Primary Objective:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives:Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPDSecondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
The study duration per participant:
- Screening period is 3-5 weeks
- Randomized investigational medicinal product (IMP) treatment period is 52 weeks for
first cohort of randomized former smoker participants [approximately 930] and cohort
of current smokers [approximately 280], and 24 to 52 weeks for potential additional
randomized former smoker participants
- Post-IMP treatment follow-up period is 20 weeks for participants not transitioning
to the extension study LTS18133 Note: A long-term, double-blinded extension study
(LTS18133) will be implemented to allow participants in this study to continue
receiving active IMP for an additional period. Only participants completing their
End-of-Treatment (EOT) visit per this study protocol will be offered to participate
in the LTS18133 study.
Drug: Itepekimab SAR440340
Pharmaceutical form: solution for injection in pre-filled syringe Route of
administration: subcutaneous
Other Name: REGN3500
Drug: Placebo
Pharmaceutical form: solution for injection in pre-filled syringe Route of
administration: subcutaneous
Inclusion criteria :
- Participant must be 40 to 85 years of age inclusive.
- Physician diagnosis of COPD for at least 1 year (based on Global Initiative for
Chronic Obstructive Lung Disease [GOLD] definition).
- Smoking history of ≥10 pack-years:
- For former smokers: participants who report that they are not currently smoking
and smoking cessation must have occurred ≥6 months prior to Screening (Visit
1A) with an intention to quit permanently.
- For current smokers: participants who report that they are currently smoking
tobacco (participant smoked at least 1 cigarette per day on average during the
past 7 days) at Screening (Visit 1A) and who are not currently participating in
or planning to initiate a smoking cessation intervention at Screening (Visit
1A) or during Screening period.
- Participants with moderate-to-severe COPD
- Participant-reported history of signs and symptoms of chronic bronchitis (chronic
productive cough for at least 3 months in the year prior to Screening in a
participant in whom other causes of chronic cough [eg, inadequately treated
gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of
bronchiectasis] has been excluded).
- Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1
severe exacerbations within the year prior to Screening (Visit 1A), with at least 1
exacerbation treated with systemic corticosteroids. At least one exacerbation must
have occurred while participants were on their current controller therapy:
- Moderate exacerbations will be recorded by the Investigator and are defined as
acute worsening of respiratory symptoms that requires either systemic
corticosteroids (IM, IV, or oral) and/or antibiotics.
- Severe exacerbations will be recorded by the Investigator and are defined as
AECOPD that require hospitalization or observation for >24 hours in emergency
department/urgent care facility.
- Participants with standard of care controller therapy, for ≥3 months prior to
Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month
prior to the Screening, including either: inhaled corticosteroid (ICS) + long-acting
beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA
+ ICS.
- Body mass index (BMI) ≥18.0 kg/m^2, or BMI ≥16.0 kg/m^2 for participants enrolled in
East-Asian countries.
- Female participant is not pregnant, not breastfeeding, and at least one of the
following conditions applies:
- not a women of child-bearing potential (WOCBP) OR
- a WOCBP who agrees to follow the contraceptive guidance during the intervention
period and for at least 20 weeks after the last dose of study intervention. -
Exclusion criteria:
- Current diagnosis of asthma according to the Global Initiative for Asthma (GINA)
guidelines, or documented history of asthma unless asthma resolved before 18 years
of age and has not recurred.
- For former smokers: Active smoking or vaping of any products (eg, nicotine,
tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A).
- For current smokers: vaping of any products (eg, nicotine, THC) within 6 months
prior to Screening (Visit 1A).
- Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior
to, or at Screening (Visit 1A) that may affect the participant's participation in
the study.
- Clinically significant and current pulmonary disease other than COPD, eg,
sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis),
diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
- Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe
pulmonary hypertension.
- Hypercapnia requiring bilevel positive airway pressure (BiPAP).
- Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening
(Visit 1A).
- Prior history of / planned: lung pneumonectomy for any reason, or lung volume
reduction procedures (including bronchoscopic volume reduction) for COPD. Note:
Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other
diseases would not be excluded.
- Unstable ischemic heart disease, including acute myocardial infarction within the
past 1 year prior to Screening, or unstable angina in the 6 months prior to
Screening (Visit 1A).
- Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
- Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic
BP >110 mm Hg with or without use of anti-hypertensive therapy).
- Participants with active tuberculosis (TB), latent TB, a history of incompletely
treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of
contracting TB (such as close contact with individuals with active or latent TB) or
received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to
Screening (Visit 1A).
- History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology
at Screening (Visit 1A).
- Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in
contact with known exposure to COVID-19 at Screening (Visit 1A); known history of
COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of
requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
secondary to COVID-19 within 3 months prior to Screening (Visit 1A); participants
who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet
sufficiently recovered to participate in the procedures of a clinical trial.
- Evidence of acute or chronic infection requiring systemic treatment with
antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications
within 4 weeks before Screening (Visit 1A), significant viral infections within 4
weeks before Screening (Visit 1A) that may not have been treated with antiviral
treatment (eg, influenza receiving only symptomatic treatment).
- Participants with active autoimmune disease or participants using immunosuppressive
therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel
disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple
sclerosis.
- History of malignancy within 5 years before Screening (Visit 1A), except completely
treated in situ carcinoma of the cervix, completely treated and resolved
nonmetastatic squamous or basal cell carcinoma of the skin.
- Previous use of itepekimab.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Synexus Phoenix Central (Central Phoenix Medical Clinic) Site Number : 8400333
Phoenix, Arizona, United States
UCSF Fresno Site Number : 8400030
Fresno, California, United States
Palmtree Clinical Research Site Number : 8400184
Palm Springs, California, United States
Probe Clinical Research Corporation Site Number : 8400188
Riverside, California, United States
Allianz Research Institute Colorado Site Number : 8400061
Denver, Colorado, United States
Helix Biomedics, LLC Site Number : 8400049
Boynton Beach, Florida, United States
Meris Clinical Research Site Number : 8400021
Brandon, Florida, United States
Innovative Research of West Florida, Inc Site Number : 8400041
Clearwater, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8400352
Cutler Bay, Florida, United States
Omega Research Site Number : 8400031
DeBary, Florida, United States
Sciences Connections, LLC Site Number : 8400045
Doral, Florida, United States
North Florida/South Georgia Veterans Health System Site Number : 8400176
Gainesville, Florida, United States
Finlay Medical Research Site Number : 8400011
Greenacres City, Florida, United States
Direct Helpers Medical Center Inc Site Number : 8400065
Hialeah, Florida, United States
Multi-Specialty Research Associates, Inc Site Number : 8400044
Lake City, Florida, United States
Advanced Pulmonary Research Institute Site Number : 8400018
Loxahatchee Groves, Florida, United States
Columbus Clinical Services Site Number : 8400054
Miami, Florida, United States
Finlay Medical Research Site Number : 8400007
Miami, Florida, United States
MCR Research Site Number : 8400425
Miami, Florida, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400009
Miami, Florida, United States
My Community Research Center Site Number : 8400060
Miami, Florida, United States
Phoenix Medical Research Site Number : 8400019
Miami, Florida, United States
Renstar Medical Research Site Number : 8400015
Ocala, Florida, United States
Central Florida Pulmonary Group, PA Site Number : 8400192
Orlando, Florida, United States
Heuer M.D. Research Site Number : 8400016
Orlando, Florida, United States
Oviedo Medical Research Site Number : 8400026
Oviedo, Florida, United States
Innovation Medical Research Center Site Number : 8400067
Palmetto Bay, Florida, United States
Pines Care Research Center LLC Site Number : 8400056
Pembroke Pines, Florida, United States
Sarasota Memorial Health Care System Clinical ResearchCenter Site Number : 8400178
Sarasota, Florida, United States
Genesis Clinical Research, LLC Site Number : 8400182
Tampa, Florida, United States
Clinical Research of West Florida, Inc Site Number : 8400008
Tampa, Florida, United States
Medster Research, LLC Site Number : 8400051
Valdosta, Georgia, United States
North Georgia Clinical Research Site Number : 8400013
Woodstock, Georgia, United States
Care Access Fairview Heights Site Number : 8400033
Fairview Heights, Illinois, United States
Captain James A. Lovell Federal Health Care Center Site Number : 8400032
North Chicago, Illinois, United States
Illinois Lung Institute Site Number : 8400024
Peoria, Illinois, United States
The Iowa Clinic Site Number : 8400034
West Des Moines, Iowa, United States
Cotton O'Neil Garfield Site Number : 8400063
Topeka, Kansas, United States
Lexington VA Health Care System Site Number : 8400036
Lexington, Kentucky, United States
Pulmonary & Critical Care Site Number : 8400047
Shreveport, Louisiana, United States
Johns Hopkins Asthma and Allergy Center Site Number : 8400055
Baltimore, Maryland, United States
Care Access Site Number : 8400276
Boston, Massachusetts, United States
Care Access Site Number : 8400281
Boston, Massachusetts, United States
Henry Ford Hospital Site Number : 8400052
Detroit, Michigan, United States
Revive Research Institute Site Number : 8400186
Lathrup Village, Michigan, United States
Washington University School of Medicine Site Number : 8400035
Saint Louis, Missouri, United States
Sierra Clinical Research Site Number : 8400005
Las Vegas, Nevada, United States
Rutgers Institute for Translational Medicine and Science/Rutgers University Site Number : 8400059
New Brunswick, New Jersey, United States
Smart Medical Research Site Number : 8400191
Brooklyn, New York, United States
VA Western New York Healthcare System Site Number : 8400050
Buffalo, New York, United States
New York - Presbyterian Queens Site Number : 8400028
Flushing, New York, United States
Schenectady Pulmonary and Critical Care Associates Site Number : 8400029
Schenectady, New York, United States
American Health Research Site Number : 8400002
Charlotte, North Carolina, United States
Advanced Respiratory and Sleep Medicine Site Number : 8400022
Huntersville, North Carolina, United States
University of Cincinnati Site Number : 8400042
Cincinnati, Ohio, United States
Remington-Davis Inc Site Number : 8400004
Columbus, Ohio, United States
Toledo Institute of Clinical Research Site Number : 8400014
Toledo, Ohio, United States
OK Clinical Research LLC Site Number : 8400001
Edmond, Oklahoma, United States
Kaiser Permanente Center for Health Research Site Number : 8400039
Portland, Oregon, United States
St. Luke's University Health Network Site Number : 8400187
Bethlehem, Pennsylvania, United States
Temple University Hospital Site Number : 8400062
Philadelphia, Pennsylvania, United States
Allegheny Health Network Site Number : 8400058
Pittsburgh, Pennsylvania, United States
Lowcountry Lung & Critical Care Site Number : 8400175
Charleston, South Carolina, United States
Medtrial, LLC Site Number : 8400048
Columbia, South Carolina, United States
VitaLink Research- Gaffney Site Number : 8400003
Gaffney, South Carolina, United States
Clinical Trials Center of Middle Tennessee Site Number : 8400025
Franklin, Tennessee, United States
TTS Research Site Number : 8400012
Boerne, Texas, United States
United Memorial Medical Center (UMMC) Site Number : 8400193
Houston, Texas, United States
Radiance Clinical Research Site Number : 8400037
Lampasas, Texas, United States
Clincove: Plano Primary Care Clinic Site Number : 8400424
Plano, Texas, United States
Sun Research Institute Site Number : 8400183
San Antonio, Texas, United States
AES Salt Lake City Site Number : 8400332
Murray, Utah, United States
The Rheumatology and Pulmonary Clinic Site Number : 8400053
Beckley, West Virginia, United States
Aurora BayCare Medical Center Site Number : 8400046
Green Bay, Wisconsin, United States
Investigational Site Number : 0320009
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320008
Caba, Buenos Aires, Argentina
Investigational Site Number : 0320001
Caba, Buenos Aires, Argentina
Investigational Site Number : 0320005
Pergamino, Buenos Aires, Argentina
Investigational Site Number : 0320006
Buenos Aires, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320002
Vicente Lopez, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe, Argentina
Investigational Site Number : 0320003
Rosario, Santa Fe, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe, Argentina
SER da Bahia Site Number : 0760020
Salvador, Bahia, Brazil
CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza Site Number : 0760018
Brasilia, Distrito Federal, Brazil
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760009
Vitoria, Espírito Santo, Brazil
Hospital Sao Domingos Site Number : 0760016
Sao Luis, Maranhão, Brazil
Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760014
Belo Horizonte, Minas Gerais, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760012
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760001
Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Ceos Site Number : 0760021
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da PUCRS Site Number : 0760007
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao Site Number : 0760006
Porto Alegre, Rio Grande Do Sul, Brazil
Faculdade de Medicina da Universidade Estadual Paulista Site Number : 0760005
Botucatu, São Paulo, Brazil
PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760010
Campinas, São Paulo, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos Site Number : 0760015
Sao Bernardo do Campo, São Paulo, Brazil
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760013
Sao Paulo, São Paulo, Brazil
Clinica de Alergia Martti Antila Site Number : 0760008
Sorocaba, São Paulo, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017
Rio de Janeiro, Brazil
CEPIC - Centro Paulista de Investigação Clínica Site Number : 0760004
Sao Paulo, Brazil
Investigational Site Number : 1000008
Blagoevgrad, Bulgaria
Investigational Site Number : 1000013
Dupnitsa, Bulgaria
Investigational Site Number : 1000004
Gabrovo, Bulgaria
Investigational Site Number : 1000009
Haskovo, Bulgaria
Investigational Site Number : 1000005
Montana, Bulgaria
Investigational Site Number : 1000002
Plovdiv, Bulgaria
Investigational Site Number : 1000012
Ruse, Bulgaria
Investigational Site Number : 1000003
Ruse, Bulgaria
Investigational Site Number : 1000001
Sofia, Bulgaria
Investigational Site Number : 1000006
Sofia, Bulgaria
Investigational Site Number : 1240006
Sherwood Park, Alberta, Canada
Investigational Site Number : 1240014
Kelowna, British Columbia, Canada
Investigational Site Number : 1240016
Penticton, British Columbia, Canada
Investigational Site Number : 1240012
Moncton, New Brunswick, Canada
Investigational Site Number : 1240021
Ajax, Ontario, Canada
Investigational Site Number : 1240020
Burlington, Ontario, Canada
Investigational Site Number : 1240023
Guelph, Ontario, Canada
Investigational Site Number : 1240009
Toronto, Ontario, Canada
Investigational Site Number : 1240022
Windsor, Ontario, Canada
Investigational Site Number : 1240018
Windsor, Ontario, Canada
Investigational Site Number : 1240004
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240005
St-charles Borrommee, Quebec, Canada
Investigational Site Number : 1240019
Terrebonne, Quebec, Canada
Investigational Site Number : 1240001
Trois-Rivieres, Quebec, Canada
Investigational Site Number : 1240002
Victoriaville, Quebec, Canada
Investigational Site Number : 1240003
Quebec, Canada
Investigational Site Number : 1520009
Valdivia, Los Ríos, Chile
Investigational Site Number : 1520002
Talca, Maule, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520008
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006
Quillota, Valparaíso, Chile
Investigational Site Number : 2030001
Jindrichuv Hradec III, Czechia
Investigational Site Number : 2030009
Mesice, Czechia
Investigational Site Number : 2030005
Mlada Boleslav, Czechia
Investigational Site Number : 2030008
Olomouc, Czechia
Investigational Site Number : 2030004
Ostrava, Czechia
Investigational Site Number : 2030002
Praha 4, Czechia
Investigational Site Number : 2030006
Teplice, Czechia
Investigational Site Number : 2030007
Varnsdorf, Czechia
Investigational Site Number : 2080001
Hvidovre, Denmark
Investigational Site Number : 2080003
Vejle, Denmark
Investigational Site Number : 2330001
Tartu, Estonia
Investigational Site Number : 2500006
Angers, France
Investigational Site Number : 2500001
Lyon, France
Investigational Site Number : 2500002
Montpellier, France
Investigational Site Number : 2500007
Paris, France
Investigational Site Number : 2500003
Pessac, France
Investigational Site Number : 2500004
Reims, France
Investigational Site Number : 2680003
Batumi, Georgia
Investigational Site Number : 2680001
Tbilisi, Georgia
Investigational Site Number : 2680002
Tbilisi, Georgia
Investigational Site Number : 2760004
Berlin, Germany
Investigational Site Number : 2760009
Berlin, Germany
Investigational Site Number : 2760010
Berlin, Germany
Investigational Site Number : 2760005
Frankfurt am Main, Germany
Investigational Site Number : 2760002
Hamburg, Germany
Investigational Site Number : 2760014
Hannover, Germany
Investigational Site Number : 2760006
Koblenz, Germany
Investigational Site Number : 2760008
Leipzig, Germany
Investigational Site Number : 2760007
Leipzig, Germany
Investigational Site Number : 2760003
Lübeck, Germany
Investigational Site Number : 2760001
Mainz, Germany
Investigational Site Number : 2760012
Neu-Isenburg, Germany
Investigational Site Number : 2760011
Rosenheim, Germany
Investigational Site Number : 3480002
Balassagyarmat, Hungary
Investigational Site Number : 3480013
Budapest, Hungary
Investigational Site Number : 3480009
Budapest, Hungary
Investigational Site Number : 3480005
Edelény, Hungary
Investigational Site Number : 3480004
Hajdunánás, Hungary
Investigational Site Number : 3480003
Puspokladany, Hungary
Investigational Site Number : 3480012
Szombathely, Hungary
Investigational Site Number : 3480001
Százhalombatta, Hungary
Investigational Site Number : 3560016
Belgaum, India
Investigational Site Number : 3560001
Chandigarh, India
Investigational Site Number : 3560014
India, India
Investigational Site Number : 3560013
Jaipur, India
Investigational Site Number : 3560019
Kanpur, India
Investigational Site Number : 3560010
Kolkata, India
Investigational Site Number : 3560017
Nagpur, India
Investigational Site Number : 3560005
Nagpur, India
Investigational Site Number : 3560009
Nashik, India
Investigational Site Number : 3560012
Pune, India
Investigational Site Number : 3560018
Pune, India
Investigational Site Number : 3760003
Jerusalem, Israel
Investigational Site Number : 3760002
Jerusalem, Israel
Investigational Site Number : 3760001
Petah-Tikva, Israel
Investigational Site Number : 3760009
Ramat Gan, Israel
Investigational Site Number : 3760004
Rehovot, Israel
Investigational Site Number : 3920023
Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920020
Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920005
Fukuoka-shi, Fukuoka, Japan
Investigational Site Number : 3920027
Fukuoka-shi, Fukuoka, Japan
Investigational Site Number : 3920030
Kurume-shi, Fukuoka, Japan
Investigational Site Number : 3920032
Yanagawa-shi, Fukuoka, Japan
Investigational Site Number : 3920015
Mizunami-shi, Gifu, Japan
Investigational Site Number : 3920010
Hiroshima-shi, Hiroshima, Japan
Investigational Site Number : 3920021
Kure-shi, Hiroshima, Japan
Investigational Site Number : 3920035
Kure-shi, Hiroshima, Japan
Investigational Site Number : 3920038
Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920042
Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920013
Himeji-shi, Hyogo, Japan
Investigational Site Number : 3920009
Sakaide-shi, Kagawa, Japan
Investigational Site Number : 3920014
Takamatsu-shi, Kagawa, Japan
Investigational Site Number : 3920033
Kawasaki-shi, Kanagawa, Japan
Investigational Site Number : 3920011
Konan-ku, Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920039
Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920043
Matsusaka-shi, Mie, Japan
Investigational Site Number : 3920034
Ikoma-shi, Nara, Japan
Investigational Site Number : 3920003
Osaka-shi, Osaka, Japan
Investigational Site Number : 3920026
Osaka-shi, Osaka, Japan
Investigational Site Number : 3920007
Sakai-shi, Osaka, Japan
Investigational Site Number : 3920006
Yao-shi, Osaka, Japan
Investigational Site Number : 3920028
Hamamatsu-shi, Shizuoka, Japan
Investigational Site Number : 3920002
Hamamatsu-shi, Shizuoka, Japan
Investigational Site Number : 3920036
Sano-shi, Tochigi, Japan
Investigational Site Number : 3920040
Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920017
Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920024
Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920019
Itabashi-ku, Tokyo, Japan
Investigational Site Number : 3920029
Kiyose-City, Tokyo, Japan
Investigational Site Number : 3920001
Meguro-ku, Tokyo, Japan
Investigational Site Number : 3920025
Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920016
Shinagawa-ku, Tokyo, Japan
Investigational Site Number : 3920037
Shinagawa-ku, Tokyo, Japan
Investigational Site Number : 3920041
Toshima-ku, Tokyo, Japan
Investigational Site Number : 4100002
Wonju, Gangwon-do, Korea, Republic of
Investigational Site Number : 4100005
Seongnam, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100003
Incheon, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001
Seoul, Korea, Republic of
Investigational Site Number : 4280002
Daugavpils, Latvia
Investigational Site Number : 4280001
Riga, Latvia
Investigational Site Number : 4400002
Kaunas, Lithuania
Investigational Site Number : 4400001
Kaunas, Lithuania
Investigational Site Number : 4400003
Klaipeda, Lithuania
Investigational Site Number : 4840008
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840009
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840002
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840010
Aguascalientes, Mexico
Investigational Site Number : 4840003
Chihuahua, Mexico
Investigational Site Number : 4840012
Durango, Durango, Mexico
Investigational Site Number : 4840007
Durango, Mexico
Investigational Site Number : 4840006
Mexico City, Mexico
Investigational Site Number : 4840001
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840004
Veracruz, Mexico
Investigational Site Number : 4840015
Yucatan, Mexico
Investigational Site Number : 5280005
Arnhem, Netherlands
Investigational Site Number : 5280001
Breda, Netherlands
Investigational Site Number : 5280006
Nijmegen, Netherlands
Investigational Site Number : 5280008
Zutphen, Netherlands
Investigational Site Number : 5280004
Zwolle, Netherlands
Investigational Site Number : 5780001
Lørenskog, Norway
Investigational Site Number : 6160005
Wolomin, Mazowieckie, Poland
Investigational Site Number : 6160008
Bialystok, Podlaskie, Poland
Investigational Site Number : 6160003
Malbork, Pomorskie, Poland
Investigational Site Number : 6160002
Katowice, Slaskie, Poland
Investigational Site Number : 6160009
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Investigational Site Number : 6200009
Almada, Portugal
Investigational Site Number : 6200006
Aveiro, Portugal
Investigational Site Number : 6200002
Braga, Portugal
Investigational Site Number : 6200004
Coimbra, Portugal
Investigational Site Number : 6200011
Guarda, Portugal
Investigational Site Number : 6200001
Guimarães, Portugal
Investigational Site Number : 6200010
Matosinhos, Portugal
Investigational Site Number : 6200003
Porto, Portugal
Cardiopulmonary Research Site Number : 8400040
Guaynabo, Puerto Rico
BRCR Medical Center, Inc. Site Number : 8400190
Ponce, Puerto Rico
BRCR Medical Center Site Number : 8400180
San Juan, Puerto Rico
Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232
Temecula, Puerto Rico
Investigational Site Number : 6430002
Moscow, Russian Federation
Investigational Site Number : 6430001
Moscow, Russian Federation
Investigational Site Number : 6430005
Moscow, Russian Federation
Investigational Site Number : 6430003
Saint-Petersburg, Russian Federation
Investigational Site Number : 6430004
St-Petersburg, Russian Federation
Investigational Site Number : 6430006
Ulyanovsk, Russian Federation
Investigational Site Number : 7100013
Benoni, South Africa
Investigational Site Number : 7100019
Cape Town, South Africa
Investigational Site Number : 7100002
Cape Town, South Africa
Investigational Site Number : 7100001
Cape Town, South Africa
Investigational Site Number : 7100015
Chatsworth, South Africa
Investigational Site Number : 7100005
Durban, South Africa
Investigational Site Number : 7100017
Durban, South Africa
Investigational Site Number : 7100006
Durban, South Africa
Investigational Site Number : 7100016
Durban, South Africa
Investigational Site Number : 7100004
Gatesville, South Africa
Investigational Site Number : 7100012
Middelburg, South Africa
Investigational Site Number : 7100003
Parow, South Africa
Investigational Site Number : 7100009
Pretoria, South Africa
Investigational Site Number : 7240004
Palma de Mallorca, Balears [Baleares], Spain
Investigational Site Number : 7240014
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Sant Boi de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240013
Santander, Cantabria, Spain
Investigational Site Number : 7240002
Mérida / Badajoz, Extremadura, Spain
Investigational Site Number : 7240009
Lleida / Lleida, Lleida [Lérida], Spain
Investigational Site Number : 7240007
Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240011
Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240008
Pozuelo De Alarcón, Madrid, Spain
Investigational Site Number : 7240010
Cáceres, Spain
Investigational Site Number : 7240003
Madrid, Spain
Investigational Site Number : 7240001
Málaga, Spain
Investigational Site Number : 7240012
Zaragoza, Spain
Investigational Site Number : 7920007
Ankara, Turkey
Investigational Site Number : 7920005
Balcali Adana, Turkey
Investigational Site Number : 7920001
Istanbul, Turkey
Investigational Site Number : 7920003
Izmir, Turkey
Investigational Site Number : 7920006
Kirikkale, Turkey
Investigational Site Number : 7920002
Mersin, Turkey
Investigational Site Number : 8260006
Wishaw, Glasgow City, United Kingdom
Investigational Site Number : 8260007
Tyne And Wear, North Tyneside, United Kingdom
Investigational Site Number : 8260002
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260003
Bradford, United Kingdom
Investigational Site Number : 8260005
Liverpool, United Kingdom
Investigational Site Number : 8260008
Milton Keynes, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, United Kingdom
Clinical Sciences & Operations, Study Director
Sanofi