Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Itepekimab SAR440340Drug: Placebo
- Registration Number
- NCT04751487
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Itepekimab Q4W in former smokers Itepekimab SAR440340 SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP Itepekimab Q4W in former smokers Placebo SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP Placebo in former smokers Placebo SC administration of matching placebo Q2W for up to 52 weeks Itepekimab Q2W in current smokers Itepekimab SAR440340 SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks Placebo in current smokers Placebo SC administration of matching placebo Q2W for 52 weeks Itepekimab Q2W in former smokers Itepekimab SAR440340 Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
- Primary Outcome Measures
Name Time Method Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
- Secondary Outcome Measures
Name Time Method Change from baseline in pre-BD FEV1 in former smokers Baseline to Week 52 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score in former smokers Baseline to Week 24 and Week 52 The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Change from baseline in post-BD FEV1 in former smokers Baseline to Week 24 and Week 52 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers Baseline to Week 24 and Week 52 The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers 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) Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers Baseline to Week 24 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time to first moderate or severe AECOPD in former smokers Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Time to first moderate or severe AECOPD over the placebo-controlled treatment period.
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score in former smokers Baseline to Week 24 and Week 52 The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
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 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) Functional itepekimab concentrations in serum in former smokers 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) Annualized rate of severe AECOPD in former smokers Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Annualized rate of severe AECOPD over the placebo-controlled treatment period.
Time to first severe AECOPD in former smokers Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Time to first severe AECOPD over the placebo-controlled treatment period.
Annualized rate of corticosteroid-treated AECOPD in former smokers Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) in former smokers Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers 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) Functional itepekimab concentrations in serum in current smokers 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) Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers 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) Change from baseline in pre-BD FEV1 in current smokers Baseline up to Week 24 and Week 52 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers 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) Annualized rate of moderate or severe AECOPD in current smokers Baseline up to Week 52 Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period.
Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers 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)
Trial Locations
- Locations (317)
Temple University Hospital Site Number : 8400062
🇺🇸Philadelphia, Pennsylvania, United States
Remington-Davis Inc Site Number : 8400004
🇺🇸Columbus, Ohio, United States
Care Access Site Number : 8400276
🇺🇸Boston, Massachusetts, United States
Columbus Clinical Services Site Number : 8400054
🇺🇸Miami, Florida, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400009
🇺🇸Miami, Florida, United States
Phoenix Medical Research Site Number : 8400019
🇺🇸Miami, Florida, United States
Sierra Clinical Research Site Number : 8400005
🇺🇸Las Vegas, Nevada, United States
Sun Research Institute Site Number : 8400183
🇺🇸San Antonio, Texas, United States
Investigational Site Number : 8260007
🇬🇧Tyne And Wear, North Tyneside, United Kingdom
SER da Bahia Site Number : 0760020
🇧🇷Salvador, Bahia, Brazil
CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza Site Number : 0760018
🇧🇷Brasilia, Distrito Federal, Brazil
Synexus Phoenix Central (Central Phoenix Medical Clinic) Site Number : 8400333
🇺🇸Phoenix, Arizona, United States
Investigational Site Number : 1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Clinica de Alergia Martti Antila Site Number : 0760008
🇧🇷Sorocaba, São Paulo, Brazil
Investigational Site Number : 4840008
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 3560010
🇮🇳Kolkata, India
Investigational Site Number : 6200009
🇵🇹Almada, Portugal
Investigational Site Number : 1520005
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 3560014
🇮🇳India, India
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760013
🇧🇷Sao Paulo, São Paulo, Brazil
Investigational Site Number : 4400002
🇱🇹Kaunas, Lithuania
Investigational Site Number : 4840010
🇲🇽Aguascalientes, Mexico
Investigational Site Number : 6200001
🇵🇹Guimarães, Portugal
Investigational Site Number : 8260002
🇬🇧Chertsey, Surrey, United Kingdom
Investigational Site Number : 3920001
🇯🇵Meguro-ku, Tokyo, Japan
Investigational Site Number : 3920017
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920024
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920019
🇯🇵Itabashi-ku, Tokyo, Japan
Investigational Site Number : 4840002
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840012
🇲🇽Durango, Durango, Mexico
Investigational Site Number : 6160008
🇵🇱Bialystok, Podlaskie, Poland
Investigational Site Number : 6200004
🇵🇹Coimbra, Portugal
Investigational Site Number : 4840006
🇲🇽Mexico City, Mexico
Investigational Site Number : 6200003
🇵🇹Porto, Portugal
Allianz Research Institute Colorado Site Number : 8400061
🇺🇸Denver, Colorado, United States
Genesis Clinical Research, LLC Site Number : 8400182
🇺🇸Tampa, Florida, United States
North Georgia Clinical Research Site Number : 8400013
🇺🇸Woodstock, Georgia, United States
Helix Biomedics, LLC Site Number : 8400049
🇺🇸Boynton Beach, Florida, United States
Probe Clinical Research Corporation Site Number : 8400188
🇺🇸Riverside, California, United States
Meris Clinical Research Site Number : 8400021
🇺🇸Brandon, Florida, United States
Direct Helpers Medical Center Inc Site Number : 8400065
🇺🇸Hialeah, Florida, United States
Omega Research Site Number : 8400031
🇺🇸DeBary, Florida, United States
Multi-Specialty Research Associates, Inc Site Number : 8400044
🇺🇸Lake City, Florida, United States
Sarasota Memorial Health Care System Clinical ResearchCenter Site Number : 8400178
🇺🇸Sarasota, Florida, United States
Clinical Research of West Florida, Inc Site Number : 8400008
🇺🇸Tampa, Florida, United States
Illinois Lung Institute Site Number : 8400024
🇺🇸Peoria, Illinois, United States
Medster Research, LLC Site Number : 8400051
🇺🇸Valdosta, Georgia, United States
The Iowa Clinic Site Number : 8400034
🇺🇸West Des Moines, Iowa, United States
Cotton O'Neil Garfield Site Number : 8400063
🇺🇸Topeka, Kansas, United States
Care Access Site Number : 8400281
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Asthma and Allergy Center Site Number : 8400055
🇺🇸Baltimore, Maryland, United States
Revive Research Institute Site Number : 8400186
🇺🇸Lathrup Village, Michigan, United States
Washington University School of Medicine Site Number : 8400035
🇺🇸Saint Louis, Missouri, United States
VA Western New York Healthcare System Site Number : 8400050
🇺🇸Buffalo, New York, United States
Rutgers Institute for Translational Medicine and Science/Rutgers University Site Number : 8400059
🇺🇸New Brunswick, New Jersey, United States
New York - Presbyterian Queens Site Number : 8400028
🇺🇸Flushing, New York, United States
Smart Medical Research Site Number : 8400191
🇺🇸Brooklyn, New York, United States
Schenectady Pulmonary and Critical Care Associates Site Number : 8400029
🇺🇸Schenectady, New York, United States
University of Cincinnati Site Number : 8400042
🇺🇸Cincinnati, Ohio, United States
St. Luke's University Health Network Site Number : 8400187
🇺🇸Bethlehem, Pennsylvania, United States
Kaiser Permanente Center for Health Research Site Number : 8400039
🇺🇸Portland, Oregon, United States
OK Clinical Research LLC Site Number : 8400001
🇺🇸Edmond, Oklahoma, United States
Clinical Trials Center of Middle Tennessee Site Number : 8400025
🇺🇸Franklin, Tennessee, United States
VitaLink Research- Gaffney Site Number : 8400003
🇺🇸Gaffney, South Carolina, United States
United Memorial Medical Center (UMMC) Site Number : 8400193
🇺🇸Houston, Texas, United States
TTS Research Site Number : 8400012
🇺🇸Boerne, Texas, United States
Clincove: Plano Primary Care Clinic Site Number : 8400424
🇺🇸Plano, Texas, United States
AES Salt Lake City Site Number : 8400332
🇺🇸Murray, Utah, United States
The Rheumatology and Pulmonary Clinic Site Number : 8400053
🇺🇸Beckley, West Virginia, United States
Investigational Site Number : 0320008
🇦🇷Caba, Buenos Aires, Argentina
Investigational Site Number : 0320001
🇦🇷Caba, Buenos Aires, Argentina
Investigational Site Number : 0320009
🇦🇷Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320007
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320002
🇦🇷Vicente Lopez, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320003
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320004
🇦🇷Rosario, Santa Fe, Argentina
Hospital Sao Domingos Site Number : 0760016
🇧🇷Sao Luis, Maranhão, Brazil
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760009
🇧🇷Vitoria, Espírito Santo, Brazil
Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760014
🇧🇷Belo Horizonte, Minas Gerais, Brazil
PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760010
🇧🇷Campinas, São Paulo, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760001
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Ceos Site Number : 0760021
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da PUCRS Site Number : 0760007
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760012
🇧🇷Curitiba, Paraná, Brazil
Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao Site Number : 0760006
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017
🇧🇷Rio de Janeiro, Brazil
CEPIC - Centro Paulista de Investigação Clínica Site Number : 0760004
🇧🇷Sao Paulo, Brazil
Investigational Site Number : 1000008
🇧🇬Blagoevgrad, Bulgaria
Investigational Site Number : 1000009
🇧🇬Haskovo, Bulgaria
Investigational Site Number : 1000013
🇧🇬Dupnitsa, Bulgaria
Investigational Site Number : 1000004
🇧🇬Gabrovo, Bulgaria
Investigational Site Number : 1000005
🇧🇬Montana, Bulgaria
Investigational Site Number : 1000002
🇧🇬Plovdiv, Bulgaria
Investigational Site Number : 1000003
🇧🇬Ruse, Bulgaria
Investigational Site Number : 1000012
🇧🇬Ruse, Bulgaria
Investigational Site Number : 1000001
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1240006
🇨🇦Sherwood Park, Alberta, Canada
Investigational Site Number : 1240014
🇨🇦Kelowna, British Columbia, Canada
Investigational Site Number : 1000006
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1240012
🇨🇦Moncton, New Brunswick, Canada
Investigational Site Number : 1240016
🇨🇦Penticton, British Columbia, Canada
Investigational Site Number : 1240021
🇨🇦Ajax, Ontario, Canada
Investigational Site Number : 1240009
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240020
🇨🇦Burlington, Ontario, Canada
Investigational Site Number : 1240023
🇨🇦Guelph, Ontario, Canada
Investigational Site Number : 1240004
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 1240018
🇨🇦Windsor, Ontario, Canada
Investigational Site Number : 1240019
🇨🇦Terrebonne, Quebec, Canada
Investigational Site Number : 1240002
🇨🇦Victoriaville, Quebec, Canada
Investigational Site Number : 1240005
🇨🇦St-charles Borrommee, Quebec, Canada
Investigational Site Number : 1520002
🇨🇱Talca, Maule, Chile
Investigational Site Number : 1240003
🇨🇦Quebec, Canada
Investigational Site Number : 1520009
🇨🇱Valdivia, Los Ríos, Chile
Investigational Site Number : 1520008
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006
🇨🇱Quillota, Valparaíso, Chile
Investigational Site Number : 2030001
🇨🇿Jindrichuv Hradec III, Czechia
Investigational Site Number : 2030009
🇨🇿Mesice, Czechia
Investigational Site Number : 2030008
🇨🇿Olomouc, Czechia
Investigational Site Number : 2030005
🇨🇿Mlada Boleslav, Czechia
Investigational Site Number : 2030007
🇨🇿Varnsdorf, Czechia
Investigational Site Number : 2080001
🇩🇰Hvidovre, Denmark
Investigational Site Number : 2030004
🇨🇿Ostrava, Czechia
Investigational Site Number : 2030006
🇨🇿Teplice, Czechia
Investigational Site Number : 2080003
🇩🇰Vejle, Denmark
Investigational Site Number : 2330001
🇪🇪Tartu, Estonia
Investigational Site Number : 2500001
🇫🇷Lyon, France
Investigational Site Number : 2500006
🇫🇷Angers, France
Investigational Site Number : 2680003
🇬🇪Batumi, Georgia
Investigational Site Number : 2500003
🇫🇷Pessac, France
Investigational Site Number : 2500004
🇫🇷Reims, France
Investigational Site Number : 2500007
🇫🇷Paris, France
Investigational Site Number : 2680001
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2680002
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2760014
🇩🇪Hannover, Germany
Investigational Site Number : 2760007
🇩🇪Leipzig, Germany
Investigational Site Number : 2760003
🇩🇪Lübeck, Germany
Investigational Site Number : 2760006
🇩🇪Koblenz, Germany
Investigational Site Number : 2760012
🇩🇪Neu-Isenburg, Germany
Investigational Site Number : 2760008
🇩🇪Leipzig, Germany
Investigational Site Number : 2760001
🇩🇪Mainz, Germany
Investigational Site Number : 2760011
🇩🇪Rosenheim, Germany
Investigational Site Number : 3480013
🇭🇺Budapest, Hungary
Investigational Site Number : 3480009
🇭🇺Budapest, Hungary
Investigational Site Number : 3480005
🇭🇺Edelény, Hungary
Investigational Site Number : 3560016
🇮🇳Belgaum, India
Investigational Site Number : 3560013
🇮🇳Jaipur, India
Investigational Site Number : 3480004
🇭🇺Hajdunánás, Hungary
Investigational Site Number : 3480012
🇭🇺Szombathely, Hungary
Investigational Site Number : 3480001
🇭🇺Százhalombatta, Hungary
Investigational Site Number : 3560001
🇮🇳Chandigarh, India
Investigational Site Number : 3560019
🇮🇳Kanpur, India
Investigational Site Number : 3560017
🇮🇳Nagpur, India
Investigational Site Number : 3560009
🇮🇳Nashik, India
Investigational Site Number : 3560005
🇮🇳Nagpur, India
Investigational Site Number : 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number : 3560012
🇮🇳Pune, India
Investigational Site Number : 3560018
🇮🇳Pune, India
Investigational Site Number : 3920023
🇯🇵Nagoya-shi, Aichi, Japan
Investigational Site Number : 3760009
🇮🇱Ramat Gan, Israel
Investigational Site Number : 3920020
🇯🇵Nagoya-shi, Aichi, Japan
Investigational Site Number : 3760002
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760004
🇮🇱Rehovot, Israel
Investigational Site Number : 3920027
🇯🇵Fukuoka-shi, Fukuoka, Japan
Investigational Site Number : 3920005
🇯🇵Fukuoka-shi, Fukuoka, Japan
Investigational Site Number : 3920015
🇯🇵Mizunami-shi, Gifu, Japan
Investigational Site Number : 3920032
🇯🇵Yanagawa-shi, Fukuoka, Japan
Investigational Site Number : 3920021
🇯🇵Kure-shi, Hiroshima, Japan
Investigational Site Number : 3920035
🇯🇵Kure-shi, Hiroshima, Japan
Investigational Site Number : 3920038
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920013
🇯🇵Himeji-shi, Hyogo, Japan
Investigational Site Number : 3920014
🇯🇵Takamatsu-shi, Kagawa, Japan
Investigational Site Number : 3920042
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920009
🇯🇵Sakaide-shi, Kagawa, Japan
Investigational Site Number : 3920033
🇯🇵Kawasaki-shi, Kanagawa, Japan
Investigational Site Number : 3920011
🇯🇵Konan-ku, Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920039
🇯🇵Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920043
🇯🇵Matsusaka-shi, Mie, Japan
Investigational Site Number : 3920026
🇯🇵Osaka-shi, Osaka, Japan
Investigational Site Number : 3920034
🇯🇵Ikoma-shi, Nara, Japan
Investigational Site Number : 3920003
🇯🇵Osaka-shi, Osaka, Japan
Investigational Site Number : 3920007
🇯🇵Sakai-shi, Osaka, Japan
Investigational Site Number : 3920006
🇯🇵Yao-shi, Osaka, Japan
Investigational Site Number : 3920028
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Investigational Site Number : 3920002
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Investigational Site Number : 3920040
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920036
🇯🇵Sano-shi, Tochigi, Japan
Investigational Site Number : 3920029
🇯🇵Kiyose-City, Tokyo, Japan
Investigational Site Number : 3920025
🇯🇵Shibuya-ku, Tokyo, Japan
Investigational Site Number : 3920041
🇯🇵Toshima-ku, Tokyo, Japan
Investigational Site Number : 4100005
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100004
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Investigational Site Number : 4100001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Incheon, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4280002
🇱🇻Daugavpils, Latvia
Investigational Site Number : 4280001
🇱🇻Riga, Latvia
Investigational Site Number : 4840003
🇲🇽Chihuahua, Mexico
Investigational Site Number : 4400001
🇱🇹Kaunas, Lithuania
Investigational Site Number : 4400003
🇱🇹Klaipeda, Lithuania
Investigational Site Number : 4840009
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840007
🇲🇽Durango, Mexico
Investigational Site Number : 4840001
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840015
🇲🇽Yucatan, Mexico
Investigational Site Number : 4840004
🇲🇽Veracruz, Mexico
Investigational Site Number : 5280005
🇳🇱Arnhem, Netherlands
Investigational Site Number : 5280006
🇳🇱Nijmegen, Netherlands
Investigational Site Number : 5280008
🇳🇱Zutphen, Netherlands
Investigational Site Number : 5280001
🇳🇱Breda, Netherlands
Investigational Site Number : 5280004
🇳🇱Zwolle, Netherlands
Investigational Site Number : 6160005
🇵🇱Wolomin, Mazowieckie, Poland
Investigational Site Number : 5780001
🇳🇴Lørenskog, Norway
Investigational Site Number : 6160003
🇵🇱Malbork, Pomorskie, Poland
Investigational Site Number : 6160002
🇵🇱Katowice, Slaskie, Poland
Investigational Site Number : 6200006
🇵🇹Aveiro, Portugal
Investigational Site Number : 6200011
🇵🇹Guarda, Portugal
Investigational Site Number : 6160009
🇵🇱Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Investigational Site Number : 6200002
🇵🇹Braga, Portugal
Investigational Site Number : 6200010
🇵🇹Matosinhos, Portugal
BRCR Medical Center, Inc. Site Number : 8400190
🇵🇷Ponce, Puerto Rico
Cardiopulmonary Research Site Number : 8400040
🇵🇷Guaynabo, Puerto Rico
Investigational Site Number : 6430002
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430003
🇷🇺Saint-Petersburg, Russian Federation
Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232
🇵🇷Temecula, Puerto Rico
Investigational Site Number : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430004
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number : 6430006
🇷🇺Ulyanovsk, Russian Federation
Investigational Site Number : 7100002
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100013
🇿🇦Benoni, South Africa
Investigational Site Number : 7100015
🇿🇦Chatsworth, South Africa
Investigational Site Number : 7100005
🇿🇦Durban, South Africa
Investigational Site Number : 7100017
🇿🇦Durban, South Africa
Advanced Pulmonary Research Institute Site Number : 8400018
🇺🇸Loxahatchee Groves, Florida, United States
Renstar Medical Research Site Number : 8400015
🇺🇸Ocala, Florida, United States
My Community Research Center Site Number : 8400060
🇺🇸Miami, Florida, United States
Investigational Site Number : 7100016
🇿🇦Durban, South Africa
Oviedo Medical Research Site Number : 8400026
🇺🇸Oviedo, Florida, United States
Innovation Medical Research Center Site Number : 8400067
🇺🇸Palmetto Bay, Florida, United States
Pines Care Research Center LLC Site Number : 8400056
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number : 7240004
🇪🇸Palma de Mallorca, Balears [Baleares], Spain
Investigational Site Number : 7100006
🇿🇦Durban, South Africa
Allegheny Health Network Site Number : 8400058
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number : 7100004
🇿🇦Gatesville, South Africa
Investigational Site Number : 7100003
🇿🇦Parow, South Africa
Investigational Site Number : 7100009
🇿🇦Pretoria, South Africa
Investigational Site Number : 7240014
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240013
🇪🇸Santander, Cantabria, Spain
Investigational Site Number : 7240002
🇪🇸Mérida / Badajoz, Extremadura, Spain
Investigational Site Number : 7240006
🇪🇸Sant Boi de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
🇪🇸Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240009
🇪🇸Lleida / Lleida, Lleida [Lérida], Spain
Investigational Site Number : 7240010
🇪🇸Cáceres, Spain
Investigational Site Number : 7240003
🇪🇸Madrid, Spain
Investigational Site Number : 7240012
🇪🇸Zaragoza, Spain
Investigational Site Number : 7920007
🇹🇷Ankara, Turkey
Investigational Site Number : 7920003
🇹🇷Izmir, Turkey
Investigational Site Number : 7920005
🇹🇷Balcali Adana, Turkey
Investigational Site Number : 7920006
🇹🇷Kirikkale, Turkey
Investigational Site Number : 7920002
🇹🇷Mersin, Turkey
Investigational Site Number : 8260003
🇬🇧Bradford, United Kingdom
Investigational Site Number : 8260008
🇬🇧Milton Keynes, United Kingdom
Investigational Site Number : 8260005
🇬🇧Liverpool, United Kingdom
Investigational Site Number : 8260001
🇬🇧Newcastle upon Tyne, United Kingdom
Henry Ford Hospital Site Number : 8400052
🇺🇸Detroit, Michigan, United States
Investigational Site Number : 3920016
🇯🇵Shinagawa-ku, Tokyo, Japan
Investigational Site Number : 3920037
🇯🇵Shinagawa-ku, Tokyo, Japan
Aurora BayCare Medical Center Site Number : 8400046
🇺🇸Green Bay, Wisconsin, United States
Toledo Institute of Clinical Research Site Number : 8400014
🇺🇸Toledo, Ohio, United States
Palmtree Clinical Research Site Number : 8400184
🇺🇸Palm Springs, California, United States
UCSF Fresno Site Number : 8400030
🇺🇸Fresno, California, United States
Faculdade de Medicina da Universidade Estadual Paulista Site Number : 0760005
🇧🇷Botucatu, São Paulo, Brazil
Investigational Site Number : 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number : 8260006
🇬🇧Wishaw, Glasgow City, United Kingdom
Radiance Clinical Research Site Number : 8400037
🇺🇸Lampasas, Texas, United States
Finlay Medical Research Site Number : 8400007
🇺🇸Miami, Florida, United States
MCR Research Site Number : 8400425
🇺🇸Miami, Florida, United States
Investigational Site Number : 2760010
🇩🇪Berlin, Germany
American Health Research Site Number : 8400002
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number : 7240008
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Advanced Respiratory and Sleep Medicine Site Number : 8400022
🇺🇸Huntersville, North Carolina, United States
Investigational Site Number : 7100019
🇿🇦Cape Town, South Africa
Investigational Site Number : 2760009
🇩🇪Berlin, Germany
Investigational Site Number : 7240001
🇪🇸Málaga, Spain
Innovative Research of West Florida, Inc Site Number : 8400041
🇺🇸Clearwater, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8400352
🇺🇸Cutler Bay, Florida, United States
Sciences Connections, LLC Site Number : 8400045
🇺🇸Doral, Florida, United States
Finlay Medical Research Site Number : 8400011
🇺🇸Greenacres City, Florida, United States
Captain James A. Lovell Federal Health Care Center Site Number : 8400032
🇺🇸North Chicago, Illinois, United States
Care Access Fairview Heights Site Number : 8400033
🇺🇸Fairview Heights, Illinois, United States
Pulmonary & Critical Care Site Number : 8400047
🇺🇸Shreveport, Louisiana, United States
Medtrial, LLC Site Number : 8400048
🇺🇸Columbia, South Carolina, United States
Investigational Site Number : 0320005
🇦🇷Pergamino, Buenos Aires, Argentina
Investigational Site Number : 0320006
🇦🇷Buenos Aires, Ciudad De Buenos Aires, Argentina
CEMEC - Centro Multidisciplinar de Estudos Clinicos Site Number : 0760015
🇧🇷Sao Bernardo do Campo, São Paulo, Brazil
Investigational Site Number : 1240022
🇨🇦Windsor, Ontario, Canada
Investigational Site Number : 1520007
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 2030002
🇨🇿Praha 4, Czechia
Investigational Site Number : 2500002
🇫🇷Montpellier, France
Investigational Site Number : 2760005
🇩🇪Frankfurt am Main, Germany
Investigational Site Number : 2760002
🇩🇪Hamburg, Germany
Investigational Site Number : 2760004
🇩🇪Berlin, Germany
Investigational Site Number : 3480002
🇭🇺Balassagyarmat, Hungary
Investigational Site Number : 3480003
🇭🇺Puspokladany, Hungary
Investigational Site Number : 3760001
🇮🇱Petah-Tikva, Israel
Investigational Site Number : 3920030
🇯🇵Kurume-shi, Fukuoka, Japan
Investigational Site Number : 3920010
🇯🇵Hiroshima-shi, Hiroshima, Japan
Investigational Site Number : 7100012
🇿🇦Middelburg, South Africa
Investigational Site Number : 7100001
🇿🇦Cape Town, South Africa
Investigational Site Number : 7920001
🇹🇷Istanbul, Turkey
Investigational Site Number : 1240001
🇨🇦Trois-Rivieres, Quebec, Canada
Investigational Site Number : 7240011
🇪🇸Madrid, Madrid, Comunidad De, Spain
BRCR Medical Center Site Number : 8400180
🇵🇷San Juan, Puerto Rico
Central Florida Pulmonary Group, PA Site Number : 8400192
🇺🇸Orlando, Florida, United States
Heuer M.D. Research Site Number : 8400016
🇺🇸Orlando, Florida, United States
Lowcountry Lung & Critical Care Site Number : 8400175
🇺🇸Charleston, South Carolina, United States
North Florida/South Georgia Veterans Health System Site Number : 8400176
🇺🇸Gainesville, Florida, United States
Lexington VA Health Care System Site Number : 8400036
🇺🇸Lexington, Kentucky, United States
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