Clinical trial NCT04701983: 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: 2021-01-08
Enrollment: 1127
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:

Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

* Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
* Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Detailed description: The study duration per participant:

* Screening period is 3-5 weeks
* Placebo-controlled treatment period is 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants
* Post-investigational medicinal product (IMP) treatment follow-up period is 20 weeks 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, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
* Participants with moderate-to-severe COPD
* Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough \[eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis\] has been excluded).
* Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:

  * Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
  * Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for \>24 hours in emergency department/urgent care facility.
* Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
* Body mass index (BMI) ≥18.0 kg/m\^2, or BMI ≥16.0 kg/m\^2 for participants enrolled in East-Asian countries.
* Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:

  * not a women of child-bearing potential (WOCBP) OR
  * a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.

Exclusion criteria:

* Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred.
* Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol \[THC\]) within 6 months prior to Screening (Visit 1A).
* Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study.
* Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
* Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
* Hypercapnia requiring bilevel positive airway pressure (BiPAP).
* Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
* Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
* Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
* Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
* Uncontrolled hypertension (ie, systolic blood pressure \[BP\] \>180 mm Hg or diastolic BP \>110 mm Hg with or without use of anti-hypertensive therapy).
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
* History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
* Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to sScreening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
* Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
* Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis.
* History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
* Previous use of itepekimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
timeFrame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary outcomes:
measure: Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline to Week 24
measure: Change from baseline in post-BD FEV1
timeFrame: Baseline to Week 24 and Week 52
measure: Change from baseline in pre-BD FEV1
timeFrame: Baseline to Week 52
measure: Time to first moderate or severe AECOPD
timeFrame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
measure: Annualized rate of severe AECOPD
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
measure: Time to first severe AECOPD
timeFrame: Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
measure: Annualized rate of corticosteroid-treated AECOPD
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
measure: Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
timeFrame: Baseline to Week 24 and Week 52
measure: Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)
timeFrame: Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
measure: Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score
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
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
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
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
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
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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Site Number : 8400012
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research Site Number : 8400178
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates Site Number : 8400392
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research Site Number : 8400182
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Research Institute Site Number : 8400431
state: Arizona
city: Huntington Park
country: United States
facility: California Research Institute Site Number : 8400400
state: California
city: La Jolla
country: United States
facility: Modena Allergy + Asthma Site Number : 8400036
state: California
city: La Palma
country: United States
facility: Imax Clinical Trials LLC 1 Site Number : 8400419
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center Inc. Site Number : 8400027
state: California
city: Los Angeles
country: United States
facility: MACRO Trials Site Number : 8400030
state: California
city: Northridge
country: United States
facility: Antelope Valley Clinical Trials Site Number : 8400003
state: California
city: Boulder
country: United States
facility: ~Alpine Clinical Research Center Site Number : 8400180
state: Colorado
city: Lafayette
country: United States
facility: Innovative Clinical Research Site Number : 8400017
state: Colorado
city: Clearwater
country: United States
facility: Clin Research W Florida Site Number : 8400004
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center Site Number : 8400037
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Site Number : 8400187
state: Florida
city: Kendall
country: United States
facility: Advanced Clinical Research Site Number : 8400409
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute Site Number : 8400455
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Center Site Number : 8400188
state: Florida
city: Miami
country: United States
facility: University of Miami/Miami VA Medical Center Site Number : 8400026
state: Florida
city: Miami
country: United States
facility: DL Research Solutions Inc Site Number : 8400033
state: Florida
city: Miami
country: United States
facility: My Community Research Center Site Number : 8400347
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research Site Number : 8400397
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida,Inc Site Number : 8400006
state: Florida
city: Miami
country: United States
facility: PROLIVE MEDICAL RESEARCH Site Number : 8400420
state: Florida
city: Miami
country: United States
facility: Reed Medical Research Site Number : 8400032
state: Florida
city: Miami
country: United States
facility: High Quality Research Site Number : 8400406
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research Site Number : 8400013
state: Florida
city: Pembroke Pines
country: United States
facility: Tellabio International Research Services Site Number : 8400411
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center Site Number : 8400376
state: Florida
city: Plantation
country: United States
facility: Broward Pulmonary and Sleep Specialists Site Number : 8400031
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Medical Research Institute Site Number : 8400044
state: Florida
city: Saint Petersburg
country: United States
facility: Pasadena Center for Medical Research Site Number : 8400043
state: Florida
city: Tampa
country: United States
facility: AdtreMed Site Number : 8400442
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates Site Number : 8400388
state: Florida
city: Adairsville
country: United States
facility: Appalachian Clinical Research Site Number : 8400024
state: Georgia
city: Atlanta
country: United States
facility: Covenant Pulmonary Critical Care Site Number : 8400183
state: Georgia
city: Cordele
country: United States
facility: David Kavtaradze MD, Inc. Site Number : 8400029
state: Georgia
city: Dunwoody
country: United States
facility: Alpha Clinical Research Georgia Site Number : 8400190
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Biomedical Research Site Number : 8400007
state: Georgia
city: Evergreen Park
country: United States
facility: GenHarp Clinical Solutions Site Number : 8400028
state: Illinois
city: Hammond
country: United States
facility: ASHA Clinical Research Site Number : 8400408
state: Indiana
city: Covington
country: United States
facility: Benchmark Research Site Number : 8400193
state: Louisiana
city: Bangor
country: United States
facility: Paul Shapero, PC Site Number : 8400016
state: Maine
city: Boston
country: United States
facility: Care Access Site Number : 8400276
state: Massachusetts
city: Boston
country: United States
facility: Care Access Site Number : 8400277
state: Massachusetts
city: Boston
country: United States
facility: Care Access Site Number : 8400278
state: Massachusetts
city: Boston
country: United States
facility: Care Access Site Number : 8400280
state: Massachusetts
city: Boston
country: United States
facility: Care Access Site Number : 8400281
state: Massachusetts
city: Fall River
country: United States
facility: Exordia Medical Research, Inc. Site Number : 8400041
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research Institute, LLC Site Number : 8400191
state: Michigan
city: Warren
country: United States
facility: Advanced Pulmonary Research Institute of Michigan Site Number : 8400403
state: Michigan
city: Hannibal
country: United States
facility: Hannibal Clinic Site Number : 8400383
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Chest Consultants, P.C. Site Number : 8400002
state: Missouri
city: Henderson
country: United States
facility: Hendeson Clinical Trials Site Number : 8400365
state: Nevada
city: Mount Kisco
country: United States
facility: Northwell Health Site Number : 8400019
state: New York
city: Schenectady
country: United States
facility: WellNow Urgent Care and Clinical Research Site Number : 8400378
state: New York
city: Gastonia
country: United States
facility: Gastonia Pharmaceutical Research Site Number : 8400010
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University Brody School Of Medicine Site Number : 8400022
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center Site Number : 8400005
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare Site Number : 8400001
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center Site Number : 8400011
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center Site Number : 8400014
state: Ohio
city: Springdale
country: United States
facility: WellNow Urgent Care and Research Site Number : 8400039
state: Ohio
city: DuBois
country: United States
facility: Clinical Research of Central PA Site Number : 8400023
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants Site Number : 8400181
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill Site Number : 8400008
state: South Carolina
city: Beaumont
country: United States
facility: REX Clinical Trials Site Number : 8400371
state: Texas
city: Carrollton
country: United States
facility: Clinrx Research Site Number : 8400021
state: Texas
city: Cedar Park
country: United States
facility: Austin Pulmonary Consultants Site Number : 8400035
state: Texas
city: Corsicana
country: United States
facility: Corsicana Medical Research, LLC Site Number : 8400018
state: Texas
city: Denison
country: United States
facility: Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center Site Number : 8400189
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute Site Number : 8400194
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic Site Number : 8400398
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center Site Number : 8400015
state: Texas
city: Mesquite
country: United States
facility: PRX Research Site Number : 8400380
state: Texas
city: North Richland Hills
country: United States
facility: The Lung and Sleep Research Institute of North Texas Site Number : 8400417
state: Texas
city: Plano
country: United States
facility: Clincove: Plano Primary Care Clinic Site Number : 8400424
state: Texas
city: Plano
country: United States
facility: EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414
state: Texas
city: Sherman
country: United States
facility: Advance Lung and Sleep Center Site Number : 8400040
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research Site Number : 8400009
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research Site Number : 8400179
state: Texas
city: Webster
country: United States
facility: Clearlake Specialties Site Number : 8400025
state: Texas
city: Caba
country: Argentina
facility: Investigational Site Number : 0320001
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigational Site Number : 0320002
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320005
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320004
city: Dimitrovgrad
country: Bulgaria
facility: Investigational Site Number : 1000005
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1000006
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1000003
city: Veliko Tyrnovo
country: Bulgaria
facility: Investigational Site Number : 1000007
city: Vidin
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Temuco
country: Chile
facility: Investigational Site Number : 1520008
state: La Araucanía
city: Curicó
country: Chile
facility: Investigational Site Number : 1520007
state: Maule
city: Talca
country: Chile
facility: Investigational Site Number : 1520002
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520009
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 : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520005
state: Valparaíso
city: Baotou
country: China
facility: Investigational Site Number : 1560003
city: Beijing
country: China
facility: Investigational Site Number : 1560004
city: Beijing
country: China
facility: Investigational Site Number : 1560030
city: Beijing
country: China
facility: Investigational Site Number : 1560014
city: Changchun
country: China
facility: Investigational Site Number : 1560002
city: Changsha
country: China
facility: Investigational Site Number : 1560012
city: Changsha
country: China
facility: Investigational Site Number : 1560013
city: Changsha
country: China
facility: Investigational Site Number : 1560047
city: Chengdu
country: China
facility: Investigational Site Number : 1560001
city: Chengdu
country: China
facility: Investigational Site Number : 1560040
city: Chongqing
country: China
facility: Investigational Site Number : 1560032
city: Guangzhou
country: China
facility: Investigational Site Number : 1560006
city: Guangzhou
country: China
facility: Investigational Site Number : 1560025
city: Haikou
country: China
facility: Investigational Site Number : 1560036
city: Hangzhou
country: China
facility: Investigational Site Number : 1560022
city: Hangzhou
country: China
facility: Investigational Site Number : 1560039
city: Hefei
country: China
facility: Investigational Site Number : 1560017
city: Hohhot
country: China
facility: Investigational Site Number : 1560008
city: Hohhot
country: China
facility: Investigational Site Number : 1560010
city: Jinan
country: China
facility: Investigational Site Number : 1560044
city: Jinan
country: China
facility: Investigational Site Number : 1560027
city: Nanchang
country: China
facility: Investigational Site Number : 1560031
city: Nanjing
country: China
facility: Investigational Site Number : 1560035
city: Nanning
country: China
facility: Investigational Site Number : 1560023
city: Pingxiang
country: China
facility: Investigational Site Number : 1560015
city: Shanghai
country: China
facility: Investigational Site Number : 1560043
city: Shanghai
country: China
facility: Investigational Site Number : 1560034
city: Shanghai
country: China
facility: Investigational Site Number : 1560009
city: Shanghai
country: China
facility: Investigational Site Number : 1560045
city: Shenyang
country: China
facility: Investigational Site Number : 1560005
city: Shenzhen
country: China
facility: Investigational Site Number : 1560020
city: Shijiazhuang
country: China
facility: Investigational Site Number : 1560028
city: Tianjin
country: China
facility: Investigational Site Number : 1560024
city: Wenzhou
country: China
facility: Investigational Site Number : 1560019
city: Wuhan
country: China
facility: Investigational Site Number : 1560029
city: Xi'an
country: China
facility: Investigational Site Number : 1560016
city: Xiangtan
country: China
facility: Investigational Site Number : 1560046
city: Xuzhou
country: China
facility: Investigational Site Number : 1560007
city: Yangzhou
country: China
facility: Investigational Site Number : 1560026
city: Zhanjiang
country: China
facility: Investigational Site Number : 1560041
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560042
city: Zhongshan
country: China
facility: Investigational Site Number : 1560048
city: Havlickuv Brod
country: Czechia
facility: Investigational Site Number : 2030006
city: Jindrichuv Hradec III
country: Czechia
facility: Investigational Site Number : 2030001
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030004
city: Praha 4
country: Czechia
facility: Investigational Site Number : 2030002
city: Praha 5 - Radotin
country: Czechia
facility: Investigational Site Number : 2030005
city: Praha 8
country: Czechia
facility: Investigational Site Number : 2030003
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680002
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680003
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680001
city: Athens
country: Greece
facility: Investigational Site Number : 3000005
city: Athens
country: Greece
facility: Investigational Site Number : 3000006
city: Heraklion
country: Greece
facility: Investigational Site Number : 3000004
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000001
city: Larisa
country: Greece
facility: Investigational Site Number : 3000007
city: Palaio Faliro, Athens
country: Greece
facility: Investigational Site Number : 3000008
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3480004
city: Gödöllö
country: Hungary
facility: Investigational Site Number : 3480001
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number : 3480002
city: Pécs
country: Hungary
facility: Investigational Site Number : 3480003
city: Coimbatore
country: India
facility: Investigational Site Number : 3560002
city: Hyderabad
country: India
facility: Investigational Site Number : 3560005
city: Jaipur
country: India
facility: Investigational Site Number : 3560004
city: Kozhikode
country: India
facility: Investigational Site Number : 3560001
city: Mumbai
country: India
facility: Investigational Site Number : 3560007
city: Nagpur
country: India
facility: Investigational Site Number : 3560003
city: Haifa
country: Israel
facility: Investigational Site Number : 3760008
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760002
city: Kfar-Saba
country: Israel
facility: Investigational Site Number : 3760006
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: Tel Aviv
country: Israel
facility: Investigational Site Number : 3760007
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800003
state: Milano
city: Foggia
country: Italy
facility: Investigational Site Number : 3800004
state: Puglia
city: Catania
country: Italy
facility: Investigational Site Number : 3800005
city: Ferrara
country: Italy
facility: Investigational Site Number : 3800001
city: Verona
country: Italy
facility: Investigational Site Number : 3800007
city: Quatre Bornes
country: Mauritius
facility: Investigational Site Number : 4800001
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840001
state: Jalisco
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840011
state: Jalisco
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840010
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Investigational Site Number : 4840007
state: Morelos
city: Cdmx
country: Mexico
facility: Investigational Site Number : 4840002
state: México
city: Oaxaca de Juarez
country: Mexico
facility: Investigational Site Number : 4840016
state: Oaxaca
city: San Juan del Rio
country: Mexico
facility: Investigational Site Number : 4840003
state: Querétaro
city: Aguascalientes
country: Mexico
facility: Investigational Site Number : 4840013
city: Benito Juarez
country: Mexico
facility: Investigational Site Number : 4840004
city: Oaxaca
country: Mexico
facility: Investigational Site Number : 4840014
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160004
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160003
state: Mazowieckie
city: Bialystok
country: Poland
facility: Investigational Site Number : 6160001
state: Podlaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigational Site Number : 6160002
state: Swietokrzyskie
city: Bragadiru
country: Romania
facility: Investigational Site Number : 6420005
city: Brasov
country: Romania
facility: Investigational Site Number : 6420006
city: Bucaresti
country: Romania
facility: Investigational Site Number : 6420012
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number : 6420002
city: Codlea
country: Romania
facility: Investigational Site Number : 6420007
city: Deva
country: Romania
facility: Investigational Site Number : 6420010
city: Iasi
country: Romania
facility: Investigational Site Number : 6420001
city: Oradea
country: Romania
facility: Investigational Site Number : 6420009
city: Timisoara
country: Romania
facility: Investigational Site Number : 6420003
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430003
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430005
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Bardejov
country: Slovakia
facility: Investigational Site Number : 7030009
city: Humenne
country: Slovakia
facility: Investigational Site Number : 7030007
city: Levice
country: Slovakia
facility: Investigational Site Number : 7030003
city: Martin
country: Slovakia
facility: Investigational Site Number : 7030011
city: Poprad
country: Slovakia
facility: Investigational Site Number : 7030002
city: Presov
country: Slovakia
facility: Investigational Site Number : 7030010
city: Spisska Nova Ves
country: Slovakia
facility: Investigational Site Number : 7030001
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number : 1580005
city: New Taipei City
country: Taiwan
facility: Investigational Site Number : 1580002
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580006
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580004
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580003
city: Yunlin
country: Taiwan
facility: Investigational Site Number : 1580008
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number : 8040003
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site Number : 8040007
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040008
city: Kharkiv
country: Ukraine
facility: Investigational Site Number : 8040006
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040004
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040001
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040005
city: Kyiv
country: Ukraine
facility: Investigational Site Number : 8040011
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Hampshire
city: Ashton-under-Lyne
country: United Kingdom
facility: Investigational Site Number : 8260015
state: Lancashire
city: Wigan
country: United Kingdom
facility: Investigational Site Number : 8260010
state: Lancashire
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260016
state: Manchester
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260003
city: Heston
country: United Kingdom
facility: Investigational Site Number : 8260014
city: London
country: United Kingdom
facility: Investigational Site Number : 8260001
city: Redruth
country: United Kingdom
facility: Investigational Site Number : 8260013
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: