Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— AERIFY-1  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701983
• Other study ID #: EFC16750
• Secondary ID: U1111-1250-27872
• Status: Recruiting
• Phase: Phase 3
• Start date: December 16, 2020
• Est. completion date: November 28, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: November 28, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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 a-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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Itepekimab SAR440340
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
• Placebo
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320001	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320002	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320005	La Plata	Buenos Aires
Argentina	Investigational Site Number : 0320004	Mendoza
Argentina	Investigational Site Number : 0320003	Rosario	Santa Fe
Bulgaria	Investigational Site Number : 1000005	Dimitrovgrad
Bulgaria	Investigational Site Number : 1000001	Sofia
Bulgaria	Investigational Site Number : 1000002	Sofia
Bulgaria	Investigational Site Number : 1000004	Sofia
Bulgaria	Investigational Site Number : 1000009	Sofia
Bulgaria	Investigational Site Number : 1000003	Stara Zagora
Bulgaria	Investigational Site Number : 1000006	Stara Zagora
Bulgaria	Investigational Site Number : 1000007	Veliko Tyrnovo
Bulgaria	Investigational Site Number : 1000008	Vidin
Chile	Investigational Site Number : 1520007	Curicó	Maule
Chile	Investigational Site Number : 1520005	Quillota	Valparaíso
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520004	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520006	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520009	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Talca	Maule
Chile	Investigational Site Number : 1520008	Temuco	La Araucanía
China	Investigational Site Number : 1560003	Baotou
China	Investigational Site Number : 1560004	Beijing
China	Investigational Site Number : 1560014	Beijing
China	Investigational Site Number : 1560030	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 : 1560027	Jinan
China	Investigational Site Number : 1560044	Jinan
China	Investigational Site Number : 1560031	Nanchang
China	Investigational Site Number : 1560035	Nanjing
China	Investigational Site Number : 1560023	Nanning
China	Investigational Site Number : 1560015	Pingxiang
China	Investigational Site Number : 1560009	Shanghai
China	Investigational Site Number : 1560034	Shanghai
China	Investigational Site Number : 1560043	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
Czechia	Investigational Site Number : 2030006	Havlickuv Brod
Czechia	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
Georgia	Investigational Site Number : 2680001	Tbilisi
Georgia	Investigational Site Number : 2680002	Tbilisi
Georgia	Investigational Site Number : 2680003	Tbilisi
Greece	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	Larisa
Greece	Investigational Site Number : 3000008	Palaio Faliro, Athens
Greece	Investigational Site Number : 3000002	Thessaloniki
Hungary	Investigational Site Number : 3480004	Debrecen
Hungary	Investigational Site Number : 3480001	Gödöllö
Hungary	Investigational Site Number : 3480002	Mosonmagyaróvár
Hungary	Investigational Site Number : 3480003	Pécs
India	Investigational Site Number : 3560002	Coimbatore
India	Investigational Site Number : 3560005	Hyderabad
India	Investigational Site Number : 3560004	Jaipur
India	Investigational Site Number : 3560001	Kozhikode
India	Investigational Site Number : 3560007	Mumbai
India	Investigational Site Number : 3560003	Nagpur
Israel	Investigational Site Number : 3760008	Haifa
Israel	Investigational Site Number : 3760002	Jerusalem
Israel	Investigational Site Number : 3760003	Jerusalem
Israel	Investigational Site Number : 3760006	Kfar-Saba
Israel	Investigational Site Number : 3760001	Petah-Tikva
Israel	Investigational Site Number : 3760009	Ramat Gan
Israel	Investigational Site Number : 3760004	Rehovot
Israel	Investigational Site Number : 3760007	Tel Aviv
Italy	Investigational Site Number : 3800005	Catania
Italy	Investigational Site Number : 3800001	Ferrara
Italy	Investigational Site Number : 3800004	Foggia	Puglia
Italy	Investigational Site Number : 3800003	Rozzano	Milano
Italy	Investigational Site Number : 3800007	Verona
Mauritius	Investigational Site Number : 4800001	Quatre Bornes
Mexico	Investigational Site Number : 4840013	Aguascalientes
Mexico	Investigational Site Number : 4840004	Benito Juarez
Mexico	Investigational Site Number : 4840002	Cdmx	México
Mexico	Investigational Site Number : 4840007	Cuernavaca	Morelos
Mexico	Investigational Site Number : 4840001	Guadalajara	Jalisco
Mexico	Investigational Site Number : 4840010	Guadalajara	Jalisco
Mexico	Investigational Site Number : 4840011	Guadalajara	Jalisco
Mexico	Investigational Site Number : 4840014	Oaxaca
Mexico	Investigational Site Number : 4840016	Oaxaca de Juarez	Oaxaca
Mexico	Investigational Site Number : 4840003	San Juan del Rio	Querétaro
Poland	Investigational Site Number : 6160001	Bialystok	Podlaskie
Poland	Investigational Site Number : 6160002	Ostrowiec Swietokrzyski	Swietokrzyskie
Poland	Investigational Site Number : 6160003	Warszawa	Mazowieckie
Poland	Investigational Site Number : 6160004	Wroclaw	Dolnoslaskie
Romania	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
Russian Federation	Investigational Site Number : 6430001	Moscow
Russian Federation	Investigational Site Number : 6430002	Moscow
Russian Federation	Investigational Site Number : 6430003	Moscow
Russian Federation	Investigational Site Number : 6430005	Saint-Petersburg
Russian Federation	Investigational Site Number : 6430006	St-Petersburg
Slovakia	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 : 7030010	Presov
Slovakia	Investigational Site Number : 7030001	Spisska Nova Ves
Taiwan	Investigational Site Number : 1580005	Kaohsiung
Taiwan	Investigational Site Number : 1580002	New Taipei City
Taiwan	Investigational Site Number : 1580006	Taichung
Taiwan	Investigational Site Number : 1580003	Taipei
Taiwan	Investigational Site Number : 1580004	Taipei
Taiwan	Investigational Site Number : 1580008	Yunlin
Ukraine	Investigational Site Number : 8040003	Ivano-Frankivsk
Ukraine	Investigational Site Number : 8040007	Ivano-Frankivsk
Ukraine	Investigational Site Number : 8040006	Kharkiv
Ukraine	Investigational Site Number : 8040008	Kharkiv
Ukraine	Investigational Site Number : 8040001	Kyiv
Ukraine	Investigational Site Number : 8040004	Kyiv
Ukraine	Investigational Site Number : 8040005	Kyiv
Ukraine	Investigational Site Number : 8040011	Kyiv
United Kingdom	Investigational Site Number : 8260015	Ashton-under-Lyne	Lancashire
United Kingdom	Investigational Site Number : 8260003	Bradford
United Kingdom	Investigational Site Number : 8260014	Heston
United Kingdom	Investigational Site Number : 8260001	London
United Kingdom	Investigational Site Number : 8260004	Portsmouth	Hampshire
United Kingdom	Investigational Site Number : 8260013	Redruth
United Kingdom	Investigational Site Number : 8260016	Salford	Manchester
United Kingdom	Investigational Site Number : 8260010	Wigan	Lancashire
United States	Appalachian Clinical Research Site Number : 8400024	Adairsville	Georgia
United States	Covenant Pulmonary Critical Care Site Number : 8400183	Atlanta	Georgia
United States	Paul Shapero, PC Site Number : 8400016	Bangor	Maine
United States	REX Clinical Trials Site Number : 8400371	Beaumont	Texas
United States	University of Alabama at Birmingham Site Number : 8400012	Birmingham	Alabama
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 : 8400280	Boston	Massachusetts
United States	Care Access Site Number : 8400281	Boston	Massachusetts
United States	~Alpine Clinical Research Center Site Number : 8400180	Boulder	Colorado
United States	Clinrx Research Site Number : 8400021	Carrollton	Texas
United States	Austin Pulmonary Consultants Site Number : 8400035	Cedar Park	Texas
United States	Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034	Chandler	Arizona
United States	Bernstein Clinical Research Center Site Number : 8400014	Cincinnati	Ohio
United States	Clin Research W Florida Site Number : 8400004	Clearwater	Florida
United States	Bogan Sleep Consultants Site Number : 8400181	Columbia	South Carolina
United States	David Kavtaradze MD, Inc. Site Number : 8400029	Cordele	Georgia
United States	Corsicana Medical Research, LLC Site Number : 8400018	Corsicana	Texas
United States	Benchmark Research Site Number : 8400193	Covington	Louisiana
United States	Beautiful Minds Clinical Research Center Site Number : 8400037	Cutler Bay	Florida
United States	Revival Research Institute, LLC Site Number : 8400191	Dearborn	Michigan
United States	Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440	Denison	Texas
United States	Clinical Research of Central PA Site Number : 8400023	DuBois	Pennsylvania
United States	Alpha Clinical Research Georgia Site Number : 8400190	Dunwoody	Georgia
United States	Texas Tech University Health Sciences Center Site Number : 8400189	El Paso	Texas
United States	GenHarp Clinical Solutions Site Number : 8400028	Evergreen Park	Illinois
United States	Exordia Medical Research, Inc. Site Number : 8400041	Fall River	Massachusetts
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	ASHA Clinical Research Site Number : 8400408	Hammond	Indiana
United States	Hannibal Clinic Site Number : 8400383	Hannibal	Missouri
United States	Hendeson Clinical Trials Site Number : 8400365	Henderson	Nevada
United States	Indago Research and Health Center Site Number : 8400187	Hialeah	Florida
United States	Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038	Houston	Texas
United States	Santa Clara Family Clinic Site Number : 8400398	Houston	Texas
United States	The Methodist Hospital Research Institute Site Number : 8400194	Houston	Texas
United States	California Research Institute Site Number : 8400400	Huntington Park	California
United States	Jasper Summit Research Site Number : 8400178	Jasper	Alabama
United States	Advanced Clinical Research Site Number : 8400409	Kendall	Florida
United States	Modena Allergy + Asthma Site Number : 8400036	La Jolla	California
United States	Imax Clinical Trials LLC 1 Site Number : 8400419	La Palma	California
United States	Innovative Clinical Research Site Number : 8400017	Lafayette	Colorado
United States	Gwinnett Biomedical Research Site Number : 8400007	Lawrenceville	Georgia
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	Advanced Pulmonary Research Institute Site Number : 8400455	Loxahatchee Groves	Florida
United States	Metroplex Pulmonary and Sleep Center Site Number : 8400015	McKinney	Texas
United States	PRX Research Site Number : 8400380	Mesquite	Texas
United States	DL Research Solutions Inc Site Number : 8400033	Miami	Florida
United States	High Quality Research Site Number : 8400406	Miami	Florida
United States	My Community Research Center Site Number : 8400347	Miami	Florida
United States	PROLIVE MEDICAL RESEARCH Site Number : 8400420	Miami	Florida
United States	Reed Medical Research Site Number : 8400032	Miami	Florida
United States	Reliant Medical Research Site Number : 8400397	Miami	Florida
United States	Research Institute of South Florida,Inc Site Number : 8400006	Miami	Florida
United States	University of Miami/Miami VA Medical Center Site Number : 8400026	Miami	Florida
United States	Deluxe Health Center Site Number : 8400188	Miami Lakes	Florida
United States	Northwell Health Site Number : 8400019	Mount Kisco	New York
United States	The Lung and Sleep Research Institute of North Texas Site Number : 8400417	North Richland Hills	Texas
United States	Antelope Valley Clinical Trials Site Number : 8400003	Northridge	California
United States	Florida Institute for Clinical Research Site Number : 8400013	Orlando	Florida
United States	Tellabio International Research Services Site Number : 8400411	Pembroke Pines	Florida
United States	Avanza Medical Research Center Site Number : 8400376	Pensacola	Florida
United States	Pulmonary Associates Site Number : 8400392	Phoenix	Arizona
United States	Clincove: Plano Primary Care Clinic Site Number : 8400424	Plano	Texas
United States	EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414	Plano	Texas
United States	Broward Pulmonary and Sleep Specialists Site Number : 8400031	Plantation	Florida
United States	Clinical Research of Rock Hill Site Number : 8400008	Rock Hill	South Carolina
United States	Midwest Chest Consultants, P.C. Site Number : 8400002	Saint Charles	Missouri
United States	Coastal Medical Research Institute Site Number : 8400044	Saint Petersburg	Florida
United States	Pasadena Center for Medical Research Site Number : 8400043	Saint Petersburg	Florida
United States	WellNow Urgent Care and Clinical Research Site Number : 8400378	Schenectady	New York
United States	Carolina Research Center Site Number : 8400005	Shelby	North Carolina
United States	Advance Lung and Sleep Center Site Number : 8400040	Sherman	Texas
United States	Sherman Clinical Research Site Number : 8400009	Sherman	Texas
United States	WellNow Urgent Care and Research Site Number : 8400039	Springdale	Ohio
United States	AdtreMed Site Number : 8400442	Tampa	Florida
United States	Premier Medical Associates Site Number : 8400388	The Villages	Florida
United States	DM Clinical Research Site Number : 8400179	Tomball	Texas
United States	Noble Clinical Research Site Number : 8400182	Tucson	Arizona
United States	Tucson Clinical Research Institute Site Number : 8400431	Tucson	Arizona
United States	Advanced Pulmonary Research Institute of Michigan Site Number : 8400403	Warren	Michigan
United States	Clearlake Specialties Site Number : 8400025	Webster	Texas
United States	Accellacare Site Number : 8400001	Wilmington	North Carolina
United States	Southeastern Research Center Site Number : 8400011	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Chile,  China,  Czechia,  Georgia,  Greece,  Hungary,  India,  Israel,  Italy,  Mauritius,  Mexico,  Poland,  Romania,  Russian Federation,  Slovakia,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)	Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period	Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 24
Secondary	Change from baseline in post-BD FEV1	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 24 and Week 52
Secondary	Change from baseline in pre-BD FEV1	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 52
Secondary	Time to first moderate or severe AECOPD	Time to first moderate or severe AECOPD over the placebo-controlled treatment period	Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Annualized rate of severe AECOPD	Annualized rate of severe AECOPD over the placebo-controlled treatment period	Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Time to first severe AECOPD	Time to first severe AECOPD over the placebo-controlled treatment period.	Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Annualized rate of corticosteroid-treated AECOPD	Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.	Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score	The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.	Baseline to Week 24 and Week 52
Secondary	Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary	Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline to Week 24 and Week 52
Secondary	Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline to Week 24 and Week 52
Secondary	Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation		Baseline up to End-of-Study (EOS) (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary	Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary	Functional itepekimab concentrations in serum		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary	Incidence of treatment-emergent anti-itepekimab antibodies responses		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)

External Links

•   EFC16750-EFC16819 COPD website