Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
AERIFY-2
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)
4 other identifiers
interventional
1,239
29 countries
296
Brief Summary
Primary Objective: Primary population (former smokers cohort):
- 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: Primary population (former smokers cohort):
- 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 Secondary population (current smokers cohort)
- Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
- Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
- Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
- Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
- Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Feb 2021
Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease
296 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2025
CompletedApril 15, 2026
April 1, 2026
4.2 years
February 8, 2021
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Outcomes (21)
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers
Baseline to Week 24
Change from baseline in post-BD FEV1 in former smokers
Baseline to Week 24 and Week 52
Change from baseline in pre-BD FEV1 in former smokers
Baseline to Week 52
Time to first moderate or severe AECOPD in former smokers
Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Annualized rate of severe AECOPD in former smokers
Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
- +16 more secondary outcomes
Study Arms (5)
Itepekimab Q2W in former smokers
EXPERIMENTALSubcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Itepekimab Q4W in former smokers
EXPERIMENTALSC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
Placebo in former smokers
PLACEBO COMPARATORSC administration of matching placebo Q2W for up to 52 weeks
Itepekimab Q2W in current smokers
EXPERIMENTALSC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks
Placebo in current smokers
PLACEBO COMPARATORSC administration of matching placebo Q2W for 52 weeks
Interventions
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Eligibility Criteria
You may qualify if:
- 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:
- For former smokers: participants who report that they are not currently smoking and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
- For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period.
- 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. -
You may not qualify if:
- 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.
- For former smokers: Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol \[THC\]) within 6 months prior to Screening (Visit 1A).
- For current smokers: vaping of any products (eg, nicotine, 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 Screening (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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (297)
Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333
Phoenix, Arizona, 85020, United States
UCSF Fresno - Site Number : 8400030
Fresno, California, 93701, United States
Palmtree Clinical Research Site Number : 8400184
Palm Springs, California, 92262, United States
Allianz Research Institute Colorado Site Number : 8400061
Denver, Colorado, 80219, United States
Helix Biomedics, LLC - Site Number : 8400049
Boynton Beach, Florida, 33435, United States
Innovative Research of West Florida, Inc- Site Number : 8400041
Clearwater, Florida, 33756, United States
Beautiful Minds Clinical Research Center Site Number : 8400352
Cutler Bay, Florida, 33157, United States
Omega Research - Site Number : 8400031
DeBary, Florida, 32713, United States
Sciences Connections, LLC Site Number : 8400045
Doral, Florida, 33178, United States
North Florida/South Georgia Veterans Health System Site Number : 8400176
Gainesville, Florida, 32608, United States
Finlay Medical Research- Site Number : 8400011
Greenacres City, Florida, 33467, United States
Direct Helpers Medical Center Inc- Site Number : 8400065
Hialeah, Florida, 33012, United States
Multi-Specialty Research Associates, Inc- Site Number : 8400044
Lake City, Florida, 32055, United States
Advanced Pulmonary Research Institute Site Number : 8400018
Loxahatchee Groves, Florida, 33470, United States
Columbus Clinical Services- Site Number : 8400054
Miami, Florida, 33125, United States
Finlay Medical Research Site Number : 8400007
Miami, Florida, 33126, United States
MCR Research Site Number : 8400425
Miami, Florida, 33126, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009
Miami, Florida, 33144, United States
My Community Research Center Site Number : 8400060
Miami, Florida, 33155, United States
Phoenix Medical Research- Site Number : 8400019
Miami, Florida, 33165, United States
Renstar Medical Research- Site Number : 8400015
Ocala, Florida, 34470, United States
Central Florida Pulmonary Group, PA- Site Number : 8400192
Orlando, Florida, 32803, United States
Heuer M.D. Research Site Number : 8400016
Orlando, Florida, 32819, United States
Oviedo Medical Research Site Number : 8400026
Oviedo, Florida, 32765, United States
Innovation Medical Research Center- Site Number : 8400067
Palmetto Bay, Florida, 33157, United States
Pines Care Research Center LLC- Site Number : 8400056
Pembroke Pines, Florida, 33025, United States
Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178
Sarasota, Florida, 34239, United States
Genesis Clinical Research, LLC Site Number : 8400182
Tampa, Florida, 33603, United States
Clinical Research of West Florida, Inc- Site Number : 8400008
Tampa, Florida, 33606, United States
Medster Research, LLC Site Number : 8400051
Valdosta, Georgia, 31605, United States
North Georgia Clinical Research Site Number : 8400013
Woodstock, Georgia, 30189, United States
Care Access Fairview Heights Site Number : 8400033
Fairview Heights, Illinois, 62208, United States
Captain James A. Lovell Federal Health Care Center Site Number : 8400032
North Chicago, Illinois, 60064, United States
Illinois Lung Institute- Site Number : 8400024
Peoria, Illinois, 61605, United States
The Iowa Clinic Site Number : 8400034
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Garfield- Site Number : 8400063
Topeka, Kansas, 66606, United States
Lexington VA Health Care System- Site Number : 8400036
Lexington, Kentucky, 40502, United States
Pulmonary & Critical Care Site Number : 8400047
Shreveport, Louisiana, 71105, United States
Johns Hopkins Asthma and Allergy Center- Site Number : 8400055
Baltimore, Maryland, 21224, United States
Care Access Site Number : 8400276
Boston, Massachusetts, 02110, United States
Care Access Site Number : 8400281
Boston, Massachusetts, 02110, United States
Henry Ford Hospital Site Number : 8400052
Detroit, Michigan, 48202, United States
Revive Research Institute Site Number : 8400186
Lathrup Village, Michigan, 48076, United States
Washington University School of Medicine- Site Number : 8400035
St Louis, Missouri, 63110, United States
Sierra Clinical Research- Site Number : 8400005
Las Vegas, Nevada, 89106, United States
Smart Medical Research Site Number : 8400191
Brooklyn, New York, 11230, United States
VA Western New York Healthcare System Site Number : 8400050
Buffalo, New York, 14215, United States
New York - Presbyterian Queens- Site Number : 8400028
Flushing, New York, 11355, United States
Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029
Schenectady, New York, 12308, United States
American Health Research- Site Number : 8400002
Charlotte, North Carolina, 28277, United States
Advanced Respiratory and Sleep Medicine- Site Number : 8400022
Huntersville, North Carolina, 28078, United States
University of Cincinnati- Site Number : 8400042
Cincinnati, Ohio, 45267, United States
Remington-Davis Inc- Site Number : 8400004
Columbus, Ohio, 43215, United States
Toledo Institute of Clinical Research- Site Number : 8400014
Toledo, Ohio, 43617, United States
OK Clinical Research LLC- Site Number : 8400001
Edmond, Oklahoma, 73034, United States
Kaiser Permanente Center for Health Research Site Number : 8400039
Portland, Oregon, 97227, United States
St. Luke's University Health Network- Site Number : 8400187
Bethlehem, Pennsylvania, 18015, United States
Temple University Hospital Site Number : 8400062
Philadelphia, Pennsylvania, 19140-5103, United States
Allegheny Health Network- Site Number : 8400058
Pittsburgh, Pennsylvania, 15212, United States
Lowcountry Lung & Critical Care- Site Number : 8400175
Charleston, South Carolina, 29406, United States
Medtrial, LLC Site Number : 8400048
Columbia, South Carolina, 29204, United States
VitaLink Research- Gaffney- Site Number : 8400003
Gaffney, South Carolina, 29340, United States
Clinical Trials Center of Middle Tennessee Site Number : 8400025
Franklin, Tennessee, 37067, United States
TTS Research- Site Number : 8400012
Boerne, Texas, 78006, United States
United Memorial Medical Center (UMMC)- Site Number : 8400193
Houston, Texas, 77091, United States
Radiance Clinical Research- Site Number : 8400037
Lampasas, Texas, 76550-1820, United States
Clincove: Plano Primary Care Clinic Site Number : 8400424
Plano, Texas, 75024, United States
Sun Research Institute - Site Number : 8400183
San Antonio, Texas, 78215, United States
AES Salt Lake City- Site Number : 8400332
Murray, Utah, 84123, United States
The Rheumatology and Pulmonary Clinic- Site Number : 8400053
Beckley, West Virginia, 25801, United States
Aurora BayCare Medical Center Site Number : 8400046
Green Bay, Wisconsin, 54311, United States
Investigational Site Number : 0320009
Berazategui, Buenos Aires, CP 1884, Argentina
Investigational Site Number : 0320008
CABA, Buenos Aires, C1023AAB, Argentina
Investigational Site Number : 0320001
CABA, Buenos Aires, C1414AIF, Argentina
Investigational Site Number : 0320005
Pergamino, Buenos Aires, B2700CPM, Argentina
Investigational Site Number : 0320006
Buenos Aires, Buenos Aires F.D., 1060, Argentina
Investigational Site Number : 0320002
Vicente Lopez, Buenos Aires F.D., B1602DQD, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320003
Rosario, Santa Fe Province, S2000DBS, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, S2000JKR, Argentina
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009
Vitória, Espírito Santo, 29055 450, Brazil
SER da Bahia- Site Number : 0760020
Salvador, Estado de Bahia, 40150-150, Brazil
CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018
Brasília, Federal District, 70710-100, Brazil
Hospital Sao Domingos- Site Number : 0760016
São Luís, Maranhão, 65060-645, Brazil
Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014
Belo Horizonte, Minas Gerais, 30150-221, Brazil
CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
Curitiba, Paraná, 80060-240, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Instituto Ceos Site Number : 0760021
Porto Alegre, Rio Grande do Sul, 90480-020, Brazil
Hospital Sao Lucas da PUCRS- Site Number : 0760007
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005
Botucatu, São Paulo, 18618-687, Brazil
PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010
Campinas, São Paulo, 13059-900, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013
São Paulo, São Paulo, 04014-002, Brazil
Clinica de Alergia Martti Antila Site Number : 0760008
Sorocaba, São Paulo, 18040-425, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017
Rio de Janeiro, 20241-180, Brazil
CEPIC - Centro Paulista de Investigação Clínica- Site Number : 0760004
São Paulo, 04266-010, Brazil
Investigational Site Number : 1000008
Blagoevgrad, 2700, Bulgaria
Investigational Site Number : 1000013
Dupnitsa, 2600, Bulgaria
Investigational Site Number : 1000004
Gabrovo, 5300, Bulgaria
Investigational Site Number : 1000009
Haskovo, 6305, Bulgaria
Investigational Site Number : 1000005
Montana, 3403, Bulgaria
Investigational Site Number : 1000002
Plovdiv, 4002, Bulgaria
Investigational Site Number : 1000012
Rousse, 7000, Bulgaria
Investigational Site Number : 1000003
Rousse, 7002, Bulgaria
Investigational Site Number : 1000001
Sofia, 1142, Bulgaria
Investigational Site Number : 1000006
Sofia, 1680, Bulgaria
Investigational Site Number : 1240006
Sherwood Park, Alberta, T8H 0N2, Canada
Investigational Site Number : 1240014
Kelowna, British Columbia, V1Y 4N7, Canada
Investigational Site Number : 1240016
Penticton, British Columbia, V2A 5L5, Canada
Investigational Site Number : 1240012
Moncton, New Brunswick, E1C2Z3, Canada
Investigational Site Number : 1240021
Ajax, Ontario, L1S 2J5, Canada
Investigational Site Number : 1240020
Burlington, Ontario, L7N 3V2, Canada
Investigational Site Number : 1240023
Guelph, Ontario, N1H 6J2, Canada
Investigational Site Number : 1240009
Toronto, Ontario, M5T 3A9, Canada
Investigational Site Number : 1240022
Windsor, Ontario, N8X 1T3, Canada
Investigational Site Number : 1240018
Windsor, Ontario, N8X 5A6, Canada
Investigational Site Number : 1240004
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240005
St-charles Borrommee, Quebec, J6E 2B4, Canada
Investigational Site Number : 1240019
Terrebonne, Quebec, J6V 2H2, Canada
Investigational Site Number : 1240001
Trois-Rivières, Quebec, G8T 7A1, Canada
Investigational Site Number : 1240002
Victoriaville, Quebec, G6P 3Z8, Canada
Investigational Site Number : 1240003
Québec, G1N 4V3, Canada
Investigational Site Number : 1520009
Valdivia, Los Ríos Region, 5110683, Chile
Investigational Site Number : 1520002
Talca, Maule Region, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, 7500010, Chile
Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, 7500587, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500692, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7500698, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 8910131, Chile
Investigational Site Number : 1520006
Quillota, Región de Valparaíso, 2260877, Chile
Investigational Site Number : 2030001
Jindrichuv Hradec III, 37701, Czechia
Investigational Site Number : 2030009
Měšice, 250 64, Czechia
Investigational Site Number : 2030005
Mladá Boleslav, 29301, Czechia
Investigational Site Number : 2030008
Olomouc, 779 00, Czechia
Investigational Site Number : 2030004
Ostrava, 70800, Czechia
Investigational Site Number : 2030002
Prague, 140 46, Czechia
Investigational Site Number : 2030006
Teplice, 415 01, Czechia
Investigational Site Number : 2030007
Varnsdorf, 40747, Czechia
Investigational Site Number : 2080001
Hvidovre, 2650, Denmark
Investigational Site Number : 2080003
Vejle, 7100, Denmark
Investigational Site Number : 2330001
Tartu, 50406, Estonia
Investigational Site Number : 2500001
Lyon, 69004, France
Investigational Site Number : 2500002
Montpellier, France
Investigational Site Number : 2500003
Pessac, 33600, France
Investigational Site Number : 2500004
Reims, 51090, France
Investigational Site Number : 2680003
Batumi, 6010, Georgia
Investigational Site Number : 2680001
Tbilisi, 0160, Georgia
Investigational Site Number : 2680002
Tbilisi, 0168, Georgia
Investigational Site Number : 2760006
Bendorf, 56068, Germany
Investigational Site Number : 2760004
Berlin, 10787, Germany
Investigational Site Number : 2760009
Berlin, 10961, Germany
Investigational Site Number : 2760010
Berlin, 12159, Germany
Investigational Site Number : 2760005
Frankfurt am Main, 60596, Germany
Investigational Site Number : 2760002
Hamburg, 20354, Germany
Investigational Site Number : 2760014
Hanover, 30625, Germany
Investigational Site Number : 2760008
Leipzig, 04299, Germany
Investigational Site Number : 2760007
Leipzig, 04347, Germany
Investigational Site Number : 2760003
Lübeck, 23552, Germany
Investigational Site Number : 2760001
Mainz, 55128, Germany
Investigational Site Number : 2760012
Neu-Isenburg, 63263, Germany
Investigational Site Number : 2760011
Rosenheim, 83022, Germany
Investigational Site Number : 3480002
Balassagyarmat, 2660, Hungary
Investigational Site Number : 3480009
Budapest, 1106, Hungary
Investigational Site Number : 3480005
Edelény, 3780, Hungary
Investigational Site Number : 3480004
Hajdunánás, 4080, Hungary
Investigational Site Number : 3480003
Püspökladány, 4150, Hungary
Investigational Site Number : 3480001
Százhalombatta, 2440, Hungary
Investigational Site Number : 3480012
Szombathely, 9700, Hungary
Investigational Site Number : 3560016
Belagavi, 590010, India
Investigational Site Number : 3560001
Chandigarh, 160012, India
Investigational Site Number : 3560014
India, 440010, India
Investigational Site Number : 3560013
Jaipur, 302023, India
Investigational Site Number : 3560019
Kanpur, 208002, India
Investigational Site Number : 3560010
Kolkata, 700107, India
Investigational Site Number : 3560017
Nagpur, 440012, India
Investigational Site Number : 3560005
Nagpur, 440015, India
Investigational Site Number : 3560009
Nashik, 422007, India
Investigational Site Number : 3560012
Pune, 411004, India
Investigational Site Number : 3560018
Pune, 411057, India
Investigational Site Number : 3760003
Jerusalem, 91031, Israel
Investigational Site Number : 3760002
Jerusalem, 91120, Israel
Investigational Site Number : 3760001
Petah Tikva, 49100, Israel
Investigational Site Number : 3760009
Ramat Gan, 5266202, Israel
Investigational Site Number : 3760004
Rehovot, 76100, Israel
Investigational Site Number : 3920023
Nagoya, Aichi-ken, 455-8530, Japan
Investigational Site Number : 3920020
Nagoya, Aichi-ken, 457-8511, Japan
Investigational Site Number : 3920005
Fukuoka, Fukuoka, 815-0032, Japan
Investigational Site Number : 3920027
Fukuoka, Fukuoka, 819-8555, Japan
Investigational Site Number : 3920030
Kurume-shi, Fukuoka, 830-0011, Japan
Investigational Site Number : 3920015
Mizunami-shi, Gifu, 509-6134, Japan
Investigational Site Number : 3920010
Hiroshima, Hiroshima, 734-8530, Japan
Investigational Site Number : 3920021
Kure-shi, Hiroshima, 737-0193, Japan
Investigational Site Number : 3920035
Kure-shi, Hiroshima, 737-8505, Japan
Investigational Site Number : 3920038
Sapporo, Hokkaido, 006-8555, Japan
Investigational Site Number : 3920042
Sapporo, Hokkaido, 064-0804, Japan
Investigational Site Number : 3920013
Himeji-shi, Hyōgo, 670-0849, Japan
Investigational Site Number : 3920009
Sakaide-shi, Kagawa-ken, 762-8550, Japan
Investigational Site Number : 3920014
Takamatsu, Kagawa-ken, 761-8073, Japan
Investigational Site Number : 3920011
Konan-ku, Yokohama-shi, Kanagawa, 234-0054, Japan
Investigational Site Number : 3920039
Yokohama, Kanagawa, 223-0059, Japan
Investigational Site Number : 3920043
Matsusaka-shi, Mie-ken, 515-8544, Japan
Investigational Site Number : 3920003
Osaka, Osaka, 530-8480, Japan
Investigational Site Number : 3920026
Osaka, Osaka, 545-8586, Japan
Investigational Site Number : 3920007
Sakai-shi, Osaka, 591-8555, Japan
Investigational Site Number : 3920006
Yao-shi, Osaka, 581-0011, Japan
Investigational Site Number : 3920036
Sano-shi, Tochigi, 327-8511, Japan
Investigational Site Number : 3920040
Chuo-ku, Tokyo, 103-0022, Japan
Investigational Site Number : 3920017
Chuo-ku, Tokyo, 104-0031, Japan
Investigational Site Number : 3920024
Chuo-ku, Tokyo, 104-0031, Japan
Investigational Site Number : 3920019
Itabashi-ku, Tokyo, 173-8610, Japan
Investigational Site Number : 3920029
Kiyose, Tokyo, 204-8522, Japan
Investigational Site Number : 3920025
Shibuya-ku, Tokyo, 150-8935, Japan
Investigational Site Number : 3920016
Shinagawa-ku, Tokyo, 140-8522, Japan
Investigational Site Number : 3920037
Shinagawa-ku, Tokyo, 142-8666, Japan
Investigational Site Number : 3920041
Toshima-ku, Tokyo, 170-0003, Japan
Investigational Site Number : 4280002
Daugavpils, LV-5417, Latvia
Investigational Site Number : 4280001
Riga, LV-1002, Latvia
Investigational Site Number : 4400002
Kaunas, 49449, Lithuania
Investigational Site Number : 4400001
Kaunas, 50161, Lithuania
Investigational Site Number : 4400003
Klaipėda, 92231, Lithuania
Investigational Site Number : 4840008
Monterrey, Nuevo León, 64710, Mexico
Investigational Site Number : 4840009
Monterrey, Nuevo León, 64718, Mexico
Investigational Site Number : 4840002
Monterrey, Nuevo León, 66465, Mexico
Investigational Site Number : 4840010
Aguascalientes, 20230, Mexico
Investigational Site Number : 4840003
Chihuahua City, 31000, Mexico
Investigational Site Number : 4840007
Durango, 34000, Mexico
Investigational Site Number : 4840012
Durango, Durango, 34080, Mexico
Investigational Site Number : 4840006
Mexico City, 14050, Mexico
Investigational Site Number : 4840001
Monterrey, Nuevo León, 64460, Mexico
Investigational Site Number : 4840004
Veracruz, 91910, Mexico
Investigational Site Number : 5280005
Arnhem, 6815 AD, Netherlands
Investigational Site Number : 5280001
Breda, 4818 CK, Netherlands
Investigational Site Number : 5280008
Zutphen, 7207 AE, Netherlands
Investigational Site Number : 5780001
Lørenskog, 1478, Norway
Investigational Site Number : 6160005
Wołomin, Masovian Voivodeship, 05-200, Poland
Investigational Site Number : 6160008
Bialystok, Podlaskie Voivodeship, 15-044, Poland
Investigational Site Number : 6160003
Malbork, Pomeranian Voivodeship, 82-200, Poland
Investigational Site Number : 6160002
Katowice, Silesian Voivodeship, 40-611, Poland
Investigational Site Number : 6160009
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Investigational Site Number : 6200009
Almada, 2801-951, Portugal
Investigational Site Number : 6200006
Aveiro, 3810-501, Portugal
Investigational Site Number : 6200002
Braga, 4710-243, Portugal
Investigational Site Number : 6200001
Guimarães, 4810-061, Portugal
Investigational Site Number : 6200010
Matosinhos Municipality, 4464-513, Portugal
Cardiopulmonary Research- Site Number : 8400040
Guaynabo, 00968, Puerto Rico
BRCR Medical Center, Inc. Site Number : 8400190
Ponce, 00717-1322, Puerto Rico
BRCR Medical Center Site Number : 8400180
San Juan, 00907, Puerto Rico
Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232
Temecula, 92590, Puerto Rico
Investigational Site Number : 6430002
Moscow, 105077, Russia
Investigational Site Number : 6430001
Moscow, 115093, Russia
Investigational Site Number : 6430005
Moscow, 115280, Russia
Investigational Site Number : 6430004
Saint Petersburg, 193231, Russia
Investigational Site Number : 6430003
Saint Petersburg, 194354, Russia
Investigational Site Number : 6430006
Ulyanovsk, 432017, Russia
Investigational Site Number : 7100013
Benoni, 1500, South Africa
Investigational Site Number : 7100019
Cape Town, 7130, South Africa
Investigational Site Number : 7100002
Cape Town, 7530, South Africa
Investigational Site Number : 7100015
Chatsworth, 4091, South Africa
Investigational Site Number : 7100005
Durban, 4001, South Africa
Investigational Site Number : 7100017
Durban, 4001, South Africa
Investigational Site Number : 7100006
Durban, 4071, South Africa
Investigational Site Number : 7100016
Durban, 4302, South Africa
Investigational Site Number : 7100004
Gatesville, 7764, South Africa
Investigational Site Number : 7100012
Middelburg, 1055, South Africa
Investigational Site Number : 7100003
Parow, 7500, South Africa
Investigational Site Number : 7100009
Pretoria, 0145, South Africa
Investigational Site Number : 4100002
Wŏnju, Gangwon-do, 26426, South Korea
Investigational Site Number : 4100005
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Investigational Site Number : 4100003
Incheon, Incheon-gwangyeoksi, 21431, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 05030, South Korea
Investigational Site Number : 4100001
Seoul, 06591, South Korea
Investigational Site Number : 7240004
Palma de Mallorca, Balears [Baleares], 07120, Spain
Investigational Site Number : 7240014
Barcelona, Barcelona [Barcelona], 08017, Spain
Investigational Site Number : 7240006
Sant Boi de Llobregat, Barcelona [Barcelona], 08830, Spain
Investigational Site Number : 7240013
Santander, Cantabria, 39008, Spain
Investigational Site Number : 7240002
Mérida / Badajoz, Extremadura, 06800, Spain
Investigational Site Number : 7240009
Lleida / Lleida, Lleida [Lérida], 25198, Spain
Investigational Site Number : 7240008
Pozuelo de Alarcón, Madrid, 28223, Spain
Investigational Site Number : 7240007
Madrid / Madrid, Madrid, Comunidad de, 28040, Spain
Investigational Site Number : 7240010
Cáceres, 10003, Spain
Investigational Site Number : 7240003
Madrid, 28007, Spain
Investigational Site Number : 7240001
Málaga, 29010, Spain
Investigational Site Number : 7240012
Zaragoza, 50009, Spain
Investigational Site Number : 7920007
Ankara, 06100, Turkey (Türkiye)
Investigational Site Number : 7920005
Balcali Adana, 01330, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, 34303, Turkey (Türkiye)
Investigational Site Number : 7920003
Izmir, 35040, Turkey (Türkiye)
Investigational Site Number : 7920006
Kırıkkale, 71450, Turkey (Türkiye)
Investigational Site Number : 7920002
Mersin, 33343, Turkey (Türkiye)
Investigational Site Number : 8260006
Wishaw, Glasgow City, ML2 0DP, United Kingdom
Investigational Site Number : 8260007
Tyne and Wear, North Tyneside, NE29 8NH, United Kingdom
Investigational Site Number : 8260002
Chertsey, Surrey, KT16 0PZ, United Kingdom
Investigational Site Number : 8260003
Bradford, BD9 6RJ, United Kingdom
Investigational Site Number : 8260005
Liverpool, L143PE, United Kingdom
Investigational Site Number : 8260008
Milton Keynes, MK15 0DU, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, NE4 6BE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2021
First Posted
February 12, 2021
Study Start
February 12, 2021
Primary Completion
April 21, 2025
Study Completion
August 28, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org