Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Launched by SANOFI · Feb 8, 2021
Trial Information
Current as of July 03, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment called itepekimab for people with Chronic Obstructive Pulmonary Disease (COPD), particularly focusing on former and current smokers who have moderate to severe symptoms. The main goal is to see if itepekimab can reduce the number of serious flare-ups or worsening of symptoms in these patients compared to a placebo (a treatment that doesn’t contain the active drug). Researchers will also look at how well it helps improve lung function and overall quality of life, as well as its safety and how the body processes the drug.
To participate, individuals must be between 40 and 85 years old and have been diagnosed with COPD for at least a year. They should have a history of smoking, either as a current smoker or as someone who has quit for at least six months. Participants will be closely monitored throughout the trial and will receive either the new treatment or the placebo. This trial is an important opportunity to potentially help improve treatment options for those living with COPD.
Gender
ALL
Eligibility criteria
- 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nyíregyháza, , Hungary
Monterrey, Nuevo León, Mexico
Braga, , Portugal
Caba, Buenos Aires, Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Monterrey, Nuevo León, , Mexico
Cape Town, , South Africa
Kolkata, , India
Hamburg, , Germany
Petah Tikva, , Israel
Shinagawa Ku, Tokyo, Japan
Monterrey, , Mexico
Bialystok, Podlaskie, Poland
Moscow, , Russian Federation
Moscow, , Russian Federation
Madrid, , Spain
Málaga, , Spain
Istanbul, , Turkey
Seoul, , Korea, Republic Of
Caba, Buenos Aires, Argentina
Caba, , Argentina
Jerusalem, , Israel
Izmir, , Turkey
Dupnitsa, , Bulgaria
Hvidovre, , Denmark
Jindrichuv Hradec Iii, , Czechia
Százhalombatta, , Hungary
Arnhem, , Netherlands
Nijmegen, , Netherlands
Zutphen, , Netherlands
Zwolle, , Netherlands
Aveiro, , Portugal
Frankfurt Am Main, , Germany
Santiago, Reg Metropolitana De Santiago, Chile
Guimarães, , Portugal
Saint Charles Borromée, Quebec, Canada
Meguro Ku, Tokyo, Japan
Talca, Maule, Chile
Ostrava, , Czechia
Praha 4, , Czechia
Jerusalem, , Israel
Rehovot, , Israel
Palm Springs, California, United States
Riverside, California, United States
San Diego, California, United States
Brandon, Florida, United States
Debary, Florida, United States
Greenacres City, Florida, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Woodstock, Georgia, United States
Chicago Ridge, Illinois, United States
Lathrup Village, Michigan, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Schenectady, New York, United States
Charlotte, North Carolina, United States
Huntersville, North Carolina, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
Charleston, South Carolina, United States
Gaffney, South Carolina, United States
Rapid City, South Dakota, United States
Franklin, Tennessee, United States
Boerne, Texas, United States
San Antonio, Texas, United States
Pergamino, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, , Brazil
Blagoevgrad, , Bulgaria
Gabrovo, , Bulgaria
Haskovo, , Bulgaria
Montana, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sherwood Park, Alberta, Canada
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
Moncton, New Brunswick, Canada
Ajax, Ontario, Canada
Burlington, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Sherbrooke, Quebec, Canada
St Charles Borrommee, Quebec, Canada
Terrebonne, Quebec, Canada
Trois Rivieres, Quebec, Canada
Victoriaville, Quebec, Canada
Quebec, , Canada
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Quillota, , Chile
Mesice, , Czechia
Mlada Boleslav, , Czechia
Olomouc, , Czechia
Teplice, , Czechia
Varnsdorf, , Czechia
Vejle, , Denmark
Lyon, , France
Montpellier, , France
Pessac, , France
Reims, , France
Berlin, , Germany
Koblenz, , Germany
Leipzig, , Germany
Lübeck, , Germany
Mainz, , Germany
Balassagyarmat, , Hungary
Edelény, , Hungary
Hajdúnánás, , Hungary
Püspökladány, , Hungary
Nagoya Shi, Aichi, Japan
Nagoya Shi, Aichi, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Kurume Shi, Fukuoka, Japan
Yanagawa Shi, Fukuoka, Japan
Gifu Shi, Gifu, Japan
Mizunami Shi, Gifu, Japan
Hiroshima Shi, Hiroshima, Japan
Kure Shi, Hiroshima, Japan
Kure Shi, Hiroshima, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Himeji Shi, Hyogo, Japan
Sakaide Shi, Kagawa, Japan
Takamatsu Shi, Kagawa, Japan
Kawasaki Shi, Kanagawa, Japan
Konan Ku, Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Ikoma Shi, Nara, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Sakai Shi, Osaka, Japan
Yao Shi, Osaka, Japan
Hamamatsu Shi, Shizuoka, Japan
Hamamatsu Shi, Shizuoka, Japan
Sano Shi, Tochigi, Japan
Chuo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Itabashi Ku, Tokyo, Japan
Kiyose City, Tokyo, Japan
Shibuya Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Hokkaido, , Japan
Wonju, Gangwon Do, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Aguascalientes, , Mexico
Chihuahua, , Mexico
Durango, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Veracruz, , Mexico
Lørenskog, , Norway
Lublin, Lubelskie, Poland
Wolomin, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Malbork, Pomorskie, Poland
Katowice, Slaskie, Poland
Piekary Slaskie, Slaskie, Poland
Almada, , Portugal
Guarda, , Portugal
Matosinhos, , Portugal
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Ulyanovsk, , Russian Federation
Bellville, , South Africa
Benoni, , South Africa
Durban, , South Africa
Durban, , South Africa
Gatesville, , South Africa
Middelburg, , South Africa
Pretoria, , South Africa
Palma De Mallorca, Balears [Baleares], Spain
Sant Boi De Llobregat, Barcelona [Barcelona], Spain
Madrid / Madrid, Madrid, Comunidad De, Spain
Pozuelo De Alarcón, Madrid, Spain
Cáceres, , Spain
Lleida, , Spain
Mérida, , Spain
Balcali Adana, , Turkey
Kirikkale, , Turkey
Mersin, , Turkey
Chertsey, Surrey, United Kingdom
Bradford, , United Kingdom
Liverpool, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Santiago, Reg Metropolitana De Santiago, Chile
Ankara, , Turkey
New York, New York, United States
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Toshima Ku, Tokyo, Japan
Parow, , South Africa
Hajdunánás, , Hungary
Gainesville, Florida, United States
Peoria, Illinois, United States
West Des Moines, Iowa, United States
Saint Louis, Missouri, United States
Flushing, New York, United States
Lampasas, Texas, United States
Botucatu, São Paulo, Brazil
Quillota, Valparaíso, Chile
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Bloemfontein, , South Africa
Cape Town, , South Africa
Pretoria, , South Africa
Lleida / Lleida, Catalunya [Cataluña], Spain
Mérida / Badajoz, Extremadura, Spain
Oviedo, Florida, United States
Bethlehem, Pennsylvania, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Santiago, Reg Metropolitana De Santiago, Chile
Guaynabo, , Puerto Rico
Clearwater, Florida, United States
Lake City, Florida, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Florida, Buenos Aires, Argentina
Nagpur, , India
Nashik, , India
Matsusaka Shi, Mie, Japan
Porto, , Portugal
Madrid / Madrid, Comunidad De Madrid, Spain
Jindřichův Hradec, , Czechia
Fresno, California, United States
Boynton Beach, Florida, United States
Doral, Florida, United States
Orlando, Florida, United States
North Chicago, Illinois, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Brooklyn, New York, United States
Murray, Utah, United States
Florida, Ciudad De Buenos Aires, Argentina
Chandigarh, , India
Sakaide, Kagawa, Japan
Ponce, , Puerto Rico
Cape Town, , South Africa
Boston, Massachusetts, United States
Miami, Florida, United States
Cincinnati, Ohio, United States
Columbia, South Carolina, United States
Beckley, West Virginia, United States
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Sao Paulo, São Paulo, Brazil
Puspokladany, , Hungary
Chatsworth, , South Africa
Durban, , South Africa
Szombathely, , Hungary
Nagpur, Maharashtra, India
Jaipur, , India
Kotobukicho, Kagawa, Japan
Kōnandai, Kanagawa, Japan
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Phoenix, Arizona, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Miami, Florida, United States
Valdosta, Georgia, United States
Topeka, Kansas, United States
Portland, Oregon, United States
Campinas, São Paulo, Brazil
India, , India
Lleida / Lleida, Lleida [Lérida], Spain
Cutler Bay, Florida, United States
Pembroke Pines, Florida, United States
Sorocaba, São Paulo, Brazil
Tartu, , Estonia
Batumi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Budapest, , Hungary
Kaunas, , Lithuania
Temecula, , Puerto Rico
Durban, , South Africa
Madrid, Madrid, Comunidad De, Spain
Buffalo, New York, United States
Natal, Rio Grande Do Norte, Brazil
Riga, , Latvia
Durango, Durango, , Mexico
Yucatan, , Mexico
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Seoul, , Korea, Republic Of
Istanbul, , Turkey
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Talca, Maule, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Jindrichuv Hradec Iii, , Czechia
Ostrava, , Czechia
Praha 4, , Czechia
Jerusalem, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Moscow, , Russian Federation
Phoenix, Arizona, United States
Fresno, California, United States
Palm Springs, California, United States
Riverside, California, United States
Denver, Colorado, United States
Boynton Beach, Florida, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Cutler Bay, Florida, United States
Debary, Florida, United States
Doral, Florida, United States
Gainesville, Florida, United States
Greenacres City, Florida, United States
Hialeah, Florida, United States
Lake City, Florida, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Oviedo, Florida, United States
Palmetto Bay, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Valdosta, Georgia, United States
Woodstock, Georgia, United States
Chicago Ridge, Illinois, United States
North Chicago, Illinois, United States
Peoria, Illinois, United States
West Des Moines, Iowa, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Lathrup Village, Michigan, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
Buffalo, New York, United States
E. Amherst, New York, United States
Flushing, New York, United States
Schenectady, New York, United States
Charlotte, North Carolina, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Gaffney, South Carolina, United States
Franklin, Tennessee, United States
Boerne, Texas, United States
Houston, Texas, United States
Lampasas, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Beckley, West Virginia, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Vicente Lopez, Ciudad De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Caba, , Argentina
Salvador, Bahia, Brazil
Brasilia, Distrito Federal, Brazil
Vitoria, Espírito Santo, Brazil
Sao Luis, Maranhão, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Natal, Rio Grande Do Norte, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Rio De Janeiro, , Brazil
Blagoevgrad, , Bulgaria
Dupnitsa, , Bulgaria
Gabrovo, , Bulgaria
Haskovo, , Bulgaria
Montana, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sherwood Park, Alberta, Canada
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
Moncton, New Brunswick, Canada
Ajax, Ontario, Canada
Burlington, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Windsor, Ontario, Canada
Sherbrooke, Quebec, Canada
St Charles Borrommee, Quebec, Canada
Terrebonne, Quebec, Canada
Trois Rivieres, Quebec, Canada
Victoriaville, Quebec, Canada
Quebec, , Canada
Valdivia, Los Ríos, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Quillota, Valparaíso, Chile
Mesice, , Czechia
Mlada Boleslav, , Czechia
Olomouc, , Czechia
Teplice, , Czechia
Varnsdorf, , Czechia
Hvidovre, , Denmark
Vejle, , Denmark
Tartu, , Estonia
Lyon, , France
Montpellier, , France
Pessac, , France
Reims, , France
Batumi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Frankfurt Am Main, , Germany
Hamburg, , Germany
Koblenz, , Germany
Leipzig, , Germany
Leipzig, , Germany
Lübeck, , Germany
Mainz, , Germany
Rosenheim, , Germany
Balassagyarmat, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Edelény, , Hungary
Hajdunánás, , Hungary
Nyíregyháza, , Hungary
Puspokladany, , Hungary
Szombathely, , Hungary
Százhalombatta, , Hungary
Belgaum, , India
Chandigarh, , India
India, , India
Jaipur, , India
Kolkata, , India
Nagpur, , India
Nagpur, , India
Nashik, , India
Pune, , India
Nagoya Shi, Aichi, Japan
Nagoya Shi, Aichi, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Kurume Shi, Fukuoka, Japan
Yanagawa Shi, Fukuoka, Japan
Gifu Shi, Gifu, Japan
Mizunami Shi, Gifu, Japan
Hiroshima Shi, Hiroshima, Japan
Kure Shi, Hiroshima, Japan
Kure Shi, Hiroshima, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Himeji Shi, Hyogo, Japan
Sakaide Shi, Kagawa, Japan
Takamatsu Shi, Kagawa, Japan
Kawasaki Shi, Kanagawa, Japan
Konan Ku, Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Matsusaka Shi, Mie, Japan
Ikoma Shi, Nara, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Sakai Shi, Osaka, Japan
Yao Shi, Osaka, Japan
Hamamatsu Shi, Shizuoka, Japan
Hamamatsu Shi, Shizuoka, Japan
Sano Shi, Tochigi, Japan
Chuo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Itabashi Ku, Tokyo, Japan
Kiyose City, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Shibuya Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Toshima Ku, Tokyo, Japan
Wonju, Gangwon Do, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, Seoul Teukbyeolsi, Korea, Republic Of
Daugavpils, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Aguascalientes, , Mexico
Chihuahua, , Mexico
Durango, Durango, , Mexico
Durango, , Mexico
Mexico City, , Mexico
Monterrey, Nuevo León, , Mexico
Veracruz, , Mexico
Yucatan, , Mexico
Arnhem, , Netherlands
Breda, , Netherlands
Nijmegen, , Netherlands
Zutphen, , Netherlands
Zwolle, , Netherlands
Lørenskog, , Norway
Wolomin, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Bialystok, Podlaskie, Poland
Malbork, Pomorskie, Poland
Katowice, Slaskie, Poland
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Almada, , Portugal
Aveiro, , Portugal
Braga, , Portugal
Coimbra, , Portugal
Guarda, , Portugal
Guimarães, , Portugal
Matosinhos, , Portugal
Porto, , Portugal
Guaynabo, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Temecula, , Puerto Rico
Moscow, , Russian Federation
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Ulyanovsk, , Russian Federation
Benoni, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Chatsworth, , South Africa
Durban, , South Africa
Durban, , South Africa
Durban, , South Africa
Durban, , South Africa
Gatesville, , South Africa
Middelburg, , South Africa
Parow, , South Africa
Pretoria, , South Africa
Palma De Mallorca, Balears [Baleares], Spain
Sant Boi De Llobregat, Barcelona [Barcelona], Spain
Santander, Cantabria, Spain
Mérida / Badajoz, Extremadura, Spain
Lleida / Lleida, Lleida [Lérida], Spain
Madrid / Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Pozuelo De Alarcón, Madrid, Spain
Cáceres, , Spain
Girona, , Spain
Madrid, , Spain
Málaga, , Spain
Zaragoza, , Spain
Ankara, , Turkey
Balcali Adana, , Turkey
Izmir, , Turkey
Kirikkale, , Turkey
Mersin, , Turkey
Wishaw, Glasgow City, United Kingdom
Tyne And Wear, North Tyneside, United Kingdom
Chertsey, Surrey, United Kingdom
Bradford, , United Kingdom
Liverpool, , United Kingdom
Milton Keynes, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Pittsburgh, Pennsylvania, United States
Green Bay, Wisconsin, United States
Angers, , France
Pune, , India
Seongnam, Gyeonggi Do, Korea, Republic Of
Berazategui, Buenos Aires, Argentina
Buenos Aires, Ciudad De Buenos Aires, Argentina
Blagoevgrad, , Bulgaria
Montana, , Bulgaria
Paris, , France
Kanpur, , India
Barcelona, Barcelona [Barcelona], Spain
Lampasas, Texas, United States
Klaipeda, , Lithuania
Cape Town, , South Africa
Detroit, Michigan, United States
Miami, Florida, United States
Fairview Heights, Illinois, United States
Plano, Texas, United States
Sorocaba, São Paulo, Brazil
Hannover, , Germany
Tampa, Florida, United States
Lampasas, Texas, United States
Guelph, Ontario, Canada
Neu Isenburg, , Germany
Sao Paulo, , Brazil
Ruse, , Bulgaria
Victoriaville, Quebec, Canada
Palma De Mallorca, , Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Phoenix, Arizona, United States
Fresno, California, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Debary, Florida, United States
Greenacres City, Florida, United States
Hialeah, Florida, United States
Lake City, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palmetto Bay, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Peoria, Illinois, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Flushing, New York, United States
Schenectady, New York, United States
Charlotte, North Carolina, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Gaffney, South Carolina, United States
Boerne, Texas, United States
Houston, Texas, United States
Lampasas, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Beckley, West Virginia, United States
Salvador, Bahia, Brazil
Brasilia, Distrito Federal, Brazil
Vitoria, Espírito Santo, Brazil
Sao Luis, Maranhão, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, , Brazil
Bendorf, , Germany
Guaynabo, , Puerto Rico
Valdivia, , Chile
Vitoria, , Brazil
Sao Luis, , Brazil
Curitiba, , Brazil
Botucatu, , Brazil
Campinas, , Brazil
Sao Bernardo Do Campo, , Brazil
Sao Paulo, , Brazil
Sorocaba, , Brazil
Quillota, , Chile
Incheon, Incheon Gwangyeoksi, Korea, Republic Of
Monterrey, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Barcelona, , Spain
Sant Boi De Llobregat, , Spain
Lleida / Lleida, , Spain
Madrid / Madrid, , Spain
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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