Search / Trial NCT03930732

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Launched by SANOFI · Apr 26, 2019

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Trial Information

Current as of August 14, 2025

Completed

Keywords

ClinConnect Summary

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

Gender

ALL

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.

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.

Locations

Seoul, Seoul Teukbyeolsi, Korea, Republic Of

Rozzano, Milano, Italy

Praha 4, , Czechia

Monterrey, Nuevo León, Mexico

Hohhot, , China

Andalusia, Alabama, United States

Birmingham, Alabama, United States

Dothan, Alabama, United States

Mobile, Alabama, United States

Tucson, Arizona, United States

Colorado Springs, Colorado, United States

Clearwater, Florida, United States

Greenacres City, Florida, United States

Miami, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Panama City, Florida, United States

Sarasota, Florida, United States

Dacula, Georgia, United States

Decatur, Georgia, United States

Marietta, Georgia, United States

Woodstock, Georgia, United States

Baltimore, Maryland, United States

White Marsh, Maryland, United States

Ann Arbor, Michigan, United States

Rochester, Minnesota, United States

Jackson, Mississippi, United States

Saint Charles, Missouri, United States

Saint Louis, Missouri, United States

Las Vegas, Nevada, United States

Buffalo, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Wilmington, North Carolina, United States

Winston Salem, North Carolina, United States

Cleveland, Ohio, United States

Dayton, Ohio, United States

Dublin, Ohio, United States

Edmond, Oklahoma, United States

Medford, Oregon, United States

Clairton, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Easley, South Carolina, United States

Gaffney, South Carolina, United States

Greenville, South Carolina, United States

Mount Pleasant, South Carolina, United States

Rock Hill, South Carolina, United States

Spartanburg, South Carolina, United States

Franklin, Tennessee, United States

Galveston, Texas, United States

Houston, Texas, United States

Mckinney, Texas, United States

Sherman, Texas, United States

Tacoma, Washington, United States

Greenfield, Wisconsin, United States

Caba, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Quilmes, Ciudad De Buenos Aires, Argentina

Rosario, Santa Fe, Argentina

San Miguel De Tucumán, Tucumán, Argentina

Buenos Aires, , Argentina

Mar Del Plata, , Argentina

Mendoza, , Argentina

Haskovo, , Bulgaria

Montana, , Bulgaria

Ruse, , Bulgaria

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Troyan, , Bulgaria

Edmonton, Alberta, Canada

Sherwood Park, Alberta, Canada

Vancouver, British Columbia, Canada

Burlington, Ontario, Canada

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

St Charles Borrommee, Quebec, Canada

Trois Rivieres, Quebec, Canada

Victoriaville, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Quebec, , Canada

Curicó, Maule, Chile

Talca, Maule, Chile

Santiago, Reg Metropolitana De Santiago, Chile

Quillota, Valparaíso, Chile

Baotou, , China

Beijing, , China

Changchun, , China

Changsha, , China

Chengdu, , China

Chongqing, , China

Fuzhou, , China

Guangzhou, , China

Haikou, , China

Hangzhou, , China

Hefei, , China

Hohhot, , China

Nanchang, , China

Nanjing, , China

Shanghai, , China

Shenyang, , China

Shenzhen, , China

Shijiazhuang, , China

Taiyuan, , China

Tianjin, , China

Urumchi, , China

Wuhan, , China

Xi'an, , China

Xuzhou, , China

Yangzhou, , China

Yinchuan, , China

Zhanjiang, , China

Zhengzhou, , China

Jindrichuv Hradec Iii, , Czechia

Karlovy Vary, , Czechia

Miroslav, , Czechia

Novy Bor, , Czechia

Praha 6 Brevnov, , Czechia

Rokycany, , Czechia

Strakonice, , Czechia

Copenhagen Nv, , Denmark

Hellerup, , Denmark

Hvidovre, , Denmark

Naestved, , Denmark

Odense C, , Denmark

Roskilde, , Denmark

Vejle, , Denmark

ålborg, , Denmark

Pori, , Finland

Tampere, , Finland

Turku, , Finland

Berlin, , Germany

Frankfurt Am Main, , Germany

Hamburg, , Germany

Koblenz, , Germany

Leipzig, , Germany

Lübeck, , Germany

Marburg, , Germany

Balassagyarmat, , Hungary

Budapest, , Hungary

Edelény, , Hungary

Gödöllö, , Hungary

Hajdunánás, , Hungary

Komarom, , Hungary

Makó, , Hungary

Mohács, , Hungary

Püspökladány, , Hungary

Szombathely, , Hungary

Százhalombatta, , Hungary

Ashkelon, , Israel

Beer Sheva, , Israel

Haifa, , Israel

Jerusalem, , Israel

Petah Tikva, , Israel

Rehovot, , Israel

Cona, Ferrara, Italy

Bologna, , Italy

Catania, , Italy

Pisa, , Italy

Reggio Emilia, , Italy

Roma, , Italy

Kasuga Shi, Fukuoka, Japan

Himeji Shi, Hyogo, Japan

Higashiibaraki Gun, Ibaraki, Japan

Naka Gun, Ibaraki, Japan

Takamatsu Shi, Kagawa, Japan

Yokohama Shi, Kanagawa, Japan

Joyo Shi, Kyoto, Japan

Kyoto Shi, Kyoto, Japan

Ueda Shi, Nagano, Japan

Urasoe Shi, Okinawa, Japan

Kawachinagano Shi, Osaka, Japan

Kishiwada Shi, Osaka, Japan

Osaka Shi, Osaka, Japan

Sakai Shi, Osaka, Japan

Hamamatsu Shi, Shizuoka, Japan

Chuo Ku, Tokyo, Japan

Kokubunji Shi, Tokyo, Japan

Shinagawa Ku, Tokyo, Japan

Toshima Ku, Tokyo, Japan

Wonju, Gangwon Do, Korea, Republic Of

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Incheon, , Korea, Republic Of

Seoul, Seoul Teukbyeolsi, Korea, Republic Of

Guadalajara, Jalisco, Mexico

Chihuahua, , Mexico

Durango, , Mexico

Mexico Distrito Federal, , Mexico

Monterrey, , Mexico

Oaxaca, , Mexico

Veracruz, , Mexico

Grudziadz, Kujawsko Pomorskie, Poland

Krakow, Malopolskie, Poland

Grodzisk Mazowiecki, Mazowieckie, Poland

Warszawa, Mazowieckie, Poland

Bialystok, Podlaskie, Poland

Elblag, Pomorskie, Poland

Katowice, Slaskie, Poland

Poznan, Wielkopolskie, Poland

Bucharest, , Romania

Bucuresti, , Romania

Cluj Napoca, , Romania

Constanta, , Romania

Timisoara, , Romania

Chelyabinsk, , Russian Federation

Kazan, , Russian Federation

Moscow, , Russian Federation

St Petersburg, , Russian Federation

Banska Bystrica, , Slovakia

Humenne, , Slovakia

Levice, , Slovakia

Poprad, , Slovakia

Spisska Nova Ves, , Slovakia

Santiago De Compostela, A Coruña [La Coruña], Spain

Barcelona, Barcelona [Barcelona], Spain

Sant Boi De Llobregat, Barcelona [Barcelona], Spain

Mérida / Badajoz, Extremadura, Spain

Pozuelo De Alarcón, Madrid, Spain

Madrid, , Spain

Málaga, , Spain

Palma De Mallorca, , Spain

Valencia, , Spain

Lund, , Sweden

Stockholm, , Sweden

örebro, , Sweden

Ankara, , Turkey

Istanbul, , Turkey

Izmir, , Turkey

Kirikkale, , Turkey

Manisa, , Turkey

Mersin, , Turkey

Chernivtsi, , Ukraine

Ivano Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Odesa, , Ukraine

Ternopil, , Ukraine

Vinnytsya, , Ukraine

Zhytomyr, , Ukraine

Quillota, , Chile

San Miguel De Tucumán, , Argentina

Barcelona, , Spain