light chain (NfL)
Change in NfL levels at the EOS compared to baseline
Changes in serum Immunoglobulin level
Changes in serum Immunoglobulin level 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
Change in serum chitinase-3 like protein 1 (Chi3L1)
Change in serum chitinase-3 like protein 1 (Chi3L1) at the EOS compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411641
Brief Title
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Acronym
HERCULES
Official Title
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 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 NRSPMS
Secondary Objective:
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 and relevant metabolites in NRSPMS 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 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
Secondary Progressive Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR442168
Arm Type
Experimental
Arm Description
Dose 1 of oral SAR442168 once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet to match SAR442168 once 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 to match Tolebrutinib
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 months CDP defined as follows:
-Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.0, or -Increase of ≥0.5 point when the baseline EDSS score is >5.0 -
Time Frame
Up to 48 approximately months
Secondary Outcome Measure Information:
Title
3-months change in T25-FW and 9-HPT
Description
Time to onset of composite CDP, confirmed over at least 3 months (3-month CCDP), by the EDSS Plus composite (EDSS score increase, or 20% increase in the T25 FW test, or 20% increase in the 9 hole peg test (9 HPT)
Time Frame
Up to approximately 48 months
Title
3-month CDP
Description
Time to onset of 3-month CDP as assessed by EDSS score
Time Frame
Up to approximately48 months
Title
New and enlarging T2 hyperintense lesions by MRI
Description
Total number of new or enlarging T2 hyperintense lesions as detected by MRI
Time Frame
From Baseline up to approximately 48 months
Title
Time to onset of confirmed disability improvement (CDI)
Description
Time to 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 approximately 48 months
Title
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
Description
Change in cognitive function at the EOS compared to baseline as assessed by the Symbol Digit Modalities Test (SDMT) and by the California Verbal Learning Test (CVLT-II)
Time Frame
From Baseline up to approximately 48 months
Title
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54)
Description
Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS
Time Frame
From Baseline up to approximately 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 until end of study up to approximately 48 months
Title
Population pharmacokinetics
Description
Plasma concentration of SAR442168 and relevant metabolites (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 at the EOS compared to baseline
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 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
Change in serum chitinase-3 like protein 1 (Chi3L1)
Description
Change in serum chitinase-3 like protein 1 (Chi3L1) at the EOS compared to baseline
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
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
18 to 60 years of age inclusive
Diagnosis of nonrelapsing secondary progressive multiple sclerosis according to the 2017 McDonald criteria
Expanded disability status scale (EDSS) between 3.0 to 6.5 points inclusive, at screening
The participant must have documented evidence of disability progression observed during the 12 months before screening
Absence of clinical relapses for at least 24 months
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a WOCBP OR
Is a WOCBP and agrees to use an acceptable contraceptive method
Exclusion criteria:
The participant has conditions that would adversely affect study participation such as short life expectancy.
History of organ transplant.
Evidence of infection with human immuodeficiency virus (HIV), transplantation, progressive multifocal leukoencephalopathy (PML), active hepatitis B or C, active or latent tuberculosis or other active infections 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 dysfunctionat 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 bleeding.
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.
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
Center for Neurology and Spine-Site Number:8400089
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
84018
Country
United States
Facility Name
Arcadia Neurology Center-Site Number:8400070
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Facility Name
UC San Diego ACTRI-Site Number:8400101
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Collaborative Neuroscience Research-Site Number:8400045
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Multiple Sclerosis Center-Site Number:8400143
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
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
Harbor UCLA-Site Number:8400088
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Regina Berkovich, MD, PhD-Site Number:8400059
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mountain Neurological Research Center, Inc.-Site Number:8400128
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
University of Colorado-Site Number:8400012
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Advanced Neurosciences Research-Site Number:8400025
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
South Florida Neurology Associates-Site Number:8400029
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Neurology Associates, PA-Site Number:8400004
City
Maitland
State/Province
Florida
ZIP/Postal Code
32761
Country
United States
Facility Name
Aqualane Clinical Research-Site Number:8400027
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
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
University of Kansas Medical Center-Site Number:8400023
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7321
Country
United States
Facility Name
CHI Saint Joseph Medical Group Neurology-Site Number:8400110
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tufts Medical Center-Site Number:8400072
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Massachusetts-Site Number:8400014
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University-Site Number:8400046
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Memorial Hospital-Site Number:8400033
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Facility Name
Minneapolis Clinic of Neurology-Site Number:8400051
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic-Site Number:8400111
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
Lou Ruvo Center for Brain Health-Site Number:8400117
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Holy Name Hospital-Site Number:8400104
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
University of New Mexico-Site Number:8400032
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
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
Facility Name
Neurology Associates of Stony Brook-Site Number:8400042
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Meridian Clinical Research, LLC-Site Number:8400005
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Sanford Brain & Spine Center-Site Number:8400126
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
University Hospitals CMC-Site Number:8400083
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic-Site Number:8400125
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Neurology Specialists-Site Number:8400002
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Columbus Neuroscience-Site Number:8400010
City
Westerville
State/Province
Ohio
ZIP/Postal Code
40382
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
Perelman Center for Advanced Medicine-Site Number:8400142
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Jefferson Neurology Associates-Site Number:8400016
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Premier Neurology-Site Number:8400069
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Mountain View Clinical Research-Site Number:8400024
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651-1817
Country
United States
Facility Name
Neurology Clinic, PC-Site Number:8400087
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Advanced Neuroscience Center-Site Number:8400035
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Baylor College of Medicine-Site Number:8400136
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurology Center of San Antonio-Site Number:8400036
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
University Of Vermont College Of Medicine-Site Number:8400130
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Medical College of Wisconsin-Site Number:8400028
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Investigational Site Number :0320002
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
C1061
Country
Argentina
Facility Name
Investigational Site Number :0320007
City
Buenos Aires
ZIP/Postal Code
1860
Country
Argentina
Facility Name
Investigational Site Number :0320006
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Investigational Site Number :0360003
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Kent Town
State/Province
South Australia
Country
Australia
Facility Name
Investigational Site Number :0360004
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Facility Name
Investigational Site Number :0360001
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Investigational Site Number :0360006
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Investigational Site Number :0400003
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Investigational Site Number :0400001
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Investigational Site Number :0400004
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Investigational Site Number :0400002
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Investigational Site Number :1120004
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Facility Name
Investigational Site Number :1120005
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Investigational Site Number :0560007
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigational Site Number :0560003
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Investigational Site Number :0560006
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number :0560008
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number :0560002
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Investigational Site Number :0560001
City
Pelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Investigational Site Number :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 :1240017
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Investigational Site Number :1240011
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
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 :1240008
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
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 :1240005
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Investigational Site Number :1240004
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Investigational Site Number :1240015
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Investigational Site Number :1240007
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number :1240021
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Investigational Site Number :1560006
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number :1560012
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Investigational Site Number :1560021
City
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Investigational Site Number :1560003
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 :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 :1560001
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Investigational Site Number :1560007
City
Hangzhou
ZIP/Postal Code
310009
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 :1560017
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
Investigational Site Number :2030002
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Investigational Site Number :2030010
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Investigational Site Number :2030005
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number :2030003
City
Teplice
ZIP/Postal Code
415 29
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 :2080004
City
Odense
ZIP/Postal Code
5000
Country
Denmark
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 :2500011
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Investigational Site Number :2500005
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Investigational Site Number :2500015
City
Gonesse
ZIP/Postal Code
95500
Country
France
Facility Name
Investigational Site Number :2500009
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number :2500006
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number :2500008
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Investigational Site Number :2500010
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500017
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number :2500016
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Investigational Site Number :2500014
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Investigational Site Number :2500007
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Investigational Site Number :2500003
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number :2500001
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Investigational Site Number :2500012
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number :2760005
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Investigational Site Number :2760009
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number :2760012
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Investigational Site Number :2760002
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Investigational Site Number :2760010
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Investigational Site Number :2760006
City
Hannover
ZIP/Postal Code
30625
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 :3000001
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Investigational Site Number :3000006
City
Athens
ZIP/Postal Code
11535
Country
Greece
Facility Name
Investigational Site Number :3000002
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigational Site Number :3000007
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
Investigational Site Number :3000004
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Investigational Site Number :3000003
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Investigational Site Number :3000005
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Investigational Site Number :3480008
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Investigational Site Number :3480004
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Investigational Site Number :3480007
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Investigational Site Number :3480002
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Investigational Site Number :3480001
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Investigational Site Number :3480006
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Investigational Site Number :3560007
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Investigational Site Number :3560003
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Facility Name
Investigational Site Number :3560005
City
India
Country
India
Facility Name
Investigational Site Number :3560004
City
Mangaluru
ZIP/Postal Code
575018
Country
India
Facility Name
Investigational Site Number :3560006
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Investigational Site Number :3560002
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Investigational Site Number :3760002
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number :3760003
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigational Site Number :3760008
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number :3760001
City
Tel HaShomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number :3760004
City
Zefat
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigational Site Number :3800011
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number :3800007
City
Cagliari
ZIP/Postal Code
09126
Country
Italy
Facility Name
Investigational Site Number :3800012
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Investigational Site Number :3800016
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Investigational Site Number :3800014
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site Number :3800013
City
L'Aquila
ZIP/Postal Code
67010
Country
Italy
Facility Name
Investigational Site Number :3800004
City
Milano
ZIP/Postal Code
20122
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 :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 :3920016
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
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 :3920011
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Investigational Site Number :3920020
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
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 :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 :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 :4400001
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Investigational Site Number :5280001
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Investigational Site Number :5280003
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Investigational Site Number :5280006
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands
Facility Name
Investigational Site Number :5280002
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Investigational Site Number :5780003
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Investigational Site Number :5780002
City
Namsos
ZIP/Postal Code
7800
Country
Norway
Facility Name
Investigational Site Number :5780001
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Investigational Site Number :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 :6160002
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Investigational Site Number :6160007
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-684
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 :6160012
City
Lublin
ZIP/Postal Code
20-016
Country
Poland
Facility Name
Investigational Site Number :6160011
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Investigational Site Number :6200001
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Investigational Site Number :6200011
City
Lisboa
ZIP/Postal Code
1162-050
Country
Portugal
Facility Name
Investigational Site Number :6200007
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Investigational Site Number :6200006
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number :6200002
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Investigational Site Number :6200010
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Investigational Site Number :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 :6420006
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Investigational Site Number :6420003
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Investigational Site Number :6420013
City
Oradea
ZIP/Postal Code
410154
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 :6430018
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Investigational Site Number :6430023
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Investigational Site Number :6430025
City
Kaliningrad
ZIP/Postal Code
236035
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Investigational Site Number :6430022
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Investigational Site Number :6430017
City
Kirov
ZIP/Postal Code
610998
Country
Russian Federation
Facility Name
Investigational Site Number :6430024
City
Krasnoyarsk
ZIP/Postal Code
660029
Country
Russian Federation
Facility Name
Investigational Site Number :6430020
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Investigational Site Number :6430013
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Investigational Site Number :6430021
City
Nizhny Novgorod
ZIP/Postal Code
603137
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Investigational Site Number :6430026
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Investigational Site Number :6430007
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Investigational Site Number :6430016
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number :6430009
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Investigational Site Number :6430019
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Investigational Site Number :6430014
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Investigational Site Number :6430011
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6430012
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Investigational Site Number :6430010
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Investigational Site Number :7240007
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site Number :7240013
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240016
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :7240014
City
Salt
State/Province
Girona [Gerona]
ZIP/Postal Code
17190
Country
Spain
Facility Name
Investigational Site Number :7240017
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
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 :7240012
City
Donostia
State/Province
Pais Vasco
ZIP/Postal Code
20014
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Investigational Site Number :7240015
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number :7240010
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240011
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site Number :7920005
City
Eskisehir
Country
Turkey
Facility Name
Investigational Site Number :7920010
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 :7920006
City
Istanbul
ZIP/Postal Code
34896
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Istanbul
Country
Turkey
Facility Name
Investigational Site Number :7920013
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Izmit
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Investigational Site Number :7920011
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
Facility Name
Investigational Site Number :7920012
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Facility Name
Investigational Site Number :7920008
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Investigational Site Number :8040008
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Investigational Site Number :8040016
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Facility Name
Investigational Site Number :8040003
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Investigational Site Number :8040010
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Investigational Site Number :8040011
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040012
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040013
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Investigational Site Number :8040005
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Investigational Site Number :8040009
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site Number :8040006
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Investigational Site Number :8040014
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Investigational Site Number :8260003
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Investigational Site Number :8260008
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Investigational Site Number :8260010
City
Swansea
State/Province
Neath Port Talbot
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Investigational Site Number :8260012
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Investigational Site Number :8260013
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DZ
Country
United Kingdom
Facility Name
Investigational Site Number :8260009
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Investigational Site Number :8260001
City
Cardiff
ZIP/Postal Code
CF4 4XY
Country
United Kingdom
Facility Name
Investigational Site Number :8260005
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Investigational Site Number :8260018
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Investigational Site Number :8260014
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Investigational Site Number :8260019
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
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