Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Launched by SANOFI · Jan 6, 2021
Trial Information
Current as of May 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called itepekimab for people with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The main goal is to see if itepekimab can reduce the number of serious flare-ups, or exacerbations, of COPD in former smokers who have been diagnosed with moderate to severe COPD. The trial will also look at how this treatment affects lung function, breathing symptoms, and the overall quality of life for participants.
To be eligible for this study, participants need to be between 40 and 85 years old, have had a COPD diagnosis for at least a year, and must have a history of smoking but have stopped for at least six months. They should also have experienced severe or moderate COPD flare-ups in the past year. If someone joins the trial, they will receive either itepekimab or a placebo (a substance with no active medicine) and will be monitored for side effects and how well the treatment works. It's important to know that this trial is currently active but not recruiting new participants.
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, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
- • 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.
- • Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol \[THC\]) 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 sScreening (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
Rozzano, Milano, Italy
Thessaloniki, , Greece
Kaohsiung, , Taiwan
Coimbatore, , India
Chengdu, , China
Gödöllö, , Hungary
Petah Tikva, , Israel
Moscow, , Russian Federation
Moscow, , Russian Federation
Levice, , Slovakia
Kharkiv, , Ukraine
Sofia, , Bulgaria
Zhongshan, , China
Jerusalem, , Israel
Bragadiru, , Romania
Timisoara, , Romania
Kyiv, , Ukraine
Caba, Buenos Aires, Argentina
Jindrichuv Hradec Iii, , Czechia
Moscow, , Russian Federation
Ivano Frankivsk, , Ukraine
Santiago, Reg Metropolitana De Santiago, Chile
Tel Aviv, , Israel
Guadalajara, Jalisco, Mexico
Changsha, , China
Mendoza, , Argentina
Birmingham, Alabama, United States
Jasper, Alabama, United States
Mobile, Alabama, United States
Tucson, Arizona, United States
Northridge, California, United States
Boulder, Colorado, United States
Lafayette, Colorado, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
East Point, Georgia, United States
Johns Creek, Georgia, United States
Lawrenceville, Georgia, United States
Covington, Louisiana, United States
Bangor, Maine, United States
Dearborn, Michigan, United States
Saint Charles, Missouri, United States
Gastonia, North Carolina, United States
Shelby, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbia, South Carolina, United States
Rock Hill, South Carolina, United States
Corsicana, Texas, United States
Mckinney, Texas, United States
Sherman, Texas, United States
Tomball, Texas, United States
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Dimitrovgrad, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Curicó, Maule, Chile
Talca, Maule, 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, , Chile
Temuco, , Chile
Baotou, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changchun, , China
Changsha, , China
Changsha, , China
Chengdu, , China
Chongqing, , China
Guangzhou, , China
Guangzhou, , China
Haikou, , China
Hangzhou, , China
Hangzhou, , China
Hefei, , China
Hohhot, , China
Hohhot, , China
Jinan, , China
Jinan, , China
Nanchang, , China
Nanchang, , China
Nanjing, , China
Nanning, , China
Pingxiang, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Shenzhen, , China
Shijiazhuang, , China
Tianjin, , China
Wenzhou, , China
Wuhan, , China
Xi'an, , China
Xiangtan, , China
Xuzhou, , China
Yangzhou, , China
Yinchuan, , China
Zhanjiang, , China
Zhengzhou, , China
Zunyi, , China
Ostrava, , Czechia
Praha 4, , Czechia
Praha 5 Radotin, , Czechia
Praha 8, , Czechia
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Debrecen, , Hungary
Gödöllő, , Hungary
Mosonmagyaróvár, , Hungary
Pécs, , Hungary
Jerusalem, , Israel
Kfar Saba, , Israel
Rehovot, , Israel
Foggia, Puglia, Italy
Catania, , Italy
Ferrara, , Italy
Verona, , Italy
Cuernavaca, Morelos, Mexico
Benito Juarez, , Mexico
Cdmx, , Mexico
San Juan Del Rio, , Mexico
Wroclaw, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Brasov, , Romania
Bucaresti, , Romania
Cluj Napoca, , Romania
Codlea, , Romania
Deva, , Romania
Iasi, , Romania
Oradea, , Romania
Saint Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Bardejov, , Slovakia
Humenne, , Slovakia
Martin, , Slovakia
Poprad, , Slovakia
Spisska Nova Ves, , Slovakia
New Taipei City, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Yunlin, , Taiwan
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Adairsville, Georgia, United States
Atlanta, Georgia, United States
East Point, Georgia, United States
Curicó, , Chile
Shanghai, , China
Athens, , Greece
East Point, Georgia, United States
Dubois, Pennsylvania, United States
Carrollton, Texas, United States
El Paso, Texas, United States
Webster, Texas, United States
Temuco, La Araucanía, Chile
Quillota, Valparaíso, Chile
Guangzhou, , China
Haifa, , Israel
Cdmx, México, Mexico
San Juan Del Rio, Querétaro, Mexico
Greenville, North Carolina, United States
Boston, Massachusetts, United States
Jasper, Alabama, United States
Atlanta, Georgia, United States
Houston, Texas, United States
Chandler, Arizona, United States
Los Angeles, California, United States
Cutler Bay, Florida, United States
Miami, Florida, United States
Cordele, Georgia, United States
Cincinnati, Ohio, United States
Jindřichův Hradec, , Czechia
Hyderabad, , India
Jaipur, , India
Kozhikode, , India
Nagpur, , India
Bucuresti, , Romania
Yuanlin, , Taiwan
Boston, Massachusetts, United States
Plantation, Florida, United States
Evergreen Park, Illinois, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Palaio Faliro, Athens, , Greece
Jaipur, , India
Mumbai, , India
La Jolla, California, United States
Los Angeles, California, United States
Miami, Florida, United States
Douliu, , Taiwan
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Springdale, Ohio, United States
Cedar Park, Texas, United States
Sherman, Texas, United States
Larissa, , Greece
Miami, Florida, United States
Henderson, Nevada, United States
Houston, Texas, United States
Tbilisi, , Georgia
Larissa, , Greece
Oradea, , Romania
Saint Petersburg, Florida, United States
Saint Petersburg, Florida, United States
Atlanta, Georgia, United States
Tbilisi, , Georgia
Tbilisi, , Georgia
Sofia, , Bulgaria
Zhongshan, , China
Jaipur, , India
Chengdu, , China
Birmingham, Alabama, United States
Jasper, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Boulder, Colorado, United States
Lafayette, Colorado, United States
Clearwater, Florida, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Saint Petersburg, Florida, United States
Saint Petersburg, Florida, United States
The Villages, Florida, United States
Adairsville, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Cordele, Georgia, United States
Lawrenceville, Georgia, United States
Evergreen Park, Illinois, United States
Covington, Louisiana, United States
Bangor, Maine, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Dearborn, Michigan, United States
Hannibal, Missouri, United States
Saint Charles, Missouri, United States
Henderson, Nevada, United States
New York, New York, United States
Schenectady, New York, United States
Gastonia, North Carolina, United States
Greenville, North Carolina, United States
Shelby, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Springdale, Ohio, United States
Dubois, Pennsylvania, United States
Columbia, South Carolina, United States
Rock Hill, South Carolina, United States
Beaumont, Texas, United States
Carrollton, Texas, United States
Cedar Park, Texas, United States
Corsicana, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Mckinney, Texas, United States
Mesquite, Texas, United States
Sherman, Texas, United States
Sherman, Texas, United States
Webster, Texas, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Mendoza, , Argentina
Dimitrovgrad, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Stara Zagora, , Bulgaria
Veliko Tyrnovo, , Bulgaria
Temuco, La Araucanía, Chile
Curicó, Maule, Chile
Talca, Maule, 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
Santiago, Reg Metropolitana De Santiago, Chile
Quillota, Valparaíso, Chile
Baotou, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changchun, , China
Changsha, , China
Changsha, , China
Changsha, , China
Chengdu, , China
Chongqing, , China
Guangzhou, , China
Guangzhou, , China
Haikou, , China
Hangzhou, , China
Hangzhou, , China
Hefei, , China
Hohhot, , China
Hohhot, , China
Jinan, , China
Jinan, , China
Nanchang, , China
Nanjing, , China
Nanning, , China
Pingxiang, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Shenzhen, , China
Shijiazhuang, , China
Tianjin, , China
Wenzhou, , China
Wuhan, , China
Xi'an, , China
Xiangtan, , China
Xuzhou, , China
Yangzhou, , China
Zhanjiang, , China
Zhengzhou, , China
Jindrichuv Hradec Iii, , Czechia
Ostrava, , Czechia
Praha 4, , Czechia
Praha 5 Radotin, , Czechia
Praha 8, , Czechia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Ioannina, , Greece
Larissa, , Greece
Palaio Faliro, Athens, , Greece
Thessaloniki, , Greece
Debrecen, , Hungary
Gödöllö, , Hungary
Mosonmagyaróvár, , Hungary
Pécs, , Hungary
Coimbatore, , India
Hyderabad, , India
Jaipur, , India
Kozhikode, , India
Mumbai, , India
Nagpur, , India
Haifa, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Rozzano, Milano, Italy
Foggia, Puglia, Italy
Catania, , Italy
Ferrara, , Italy
Verona, , Italy
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Cuernavaca, Morelos, Mexico
Cdmx, México, Mexico
San Juan Del Rio, Querétaro, Mexico
Benito Juarez, , Mexico
Wroclaw, Dolnoslaskie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Bragadiru, , Romania
Brasov, , Romania
Bucaresti, , Romania
Cluj Napoca, , Romania
Codlea, , Romania
Deva, , Romania
Iasi, , Romania
Oradea, , Romania
Timisoara, , Romania
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
St Petersburg, , Russian Federation
Bardejov, , Slovakia
Humenne, , Slovakia
Levice, , Slovakia
Martin, , Slovakia
Poprad, , Slovakia
Spisska Nova Ves, , Slovakia
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Yunlin, , Taiwan
Ivano Frankivsk, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Bradford, , United Kingdom
Quatre Bornes, , Mauritius
Phoenix, Arizona, United States
Warren, Michigan, United States
Vidin, , Bulgaria
Havlickuv Brod, , Czechia
Miami, Florida, United States
Miami, Florida, United States
Beaumont, Texas, United States
Presov, , Slovakia
La Plata, Buenos Aires, Argentina
Huntington Park, California, United States
Mount Kisco, New York, United States
Cedar Park, Texas, United States
Houston, Texas, United States
Tomball, Texas, United States
Portsmouth, Hampshire, United Kingdom
La Palma, California, United States
Hammond, Indiana, United States
Plano, Texas, United States
London, , United Kingdom
Tucson, Arizona, United States
Kendall, Florida, United States
Larisa, , Greece
Redruth, , United Kingdom
Plano, Texas, United States
Wigan, Lancashire, United Kingdom
Heston, , United Kingdom
Tampa, Florida, United States
Dunwoody, Georgia, United States
Oaxaca De Juarez, Oaxaca, Mexico
Loxahatchee Groves, Florida, United States
Pembroke Pines, Florida, United States
Oaxaca, , Mexico
Brasov, , Romania
Ashton Under Lyne, Lancashire, United Kingdom
La Palma, California, United States
Miami, Florida, United States
Indianapolis, Indiana, United States
North Richland Hills, Texas, United States
Santiago, Reg Metropolitana De Santiago, Chile
Aguascalientes, , Mexico
Boulder, Colorado, United States
Denison, Texas, United States
Salford, Manchester, United Kingdom
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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