MedPath

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

Phase 3
Completed
Conditions
Secondary Progressive Multiple Sclerosis
Interventions
Drug: Placebo to match Tolebrutinib
Registration Number
NCT04411641
Lead Sponsor
Sanofi
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1131
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo to match TolebrutinibPlacebo tablet to match SAR442168 once daily
SAR442168TolebrutinibDose 1 of oral SAR442168 once daily
Primary Outcome Measures
NameTimeMethod
6-month confirmed disability progression (CDP)Up to 48 approximately months

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
NameTimeMethod
3-month CDPUp to approximately 48 months

Time to onset of 3-month CDP as assessed by EDSS score

New and enlarging T2 hyperintense lesions by MRIFrom Baseline up to approximately 48 months

Total number of new or enlarging T2 hyperintense lesions as detected by MRI

3-months change in 9-HPTUp to approximately 48 months

Time to onset of sustained 20% increase in the 9 hole peg test (9-HPT) for at least 3 months

3-months change in T25-FWUp to approximately 48 months

Time to onset of sustained 20% increase in the T25-FW for at least 3 months

Time to onset of confirmed disability improvement (CDI)From Baseline up to approximately 48 months

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)From 6 Months up to approximately 48 months

Percent change in Brain volume loss (BVL) as detected by brain MRI at the EOS compared to month 6

Change in cognitive functionFrom Baseline up to approximately 48 months

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)From Baseline up to approximately 48 months

Change in Multiple Sclerosis Quality of Life-54 (MSQoL-54) from the baseline through the EOS

Safety and TolerabilityFrom Screening until end of study up to approximately 48 months

Number of participants with adverse events (AEs), Serious AEs, AEs leading to permanent study intervention discontinuation, and adverse events of special interest (AESI)

Population pharmacokineticsMonths 6, 9 and 12

Plasma concentration of SAR442168 and relevant metabolites (population PK assessment) at Months 6, 9, and 12

Change in plasma neurofilament light chain (NfL)From Baseline up to approximately 48 months

Change in NfL levels at the EOS compared to baseline

Changes in serum Immunoglobulin levelFrom Baseline up to approximately 48 months

Changes in serum Immunoglobulin level at the EOS compared to baseline

Change in lymphocyte phenotype subsetsFrom Baseline up to approximately 48 months

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)From Baseline up to approximately 48 months

Change in serum chitinase-3 like protein 1 (Chi3L1) at the EOS compared to baseline

Trial Locations

Locations (306)

University of Alabama MS Center-Site Number:8400013

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Birmingham, Alabama, United States

Center for Neurology and Spine-Site Number:8400089

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Phoenix, Arizona, United States

Arcadia Neurology Center-Site Number:8400070

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Arcadia, California, United States

UC San Diego ACTRI-Site Number:8400101

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La Jolla, California, United States

Collaborative Neuroscience Research-Site Number:8400045

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Long Beach, California, United States

Multiple Sclerosis Center-Site Number:8400143

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Los Angeles, California, United States

University of San Francisco, Sandler Neurosciences Center-Site Number:8400137

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San Francisco, California, United States

Harbor UCLA-Site Number:8400088

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Torrance, California, United States

Regina Berkovich, MD, PhD-Site Number:8400059

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West Hollywood, California, United States

Mountain Neurological Research Center, Inc.-Site Number:8400128

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Basalt, Colorado, United States

University of Colorado-Site Number:8400012

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Denver, Colorado, United States

Advanced Neurosciences Research-Site Number:8400025

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Fort Collins, Colorado, United States

South Florida Neurology Associates-Site Number:8400029

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Boca Raton, Florida, United States

Neurology Associates, PA-Site Number:8400004

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Maitland, Florida, United States

Aqualane Clinical Research-Site Number:8400027

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Naples, Florida, United States

Axiom Clinical Research of Florida-Site Number:8400001

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Tampa, Florida, United States

University of South Florida-Site Number:8400006

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Tampa, Florida, United States

Meridian Clinical Research-Site Number:8400003

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Savannah, Georgia, United States

Consultants In Neurology-Site Number:8400011

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Northbrook, Illinois, United States

University of Kansas Medical Center-Site Number:8400023

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Kansas City, Kansas, United States

CHI Saint Joseph Medical Group Neurology-Site Number:8400110

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Lexington, Kentucky, United States

Tufts Medical Center-Site Number:8400072

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Boston, Massachusetts, United States

University of Massachusetts-Site Number:8400014

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Worcester, Massachusetts, United States

Wayne State University-Site Number:8400046

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Detroit, Michigan, United States

The Memorial Hospital-Site Number:8400033

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Owosso, Michigan, United States

Minneapolis Clinic of Neurology-Site Number:8400051

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Minneapolis, Minnesota, United States

Mayo Clinic-Site Number:8400111

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Rochester, Minnesota, United States

Missouri Baptist Medical Center-Site Number:8400019

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Saint Louis, Missouri, United States

Lou Ruvo Center for Brain Health-Site Number:8400117

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Las Vegas, Nevada, United States

Holy Name Hospital-Site Number:8400104

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Teaneck, New Jersey, United States

University of New Mexico-Site Number:8400032

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Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038

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New York, New York, United States

Neurology Associates of Stony Brook-Site Number:8400042

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Stony Brook, New York, United States

Meridian Clinical Research, LLC-Site Number:8400005

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Raleigh, North Carolina, United States

Sanford Brain & Spine Center-Site Number:8400126

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Fargo, North Dakota, United States

University Hospitals CMC-Site Number:8400083

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Cleveland, Ohio, United States

Cleveland Clinic-Site Number:8400125

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Cleveland, Ohio, United States

Optimed Research, LTD-Site Number:8400147

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Columbus, Ohio, United States

Neurology Specialists-Site Number:8400002

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Dayton, Ohio, United States

Columbus Neuroscience-Site Number:8400010

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Westerville, Ohio, United States

Providence Multiple Sclerosis Center-Site Number:8400020

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Portland, Oregon, United States

Perelman Center for Advanced Medicine-Site Number:8400142

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Philadelphia, Pennsylvania, United States

Jefferson Neurology Associates-Site Number:8400016

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Philadelphia, Pennsylvania, United States

Premier Neurology-Site Number:8400069

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Greer, South Carolina, United States

Mountain View Clinical Research-Site Number:8400024

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Greer, South Carolina, United States

Neurology Clinic, PC-Site Number:8400087

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Cordova, Tennessee, United States

Advanced Neuroscience Center-Site Number:8400035

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Franklin, Tennessee, United States

Baylor College of Medicine-Site Number:8400136

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Houston, Texas, United States

Neurology Center of San Antonio-Site Number:8400036

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San Antonio, Texas, United States

University Of Vermont College Of Medicine-Site Number:8400130

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Burlington, Vermont, United States

Medical College of Wisconsin-Site Number:8400028

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Milwaukee, Wisconsin, United States

Investigational Site Number :0320002

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Capital Federal, Buenos Aires, Argentina

Investigational Site Number :0320001

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Caba, Ciudad De Buenos Aires, Argentina

Investigational Site Number :0320007

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Buenos Aires, Argentina

Investigational Site Number :0320006

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Córdoba, Argentina

Investigational Site Number :0320005

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San Miguel de Tucuman, Argentina

Investigational Site Number : 0360007

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St Leonards, New South Wales, Australia

Investigational Site Number :0360003

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Woolloongabba, Queensland, Australia

Investigational Site Number :0360002

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Kent Town, South Australia, Australia

Investigational Site Number :0360004

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Hobart, Tasmania, Australia

Investigational Site Number :0360001

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Fitzroy, Victoria, Australia

Investigational Site Number :0360006

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Heidelberg West, Victoria, Australia

Investigational Site Number :0400003

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Innsbruck, Austria

Investigational Site Number :0400001

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Linz, Austria

Investigational Site Number :0400004

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Linz, Austria

Investigational Site Number :0400002

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Wien, Austria

Investigational Site Number :1120004

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Vitebsk, Belarus

Investigational Site Number :1120005

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Vitebsk, Belarus

Investigational Site Number : 0560009

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Bruxelles, Belgium

Investigational Site Number :0560007

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Bruxelles, Belgium

Investigational Site Number :0560003

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Edegem, Belgium

Investigational Site Number : 0560004

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Gent, Belgium

Investigational Site Number :0560006

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Leuven, Belgium

Investigational Site Number :0560008

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Liège, Belgium

Investigational Site Number :2030005

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Praha 2, Czechia

Investigational Site Number :0560002

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Mons, Belgium

Investigational Site Number :0560001

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Pelt, Belgium

Investigational Site Number :1000002

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Pleven, Bulgaria

Investigational Site Number :1000005

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Plovdiv, Bulgaria

Investigational Site Number :1000004

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Sofia, Bulgaria

Investigational Site Number :1000008

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Sofia, Bulgaria

Investigational Site Number :1000001

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Sofia, Bulgaria

Investigational Site Number :1000006

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Sofia, Bulgaria

Investigational Site Number :1000009

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Sofia, Bulgaria

Investigational Site Number :1240017

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Burnaby, British Columbia, Canada

Investigational Site Number :1240011

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Halifax, Nova Scotia, Canada

Investigational Site Number :1240003

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Ottawa, Ontario, Canada

Investigational Site Number :1240008

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Toronto, Ontario, Canada

Investigational Site Number :1240006

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Gatineau, Quebec, Canada

Investigational Site Number :1240005

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Greenfield Park, Quebec, Canada

Investigational Site Number :1240004

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Montreal, Quebec, Canada

Investigational Site Number :1240015

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Montreal, Quebec, Canada

Investigational Site Number :1240007

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Sherbrooke, Quebec, Canada

Investigational Site Number : 1240001

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Quebec, Canada

Investigational Site Number :1240021

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Quebec, Canada

Investigational Site Number :1560006

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Beijing, China

Investigational Site Number :1560012

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Beijing, China

Investigational Site Number :1560021

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Beijing, China

Investigational Site Number :1560003

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Beijing, China

Investigational Site Number :1560009

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Beijing, China

Investigational Site Number :1560004

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Changchun, China

Investigational Site Number :1560015

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Changsha, China

Investigational Site Number :1560005

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Chengdu, China

Investigational Site Number :1560019

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Chongqing, China

Investigational Site Number :1560035

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Fuzhou, China

Investigational Site Number :2030010

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Ostrava - Poruba, Czechia

Investigational Site Number :1560001

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Guangzhou, China

Investigational Site Number :1560007

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Hangzhou, China

Investigational Site Number :1560014

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Shijiazhuang, China

Investigational Site Number :1560008

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Taiyuan, China

Investigational Site Number :1560017

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Xi'an, China

Investigational Site Number :2030002

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Brno, Czechia

Investigational Site Number :2030004

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Hradec Kralove, Czechia

Investigational Site Number :2030001

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Jihlava, Czechia

Investigational Site Number :2030003

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Teplice, Czechia

Investigational Site Number :2080001

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Esbjerg, Denmark

Investigational Site Number :2080005

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Holstebro, Denmark

Investigational Site Number :2080004

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Odense, Denmark

Investigational Site Number :2460003

🇫🇮

Helsinki, Finland

Investigational Site Number :2460001

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Tampere, Finland

Investigational Site Number :2460002

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Turku, Finland

Investigational Site Number :2500011

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Bron, France

Investigational Site Number :2500005

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Clermont Ferrand, France

Investigational Site Number :2500015

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Gonesse, France

Investigational Site Number :2500009

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Lille, France

Investigational Site Number :2500006

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Montpellier, France

Investigational Site Number :2500008

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Nancy, France

Investigational Site Number :2500010

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Nantes, France

Investigational Site Number :2500017

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Nimes, France

Investigational Site Number :2500016

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Paris, France

Investigational Site Number :2500014

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Paris, France

Investigational Site Number :2500007

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Paris, France

Investigational Site Number :2500003

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Rennes, France

Investigational Site Number :2500001

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Strasbourg, France

Investigational Site Number :2500012

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Toulouse, France

Investigational Site Number :2760005

🇩🇪

Bayreuth, Germany

Investigational Site Number :2760009

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Berlin, Germany

Investigational Site Number :2760001

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Dresden, Germany

Investigational Site Number :2760012

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Essen, Germany

Investigational Site Number :2760002

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Gießen, Germany

Investigational Site Number :2760010

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Halle (Saale), Germany

Investigational Site Number :2760006

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Hannover, Germany

Investigational Site Number :2760008

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Münster, Germany

Investigational Site Number :2760004

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Rostock, Germany

Investigational Site Number :2760011

🇩🇪

Ulm, Germany

Investigational Site Number :3000001

🇬🇷

Athens, Greece

Investigational Site Number :3000006

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Athens, Greece

Investigational Site Number :3000002

🇬🇷

Athens, Greece

Investigational Site Number :3000007

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Athens, Greece

Investigational Site Number :3000004

🇬🇷

Larissa, Greece

Investigational Site Number :3000003

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Thessaloniki, Greece

Investigational Site Number :3000005

🇬🇷

Thessaloniki, Greece

Investigational Site Number :3480008

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Budapest, Hungary

Investigational Site Number :3480004

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Budapest, Hungary

Investigational Site Number :3480007

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Budapest, Hungary

Investigational Site Number :3480002

🇭🇺

Pécs, Hungary

Investigational Site Number :3480001

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Szeged, Hungary

Investigational Site Number :3480006

🇭🇺

Tatabánya, Hungary

Investigational Site Number :3560007

🇮🇳

Gurgaon, India

Investigational Site Number :3560003

🇮🇳

Gurgaon, India

Investigational Site Number :3560005

🇮🇳

India, India

Investigational Site Number :3560004

🇮🇳

Mangaluru, India

Investigational Site Number : 3560009

🇮🇳

Nagpur, India

Investigational Site Number :3560006

🇮🇳

New Delhi, India

Investigational Site Number :3560002

🇮🇳

New Delhi, India

Investigational Site Number :3760002

🇮🇱

Ashkelon, Israel

Investigational Site Number :3760003

🇮🇱

Haifa, Israel

Investigational Site Number :3760008

🇮🇱

Jerusalem, Israel

Investigational Site Number :3760001

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Tel HaShomer, Israel

Investigational Site Number :3760004

🇮🇱

Zefat, Israel

Investigational Site Number :3800011

🇮🇹

Bergamo, Italy

Investigational Site Number :3800007

🇮🇹

Cagliari, Italy

Investigational Site Number :3800012

🇮🇹

Firenze, Italy

Investigational Site Number :3800016

🇮🇹

Firenze, Italy

Investigational Site Number :3800014

🇮🇹

Genova, Italy

Investigational Site Number :3800013

🇮🇹

L'Aquila, Italy

Investigational Site Number :3800004

🇮🇹

Milano, Italy

Investigational Site Number :3800001

🇮🇹

Milano, Italy

Investigational Site Number :3800010

🇮🇹

Milano, Italy

Investigational Site Number :3800008

🇮🇹

Pavia, Italy

Investigational Site Number :3800005

🇮🇹

Roma, Italy

Investigational Site Number :3800009

🇮🇹

Roma, Italy

Investigational Site Number :3920016

🇯🇵

Chiba-shi, Chiba, Japan

Investigational Site Number :3920022

🇯🇵

Morioka-shi, Iwate, Japan

Investigational Site Number :3920011

🇯🇵

Kyoto-shi, Kyoto, Japan

Investigational Site Number :3920020

🇯🇵

Sendai-shi, Miyagi, Japan

Investigational Site Number :3920005

🇯🇵

Niigata-shi, Niigata, Japan

Investigational Site Number :3920004

🇯🇵

Moriguchi-shi, Osaka, Japan

Investigational Site Number :3920001

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Osaka-shi, Osaka, Japan

Investigational Site Number :3920018

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Kawagoe-shi, Saitama, Japan

Investigational Site Number :3920003

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Kodaira-shi, Tokyo, Japan

Investigational Site Number :3920010

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Ota-ku, Tokyo, Japan

Investigational Site Number :3920009

🇯🇵

Ube-shi, Yamaguchi, Japan

Investigational Site Number :3920023

🇯🇵

Sagamihara-shi, Japan

Investigational Site Number :4400003

🇱🇹

Kaunas, Lithuania

Investigational Site Number :4400002

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Klaipeda, Lithuania

Investigational Site Number :4400001

🇱🇹

Vilnius, Lithuania

Investigational Site Number :5280001

🇳🇱

Amsterdam, Netherlands

Investigational Site Number :5280003

🇳🇱

Breda, Netherlands

Investigational Site Number :5280006

🇳🇱

Groningen, Netherlands

Investigational Site Number :5280002

🇳🇱

Sittard-Geleen, Netherlands

Investigational Site Number :5780003

🇳🇴

Bergen, Norway

Investigational Site Number :5780002

🇳🇴

Namsos, Norway

Investigational Site Number :5780001

🇳🇴

Oslo, Norway

Investigational Site Number :6160003

🇵🇱

Bydgoszcz, Kujawsko-pomorskie, Poland

Investigational Site Number :6160005

🇵🇱

Warszawa, Mazowieckie, Poland

Investigational Site Number :6160006

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Warszawa, Mazowieckie, Poland

Investigational Site Number :6160002

🇵🇱

Katowice, Slaskie, Poland

Investigational Site Number :6160007

🇵🇱

Katowice, Slaskie, Poland

Investigational Site Number :6160004

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Katowice, Slaskie, Poland

Investigational Site Number :6420006

🇷🇴

Cluj-Napoca, Romania

Investigational Site Number :6420003

🇷🇴

Constanta, Romania

Investigational Site Number :6420013

🇷🇴

Oradea, Romania

Investigational Site Number :6160008

🇵🇱

Plewiska, Wielkopolskie, Poland

Investigational Site Number :6160001

🇵🇱

Lodz, Poland

Investigational Site Number :6160012

🇵🇱

Lublin, Poland

Investigational Site Number :6160011

🇵🇱

Zabrze, Poland

Investigational Site Number :6200001

🇵🇹

Braga, Portugal

Investigational Site Number :6200011

🇵🇹

Lisboa, Portugal

Investigational Site Number :6200007

🇵🇹

Lisboa, Portugal

Investigational Site Number :6200006

🇵🇹

Lisboa, Portugal

Investigational Site Number :6200002

🇵🇹

Matosinhos, Portugal

Investigational Site Number :6200010

🇵🇹

Porto, Portugal

Investigational Site Number :6420008

🇷🇴

Bucuresti, Romania

Investigational Site Number :6420004

🇷🇴

Campulung, Romania

Investigational Site Number :6420005

🇷🇴

Sibiu, Romania

Investigational Site Number :6420001

🇷🇴

Targu Mures, Romania

Investigational Site Number :6420002

🇷🇴

Timisoara, Romania

Investigational Site Number :6430018

🇷🇺

Barnaul, Russian Federation

Investigational Site Number :6430023

🇷🇺

Ekaterinburg, Russian Federation

Investigational Site Number :6430025

🇷🇺

Kaliningrad, Russian Federation

Investigational Site Number :6430003

🇷🇺

Kazan, Russian Federation

Investigational Site Number :6430022

🇷🇺

Kemerovo, Russian Federation

Investigational Site Number :6430017

🇷🇺

Kirov, Russian Federation

Investigational Site Number :6430024

🇷🇺

Krasnoyarsk, Russian Federation

Investigational Site Number :6430020

🇷🇺

Moscow, Russian Federation

Investigational Site Number :6430002

🇷🇺

Moscow, Russian Federation

Investigational Site Number :6430013

🇷🇺

Moscow, Russian Federation

Investigational Site Number :6430001

🇷🇺

Moscow, Russian Federation

Investigational Site Number :6430008

🇷🇺

Moscow, Russian Federation

Investigational Site Number :6430021

🇷🇺

Nizhny Novgorod, Russian Federation

Investigational Site Number :6430006

🇷🇺

Nizhny Novgorod, Russian Federation

Investigational Site Number :6430005

🇷🇺

Novosibirsk, Russian Federation

Investigational Site Number :6430026

🇷🇺

Perm, Russian Federation

Investigational Site Number :6430007

🇷🇺

Pyatigorsk, Russian Federation

Investigational Site Number :6430016

🇷🇺

Rostov-on-Don, Russian Federation

Investigational Site Number :6430004

🇷🇺

Saint-Petersburg, Russian Federation

Investigational Site Number :6430009

🇷🇺

Samara, Russian Federation

Investigational Site Number :6430019

🇷🇺

Saransk, Russian Federation

Investigational Site Number :6430014

🇷🇺

Smolensk, Russian Federation

Investigational Site Number :6430011

🇷🇺

St-Petersburg, Russian Federation

Investigational Site Number :6430012

🇷🇺

Tyumen, Russian Federation

Investigational Site Number :6430010

🇷🇺

Ufa, Russian Federation

Investigational Site Number :7240007

🇪🇸

Sevilla, Andalucia, Spain

Investigational Site Number :7240013

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :8040007

🇺🇦

Kharkiv, Ukraine

Investigational Site Number :7240016

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240014

🇪🇸

Salt, Girona [Gerona], Spain

Investigational Site Number :7240017

🇪🇸

Las Palmas de Gran Canaria, Las Palmas, Spain

Investigational Site Number :7240004

🇪🇸

Majadahonda, Madrid, Spain

Investigational Site Number :7240001

🇪🇸

Pozuelo De Alarcón, Madrid, Spain

Investigational Site Number :7240012

🇪🇸

Donostia, Pais Vasco, Spain

Investigational Site Number :7240008

🇪🇸

Córdoba, Spain

Investigational Site Number :7240015

🇪🇸

Lleida, Spain

Investigational Site Number :7240005

🇪🇸

Madrid, Spain

Investigational Site Number :7240002

🇪🇸

Madrid, Spain

Investigational Site Number :7240003

🇪🇸

Madrid, Spain

Investigational Site Number :7240010

🇪🇸

Murcia, Spain

Investigational Site Number :7240009

🇪🇸

Málaga, Spain

Investigational Site Number :7240011

🇪🇸

Valencia, Spain

Investigational Site Number :7920005

🇹🇷

Eskisehir, Turkey

Investigational Site Number :7920010

🇹🇷

Hatay, Turkey

Investigational Site Number :7920002

🇹🇷

Istanbul, Turkey

Investigational Site Number :7920009

🇹🇷

Istanbul, Turkey

Investigational Site Number :7920007

🇹🇷

Istanbul, Turkey

Investigational Site Number :7920006

🇹🇷

Istanbul, Turkey

Investigational Site Number :7920003

🇹🇷

Istanbul, Turkey

Investigational Site Number :7920013

🇹🇷

Izmir, Turkey

Investigational Site Number :7920001

🇹🇷

Izmit, Turkey

Investigational Site Number :7920011

🇹🇷

Kütahya, Turkey

Investigational Site Number :7920012

🇹🇷

Mersin, Turkey

Investigational Site Number :7920008

🇹🇷

Trabzon, Turkey

Investigational Site Number :8040008

🇺🇦

Chernivtsi, Ukraine

Investigational Site Number :8040016

🇺🇦

Chernivtsi, Ukraine

Investigational Site Number :8040003

🇺🇦

Dnipro, Ukraine

Investigational Site Number :8040010

🇺🇦

Ivano-Frankivsk, Ukraine

Investigational Site Number :8040011

🇺🇦

Kharkiv, Ukraine

Investigational Site Number :8040012

🇺🇦

Kharkiv, Ukraine

Investigational Site Number :8040013

🇺🇦

Kyiv, Ukraine

Investigational Site Number :8040005

🇺🇦

Lutsk, Ukraine

Investigational Site Number :8040009

🇺🇦

Lviv, Ukraine

Investigational Site Number :8040004

🇺🇦

Lviv, Ukraine

Investigational Site Number :8040002

🇺🇦

Odesa, Ukraine

Investigational Site Number :8040006

🇺🇦

Vinnytsia, Ukraine

Investigational Site Number :8040014

🇺🇦

Zhytomyr, Ukraine

Investigational Site Number :8260003

🇬🇧

Exeter, Devon, United Kingdom

Investigational Site Number :8260008

🇬🇧

Plymouth, Devon, United Kingdom

Investigational Site Number :8260010

🇬🇧

Swansea, Neath Port Talbot, United Kingdom

Investigational Site Number :8260012

🇬🇧

Nottingham, Nottinghamshire, United Kingdom

Investigational Site Number :8260013

🇬🇧

Oxford, Oxfordshire, United Kingdom

Investigational Site Number :8260009

🇬🇧

Bristol, United Kingdom

Investigational Site Number :8260001

🇬🇧

Cardiff, United Kingdom

Investigational Site Number :8260005

🇬🇧

London, United Kingdom

Investigational Site Number :8260018

🇬🇧

London, United Kingdom

Investigational Site Number :8260014

🇬🇧

Newcastle Upon Tyne, United Kingdom

Investigational Site Number :8260019

🇬🇧

Salford, United Kingdom

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