Primary Objective: 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: - 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
The study duration per participant:
- Screening period is 3-5 weeks
- Placebo-controlled treatment period is 52 weeks for first approximately 960 randomized
participants, and 24 to 52 weeks for potential additional randomized participants
- Post-investigational medicinal product (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, 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.
University of Alabama at Birmingham-Site Number:8400012
Birmingham, Alabama, United States
Jasper Summit Research-Site Number:8400178
Jasper, Alabama, United States
MedPharmics, LLC-Site Number:8400185
Mobile, Alabama, United States
Chandler Clinical Trials (Elite Clinical Network)-Site Number:8400034
Chandler, Arizona, United States
Noble Clinical Research-Site Number:8400182
Tucson, Arizona, United States
Modena Allergy + Asthma-Site Number:8400036
La Jolla, California, United States
Downtown LA Research Center Inc.-Site Number:8400027
Los Angeles, California, United States
MACRO Trials-Site Number:8400030
Los Angeles, California, United States
Antelope Valley Clinical Trials-Site Number:8400003
Northridge, California, United States
Alpine Clinical Research Center-Site Number:8400180
Boulder, Colorado, United States
Innovative Clinical Research-Site Number:8400017
Lafayette, Colorado, United States
Clin Research W Florida-Site Number:8400004
Clearwater, Florida, United States
Beautiful Minds Clinical Research Center-Site Number:8400037
Cutler Bay, Florida, United States
Indago Research and Health Center-Site Number:8400187
Hialeah, Florida, United States
Deluxe Health Center-Site Number:8400188
Miami Lakes, Florida, United States
DL Research Solutions Inc-Site Number:8400033
Miami, Florida, United States
Research Institute of South Florida,Inc-Site Number:8400006
Miami, Florida, United States
Reed Medical Research-Site Number:8400032
Miami, Florida, United States
Florida Institute for Clinical Research-Site Number:8400013
Orlando, Florida, United States
Broward Pulmonary and Sleep Specialists-Site Number:8400031
Plantation, Florida, United States
Appalachian Clinical Research-Site Number:8400024
Adairsville, Georgia, United States
Alpha Clinical Research Georgia-Site Number:8400190
Atlanta, Georgia, United States
David Kavtaradze MD, Inc.-Site Number:8400029
Cordele, Georgia, United States
Covenant medical group-Site Number:8400183
East Point, Georgia, United States
Gwinnett Biomedical Research-Site Number:8400007
Lawrenceville, Georgia, United States
GenHarp Clinical Solutions-Site Number:8400028
Evergreen Park, Illinois, United States
Benchmark Research-Site Number:8400193
Covington, Louisiana, United States
Paul Shapero, PC-Site Number:8400016
Bangor, Maine, United States
Care Access-Site Number:8400275
Boston, Massachusetts, United States
Care Access-Site Number:8400276
Boston, Massachusetts, United States
Care Access-Site Number:8400277
Boston, Massachusetts, United States
Care Access-Site Number:8400278
Boston, Massachusetts, United States
Care Access-Site Number:8400281
Boston, Massachusetts, United States
Revival Research Institute, LLC-Site Number:8400191
Dearborn, Michigan, United States
Midwest Chest Consultants, P.C.-Site Number:8400002
Saint Charles, Missouri, United States
Northwell/ Lenox Hill Hospital-Site Number:8400019
New York, New York, United States
Gastonia Pharmaceutical Research-Site Number:8400010
Gastonia, North Carolina, United States
East Carolina University Brody School Of Medicine-Site Number:8400022
Greenville, North Carolina, United States
Carolina Research Center-Site Number:8400005
Shelby, North Carolina, United States
Accellacare-Site Number:8400001
Wilmington, North Carolina, United States
Southeastern Research Center-Site Number:8400011
Winston-Salem, North Carolina, United States
Bernstein Clinical Research Center-Site Number:8400014
Cincinnati, Ohio, United States
WellNow Urgent Care and Research-Site Number:8400039
Springdale, Ohio, United States
Clinical Research of Central PA-Site Number:8400023
DuBois, Pennsylvania, United States
Bogan Sleep Consultants-Site Number:8400181
Columbia, South Carolina, United States
Clinical Research of Rock Hill-Site Number:8400008
Rock Hill, South Carolina, United States
Clinrx Research-Site Number:8400021
Carrollton, Texas, United States
Austin Pulmonary Consultants-Site Number:8400035
Cedar Park, Texas, United States
Corsicana Medical Research, LLC-Site Number:8400018
Corsicana, Texas, United States
Texas Tech University Health Sciences Center-Site Number:8400189
El Paso, Texas, United States
The Methodist Hospital Research Institute-Site Number:8400194
Houston, Texas, United States
DM Clinical Research-Site Number:8400179
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center-Site Number:8400015
McKinney, Texas, United States
Advance Lung and Sleep Center-Site Number:8400040
Sherman, Texas, United States
Sherman Clinical Research-Site Number:8400009
Sherman, Texas, United States
Clearlake Specialties-Site Number:8400025
Webster, Texas, United States
Investigational Site Number :0320001
Caba, Buenos Aires, Argentina
Investigational Site Number :0320002
Caba, Buenos Aires, Argentina
Investigational Site Number :0320003
Rosario, Santa Fe, Argentina
Investigational Site Number :0320004
Mendoza, Argentina
Investigational Site Number :1000005
Dimitrovgrad, Bulgaria
Investigational Site Number :1000001
Sofia, Bulgaria
Investigational Site Number :1000004
Sofia, Bulgaria
Investigational Site Number :1000002
Sofia, Bulgaria
Investigational Site Number :1000003
Stara Zagora, Bulgaria
Investigational Site Number :1520008
Temuco, La Araucanía, Chile
Investigational Site Number :1520007
Curicó, Maule, Chile
Investigational Site Number :1520002
Talca, Maule, Chile
Investigational Site Number :1520009
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520003
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520001
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520006
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520004
Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1520005
Quillota, Valparaíso, Chile
Investigational Site Number :1560003
Baotou, China
Investigational Site Number :1560004
Beijing, China
Investigational Site Number :1560030
Beijing, China
Investigational Site Number :1560014
Beijing, China
Investigational Site Number :1560002
Changchun, China
Investigational Site Number :1560012
Changsha, China
Investigational Site Number :1560013
Changsha, China
Investigational Site Number :1560047
Changsha, China
Investigational Site Number :1560001
Chengdu, China
Investigational Site Number :1560040
Chengdu, China
Investigational Site Number :1560032
Chongqing, China
Investigational Site Number :1560006
Guangzhou, China
Investigational Site Number :1560025
Guangzhou, China
Investigational Site Number :1560036
Haikou, China
Investigational Site Number :1560022
Hangzhou, China
Investigational Site Number :1560039
Hangzhou, China
Investigational Site Number :1560017
Hefei, China
Investigational Site Number :1560008
Hohhot, China
Investigational Site Number :1560010
Hohhot, China
Investigational Site Number :1560044
Jinan, China
Investigational Site Number :1560027
Jinan, China
Investigational Site Number :1560031
Nanchang, China
Investigational Site Number :1560038
Nanchang, China
Investigational Site Number :1560035
Nanjing, China
Investigational Site Number :1560023
Nanning, China
Investigational Site Number :1560015
Pingxiang, China
Investigational Site Number :1560043
Shanghai, China
Investigational Site Number :1560034
Shanghai, China
Investigational Site Number :1560009
Shanghai, China
Investigational Site Number :1560045
Shanghai, China
Investigational Site Number :1560005
Shenyang, China
Investigational Site Number :1560020
Shenzhen, China
Investigational Site Number :1560028
Shijiazhuang, China
Investigational Site Number :1560024
Tianjin, China
Investigational Site Number :1560019
Wenzhou, China
Investigational Site Number :1560029
Wuhan, China
Investigational Site Number :1560016
Xi'an, China
Investigational Site Number :1560046
Xiangtan, China
Investigational Site Number :1560007
Xuzhou, China
Investigational Site Number :1560026
Yangzhou, China
Investigational Site Number :1560041
Zhanjiang, China
Investigational Site Number :1560042
Zhengzhou, China
Investigational Site Number :1560048
Zhongshan, China
Investigational Site Number :2030001
Jindrichuv Hradec III, Czechia
Investigational Site Number :2030004
Ostrava, Czechia
Investigational Site Number :2030002
Praha 4, Czechia
Investigational Site Number :2030005
Praha 5 - Radotin, Czechia
Investigational Site Number :2030003
Praha 8, Czechia
Investigational Site Number :3000005
Athens, Greece
Investigational Site Number :3000006
Athens, Greece
Investigational Site Number :3000004
Heraklion, Greece
Investigational Site Number :3000001
Ioannina, Greece
Investigational Site Number :3000007
Larissa, Greece
Investigational Site Number :3000008
Palaio Faliro, Athens, Greece
Investigational Site Number :3000002
Thessaloniki, Greece
Investigational Site Number :3480004
Debrecen, Hungary
Investigational Site Number :3480001
Gödöllö, Hungary
Investigational Site Number :3480002
Mosonmagyaróvár, Hungary
Investigational Site Number :3480003
Pécs, Hungary
Investigational Site Number :3560002
Coimbatore, India
Investigational Site Number :3560005
Hyderabad, India
Investigational Site Number :3560004
Jaipur, India
Investigational Site Number :3560008
Jaipur, India
Investigational Site Number :3560001
Kozhikode, India
Investigational Site Number :3560007
Mumbai, India
Investigational Site Number :3560003
Nagpur, India
Investigational Site Number :3760008
Haifa, Israel
Investigational Site Number :3760003
Jerusalem, Israel
Investigational Site Number :3760002
Jerusalem, Israel
Investigational Site Number :3760006
Kfar-Saba, Israel
Investigational Site Number :3760001
Petah-Tikva, Israel
Investigational Site Number :3760004
Rehovot, Israel
Investigational Site Number :3760007
Tel Aviv, Israel
Investigational Site Number :3800003
Rozzano, Milano, Italy
Investigational Site Number :3800004
Foggia, Puglia, Italy
Investigational Site Number :3800005
Catania, Italy
Investigational Site Number :3800001
Ferrara, Italy
Investigational Site Number :3800007
Verona, Italy
Investigational Site Number :4840001
Guadalajara, Jalisco, Mexico
Investigational Site Number :4840007
Cuernavaca, Morelos, Mexico
Investigational Site Number :4840002
Cdmx, México, Mexico
Investigational Site Number :4840003
San Juan del Rio, Querétaro, Mexico
Investigational Site Number :4840004
Benito Juarez, Mexico
Investigational Site Number :6160004
Wroclaw, Dolnoslaskie, Poland
Investigational Site Number :6160003
Warszawa, Mazowieckie, Poland
Investigational Site Number :6160001
Bialystok, Podlaskie, Poland
Investigational Site Number :6160002
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Investigational Site Number :6420005
Bragadiru, Romania
Investigational Site Number :6420006
Brasov, Romania
Investigational Site Number :6420012
Bucaresti, Romania
Investigational Site Number :6420002
Cluj-Napoca, Romania
Investigational Site Number :6420007
Codlea, Romania
Investigational Site Number :6420010
Deva, Romania
Investigational Site Number :6420001
Iasi, Romania
Investigational Site Number :6420009
Oradea, Romania
Investigational Site Number :6420003
Timisoara, Romania
Investigational Site Number :6430001
Moscow, Russian Federation
Investigational Site Number :6430003
Moscow, Russian Federation
Investigational Site Number :6430002
Moscow, Russian Federation
Investigational Site Number :6430005
Saint-Petersburg, Russian Federation
Investigational Site Number :6430006
St-Petersburg, Russian Federation
Investigational Site Number :7030009
Bardejov, Slovakia
Investigational Site Number :7030007
Humenne, Slovakia
Investigational Site Number :7030003
Levice, Slovakia
Investigational Site Number :7030011
Martin, Slovakia
Investigational Site Number :7030002
Poprad, Slovakia
Investigational Site Number :7030001
Spisska Nova Ves, Slovakia
Investigational Site Number :1580005
Kaohsiung, Taiwan
Investigational Site Number :1580002
New Taipei City, Taiwan
Investigational Site Number :1580007
Taichung, Taiwan
Investigational Site Number :1580006
Taichung, Taiwan
Investigational Site Number :1580004
Taipei, Taiwan
Investigational Site Number :1580003
Taipei, Taiwan
Investigational Site Number :1580008
Yunlin, Taiwan
Investigational Site Number :8040003
Ivano-Frankivsk, Ukraine
Investigational Site Number :8040007
Ivano-Frankivsk, Ukraine
Investigational Site Number :8040008
Kharkiv, Ukraine
Investigational Site Number :8040006
Kharkiv, Ukraine
Investigational Site Number :8040004
Kyiv, Ukraine
Investigational Site Number :8040001
Kyiv, Ukraine
Investigational Site Number :8040005
Kyiv, Ukraine
Investigational Site Number :8040011
Kyiv, Ukraine
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