Clinical trial NCT03930732: 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: 2019-04-29
Enrollment: 939
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 and 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 anti-drug 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 patient 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 acute exacerbation of COPD (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 was contraindicated.
* Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion criteria:

* COPD diagnosis for less than 12 months prior to randomization.
* A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
* 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.
* Treatment with oxygen of more than 12 hours per day.
* 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. Patients who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).
* Diagnosis of α-1 anti-trypsin deficiency.

The above information was 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 (BD) Forced Expiratory Volume in One Second (FEV1) at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Pre-BD FEV1 at Week 52
timeFrame: Baseline (Day 1) to Week 52
measure: Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb)
timeFrame: Baseline (Day 1) to Week 12
measure: Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb
timeFrame: Baseline (Day 1) to Week 52
measure: Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
timeFrame: Baseline (Day 1) to Week 52
measure: Percentage of Participants With SGRQ Improvement >=4 Points at Week 52
timeFrame: Baseline (Day 1) to Week 52
measure: Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52
timeFrame: Baseline (Day 1) to Week 52
measure: Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb
timeFrame: Baseline (Day 1) to Week 52
measure: Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44
timeFrame: Baseline (Day 1) to Weeks 2, 4, 8, 24, 36 and 44
measure: Change From Baseline in Post-BD FEV1 to Weeks 2, 4, 8, 12, 24, 36 and 52
timeFrame: Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52
measure: Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52
timeFrame: Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36, 44 and 52
measure: Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52
timeFrame: Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52
measure: Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period
timeFrame: Baseline (Day 1) to Week 52
measure: Time to First Moderate or Severe COPD Exacerbation 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: TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days
measure: Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: SEC Clinical Research, LLC-Site Number:8400030
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC-Site Number:8400041
state: Alabama
city: Birmingham
country: United States
facility: UAB Lung Health Center-Site Number:8400013
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research, LLC-Site Number:8400059
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile, P.C.-Site Number:8400057
state: Alabama
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC-Site Number:8400034
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research Of West Florida Inc-Site Number:8400010
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research-Site Number:8400014
state: Florida
city: Miami
country: United States
facility: Project 4 research, Inc.-Site Number:8400023
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research-Site Number:8400062
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research-Site Number:8400051
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research, LLC-Site Number:8400029
state: Florida
city: Panama City
country: United States
facility: Emerald Coast Research Associates-Site Number:8400032
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research-Site Number:8400026
state: Florida
city: Dacula
country: United States
facility: VitaLink research-Hamilton Mill-Site Number:8400055
state: Georgia
city: Marietta
country: United States
facility: DC Research Works-Site Number:8400016
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research-Site Number:8400025
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
state: Maryland
city: White Marsh
country: United States
facility: Asthma Allergy & Sinus Center-Site Number:8400038
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Medicine (University of Michigan)-Site Number:8400050
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Lanmark Center 2-46-Site Number:8400065
state: Minnesota
city: Saint Charles
country: United States
facility: Midwest Chest Consultants, P.C.-Site Number:8400011
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Site Number:8400004
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research-Site Number:8400035
state: Nevada
city: Buffalo
country: United States
facility: Va Western New York Healthcare-Site Number:8400067
state: New York
city: New York
country: United States
facility: IMA Clinical Research, LLC-Site Number:8400070
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
state: North Carolina
city: Charlotte
country: United States
facility: American Health Research-Site Number:8400061
state: North Carolina
city: Durham
country: United States
facility: Duke Asthma, Allergy and Airway Center-Site Number:8400064
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare-Site Number:8400052
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center-Site Number:8400060
state: North Carolina
city: Dayton
country: United States
facility: Midwest Pulmonary and Sleep Research Center-Site Number:8400040
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research, Inc-Site Number:8400024
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research-Site Number:8400005
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford-Site Number:8400001
state: Oregon
city: Clairton
country: United States
facility: Jefferson Associates in Internal Medicine-Site Number:8400037
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital-Site Number:8400009
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
state: Pennsylvania
city: Easley
country: United States
facility: VitaLink Research-Easley-Site Number:8400022
state: South Carolina
city: Gaffney
country: United States
facility: VitaLink Research- Gaffney-Site Number:8400047
state: South Carolina
city: Greenville
country: United States
facility: VitaLink Research-Greenville-Site Number:8400007
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research of Charleston-Site Number:8400044
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill-Site Number:8400046
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research - Spartanburg-Site Number:8400048
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee-Site Number:8400073
state: Tennessee
city: Houston
country: United States
facility: Bayer College of Medicine-Site Number:8400018
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center-Site Number:8400021
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research-Site Number:8400027
state: Texas
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation-Site Number:8400036
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008
state: Wisconsin
city: Caba
country: Argentina
facility: Investigational Site Number :0320011
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number :0320002
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number :0320003
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number :0320004
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number :0320012
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Investigational Site Number :0320007
state: Ciudad De Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number :0320006
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number :0320009
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number :0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number :0320005
city: Mar Del Plata
country: Argentina
facility: Investigational Site Number :0320008
city: Mendoza
country: Argentina
facility: Investigational Site Number :0320010
city: Haskovo
country: Bulgaria
facility: Investigational Site Number :1001004
city: Montana
country: Bulgaria
facility: Investigational Site Number :1001003
city: Ruse
country: Bulgaria
facility: Investigational Site Number :1001006
city: Sofia
country: Bulgaria
facility: Investigational Site Number :1001009
city: Sofia
country: Bulgaria
facility: Investigational Site Number :1001002
city: Sofia
country: Bulgaria
facility: Investigational Site Number :1001001
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number :1001005
city: Troyan
country: Bulgaria
facility: Investigational Site Number :1001010
city: Edmonton
country: Canada
facility: Investigational Site Number :1240021
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number :1240015
state: Alberta
city: Sherwood Park
country: Canada
facility: Investigational Site Number :1240016
state: Alberta
city: Vancouver
country: Canada
facility: Investigational Site Number :1240017
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number :1240007
state: British Columbia
city: Burlington
country: Canada
facility: Investigational Site Number :1240002
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number :1240012
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number :1240013
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number :1240009
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number :1240003
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number :1240001
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number :1240010
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number :1240011
state: Quebec
city: St-charles Borrommee
country: Canada
facility: Investigational Site Number :1240006
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Investigational Site Number :1240008
state: Quebec
city: Victoriaville
country: Canada
facility: Investigational Site Number :1240020
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site Number :1240005
city: Quebec
country: Canada
facility: Investigational Site Number :1240004
city: Quebec
country: Canada
facility: Investigational Site Number :1240019
city: Quebec
country: Canada
facility: Investigational Site Number :1240018
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 :1520009
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 :1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number :1520008
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: Baotou
country: China
facility: Investigational Site Number :1560037
city: Beijing
country: China
facility: Investigational Site Number :1560006
city: Changchun
country: China
facility: Investigational Site Number :1560003
city: Changsha
country: China
facility: Investigational Site Number :1560022
city: Changsha
country: China
facility: Investigational Site Number :1560021
city: Chengdu
country: China
facility: Investigational Site Number :1560001
city: Chengdu
country: China
facility: Investigational Site Number :1560017
city: Chongqing
country: China
facility: Investigational Site Number :1560012
city: Chongqing
country: China
facility: Investigational Site Number :1560005
city: Fuzhou
country: China
facility: Investigational Site Number :1560053
city: Guangzhou
country: China
facility: Investigational Site Number :1560036
city: Guangzhou
country: China
facility: Investigational Site Number :1560019
city: Haikou
country: China
facility: Investigational Site Number :1560045
city: Haikou
country: China
facility: Investigational Site Number :1560018
city: Hangzhou
country: China
facility: Investigational Site Number :1560046
city: Hefei
country: China
facility: Investigational Site Number :1560009
city: Hefei
country: China
facility: Investigational Site Number :1560041
city: Hohhot
country: China
facility: Investigational Site Number :1560015
city: Hohhot
country: China
facility: Investigational Site Number :1560008
city: Nanchang
country: China
facility: Investigational Site Number :1560027
city: Nanjing
country: China
facility: Investigational Site Number :1560034
city: Shanghai
country: China
facility: Investigational Site Number :1560032
city: Shanghai
country: China
facility: Investigational Site Number :1560013
city: Shanghai
country: China
facility: Investigational Site Number :1560007
city: Shenyang
country: China
facility: Investigational Site Number :1560014
city: Shenyang
country: China
facility: Investigational Site Number :1560004
city: Shenzhen
country: China
facility: Investigational Site Number :1560051
city: Shijiazhuang
country: China
facility: Investigational Site Number :1560016
city: Taiyuan
country: China
facility: Investigational Site Number :1560024
city: Tianjin
country: China
facility: Investigational Site Number :1560010
city: Urumchi
country: China
facility: Investigational Site Number :1560028
city: Wuhan
country: China
facility: Investigational Site Number :1560052
city: Xi'An
country: China
facility: Investigational Site Number :1560020
city: Xuzhou
country: China
facility: Investigational Site Number :1560054
city: Yangzhou
country: China
facility: Investigational Site Number :1560011
city: Zhanjiang
country: China
facility: Investigational Site Number :1560031
city: Zhengzhou
country: China
facility: Investigational Site Number :1560002
city: Jindrichuv Hradec III
country: Czechia
facility: Investigational Site Number :2030002
city: Karlovy Vary
country: Czechia
facility: Investigational Site Number :2030005
city: Miroslav
country: Czechia
facility: Investigational Site Number :2030009
city: Novy Bor
country: Czechia
facility: Investigational Site Number :2030001
city: Praha 4
country: Czechia
facility: Investigational Site Number :2030003
city: Praha 6 - Brevnov
country: Czechia
facility: Investigational Site Number :2030008
city: Rokycany
country: Czechia
facility: Investigational Site Number :2030004
city: Strakonice
country: Czechia
facility: Investigational Site Number :2030006
city: Copenhagen Nv
country: Denmark
facility: Investigational Site Number :2080001
city: Hvidovre
country: Denmark
facility: Investigational Site Number :2080002
city: Naestved
country: Denmark
facility: Investigational Site Number :2080006
city: Odense C
country: Denmark
facility: Investigational Site Number :2080005
city: Roskilde
country: Denmark
facility: Investigational Site Number :2080004
city: Vejle
country: Denmark
facility: Investigational Site Number :2080007
city: Ålborg
country: Denmark
facility: Investigational Site Number :2080003
city: Pori
country: Finland
facility: Investigational Site Number :2460003
city: Turku
country: Finland
facility: Investigational Site Number :2460001
city: Berlin
country: Germany
facility: Investigational Site Number :2760006
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number :2760009
city: Hamburg
country: Germany
facility: Investigational Site Number :2760002
city: Koblenz
country: Germany
facility: Investigational Site Number :2760007
city: Leipzig
country: Germany
facility: Investigational Site Number :2760011
city: Lübeck
country: Germany
facility: Investigational Site Number :2760010
city: Marburg
country: Germany
facility: Investigational Site Number :2760008
city: Balassagyarmat
country: Hungary
facility: Investigational Site Number :3480007
city: Budapest
country: Hungary
facility: Investigational Site Number :3480011
city: Edelény
country: Hungary
facility: Investigational Site Number :3480008
city: Gödöllö
country: Hungary
facility: Investigational Site Number :3480001
city: Hajdunánás
country: Hungary
facility: Investigational Site Number :3480010
city: Komarom
country: Hungary
facility: Investigational Site Number :3480002
city: Makó
country: Hungary
facility: Investigational Site Number :3480003
city: Mohács
country: Hungary
facility: Investigational Site Number :3480006
city: Puspokladany
country: Hungary
facility: Investigational Site Number :3480012
city: Szombathely
country: Hungary
facility: Investigational Site Number :3480005
city: Százhalombatta
country: Hungary
facility: Investigational Site Number :3480004
city: Ashkelon
country: Israel
facility: Investigational Site Number :3760006
city: Beer Sheva
country: Israel
facility: Investigational Site Number :3760007
city: Haifa
country: Israel
facility: Investigational Site Number :3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number :3760005
city: Jerusalem
country: Israel
facility: Investigational Site Number :3760004
city: Petah-Tikva
country: Israel
facility: Investigational Site Number :3760001
city: Rehovot
country: Israel
facility: Investigational Site Number :3760002
city: Cona
country: Italy
facility: Investigational Site Number :3800004
state: Ferrara
city: Rozzano
country: Italy
facility: Investigational Site Number :3800003
state: Milano
city: Pisa
country: Italy
facility: Investigational Site Number :3800007
city: Reggio Emilia
country: Italy
facility: Investigational Site Number :3800001
city: Roma
country: Italy
facility: Investigational Site Number :3800005
city: Kasuga-shi
country: Japan
facility: Investigational Site Number :3920013
state: Fukuoka
city: Himeji-shi
country: Japan
facility: Investigational Site Number :3920011
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Investigational Site Number :3920023
state: Ibaraki
city: Naka-gun
country: Japan
facility: Investigational Site Number :3920014
state: Ibaraki
city: Takamatsu-shi
country: Japan
facility: Investigational Site Number :3920019
state: Kagawa
city: Yokohama-shi
country: Japan
facility: Investigational Site Number :3920027
state: Kanagawa
city: Joyo-shi
country: Japan
facility: Investigational Site Number :3920003
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Investigational Site Number :3920017
state: Kyoto
city: Ueda-shi
country: Japan
facility: Investigational Site Number :3920006
state: Nagano
city: Urasoe-shi
country: Japan
facility: Investigational Site Number :3920029
state: Okinawa
city: Kawachinagano-shi
country: Japan
facility: Investigational Site Number :3920018
state: Osaka
city: Kishiwada-shi
country: Japan
facility: Investigational Site Number :3920001
state: Osaka
city: Osaka-shi
country: Japan
facility: Investigational Site Number :3920028
state: Osaka
city: Sakai-shi
country: Japan
facility: Investigational Site Number :3920012
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Investigational Site Number :3920021
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Investigational Site Number :3920008
state: Tokyo
city: Chuo-ku
country: Japan
facility: Investigational Site Number :3920030
state: Tokyo
city: Chuo-ku
country: Japan
facility: Investigational Site Number :3920005
state: Tokyo
city: Kokubunji-shi
country: Japan
facility: Investigational Site Number :3920015
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Investigational Site Number :3920016
state: Tokyo
city: Toshima-ku
country: Japan
facility: Investigational Site Number :3920004
state: Tokyo
city: Toshima-ku
country: Japan
facility: Investigational Site Number :3920026
state: Tokyo
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number :4100003
state: Gangwon-do
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number :4100004
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number :4100008
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100001
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100009
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number :4100007
state: Seoul-teukbyeolsi
city: Guadalajara
country: Mexico
facility: Investigational Site Number :4840002
state: Jalisco
city: Monterrey
country: Mexico
facility: Investigational Site Number :4840001
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigational Site Number :4840004
city: Durango
country: Mexico
facility: Investigational Site Number :4840003
city: Mexico Distrito Federal
country: Mexico
facility: Investigational Site Number :4840006
city: Oaxaca
country: Mexico
facility: Investigational Site Number :4840007
city: Veracruz
country: Mexico
facility: Investigational Site Number :4840005
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: Warszawa
country: Poland
facility: Investigational Site Number :6160012
state: Mazowieckie
city: Bialystok
country: Poland
facility: Investigational Site Number :6160008
state: Podlaskie
city: Elblag
country: Poland
facility: Investigational Site Number :6160014
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site Number :6160011
state: Slaskie
city: Poznan
country: Poland
facility: Investigational Site Number :6160016
state: Wielkopolskie
city: Poznan
country: Poland
facility: Investigational Site Number :6160006
state: Wielkopolskie
city: Bucharest
country: Romania
facility: Investigational Site Number :6420001
city: Bucuresti
country: Romania
facility: Investigational Site Number :6420009
city: Bucuresti
country: Romania
facility: Investigational Site Number :6420008
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number :6420003
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number :6420004
city: Constanta
country: Romania
facility: Investigational Site Number :6420007
city: Timisoara
country: Romania
facility: Investigational Site Number :6420006
city: Timisoara
country: Romania
facility: Investigational Site Number :6420010
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number :6430003
city: Kazan
country: Russian Federation
facility: Investigational Site Number :6430004
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430006
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430008
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430002
city: Moscow
country: Russian Federation
facility: Investigational Site Number :6430009
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number :6430007
city: Banska Bystrica
country: Slovakia
facility: Investigational Site Number :7030007
city: Humenne
country: Slovakia
facility: Investigational Site Number :7030006
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: Santiago de Compostela
country: Spain
facility: Investigational Site Number :7240096
state: A Coruña [La Coruña]
city: Barcelona
country: Spain
facility: Investigational Site Number :7240002
state: Barcelona [Barcelona]
city: Sant Boi de Llobregat
country: Spain
facility: Investigational Site Number :7240007
state: Barcelona [Barcelona]
city: Mérida / Badajoz
country: Spain
facility: Investigational Site Number :7240005
state: Extremadura
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number :7240006
state: Madrid
city: Madrid
country: Spain
facility: Investigational Site Number :7240003
city: Málaga
country: Spain
facility: Investigational Site Number :7240001
city: Palma de Mallorca
country: Spain
facility: Investigational Site Number :7240010
city: Valencia
country: Spain
facility: Investigational Site Number :7240004
city: Lund
country: Sweden
facility: Investigational Site Number :7520001
city: Stockholm
country: Sweden
facility: Investigational Site Number :7520002
city: Ankara
country: Turkey
facility: Investigational Site Number :7920004
city: Istanbul
country: Turkey
facility: Investigational Site Number :7920001
city: Izmir
country: Turkey
facility: Investigational Site Number :7920006
city: Izmir
country: Turkey
facility: Investigational Site Number :7920007
city: Kirikkale
country: Turkey
facility: Investigational Site Number :7920008
city: Manisa
country: Turkey
facility: Investigational Site Number :7920005
city: Mersin
country: Turkey
facility: Investigational Site Number :7920002
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number :8040003
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number :8040001
city: Kharkiv
country: Ukraine
facility: Investigational Site Number :8040006
city: Kyiv
country: Ukraine
facility: Investigational Site Number :8040004
city: Odesa
country: Ukraine
facility: Investigational Site Number :8040009
city: Ternopil
country: Ukraine
facility: Investigational Site Number :8040002
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number :8040005
city: Zhytomyr
country: Ukraine
facility: Investigational Site Number :8040007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: