Clinical trial NCT04456673: Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2020-07-02
Enrollment: 935
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

* Annualized rate of acute moderate or severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

* Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
* Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
* Pre-bronchodilator FEV1 over 52 weeks compared to placebo
* Lung function assessments
* Moderate and severe COPD exacerbations
* To evaluate safety and tolerability
* To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

Detailed description: Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up

Eligibility criteria: Inclusion Criteria:

* Participants with a physician diagnosis of COPD who met the following criteria at screening:

  * Current or former smokers with a smoking history of ≥10 pack-years.
  * Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity \[FVC\] ratio \<0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%).
  * Medical Research Council (MRC) Dyspnea Scale grade ≥2.
  * Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
  * Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were recorded by the investigator and defined as AECOPD requiring hospitalization or observation \> 24 hours in emergency department/urgent care facility.
  * Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
* Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion Criteria:

* COPD diagnosis for less than 12 months prior to randomization.
* Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
* Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
* Cor pulmonale, evidence of right cardiac failure.
* Long-term treatment with oxygen \>4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation \>88%
* Hypercapnia requiring Bi-level ventilation.
* AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
* Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
* History of, or planned pneumonectomy or lung volume reduction surgery. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
* Diagnosis of α-1 anti-trypsin deficiency.

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

Primary outcomes:
measure: Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period
timeFrame: Baseline (Day 1) to Week 52
Secondary outcomes:
measure: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52
timeFrame: Baseline (Day 1) and Week 52
measure: Percentage of Participants With Saint George's Respiratory Questionnaire Improvement ≥4 Points at Week 52
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52
timeFrame: Baseline (Day 1) and Week 52
measure: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 24, 36, and 44
timeFrame: Baseline (Day 1) and Weeks 2, 4, 8, 24, 36 and 44
measure: Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 12, 24, 36, and 52
timeFrame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Forced Expiratory Flow (FEF) 25 to 75 Percent (%) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52
timeFrame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 44 and 52
measure: Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period
timeFrame: Baseline (Day 1) to Week 52
measure: Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbation Event During the 52-week Treatment Period
timeFrame: Baseline (Day 1) and up to Weeks 12, 24, 36 and 52
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
measure: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology
timeFrame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
measure: Percentage of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry
timeFrame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
measure: Percentage of Participants With Abnormal Results for Urine Protein in Urinalysis
timeFrame: Baseline (Day 1), Weeks 4, 8, 12, 24, 36, 52 and 64
measure: Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Research Center, LLC Site Number : 8400095
state: Alabama
city: Jasper
country: United States
facility: Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090
state: Alabama
city: Scottsboro
country: United States
facility: Scottsboro Quick Care Clinic Site Number : 8400116
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Group Site Number : 8400061
state: Arizona
city: Tempe
country: United States
facility: Medical Advancement Center of Arizona Site Number : 8400107
state: Arizona
city: Little Rock
country: United States
facility: Asthma and Allergy Institute Site Number : 8400022
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research, Inc Site Number : 8400031
state: California
city: Newport Beach
country: United States
facility: NewportNativeMD, Inc Site Number : 8400032
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations, Inc. Site Number : 8400063
state: California
city: San Diego
country: United States
facility: ACRC Studies Site Number : 8400094
state: California
city: San Diego
country: United States
facility: Institute of HealthCare Assessment, Inc. Site Number : 8400015
state: California
city: Westminster
country: United States
facility: Allianz Research Institute Site Number : 8400007
state: California
city: Lafayette
country: United States
facility: Innovative Clinical Research Site Number : 8400018
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC Site Number : 8400035
state: Florida
city: Boynton Beach
country: United States
facility: Pioneer Clinical Research Site Number : 8400043
state: Florida
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group, Inc Site Number : 8400092
state: Florida
city: Clearwater
country: United States
facility: St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center Site Number : 8400081
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants, LLC Site Number : 8400021
state: Florida
city: Doral
country: United States
facility: Sciences Connections, LLC Site Number : 8400133
state: Florida
city: Fort Lauderdale
country: United States
facility: InvesClinic, LLC Site Number : 8400039
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research Site Number : 8400071
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Medical Center Inc Site Number : 8400079
state: Florida
city: Miami
country: United States
facility: DL Research Solutions Inc Site Number : 8400089
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research, LLC Site Number : 8400012
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services Site Number : 8400062
state: Florida
city: Miami
country: United States
facility: Reed Medical Research Site Number : 8400123
state: Florida
city: Miami
country: United States
facility: De La Cruz Research Center, LLC Site Number : 8400075
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research Site Number : 8400129
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA Site Number : 8400101
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center Site Number : 8400114
state: Florida
city: Plant City
country: United States
facility: Family Medical Specialists of Florida, PA Site Number : 8400077
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary And Critical Care Site Number : 8400013
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Center Site Number : 8400001
state: Florida
city: Adairsville
country: United States
facility: Appalachian Clinical Research Site Number : 8400048
state: Georgia
city: Atlanta
country: United States
facility: Northlake Medical Group Site Number : 8400099
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research, LLC Site Number : 8400045
state: Georgia
city: Conyers
country: United States
facility: Medical Centre of Conyers Site Number : 8400064
state: Georgia
city: Cordele
country: United States
facility: David Kavtaradze MD, Inc. Site Number : 8400135
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Biomedical Research Site Number : 8400052
state: Georgia
city: Rincon
country: United States
facility: Southeast Lung Associates Site Number : 8400003
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research LLC Site Number : 8400078
state: Georgia
city: Crowley
country: United States
facility: Avant Research Associates LLC Site Number : 8400118
state: Louisiana
city: Fall River
country: United States
facility: Genesis Clinical Research & Consulting Site Number : 8400050
state: Massachusetts
city: South Dartmouth
country: United States
facility: Infinity Medical Research Site Number : 8400004
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System Site Number : 8400053
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute Site Number : 8400120
state: Michigan
city: Rochester
country: United States
facility: Romedica, LLC Site Number : 8400034
state: Michigan
city: Saginaw
country: United States
facility: Covenant Healthcare Site Number : 8400057
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute Site Number : 8400096
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research Site Number : 8400019
state: Montana
city: Lincoln
country: United States
facility: Somnos Clinical Research Site Number : 8400016
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc. Site Number : 8400073
state: Nebraska
city: Jersey City
country: United States
facility: Jersey City Breathing Center Site Number : 8400137
state: New Jersey
city: E. Amherst
country: United States
facility: WellNow Urgent Care Site Number : 8400132
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health Site Number : 8400054
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research PLLC Site Number : 8400037
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research Site Number : 8400044
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions LLC Site Number : 8400042
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research of Gastonia Site Number : 8400010
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research Site Number : 8400087
state: North Carolina
city: Mooresville
country: United States
facility: Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006
state: North Carolina
city: Mooresville
country: United States
facility: Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A. Site Number : 8400025
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center Site Number : 8400068
state: North Carolina
city: Columbus
country: United States
facility: Optimed Research, LTD Site Number : 8400082
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research Site Number : 8400024
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center Site Number : 8400127
state: Oklahoma
city: DuBois
country: United States
facility: Clinical Research of Central PA Site Number : 8400009
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC Site Number : 8400049
state: Pennsylvania
city: Clinton
country: United States
facility: Carolina Medical Research, LLC Site Number : 8400026
state: South Carolina
city: Lancaster
country: United States
facility: MD First Research Site Number : 8400105
state: South Carolina
city: Myrtle Beach
country: United States
facility: LLM Research Site Number : 8400125
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts Site Number : 8400027
state: South Dakota
city: Dickson
country: United States
facility: Pulmonary & Sleep Specialists Site Number : 8400136
state: Tennessee
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee Site Number : 8400066
state: Tennessee
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research Site Number : 8400110
state: Tennessee
city: Beaumont
country: United States
facility: REX Clinical Trials Site Number : 8400143
state: Texas
city: Carrollton
country: United States
facility: Clinrx Research Site Number : 8400059
state: Texas
city: Cypress
country: United States
facility: Houston Pulmonary and Sleep Associates Site Number : 8400011
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center Site Number : 8400128
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc. Site Number : 8400070
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research Site Number : 8400029
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research Site Number : 8400028
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center Site Number : 8400131
state: Texas
city: Plano
country: United States
facility: Clinrx Research, LLC Site Number : 8400069
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group Site Number : 8400038
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research Site Number : 8400115
state: Texas
city: Abingdon
country: United States
facility: Pulmonary Research of Abingdon, LLC Site Number : 8400030
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners Site Number : 8400040
state: Virginia
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088
state: Wisconsin
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320007
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320006
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320004
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320001
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320003
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320010
state: Buenos Aires
city: Lobos
country: Argentina
facility: Investigational Site Number : 0320013
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Investigational Site Number : 0320005
state: Ciudad De Buenos Aires
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320011
state: Córdoba
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320008
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320009
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Launs Este
country: Argentina
facility: Investigational Site Number : 0320012
city: Kent Town
country: Australia
facility: Investigational Site Number : 0360008
state: South Australia
city: Clayton
country: Australia
facility: Investigational Site Number : 0360005
state: Victoria
city: Spearwood
country: Australia
facility: Investigational Site Number : 0360001
state: Western Australia
city: Edegem
country: Belgium
facility: Investigational Site Number : 0560002
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560001
city: Liege
country: Belgium
facility: Investigational Site Number : 0560003
city: Mechelen
country: Belgium
facility: Investigational Site Number : 0560004
city: Salvador
country: Brazil
facility: SER da Bahia Site Number : 0760019
state: Bahia
city: Vitoria
country: Brazil
facility: CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020
state: Espírito Santo
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa e Saude Site Number : 0760008
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas Site Number : 0760001
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: HOSPITAL DIA DO PULMAO Site Number : 0760006
state: Santa Catarina
city: Florianópolis
country: Brazil
facility: UFSC - Hospital Universitário Site Number : 0760018
state: Santa Catarina
city: Campinas
country: Brazil
facility: PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015
state: São Paulo
city: Santo Andre
country: Brazil
facility: FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007
state: São Paulo
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica Site Number : 0760003
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021
state: São Paulo
city: Sao Paulo
country: Brazil
facility: InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila Site Number : 0760009
state: São Paulo
city: Burgas
country: Bulgaria
facility: Investigational Site Number : 1005025
city: Dupnitsa
country: Bulgaria
facility: Investigational Site Number : 1005021
city: Haskovo
country: Bulgaria
facility: Investigational Site Number : 1005012
city: Montana
country: Bulgaria
facility: Investigational Site Number : 1005011
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number : 1005008
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1005015
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1005013
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005018
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005003
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005006
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005002
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1005026
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1005024
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1005004
city: Veliko Tyrnovo
country: Bulgaria
facility: Investigational Site Number : 1005023
city: Veliko Tyrnovo
country: Bulgaria
facility: Investigational Site Number : 1005027
city: Vidin
country: Bulgaria
facility: Investigational Site Number : 1005019
city: Vratsa
country: Bulgaria
facility: Investigational Site Number : 1005020
city: Calgary
country: Canada
facility: Investigational Site Number : 1240015
state: Alberta
city: Kamloops
country: Canada
facility: Investigational Site Number : 1240018
state: British Columbia
city: Kelowna
country: Canada
facility: Investigational Site Number : 1240017
state: British Columbia
city: Moncton
country: Canada
facility: Investigational Site Number : 1240014
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational Site Number : 1240010
state: Ontario
city: Sarnia
country: Canada
facility: Investigational Site Number : 1240009
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240007
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Québec
country: Canada
facility: Investigational Site Number : 1240012
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site Number : 1240001
city: Quebec
country: Canada
facility: Investigational Site Number : 1240005
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520009
state: Los Ríos
city: Curicó
country: Chile
facility: Investigational Site Number : 1520006
state: Maule
city: Talca
country: Chile
facility: Investigational Site Number : 1520001
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520007
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520004
state: Valparaíso
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700002
city: Bucaramanga
country: Colombia
facility: Investigational Site Number : 1700007
city: Manizales
country: Colombia
facility: Investigational Site Number : 1700005
city: Havlickuv Brod
country: Czechia
facility: Investigational Site Number : 2030009
city: Jihlava
country: Czechia
facility: Investigational Site Number : 2030004
city: Jindrichuv Hradec III
country: Czechia
facility: Investigational Site Number : 2030001
city: Kralupy nad Vltavou
country: Czechia
facility: Investigational Site Number : 2030007
city: Miroslav
country: Czechia
facility: Investigational Site Number : 2030003
city: Nymburk
country: Czechia
facility: Investigational Site Number : 2030010
city: Strakonice
country: Czechia
facility: Investigational Site Number : 2030002
city: Bayonne
country: France
facility: Investigational Site Number : 2500009
city: Dijon
country: France
facility: Investigational Site Number : 2500002
city: Lyon
country: France
facility: Investigational Site Number : 2500005
city: Montpellier
country: France
facility: Investigational Site Number : 2500003
city: Paris
country: France
facility: Investigational Site Number : 2500007
city: Paris
country: France
facility: Investigational Site Number : 2500008
city: Pessac
country: France
facility: Investigational Site Number : 2500006
city: Saint Herblain
country: France
facility: Investigational Site Number : 2500001
city: Berlin
country: Germany
facility: Investigational Site Number : 2760024
city: Berlin
country: Germany
facility: Investigational Site Number : 2760025
city: Darmstadt
country: Germany
facility: Investigational Site Number : 2760017
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number : 2760009
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760002
city: Hannover
country: Germany
facility: Investigational Site Number : 2760003
city: Koblenz
country: Germany
facility: Investigational Site Number : 2760007
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760023
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760011
city: Lübeck
country: Germany
facility: Investigational Site Number : 2760010
city: Mainz
country: Germany
facility: Investigational Site Number : 2760012
city: Marburg
country: Germany
facility: Investigational Site Number : 2760008
city: Peine
country: Germany
facility: Investigational Site Number : 2760020
city: Rosenheim
country: Germany
facility: Investigational Site Number : 2760016
city: Wiesbaden
country: Germany
facility: Investigational Site Number : 2760018
city: Athens
country: Greece
facility: Investigational Site Number : 3000006
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Heraklion
country: Greece
facility: Investigational Site Number : 3000003
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000002
city: Palaio Faliro, Athens
country: Greece
facility: Investigational Site Number : 3000007
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000004
city: Edelény
country: Hungary
facility: Investigational Site Number : 3480003
city: Gödöllö
country: Hungary
facility: Investigational Site Number : 3480004
city: Hajdunánás
country: Hungary
facility: Investigational Site Number : 3480002
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number : 3480006
city: Szombathely
country: Hungary
facility: Investigational Site Number : 3480005
city: Százhalombatta
country: Hungary
facility: Investigational Site Number : 3480001
city: Balvi
country: Latvia
facility: Investigational Site Number : 4280008
city: Rezekne
country: Latvia
facility: Investigational Site Number : 4280007
city: Riga
country: Latvia
facility: Investigational Site Number : 4280001
city: Riga
country: Latvia
facility: Investigational Site Number : 4280005
city: Riga
country: Latvia
facility: Investigational Site Number : 4280006
city: Riga
country: Latvia
facility: Investigational Site Number : 4280002
city: Riga
country: Latvia
facility: Investigational Site Number : 4280003
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400001
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400003
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400008
city: Klaipeda
country: Lithuania
facility: Investigational Site Number : 4400007
city: Vilnius
country: Lithuania
facility: Investigational Site Number : 4400005
city: Benito Juarez
country: Mexico
facility: Investigational Site Number : 4840008
state: Ciudad De Mexico
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840002
state: Jalisco
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840013
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigational Site Number : 4840011
state: Jalisco
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840004
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840003
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840010
city: Durango
country: Mexico
facility: Investigational Site Number : 4840006
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840007
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840009
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840005
city: Arnhem
country: Netherlands
facility: Investigational Site Number : 5280005
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280001
city: Dordrecht
country: Netherlands
facility: Investigational Site Number : 5280010
city: Harderwijk
country: Netherlands
facility: Investigational Site Number : 5280009
city: Leeuwarden
country: Netherlands
facility: Investigational Site Number : 5280002
city: Nijmegen
country: Netherlands
facility: Investigational Site Number : 5280006
city: Roermond
country: Netherlands
facility: Investigational Site Number : 5280011
city: Zutphen
country: Netherlands
facility: Investigational Site Number : 5280008
city: Zwolle
country: Netherlands
facility: Investigational Site Number : 5280004
city: Lima Lima
country: Peru
facility: Investigational Site Number : 6040002
city: Lima
country: Peru
facility: Investigational Site Number : 6040006
city: Lima
country: Peru
facility: Investigational Site Number : 6040004
city: Lima
country: Peru
facility: Investigational Site Number : 6040001
city: Piura
country: Peru
facility: Investigational Site Number : 6040005
city: Grudziadz
country: Poland
facility: Investigational Site Number : 6160009
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6160007
state: Malopolskie
city: Grodzisk Mazowiecki
country: Poland
facility: Investigational Site Number : 6160015
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Investigational Site Number : 6160010
state: Podkarpackie
city: Bialystok
country: Poland
facility: Investigational Site Number : 6160008
state: Podlaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160018
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160011
state: Slaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigational Site Number : 6160022
state: Swietokrzyskie
city: Elblag
country: Poland
facility: Investigational Site Number : 6160014
state: Warminsko-mazurskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6160019
city: Nowa Sol
country: Poland
facility: Investigational Site Number : 6160020
city: Almada
country: Portugal
facility: Investigational Site Number : 6200007
city: Aveiro
country: Portugal
facility: Investigational Site Number : 6200006
city: Guimarães
country: Portugal
facility: Investigational Site Number : 6200002
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200009
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200012
city: Bacau
country: Romania
facility: Investigational Site Number : 6425004
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number : 6425003
city: Constanta
country: Romania
facility: Investigational Site Number : 6425005
city: Iasi
country: Romania
facility: Investigational Site Number : 6425002
city: Pitesti
country: Romania
facility: Investigational Site Number : 6425006
city: Timisoara
country: Romania
facility: Investigational Site Number : 6425001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number : 6430009
city: Ryazan
country: Russian Federation
facility: Investigational Site Number : 6430010
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430013
city: Saint Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430014
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Stavropol
country: Russian Federation
facility: Investigational Site Number : 6430012
city: Tomsk
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Ulyanovsk
country: Russian Federation
facility: Investigational Site Number : 6430008
city: Voronezh
country: Russian Federation
facility: Investigational Site Number : 6430005
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880005
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880006
city: Belgrade
country: Serbia
facility: Investigational Site Number : 6880007
city: Kragujevac
country: Serbia
facility: Investigational Site Number : 6880003
city: Sremska Kamenica
country: Serbia
facility: Investigational Site Number : 6880001
city: Valjevo
country: Serbia
facility: Investigational Site Number : 6880002
city: Banska Bystrica
country: Slovakia
facility: Investigational Site Number : 7030007
city: Humenne
country: Slovakia
facility: Investigational Site Number : 7030006
city: Kosice
country: Slovakia
facility: Investigational Site Number : 7030005
city: Levice
country: Slovakia
facility: Investigational Site Number : 7030003
city: Poprad
country: Slovakia
facility: Investigational Site Number : 7030001
city: Spisska Nova Ves
country: Slovakia
facility: Investigational Site Number : 7030002
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100015
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100004
city: Chatsworth
country: South Africa
facility: Investigational Site Number : 7100014
city: Durban
country: South Africa
facility: Investigational Site Number : 7100001
city: Durban
country: South Africa
facility: Investigational Site Number : 7100013
city: Durban
country: South Africa
facility: Investigational Site Number : 7100003
city: Durban
country: South Africa
facility: Investigational Site Number : 7100010
city: Gatesville
country: South Africa
facility: Investigational Site Number : 7100002
city: Gauteng
country: South Africa
facility: Investigational Site Number : 7100011
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100009
city: Middelburg
country: South Africa
facility: Investigational Site Number : 7100012
city: Parow
country: South Africa
facility: Investigational Site Number : 7100006
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100005
city: Somerset West
country: South Africa
facility: Investigational Site Number : 7100008
city: Oviedo
country: Spain
facility: Investigational Site Number : 7240007
state: Asturias
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240002
state: Barcelona [Barcelona]
city: Badalona
country: Spain
facility: Investigational Site Number : 7240009
state: Catalunya [Cataluña]
city: Caceres
country: Spain
facility: Investigational Site Number : 7240012
state: Cáceres
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Investigational Site Number : 7240008
state: Valenciana, Comunidad
city: Málaga
country: Spain
facility: Investigational Site Number : 7240010
city: Zaragoza
country: Spain
facility: Investigational Site Number : 7240011
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number : 8040011
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number : 8040002
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number : 8040003
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040001
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040007
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040004
city: Lviv
country: Ukraine
facility: Investigational Site Number : 8040006
city: Ternopil
country: Ukraine
facility: Investigational Site Number : 8040010
city: Zaporizhzhia
country: Ukraine
facility: Investigational Site Number : 8040008
city: Zaporizhzhya
country: Ukraine
facility: Investigational Site Number : 8040009
city: Cambridge
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Cambridgeshire
city: Blackpool
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Lancashire
city: Swansea
country: United Kingdom
facility: Investigational Site Number : 8260006
state: Neath Port Talbot
city: North Shields
country: United Kingdom
facility: Investigational Site Number : 8260007
state: Newcastle Upon Tyne
city: South Shields
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Newcastle Upon Tyne
city: Nottingham
country: United Kingdom
facility: Investigational Site Number : 8260013
state: Nottinghamshire
city: Aylesbury
country: United Kingdom
facility: Investigational Site Number : 8260012
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260001
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260005
city: Chippenham
country: United Kingdom
facility: Investigational Site Number : 8260011
city: Derby
country: United Kingdom
facility: Investigational Site Number : 8260015
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: