Clinical trial NCT04751487: Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-02-12
Enrollment: 1239
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: The study duration per participant:

* Screening period is 3-5 weeks
* Randomized investigational medicinal product (IMP) treatment period is 52 weeks for first cohort of randomized former smoker participants \[approximately 930\] and cohort of current smokers \[approximately 280\], and 24 to 52 weeks for potential additional randomized former smoker participants
* Post-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.

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:

  * 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. -

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.
* 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.
* 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.

Primary outcomes:
measure: Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers
timeFrame: 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:
measure: Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers
timeFrame: Baseline to Week 24
measure: Change from baseline in post-BD FEV1 in former smokers
timeFrame: Baseline to Week 24 and Week 52
measure: Change from baseline in pre-BD FEV1 in former smokers
timeFrame: Baseline to Week 52
measure: Time to first moderate or severe AECOPD in former smokers
timeFrame: Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
measure: Annualized rate of severe AECOPD in former smokers
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
measure: Time to first severe AECOPD in former smokers
timeFrame: Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
measure: Annualized rate of corticosteroid-treated AECOPD in former smokers
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
measure: Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score in former smokers
timeFrame: Baseline to Week 24 and Week 52
measure: Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) in former smokers
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers
timeFrame: Baseline to Week 24 and Week 52
measure: Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score in former smokers
timeFrame: Baseline to Week 24 and Week 52
measure: 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 in former smokers
timeFrame: 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)
measure: Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers
timeFrame: 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)
measure: Functional itepekimab concentrations in serum in former smokers
timeFrame: 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)
measure: Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers
timeFrame: 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)
measure: Annualized rate of moderate or severe AECOPD in current smokers
timeFrame: Baseline up to Week 52
measure: Change from baseline in pre-BD FEV1 in current smokers
timeFrame: Baseline up to Week 24 and Week 52
measure: Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers
timeFrame: Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
measure: Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers
timeFrame: Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
measure: Functional itepekimab concentrations in serum in current smokers
timeFrame: Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
measure: Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers
timeFrame: Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno - Site Number : 8400030
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Site Number : 8400184
state: California
city: Denver
country: United States
facility: Allianz Research Institute Colorado Site Number : 8400061
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC - Site Number : 8400049
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc- Site Number : 8400041
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center Site Number : 8400352
state: Florida
city: DeBary
country: United States
facility: Omega Research - Site Number : 8400031
state: Florida
city: Doral
country: United States
facility: Sciences Connections, LLC Site Number : 8400045
state: Florida
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System Site Number : 8400176
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research- Site Number : 8400011
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Medical Center Inc- Site Number : 8400065
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc- Site Number : 8400044
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute Site Number : 8400018
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services- Site Number : 8400054
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research Site Number : 8400007
state: Florida
city: Miami
country: United States
facility: MCR Research Site Number : 8400425
state: Florida
city: Miami
country: United States
facility: Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009
state: Florida
city: Miami
country: United States
facility: My Community Research Center Site Number : 8400060
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research- Site Number : 8400019
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research- Site Number : 8400015
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA- Site Number : 8400192
state: Florida
city: Orlando
country: United States
facility: Heuer M.D. Research Site Number : 8400016
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research Site Number : 8400026
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center- Site Number : 8400067
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center LLC- Site Number : 8400056
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC Site Number : 8400182
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc- Site Number : 8400008
state: Florida
city: Valdosta
country: United States
facility: Medster Research, LLC Site Number : 8400051
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research Site Number : 8400013
state: Georgia
city: Fairview Heights
country: United States
facility: Care Access Fairview Heights Site Number : 8400033
state: Illinois
city: North Chicago
country: United States
facility: Captain James A. Lovell Federal Health Care Center Site Number : 8400032
state: Illinois
city: Peoria
country: United States
facility: Illinois Lung Institute- Site Number : 8400024
state: Illinois
city: West Des Moines
country: United States
facility: The Iowa Clinic Site Number : 8400034
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Garfield- Site Number : 8400063
state: Kansas
city: Lexington
country: United States
facility: Lexington VA Health Care System- Site Number : 8400036
state: Kentucky
city: Shreveport
country: United States
facility: Pulmonary & Critical Care Site Number : 8400047
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center- Site Number : 8400055
state: Maryland
city: Boston
country: United States
facility: Care Access Site Number : 8400276
state: Massachusetts
city: Boston
country: United States
facility: Care Access Site Number : 8400281
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital Site Number : 8400052
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute Site Number : 8400186
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine- Site Number : 8400035
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research- Site Number : 8400005
state: Nevada
city: Brooklyn
country: United States
facility: Smart Medical Research Site Number : 8400191
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System Site Number : 8400050
state: New York
city: Flushing
country: United States
facility: New York - Presbyterian Queens- Site Number : 8400028
state: New York
city: Schenectady
country: United States
facility: Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029
state: New York
city: Charlotte
country: United States
facility: American Health Research- Site Number : 8400002
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine- Site Number : 8400022
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati- Site Number : 8400042
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Inc- Site Number : 8400004
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research- Site Number : 8400014
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research LLC- Site Number : 8400001
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research Site Number : 8400039
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network- Site Number : 8400187
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital Site Number : 8400062
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network- Site Number : 8400058
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung & Critical Care- Site Number : 8400175
state: South Carolina
city: Columbia
country: United States
facility: Medtrial, LLC Site Number : 8400048
state: South Carolina
city: Gaffney
country: United States
facility: VitaLink Research- Gaffney- Site Number : 8400003
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee Site Number : 8400025
state: Tennessee
city: Boerne
country: United States
facility: TTS Research- Site Number : 8400012
state: Texas
city: Houston
country: United States
facility: United Memorial Medical Center (UMMC)- Site Number : 8400193
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research- Site Number : 8400037
state: Texas
city: Plano
country: United States
facility: Clincove: Plano Primary Care Clinic Site Number : 8400424
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute - Site Number : 8400183
state: Texas
city: Murray
country: United States
facility: AES Salt Lake City- Site Number : 8400332
state: Utah
city: Beckley
country: United States
facility: The Rheumatology and Pulmonary Clinic- Site Number : 8400053
state: West Virginia
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center Site Number : 8400046
state: Wisconsin
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320009
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320008
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320001
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Investigational Site Number : 0320005
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320006
state: Ciudad De Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Investigational Site Number : 0320002
state: Ciudad De Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320004
state: Santa Fe
city: Salvador
country: Brazil
facility: SER da Bahia- Site Number : 0760020
state: Bahia
city: Brasilia
country: Brazil
facility: CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018
state: Distrito Federal
city: Vitoria
country: Brazil
facility: CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009
state: Espírito Santo
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos- Site Number : 0760016
state: Maranhão
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014
state: Minas Gerais
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto Ceos Site Number : 0760021
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS- Site Number : 0760007
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005
state: São Paulo
city: Campinas
country: Brazil
facility: PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila Site Number : 0760008
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica- Site Number : 0760004
city: Blagoevgrad
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Dupnitsa
country: Bulgaria
facility: Investigational Site Number : 1000013
city: Gabrovo
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Haskovo
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Montana
country: Bulgaria
facility: Investigational Site Number : 1000005
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1000012
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1000003
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000006
city: Sherwood Park
country: Canada
facility: Investigational Site Number : 1240006
state: Alberta
city: Kelowna
country: Canada
facility: Investigational Site Number : 1240014
state: British Columbia
city: Penticton
country: Canada
facility: Investigational Site Number : 1240016
state: British Columbia
city: Moncton
country: Canada
facility: Investigational Site Number : 1240012
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational Site Number : 1240021
state: Ontario
city: Burlington
country: Canada
facility: Investigational Site Number : 1240020
state: Ontario
city: Guelph
country: Canada
facility: Investigational Site Number : 1240023
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240009
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240022
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: St-charles Borrommee
country: Canada
facility: Investigational Site Number : 1240005
state: Quebec
city: Terrebonne
country: Canada
facility: Investigational Site Number : 1240019
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Victoriaville
country: Canada
facility: Investigational Site Number : 1240002
state: Quebec
city: Quebec
country: Canada
facility: Investigational Site Number : 1240003
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520009
state: Los Ríos
city: Talca
country: Chile
facility: Investigational Site Number : 1520002
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520007
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520008
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520006
state: Valparaíso
city: Jindrichuv Hradec III
country: Czechia
facility: Investigational Site Number : 2030001
city: Mesice
country: Czechia
facility: Investigational Site Number : 2030009
city: Mlada Boleslav
country: Czechia
facility: Investigational Site Number : 2030005
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030008
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030004
city: Praha 4
country: Czechia
facility: Investigational Site Number : 2030002
city: Teplice
country: Czechia
facility: Investigational Site Number : 2030006
city: Varnsdorf
country: Czechia
facility: Investigational Site Number : 2030007
city: Hvidovre
country: Denmark
facility: Investigational Site Number : 2080001
city: Vejle
country: Denmark
facility: Investigational Site Number : 2080003
city: Tartu
country: Estonia
facility: Investigational Site Number : 2330001
city: Lyon
country: France
facility: Investigational Site Number : 2500001
city: Montpellier
country: France
facility: Investigational Site Number : 2500002
city: Pessac
country: France
facility: Investigational Site Number : 2500003
city: Reims
country: France
facility: Investigational Site Number : 2500004
city: Batumi
country: Georgia
facility: Investigational Site Number : 2680003
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680001
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680002
city: Bendorf
country: Germany
facility: Investigational Site Number : 2760006
city: Berlin
country: Germany
facility: Investigational Site Number : 2760004
city: Berlin
country: Germany
facility: Investigational Site Number : 2760009
city: Berlin
country: Germany
facility: Investigational Site Number : 2760010
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number : 2760005
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760002
city: Hannover
country: Germany
facility: Investigational Site Number : 2760014
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760008
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760007
city: Lübeck
country: Germany
facility: Investigational Site Number : 2760003
city: Mainz
country: Germany
facility: Investigational Site Number : 2760001
city: Neu-Isenburg
country: Germany
facility: Investigational Site Number : 2760012
city: Rosenheim
country: Germany
facility: Investigational Site Number : 2760011
city: Balassagyarmat
country: Hungary
facility: Investigational Site Number : 3480002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480009
city: Edelény
country: Hungary
facility: Investigational Site Number : 3480005
city: Hajdunánás
country: Hungary
facility: Investigational Site Number : 3480004
city: Puspokladany
country: Hungary
facility: Investigational Site Number : 3480003
city: Szombathely
country: Hungary
facility: Investigational Site Number : 3480012
city: Százhalombatta
country: Hungary
facility: Investigational Site Number : 3480001
city: Belgaum
country: India
facility: Investigational Site Number : 3560016
city: Chandigarh
country: India
facility: Investigational Site Number : 3560001
city: India
country: India
facility: Investigational Site Number : 3560014
city: Jaipur
country: India
facility: Investigational Site Number : 3560013
city: Kanpur
country: India
facility: Investigational Site Number : 3560019
city: Kolkata
country: India
facility: Investigational Site Number : 3560010
city: Nagpur
country: India
facility: Investigational Site Number : 3560017
city: Nagpur
country: India
facility: Investigational Site Number : 3560005
city: Nashik
country: India
facility: Investigational Site Number : 3560009
city: Pune
country: India
facility: Investigational Site Number : 3560012
city: Pune
country: India
facility: Investigational Site Number : 3560018
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760002
city: Petah-Tikva
country: Israel
facility: Investigational Site Number : 3760001
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760009
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760004
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920023
state: Aichi
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920020
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Investigational Site Number : 3920005
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Investigational Site Number : 3920027
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Investigational Site Number : 3920030
state: Fukuoka
city: Mizunami-shi
country: Japan
facility: Investigational Site Number : 3920015
state: Gifu
city: Hiroshima-shi
country: Japan
facility: Investigational Site Number : 3920010
state: Hiroshima
city: Kure-shi
country: Japan
facility: Investigational Site Number : 3920021
state: Hiroshima
city: Kure-shi
country: Japan
facility: Investigational Site Number : 3920035
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920038
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920042
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Investigational Site Number : 3920013
state: Hyogo
city: Sakaide-shi
country: Japan
facility: Investigational Site Number : 3920009
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Investigational Site Number : 3920014
state: Kagawa
city: Konan-ku, Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920011
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920039
state: Kanagawa
city: Matsusaka-shi
country: Japan
facility: Investigational Site Number : 3920043
state: Mie
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Osaka
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920026
state: Osaka
city: Sakai-shi
country: Japan
facility: Investigational Site Number : 3920007
state: Osaka
city: Yao-shi
country: Japan
facility: Investigational Site Number : 3920006
state: Osaka
city: Sano-shi
country: Japan
facility: Investigational Site Number : 3920036
state: Tochigi
city: Chuo-ku
country: Japan
facility: Investigational Site Number : 3920040
state: Tokyo
city: Chuo-ku
country: Japan
facility: Investigational Site Number : 3920017
state: Tokyo
city: Chuo-ku
country: Japan
facility: Investigational Site Number : 3920024
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Investigational Site Number : 3920019
state: Tokyo
city: Kiyose-City
country: Japan
facility: Investigational Site Number : 3920029
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Investigational Site Number : 3920025
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Investigational Site Number : 3920016
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Investigational Site Number : 3920037
state: Tokyo
city: Toshima-ku
country: Japan
facility: Investigational Site Number : 3920041
state: Tokyo
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gangwon-do
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number : 4100005
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
city: Daugavpils
country: Latvia
facility: Investigational Site Number : 4280002
city: Riga
country: Latvia
facility: Investigational Site Number : 4280001
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400002
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400001
city: Klaipeda
country: Lithuania
facility: Investigational Site Number : 4400003
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840008
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840009
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840002
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Investigational Site Number : 4840010
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840003
city: Durango, Durango
country: Mexico
facility: Investigational Site Number : 4840012
city: Durango
country: Mexico
facility: Investigational Site Number : 4840007
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840006
city: Monterrey, Nuevo León
country: Mexico
facility: Investigational Site Number : 4840001
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840004
city: Arnhem
country: Netherlands
facility: Investigational Site Number : 5280005
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280001
city: Zutphen
country: Netherlands
facility: Investigational Site Number : 5280008
city: Lørenskog
country: Norway
facility: Investigational Site Number : 5780001
city: Wolomin
country: Poland
facility: Investigational Site Number : 6160005
state: Mazowieckie
city: Bialystok
country: Poland
facility: Investigational Site Number : 6160008
state: Podlaskie
city: Malbork
country: Poland
facility: Investigational Site Number : 6160003
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160002
state: Slaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigational Site Number : 6160009
state: Swietokrzyskie
city: Almada
country: Portugal
facility: Investigational Site Number : 6200009
city: Aveiro
country: Portugal
facility: Investigational Site Number : 6200006
city: Braga
country: Portugal
facility: Investigational Site Number : 6200002
city: Guimarães
country: Portugal
facility: Investigational Site Number : 6200001
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200010
city: Guaynabo
country: Puerto Rico
facility: Cardiopulmonary Research- Site Number : 8400040
city: Ponce
country: Puerto Rico
facility: BRCR Medical Center, Inc. Site Number : 8400190
city: San Juan
country: Puerto Rico
facility: BRCR Medical Center Site Number : 8400180
city: Temecula
country: Puerto Rico
facility: Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430005
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430003
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Ulyanovsk
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100013
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100019
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100002
city: Chatsworth
country: South Africa
facility: Investigational Site Number : 7100015
city: Durban
country: South Africa
facility: Investigational Site Number : 7100005
city: Durban
country: South Africa
facility: Investigational Site Number : 7100017
city: Durban
country: South Africa
facility: Investigational Site Number : 7100006
city: Durban
country: South Africa
facility: Investigational Site Number : 7100016
city: Gatesville
country: South Africa
facility: Investigational Site Number : 7100004
city: Middelburg
country: South Africa
facility: Investigational Site Number : 7100012
city: Parow
country: South Africa
facility: Investigational Site Number : 7100003
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100009
city: Palma de Mallorca
country: Spain
facility: Investigational Site Number : 7240004
state: Balears [Baleares]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240014
state: Barcelona [Barcelona]
city: Sant Boi de Llobregat
country: Spain
facility: Investigational Site Number : 7240006
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Investigational Site Number : 7240013
state: Cantabria
city: Mérida / Badajoz
country: Spain
facility: Investigational Site Number : 7240002
state: Extremadura
city: Lleida / Lleida
country: Spain
facility: Investigational Site Number : 7240009
state: Lleida [Lérida]
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number : 7240007
state: Madrid, Comunidad De
city: Pozuelo De Alarcón
country: Spain
facility: Investigational Site Number : 7240008
state: Madrid
city: Cáceres
country: Spain
facility: Investigational Site Number : 7240010
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Málaga
country: Spain
facility: Investigational Site Number : 7240001
city: Zaragoza
country: Spain
facility: Investigational Site Number : 7240012
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920007
city: Balcali Adana
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920003
city: Kirikkale
country: Turkey
facility: Investigational Site Number : 7920006
city: Mersin
country: Turkey
facility: Investigational Site Number : 7920002
city: Wishaw
country: United Kingdom
facility: Investigational Site Number : 8260006
state: Glasgow City
city: Tyne And Wear
country: United Kingdom
facility: Investigational Site Number : 8260007
state: North Tyneside
city: Chertsey
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Surrey
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260003
city: Liverpool
country: United Kingdom
facility: Investigational Site Number : 8260005
city: Milton Keynes
country: United Kingdom
facility: Investigational Site Number : 8260008
city: Newcastle upon Tyne
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: