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
- NCT04701983
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 960
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Itepekimab Q2W Itepekimab SAR440340 Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks Placebo Placebo SC administration of matching placebo Q2W for up to 52 weeks Itepekimab Q4W 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 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
- Primary Outcome Measures
Name Time Method Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
- Secondary Outcome Measures
Name Time Method 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 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) Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) Baseline to Week 24 FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in post-BD FEV1 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 pre-BD FEV1 Baseline to Week 52 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 Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Annualized rate of severe AECOPD Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of severe AECOPD over the placebo-controlled treatment period
Annualized rate of corticosteroid-treated AECOPD Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Time to first severe AECOPD Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) Time to first severe AECOPD over the placebo-controlled treatment period.
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score 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.
Functional itepekimab concentrations in serum 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) Incidence of treatment-emergent anti-itepekimab antibodies responses 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) Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants) 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 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.
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score 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 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)
Trial Locations
- Locations (248)
MACRO Trials Site Number : 8400030
🇺🇸Los Angeles, California, United States
Covenant Pulmonary Critical Care Site Number : 8400183
🇺🇸Atlanta, Georgia, United States
Clinical Research of Central PA Site Number : 8400023
🇺🇸DuBois, Pennsylvania, United States
Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440
🇺🇸Denison, Texas, United States
Care Access Site Number : 8400276
🇺🇸Boston, Massachusetts, United States
Reliant Medical Research Site Number : 8400397
🇺🇸Miami, Florida, United States
PROLIVE MEDICAL RESEARCH Site Number : 8400420
🇺🇸Miami, Florida, United States
Reed Medical Research Site Number : 8400032
🇺🇸Miami, Florida, United States
High Quality Research Site Number : 8400406
🇺🇸Miami, Florida, United States
Investigational Site Number : 1000005
🇧🇬Dimitrovgrad, Bulgaria
Investigational Site Number : 1000006
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number : 1000003
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number : 1000008
🇧🇬Vidin, Bulgaria
Investigational Site Number : 3000002
🇬🇷Thessaloniki, Greece
Investigational Site Number : 3000005
🇬🇷Athens, Greece
Investigational Site Number : 3000006
🇬🇷Athens, Greece
Investigational Site Number : 4840007
🇲🇽Cuernavaca, Morelos, Mexico
Investigational Site Number : 3760007
🇮🇱Tel Aviv, Israel
Investigational Site Number : 4840016
🇲🇽Oaxaca de Juarez, Oaxaca, Mexico
Investigational Site Number : 6420007
🇷🇴Codlea, Romania
Investigational Site Number : 6430003
🇷🇺Moscow, Russian Federation
Investigational Site Number : 7030002
🇸🇰Poprad, Slovakia
Investigational Site Number : 1580006
🇨🇳Taichung, Taiwan
Investigational Site Number : 8260004
🇬🇧Portsmouth, Hampshire, United Kingdom
Investigational Site Number : 8040004
🇺🇦Kyiv, Ukraine
Investigational Site Number : 1560006
🇨🇳Guangzhou, China
Investigational Site Number : 1560027
🇨🇳Jinan, China
Investigational Site Number : 1560031
🇨🇳Nanchang, China
Investigational Site Number : 1560023
🇨🇳Nanning, China
Investigational Site Number : 1560015
🇨🇳Pingxiang, China
Investigational Site Number : 1560035
🇨🇳Nanjing, China
Investigational Site Number : 1560043
🇨🇳Shanghai, China
Investigational Site Number : 1560005
🇨🇳Shenyang, China
Investigational Site Number : 1560020
🇨🇳Shenzhen, China
Investigational Site Number : 1560019
🇨🇳Wenzhou, China
Investigational Site Number : 1560029
🇨🇳Wuhan, China
Investigational Site Number : 8260016
🇬🇧Salford, Manchester, United Kingdom
University of Alabama at Birmingham Site Number : 8400012
🇺🇸Birmingham, Alabama, United States
Indago Research and Health Center Site Number : 8400187
🇺🇸Hialeah, Florida, United States
University of Miami/Miami VA Medical Center Site Number : 8400026
🇺🇸Miami, Florida, United States
Clin Research W Florida Site Number : 8400004
🇺🇸Clearwater, Florida, United States
Care Access Site Number : 8400277
🇺🇸Boston, Massachusetts, United States
Care Access Site Number : 8400280
🇺🇸Boston, Massachusetts, United States
Pasadena Center for Medical Research Site Number : 8400043
🇺🇸Saint Petersburg, Florida, United States
Gwinnett Biomedical Research Site Number : 8400007
🇺🇸Lawrenceville, Georgia, United States
Broward Pulmonary and Sleep Specialists Site Number : 8400031
🇺🇸Plantation, Florida, United States
Alpha Clinical Research Georgia Site Number : 8400190
🇺🇸Dunwoody, Georgia, United States
Coastal Medical Research Institute Site Number : 8400044
🇺🇸Saint Petersburg, Florida, United States
Avanza Medical Research Center Site Number : 8400376
🇺🇸Pensacola, Florida, United States
David Kavtaradze MD, Inc. Site Number : 8400029
🇺🇸Cordele, Georgia, United States
Midwest Chest Consultants, P.C. Site Number : 8400002
🇺🇸Saint Charles, Missouri, United States
Metroplex Pulmonary and Sleep Center Site Number : 8400015
🇺🇸McKinney, Texas, United States
PRX Research Site Number : 8400380
🇺🇸Mesquite, Texas, United States
Care Access Site Number : 8400281
🇺🇸Boston, Massachusetts, United States
Corsicana Medical Research, LLC Site Number : 8400018
🇺🇸Corsicana, Texas, United States
Hendeson Clinical Trials Site Number : 8400365
🇺🇸Henderson, Nevada, United States
Exordia Medical Research, Inc. Site Number : 8400041
🇺🇸Fall River, Massachusetts, United States
Care Access Site Number : 8400278
🇺🇸Boston, Massachusetts, United States
Santa Clara Family Clinic Site Number : 8400398
🇺🇸Houston, Texas, United States
East Carolina University Brody School Of Medicine Site Number : 8400022
🇺🇸Greenville, North Carolina, United States
REX Clinical Trials Site Number : 8400371
🇺🇸Beaumont, Texas, United States
Bernstein Clinical Research Center Site Number : 8400014
🇺🇸Cincinnati, Ohio, United States
Gastonia Pharmaceutical Research Site Number : 8400010
🇺🇸Gastonia, North Carolina, United States
Carolina Research Center Site Number : 8400005
🇺🇸Shelby, North Carolina, United States
WellNow Urgent Care and Research Site Number : 8400039
🇺🇸Springdale, Ohio, United States
The Methodist Hospital Research Institute Site Number : 8400194
🇺🇸Houston, Texas, United States
The Lung and Sleep Research Institute of North Texas Site Number : 8400417
🇺🇸North Richland Hills, Texas, United States
Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038
🇺🇸Houston, Texas, United States
Sherman Clinical Research Site Number : 8400009
🇺🇸Sherman, Texas, United States
DM Clinical Research Site Number : 8400179
🇺🇸Tomball, Texas, United States
Investigational Site Number : 1520007
🇨🇱Curicó, Maule, Chile
Investigational Site Number : 1560012
🇨🇳Changsha, China
Investigational Site Number : 1000001
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1520002
🇨🇱Talca, Maule, Chile
Investigational Site Number : 1560002
🇨🇳Changchun, China
Investigational Site Number : 1560047
🇨🇳Changsha, China
Investigational Site Number : 1560025
🇨🇳Guangzhou, China
Investigational Site Number : 1560003
🇨🇳Baotou, China
Investigational Site Number : 1560004
🇨🇳Beijing, China
Investigational Site Number : 1560030
🇨🇳Beijing, China
Investigational Site Number : 1560013
🇨🇳Changsha, China
Investigational Site Number : 1560001
🇨🇳Chengdu, China
Investigational Site Number : 1560040
🇨🇳Chengdu, China
Investigational Site Number : 1560032
🇨🇳Chongqing, China
Investigational Site Number : 1560036
🇨🇳Haikou, China
Investigational Site Number : 1560022
🇨🇳Hangzhou, China
Investigational Site Number : 1560010
🇨🇳Hohhot, China
Investigational Site Number : 1560039
🇨🇳Hangzhou, China
Investigational Site Number : 1560017
🇨🇳Hefei, China
Investigational Site Number : 1560008
🇨🇳Hohhot, China
Investigational Site Number : 1560044
🇨🇳Jinan, China
Investigational Site Number : 1560045
🇨🇳Shanghai, China
Investigational Site Number : 1560028
🇨🇳Shijiazhuang, China
Investigational Site Number : 1560024
🇨🇳Tianjin, China
Investigational Site Number : 2680003
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2680001
🇬🇪Tbilisi, Georgia
Investigational Site Number : 2030004
🇨🇿Ostrava, Czechia
Investigational Site Number : 3800003
🇮🇹Rozzano, Milano, Italy
Investigational Site Number : 3800004
🇮🇹Foggia, Puglia, Italy
Investigational Site Number : 3560007
🇮🇳Mumbai, India
Investigational Site Number : 3760002
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760009
🇮🇱Ramat Gan, Israel
Investigational Site Number : 3760004
🇮🇱Rehovot, Israel
Investigational Site Number : 6420009
🇷🇴Oradea, Romania
Imax Clinical Trials LLC 1 Site Number : 8400419
🇺🇸La Palma, California, United States
AdtreMed Site Number : 8400442
🇺🇸Tampa, Florida, United States
Clincove: Plano Primary Care Clinic Site Number : 8400424
🇺🇸Plano, Texas, United States
EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414
🇺🇸Plano, Texas, United States
Clearlake Specialties Site Number : 8400025
🇺🇸Webster, Texas, United States
Investigational Site Number : 1560009
🇨🇳Shanghai, China
Investigational Site Number : 1560042
🇨🇳Zhengzhou, China
Investigational Site Number : 3480003
🇭🇺Pécs, Hungary
Advanced Pulmonary Research Institute Site Number : 8400455
🇺🇸Loxahatchee Groves, Florida, United States
Accellacare Site Number : 8400001
🇺🇸Wilmington, North Carolina, United States
Beautiful Minds Clinical Research Center Site Number : 8400037
🇺🇸Cutler Bay, Florida, United States
Advanced Clinical Research Site Number : 8400409
🇺🇸Kendall, Florida, United States
Research Institute of South Florida,Inc Site Number : 8400006
🇺🇸Miami, Florida, United States
Florida Institute for Clinical Research Site Number : 8400013
🇺🇸Orlando, Florida, United States
Southeastern Research Center Site Number : 8400011
🇺🇸Winston-Salem, North Carolina, United States
Jasper Summit Research Site Number : 8400178
🇺🇸Jasper, Alabama, United States
California Research Institute Site Number : 8400400
🇺🇸Huntington Park, California, United States
Modena Allergy + Asthma Site Number : 8400036
🇺🇸La Jolla, California, United States
Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034
🇺🇸Chandler, Arizona, United States
Tucson Clinical Research Institute Site Number : 8400431
🇺🇸Tucson, Arizona, United States
Investigational Site Number : 1560026
🇨🇳Yangzhou, China
Downtown LA Research Center Inc. Site Number : 8400027
🇺🇸Los Angeles, California, United States
~Alpine Clinical Research Center Site Number : 8400180
🇺🇸Boulder, Colorado, United States
Antelope Valley Clinical Trials Site Number : 8400003
🇺🇸Northridge, California, United States
Innovative Clinical Research Site Number : 8400017
🇺🇸Lafayette, Colorado, United States
Deluxe Health Center Site Number : 8400188
🇺🇸Miami Lakes, Florida, United States
DL Research Solutions Inc Site Number : 8400033
🇺🇸Miami, Florida, United States
My Community Research Center Site Number : 8400347
🇺🇸Miami, Florida, United States
Appalachian Clinical Research Site Number : 8400024
🇺🇸Adairsville, Georgia, United States
Premier Medical Associates Site Number : 8400388
🇺🇸The Villages, Florida, United States
GenHarp Clinical Solutions Site Number : 8400028
🇺🇸Evergreen Park, Illinois, United States
ASHA Clinical Research Site Number : 8400408
🇺🇸Hammond, Indiana, United States
Hannibal Clinic Site Number : 8400383
🇺🇸Hannibal, Missouri, United States
Revival Research Institute, LLC Site Number : 8400191
🇺🇸Dearborn, Michigan, United States
Northwell Health Site Number : 8400019
🇺🇸Mount Kisco, New York, United States
Advanced Pulmonary Research Institute of Michigan Site Number : 8400403
🇺🇸Warren, Michigan, United States
Bogan Sleep Consultants Site Number : 8400181
🇺🇸Columbia, South Carolina, United States
Texas Tech University Health Sciences Center Site Number : 8400189
🇺🇸El Paso, Texas, United States
Austin Pulmonary Consultants Site Number : 8400035
🇺🇸Cedar Park, Texas, United States
Advance Lung and Sleep Center Site Number : 8400040
🇺🇸Sherman, Texas, United States
Investigational Site Number : 1560048
🇨🇳Zhongshan, China
Investigational Site Number : 0320001
🇦🇷Caba, Buenos Aires, Argentina
Investigational Site Number : 1560014
🇨🇳Beijing, China
Investigational Site Number : 1560034
🇨🇳Shanghai, China
Investigational Site Number : 1560007
🇨🇳Xuzhou, China
Investigational Site Number : 1560046
🇨🇳Xiangtan, China
Investigational Site Number : 1560016
🇨🇳Xi'an, China
Investigational Site Number : 1560041
🇨🇳Zhanjiang, China
Investigational Site Number : 2030006
🇨🇿Havlickuv Brod, Czechia
Investigational Site Number : 2030001
🇨🇿Jindrichuv Hradec III, Czechia
Investigational Site Number : 2030002
🇨🇿Praha 4, Czechia
Investigational Site Number : 2030005
🇨🇿Praha 5 - Radotin, Czechia
Investigational Site Number : 2680002
🇬🇪Tbilisi, Georgia
Investigational Site Number : 3000001
🇬🇷Ioannina, Greece
Investigational Site Number : 2030003
🇨🇿Praha 8, Czechia
Investigational Site Number : 3000008
🇬🇷Palaio Faliro, Athens, Greece
Investigational Site Number : 3000004
🇬🇷Heraklion, Greece
Investigational Site Number : 3000007
🇬🇷Larisa, Greece
Investigational Site Number : 3480004
🇭🇺Debrecen, Hungary
Investigational Site Number : 3480002
🇭🇺Mosonmagyaróvár, Hungary
Investigational Site Number : 3480001
🇭🇺Gödöllö, Hungary
Investigational Site Number : 3560005
🇮🇳Hyderabad, India
Investigational Site Number : 3560002
🇮🇳Coimbatore, India
Investigational Site Number : 3560004
🇮🇳Jaipur, India
Investigational Site Number : 3800005
🇮🇹Catania, Italy
Investigational Site Number : 3560003
🇮🇳Nagpur, India
Investigational Site Number : 3560001
🇮🇳Kozhikode, India
Investigational Site Number : 3760008
🇮🇱Haifa, Israel
Investigational Site Number : 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760006
🇮🇱Kfar-Saba, Israel
Investigational Site Number : 3760001
🇮🇱Petah-Tikva, Israel
Investigational Site Number : 3800007
🇮🇹Verona, Italy
Investigational Site Number : 3800001
🇮🇹Ferrara, Italy
Investigational Site Number : 4840003
🇲🇽San Juan del Rio, Querétaro, Mexico
Investigational Site Number : 6160004
🇵🇱Wroclaw, Dolnoslaskie, Poland
Investigational Site Number : 4840013
🇲🇽Aguascalientes, Mexico
Investigational Site Number : 4840004
🇲🇽Benito Juarez, Mexico
Tellabio International Research Services Site Number : 8400411
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number : 6160003
🇵🇱Warszawa, Mazowieckie, Poland
Investigational Site Number : 6160001
🇵🇱Bialystok, Podlaskie, Poland
Investigational Site Number : 4840014
🇲🇽Oaxaca, Mexico
Investigational Site Number : 6160002
🇵🇱Ostrowiec Swietokrzyski, Swietokrzyskie, Poland
Investigational Site Number : 6420006
🇷🇴Brasov, Romania
Investigational Site Number : 6420002
🇷🇴Cluj-Napoca, Romania
Investigational Site Number : 6420010
🇷🇴Deva, Romania
Investigational Site Number : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6420003
🇷🇴Timisoara, Romania
Investigational Site Number : 6430005
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number : 7030007
🇸🇰Humenne, Slovakia
Investigational Site Number : 6430006
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number : 7030003
🇸🇰Levice, Slovakia
Investigational Site Number : 7030010
🇸🇰Presov, Slovakia
Investigational Site Number : 7030011
🇸🇰Martin, Slovakia
Investigational Site Number : 7030001
🇸🇰Spisska Nova Ves, Slovakia
Investigational Site Number : 1580005
🇨🇳Kaohsiung, Taiwan
Investigational Site Number : 1580002
🇨🇳New Taipei City, Taiwan
Investigational Site Number : 8040008
🇺🇦Kharkiv, Ukraine
Investigational Site Number : 1580003
🇨🇳Taipei, Taiwan
Investigational Site Number : 8040003
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number : 1580008
🇨🇳Yunlin, Taiwan
Investigational Site Number : 8040007
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number : 8040001
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8040005
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8040011
🇺🇦Kyiv, Ukraine
Investigational Site Number : 8260015
🇬🇧Ashton-under-Lyne, Lancashire, United Kingdom
Investigational Site Number : 8260003
🇬🇧Bradford, United Kingdom
Investigational Site Number : 8260014
🇬🇧Heston, United Kingdom
Investigational Site Number : 8260010
🇬🇧Wigan, Lancashire, United Kingdom
Investigational Site Number : 8260013
🇬🇧Redruth, United Kingdom
Investigational Site Number : 8260001
🇬🇧London, United Kingdom
Investigational Site Number : 0320004
🇦🇷Mendoza, Argentina
Investigational Site Number : 1000004
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1000009
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1000007
🇧🇬Veliko Tyrnovo, Bulgaria
Investigational Site Number : 1520009
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520004
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Benchmark Research Site Number : 8400193
🇺🇸Covington, Louisiana, United States
Investigational Site Number : 0320003
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320002
🇦🇷Caba, Buenos Aires, Argentina
Investigational Site Number : 0320005
🇦🇷La Plata, Buenos Aires, Argentina
Investigational Site Number : 1000002
🇧🇬Sofia, Bulgaria
Noble Clinical Research Site Number : 8400182
🇺🇸Tucson, Arizona, United States
Paul Shapero, PC Site Number : 8400016
🇺🇸Bangor, Maine, United States
Pulmonary Associates Site Number : 8400392
🇺🇸Phoenix, Arizona, United States
Clinical Research of Rock Hill Site Number : 8400008
🇺🇸Rock Hill, South Carolina, United States
Investigational Site Number : 1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 4800001
🇲🇺Quatre Bornes, Mauritius
Investigational Site Number : 6420012
🇷🇴Bucaresti, Romania
Investigational Site Number : 6420001
🇷🇴Iasi, Romania
Investigational Site Number : 7030009
🇸🇰Bardejov, Slovakia
Investigational Site Number : 4840011
🇲🇽Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840010
🇲🇽Guadalajara, Jalisco, Mexico
Investigational Site Number : 1520005
🇨🇱Quillota, Valparaíso, Chile
Investigational Site Number : 4840002
🇲🇽Cdmx, México, Mexico
Investigational Site Number : 6430002
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6420005
🇷🇴Bragadiru, Romania
Investigational Site Number : 8040006
🇺🇦Kharkiv, Ukraine
Investigational Site Number : 1580004
🇨🇳Taipei, Taiwan
Investigational Site Number : 4840001
🇲🇽Guadalajara, Jalisco, Mexico
WellNow Urgent Care and Clinical Research Site Number : 8400378
🇺🇸Schenectady, New York, United States
Clinrx Research Site Number : 8400021
🇺🇸Carrollton, Texas, United States
Investigational Site Number : 1520008
🇨🇱Temuco, La Araucanía, Chile
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