Official Title
Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary

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

Detailed Description

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

Recruiting
Chronic Obstructive Pulmonary Disease

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: 85 Years
Countries
Argentina
Bulgaria
Chile
China
Czechia
Greece
Hungary
India
Israel
Italy
Mexico
Poland
Romania
Russian Federation
Slovakia
Taiwan
Ukraine
United States
Locations

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

Contacts

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

Regeneron Pharmaceuticals
NCT Number
MeSH Terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive