Clinical trial NCT05097287: Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
Official title: A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-10-28
Enrollment: 1324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
* Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
* Treatment with medium to high dose inhaled corticosteroids (ICS) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), leukotriene receptor antagonists (LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1. Patients requiring an additional controller as a fourth controller (Montelukast) for another type 2 comorbid condition such as allergic rhinitis will be considered eligible for this study, and should be on a stable dose for ≥1 month prior to Visit 1.
* Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization
* Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.
* Variable airflow obstruction as documented by one or more of the following (at least 1 needs to be met):

  i) Positive reversibility test: ≥12% and 200 mL improvement in FEV1 after SABA administration prior to randomization, or documented in the 24 months prior to Visit 1. OR, ii) Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine, or ≥15% with standardized hyperventilation, hypertonic saline or mannitol challenge prior to randomization or documented in the 24 months prior to Visit 1 OR, iii) Average daily diurnal Peak flow variability of \>10% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. OR, iv) Airflow variability in clinic FEV1 \>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Screening Visit 1. OR v) FEV1 increases by more than 12% and 200mL from baseline after 4 weeks of anti-inflammatory treatment.
* Reversibility test: Three attempts may be made during the Screening Period until the Baseline visit to meet the qualifying criteria for reversibility. This is only required if reversibility or other evidence of expiratory airflow limitation eligibility criteria was not performed within 24 months prior to Visit 1.
* FeNO ≥35 ppb at Visit 2, prior to randomization.
* History of ≥1 severe exacerbation(s) in the previous year before Visit1 defined as a deterioration of asthma requiring:

  i) Use of systemic corticosteroids for ≥3 days; or ii) Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).
* Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.
* Current acute bronchospasm or status asthmaticus.
* Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms \[CRFs\], etc).
* Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.
* Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.
* History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
* Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
* Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
* Previous smoker with a smoking history \>10 pack-years.
* History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
* Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.
* Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.

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

Primary outcomes:
measure: Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population
timeFrame: Week 8 to Week 52
Secondary outcomes:
measure: Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population
timeFrame: Week 8 to Week 52
measure: Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population
timeFrame: Week 8 to Week 104
measure: Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population
timeFrame: Week 8 to Week 104
measure: Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 104 in FeNO levels in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 104 in ACQ-7 in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 104 FVC in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations
timeFrame: Baseline to Week 52
measure: Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations
timeFrame: Baseline to Week 104
measure: Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations
timeFrame: Week 8 to Week 156
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Baseline to Week 168
measure: Incidence of adverse events of special interest (AESIs)
timeFrame: Baseline to Week 168
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Research Center- Site Number : 8400001
state: Alabama
city: Sheffield
country: United States
facility: Shoals Primary Care - Sheffield- Site Number : 8400015
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Research Trials- Site Number : 8400147
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates - Deer Valley Office- Site Number : 8400155
state: Arizona
city: Phoenix
country: United States
facility: Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management - Tucson- Site Number : 8400017
state: Arizona
city: Bakersfield
country: United States
facility: Kern Allergy and Medical Research- Site Number : 8400037
state: California
city: Beverly Hills
country: United States
facility: Vitality Clinical Research- Site Number : 8400142
state: California
city: Fullerton
country: United States
facility: Ascada Research - Fullerton- Site Number : 8400076
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group- Site Number : 8400162
state: California
city: Newport Beach
country: United States
facility: Newport Native MD- Site Number : 8400054
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations- Site Number : 8400131
state: California
city: Sacramento
country: United States
facility: Mercy Medical Group - Midtown- Site Number : 8400164
state: California
city: Upland
country: United States
facility: Integrated Research of Inland- Site Number : 8400156
state: California
city: Westminster
country: United States
facility: Allianz Research Institute- Site Number : 8400018
state: California
city: Woodland
country: United States
facility: Woodland Clinic - Woodland- Site Number : 8400171
state: California
city: Altamonte Springs
country: United States
facility: Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035
state: Florida
city: Aventura
country: United States
facility: Florida Center for Allergy & Asthma Research- Site Number : 8400032
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center- Site Number : 8400141
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023
state: Florida
city: Kissimmee
country: United States
facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research - Miami Lakes- Site Number : 8400091
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group- Site Number : 8400063
state: Florida
city: Miami
country: United States
facility: My Preferred Research- Site Number : 8400073
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida- Site Number : 8400079
state: Florida
city: Orlando
country: United States
facility: Heuer M.D. Research- Site Number : 8400024
state: Florida
city: Tampa
country: United States
facility: JSV Clinical Research- Site Number : 8400150
state: Florida
city: Calhoun
country: United States
facility: Appalachian Clinical Research- Site Number : 8400129
state: Georgia
city: Dunwoody
country: United States
facility: Alpha Clinical Research Group - Dunwoody- Site Number : 8400116
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Laboratory- Site Number : 8400114
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center- Site Number : 8400146
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie- Site Number : 8400138
state: Illinois
city: Louisville
country: United States
facility: Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160
state: Kentucky
city: Owensboro
country: United States
facility: Allergy and Asthma Specialist- Site Number : 8400007
state: Kentucky
city: Crowley
country: United States
facility: Avant Research Associates - Crowley- Site Number : 8400117
state: Louisiana
city: Metairie
country: United States
facility: Tandem Clinical Research - Metairie- Site Number : 8400163
state: Louisiana
city: Annapolis
country: United States
facility: Javara - Privia Medical Group - Annapolis- Site Number : 8400087
state: Maryland
city: Columbia
country: United States
facility: Kur Research - Columbia Medical- Site Number : 8400169
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research - White Marsh- Site Number : 8400119
state: Maryland
city: Fall River
country: United States
facility: Genesis Clinical Research - Fall River- Site Number : 8400050
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System - Ann Arbor- Site Number : 8400030
state: Michigan
city: Dearborn
country: United States
facility: Revival Research Institute - Dearborn- Site Number : 8400097
state: Michigan
city: Lathrup Village
country: United States
facility: Revive Research Institute - Lathrup Village- Site Number : 8400100
state: Michigan
city: Rochester
country: United States
facility: Romedica- Site Number : 8400043
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute Site Number : 8400111
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute- Site Number : 8400111
state: Michigan
city: Ypsilanti
country: United States
facility: Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107
state: Michigan
city: Bellevue
country: United States
facility: The Asthma and Allergy Center- Site Number : 8400055
state: Nebraska
city: Jersey City
country: United States
facility: Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143
state: New Jersey
city: Bronx
country: United States
facility: Urban Health Plan- Site Number : 8400144
state: New York
city: Gastonia
country: United States
facility: Clinical Research Of Gastonia- Site Number : 8400012
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056
state: North Carolina
city: Mooresville
country: United States
facility: Lapis Clinical Research - Mooresville- Site Number : 8400112
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center- Site Number : 8400153
state: North Carolina
city: Toledo
country: United States
facility: Asthma & Allergy Center - Toledo- Site Number : 8400051
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Hospital- Site Number : 8400099
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital- Site Number : 8400038
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042
state: Pennsylvania
city: Columbia
country: United States
facility: Bogan Sleep Consultants- Site Number : 8400102
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research, PA- Site Number : 8400026
state: South Carolina
city: Little River
country: United States
facility: Main Street Physician's Care- Site Number : 8400077
state: South Carolina
city: North Charleston
country: United States
facility: National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts- Site Number : 8400006
state: South Dakota
city: Beaumont
country: United States
facility: REX Clinical Trials - Beaumont- Site Number : 8400135
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8400009
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials - Dallas- Site Number : 8400123
state: Texas
city: Dallas
country: United States
facility: IntraCare- Site Number : 8400003
state: Texas
city: Houston
country: United States
facility: C & R Research Services - Houston- Site Number : 8400067
state: Texas
city: Houston
country: United States
facility: Clear Brook Medical Associates- Site Number : 8400080
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center- Site Number : 8400014
state: Texas
city: San Antonio
country: United States
facility: Andante Research- Site Number : 8400140
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - 710 Lawrence Street- Site Number : 8400103
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine and Research- Site Number : 8400170
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia- Site Number : 8400082
state: Virginia
city: Brussels
country: Belgium
facility: Investigational Site Number : 0560002
city: Liège
country: Belgium
facility: Investigational Site Number : 0560003
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760006
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760003
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760005
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmão- Site Number : 0760002
state: Santa Catarina
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760009
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760007
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
city: Dupnitsa
country: Bulgaria
facility: Investigational Site Number : 1000005
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number : 1000012
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1000011
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000014
city: Vratsa
country: Bulgaria
facility: Investigational Site Number : 1000013
city: Calgary
country: Canada
facility: Investigational Site Number : 1240028
state: Alberta
city: Kelowna
country: Canada
facility: Investigational Site Number : 1240020
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240022
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240004
state: British Columbia
city: Moncton
country: Canada
facility: Investigational Site Number : 1240010
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational Site Number : 1240015
state: Ontario
city: Niagara Falls
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240011
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240001
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240007
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240014
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240017
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240023
state: Quebec
city: Quebec City
country: Canada
facility: Investigational Site Number : 1240002
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240025
state: Quebec
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240024
state: Saskatchewan
city: Beijing
country: China
facility: Investigational Site Number : 1560017
city: Beijing
country: China
facility: Investigational Site Number : 1560022
city: Beijing
country: China
facility: Investigational Site Number : 1560030
city: Bengbu
country: China
facility: Investigational Site Number : 1560024
city: Dongguan
country: China
facility: Investigational Site Number : 1560006
city: Guangzhou
country: China
facility: Investigational Site Number : 1560007
city: Guiyang
country: China
facility: Investigational Site Number : 1560019
city: Hebei
country: China
facility: Investigational Site Number : 1560003
city: Luzhou
country: China
facility: Investigational Site Number : 1560029
city: Nanchang
country: China
facility: Investigational Site Number : 1560002
city: Nanjing
country: China
facility: Investigational Site Number : 1560014
city: Ningbo
country: China
facility: Investigational Site Number : 1560008
city: Ningbo
country: China
facility: Investigational Site Number : 1560031
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Taiyuan
country: China
facility: Investigational Site Number : 1560011
city: Tianjin
country: China
facility: Investigational Site Number : 1560004
city: Tianjin
country: China
facility: Investigational Site Number : 1560025
city: Wuxi
country: China
facility: Investigational Site Number : 1560009
city: Xi An
country: China
facility: Investigational Site Number : 1560028
city: Xiamen
country: China
facility: Investigational Site Number : 1560020
city: Yichang
country: China
facility: Investigational Site Number : 1560013
city: Yueyang
country: China
facility: Investigational Site Number : 1560010
city: Athens
country: Greece
facility: Investigational Site Number : 3000003
city: Athens
country: Greece
facility: Investigational Site Number : 3000010
city: Athens
country: Greece
facility: Investigational Site Number : 3000007
city: Athens
country: Greece
facility: Investigational Site Number : 3000004
city: Athens
country: Greece
facility: Investigational Site Number : 3000006
city: Athens
country: Greece
facility: Investigational Site Number : 3000005
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000002
city: Palaio Faliro
country: Greece
facility: Investigational Site Number : 3000009
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000008
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000001
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480011
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480012
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3480008
city: Edelény
country: Hungary
facility: Investigational Site Number : 3480005
city: Hajdúnánás
country: Hungary
facility: Investigational Site Number : 3480004
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number : 3480007
city: Püspökladány
country: Hungary
facility: Investigational Site Number : 3480003
city: Szekszárd
country: Hungary
facility: Investigational Site Number : 3480013
city: Szombathely
country: Hungary
facility: Investigational Site Number : 3480006
city: Százhalombatta
country: Hungary
facility: Investigational Site Number : 3480001
city: Ahmedabad
country: India
facility: Investigational Site Number : 3560011
city: Chandigarh
country: India
facility: Investigational Site Number : 3560003
city: Coimbatore
country: India
facility: Investigational Site Number : 3560008
city: Faridabad
country: India
facility: Investigational Site Number : 3560016
city: Jaipur
country: India
facility: Investigational Site Number : 3560001
city: Jodhpur
country: India
facility: Investigational Site Number : 3560019
city: Kozhikode
country: India
facility: Investigational Site Number : 3560002
city: Lucknow
country: India
facility: Investigational Site Number : 3560014
city: Mangaluru
country: India
facility: Investigational Site Number : 3560006
city: Mysuru
country: India
facility: Investigational Site Number : 3560018
city: Nagpur
country: India
facility: Investigational Site Number : 3560009
city: Nagpur
country: India
facility: Investigational Site Number : 3560012
city: New Delhi
country: India
facility: Investigational Site Number : 3560015
city: Pune
country: India
facility: Investigational Site Number : 3560020
city: Vadodara
country: India
facility: Investigational Site Number : 3560004
city: Cork
country: Ireland
facility: Investigational Site Number : 3720001
city: Dublin
country: Ireland
facility: Investigational Site Number : 3720003
city: Busan
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Busan-gwangyeoksi
city: Wonju-si
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Gangwon-do
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Gyeongsangbuk-do
city: Bupyeong-gu
country: Korea, Republic of
facility: Investigational Site Number : 4100010
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100009
state: Seoul-teukbyeolsi
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
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100005
state: Seoul-teukbyeolsi
city: Mexico City
country: Mexico
facility: Investigational Site Number : 4840006
state: Ciudad De Mexico
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840002
state: Jalisco
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840008
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840005
state: Nuevo León
city: San Juan Del Río
country: Mexico
facility: Investigational Site Number : 4840014
state: Querétaro
city: Villahermosa
country: Mexico
facility: Investigational Site Number : 4840010
state: Tabasco
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840016
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840012
city: Durango
country: Mexico
facility: Investigational Site Number : 4840001
city: Oaxaca
country: Mexico
facility: Investigational Site Number : 4840013
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840003
city: Muscat
country: Oman
facility: Investigational Site Number : 5120001
city: Muscat
country: Oman
facility: Investigational Site Number : 5120002
city: Lima
country: Peru
facility: Investigational Site Number : 6040001
city: Lima
country: Peru
facility: Investigational Site Number : 6040002
city: Piura
country: Peru
facility: Investigational Site Number : 6040003
city: Guaynabo
country: Puerto Rico
facility: Cardio Pulmonary Research Center- Site Number : 8400126
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research- Site Number : 8400121
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico - Medical Sciences Campus- Site Number : 8400128
city: Baia Mare
country: Romania
facility: Investigational Site Number : 6420010
city: Bragadiru
country: Romania
facility: Investigational Site Number : 6420005
city: Brasov
country: Romania
facility: Investigational Site Number : 6420007
city: Brașov
country: Romania
facility: Investigational Site Number : 6420002
city: Codlea
country: Romania
facility: Investigational Site Number : 6420004
city: Craiova
country: Romania
facility: Investigational Site Number : 6420011
city: Deva
country: Romania
facility: Investigational Site Number : 6420001
city: Pitești
country: Romania
facility: Investigational Site Number : 6420008
city: Timisoara
country: Romania
facility: Investigational Site Number : 6420009
city: Levice
country: Slovakia
facility: Investigational Site Number : 7030003
city: Poprad
country: Slovakia
facility: Investigational Site Number : 7030001
city: Spišská Nová Ves
country: Slovakia
facility: Investigational Site Number : 7030002
city: Topoľčany
country: Slovakia
facility: Investigational Site Number : 7030005
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100006
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100013
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100001
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100004
city: Chatsworth
country: South Africa
facility: Investigational Site Number : 7100012
city: Durban
country: South Africa
facility: Investigational Site Number : 7100003
city: Durban
country: South Africa
facility: Investigational Site Number : 7100009
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100014
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100002
city: Somerset West
country: South Africa
facility: Investigational Site Number : 7100008
city: Vereeniging
country: South Africa
facility: Investigational Site Number : 7100007
city: Douliu
country: Taiwan
facility: Investigational Site Number : 1580003
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580004
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580002
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920007
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920008
city: Balcali Adana
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920006
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920009
city: Kirikkale
country: Turkey
facility: Investigational Site Number : 7920004
city: Mersin
country: Turkey
facility: Investigational Site Number : 7920002
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840001
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840002
city: Cambridge
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Cambridgeshire
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Oxfordshire
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260002
city: Liverpool
country: United Kingdom
facility: Investigational Site Number : 8260005
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number : 8260001
city: Wakefield
country: United Kingdom
facility: Investigational Site Number : 8260008
Study officials:
References: