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 COPD Secondary 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 COPD Secondary 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
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
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
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
Sarasota Memorial Health Care System Clinical ResearchCenter-Site Number:8400178
Sarasota, Florida, United States
Clinical Research Of West Florida Inc-Site Number:8400008
Tampa, Florida, United States
Genesis Clinical Research, LLC-Site Number:8400182
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
Midwest Pulmonology, Critical Care and Sleep Associates-Site Number:8400033
Chicago Ridge, 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
Care Access-Site Number:8400275
Boston, Massachusetts, United States
Care Access-Site Number:8400276
Boston, Massachusetts, United States
Care Access-Site Number:8400278
Boston, Massachusetts, United States
Care Access-Site Number:8400281
Boston, Massachusetts, 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
Smart Medical Research-Site Number:8400191
Brooklyn, New York, United States
New York - Presbyterian Queens-Site Number:8400028
Flushing, New York, United States
IMA Clinical Research, LLC-Site Number:8400027
New York, 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
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
FMC Science-Site Number:8400037
Lampasas, 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
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 :0320002
Florida, 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
Investigational Site Number :0320006
Caba, Argentina
Investigational Site Number :0760014
Belo Horizonte, Minas Gerais, Brazil
Investigational Site Number :0760012
Curitiba, Paraná, Brazil
Investigational Site Number :0760001
Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760007
Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760006
Porto Alegre, Rio Grande Do Sul, Brazil
Investigational Site Number :0760005
Botucatu, São Paulo, Brazil
Investigational Site Number :0760010
Campinas, São Paulo, Brazil
Investigational Site Number :0760013
Sao Paulo, São 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 :1240009
Toronto, 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 :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 :2500001
Lyon, France
Investigational Site Number :2500002
Montpellier, France
Investigational Site Number :2500003
Pessac, France
Investigational Site Number :2500004
Reims, France
Investigational Site Number :2760004
Berlin, Germany
Investigational Site Number :2760005
Frankfurt am Main, Germany
Investigational Site Number :2760002
Hamburg, Germany
Investigational Site Number :2760006
Koblenz, Germany
Investigational Site Number :2760007
Leipzig, Germany
Investigational Site Number :2760003
Lübeck, Germany
Investigational Site Number :2760001
Mainz, Germany
Investigational Site Number :3480002
Balassagyarmat, Hungary
Investigational Site Number :3480005
Edelény, Hungary
Investigational Site Number :3480004
Hajdunánás, Hungary
Investigational Site Number :3480007
Nyíregyháza, Hungary
Investigational Site Number :3480003
Puspokladany, Hungary
Investigational Site Number :3480012
Szombathely, Hungary
Investigational Site Number :3480001
Százhalombatta, Hungary
Investigational Site Number :3560001
Chandigarh, India
Investigational Site Number :3560014
India, India
Investigational Site Number :3560013
Jaipur, India
Investigational Site Number :3560005
Nagpur, India
Investigational Site Number :3560009
Nashik, India
Investigational Site Number :3760003
Jerusalem, Israel
Investigational Site Number :3760002
Jerusalem, Israel
Investigational Site Number :3760001
Petah-Tikva, 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 :3920031
Gifu-shi, Gifu, 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 :3920004
Sapporo-shi, Hokkaido, Japan
Investigational Site Number :3920038
Sapporo-shi, Hokkaido, Japan
Investigational Site Number :3920008
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 :3920022
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 :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 :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 :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 :5280005
Arnhem, 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 :6160001
Bialystok, Podlaskie, Poland
Investigational Site Number :6160003
Malbork, Pomorskie, Poland
Investigational Site Number :6160002
Katowice, Slaskie, Poland
Investigational Site Number :6200009
Almada, Portugal
Investigational Site Number :6200006
Aveiro, Portugal
Investigational Site Number :6200002
Braga, 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
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 :7100010
Bloemfontein, 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 :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 :7240006
Sant Boi de Llobregat, Barcelona [Barcelona], 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 :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 :8260002
Chertsey, Surrey, United Kingdom
Investigational Site Number :8260003
Bradford, United Kingdom
Investigational Site Number :8260005
Liverpool, United Kingdom
Investigational Site Number :8260001
Newcastle upon Tyne, United Kingdom
Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610 - option 6
Contact-US@sanofi.com
Clinical Sciences & Operations, Study Director
Sanofi