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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04456673
Other study ID # EFC15805
Secondary ID U1111-1211-88372
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 6, 2020
Est. completion date May 22, 2024

Study information

Verified date March 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)


Description:

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 935
Est. completion date May 22, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - Participants with a physician diagnosis of COPD who meet the following criteria at screening: - Current or former smokers with a smoking history of =10 pack-years. - Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and =70%). - Medical Research Council (MRC) Dyspnea Scale grade =2. - Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough. - Documented history of high exacerbation risk defined as exacerbation history of =2 moderate or =1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation > 24 hours in emergency department/urgent care facility. - Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for =1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated. - Evidence of Type 2 inflammation: Patients with blood eosinophils =300 cells/microliter at Visit 1. Exclusion Criteria: - COPD diagnosis for less than 12 months prior to randomization. - Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma. - Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. - Cor pulmonale, evidence of right cardiac failure. - Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88% - Hypercapnia requiring Bi-level ventilation. - AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period. - Respiratory tract infection within 4 weeks prior to screening, or during the screening period. - History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included). - Diagnosis of a-1 anti-trypsin deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dupilumab SAR231893
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Locations

Country Name City State
Argentina Investigational Site Number : 0320007 Berazategui Buenos Aires
Argentina Investigational Site Number : 0320002 Buenos Aires
Argentina Investigational Site Number : 0320001 Caba Buenos Aires
Argentina Investigational Site Number : 0320003 Caba Buenos Aires
Argentina Investigational Site Number : 0320004 Caba Buenos Aires
Argentina Investigational Site Number : 0320006 Caba Buenos Aires
Argentina Investigational Site Number : 0320011 Cordoba Córdoba
Argentina Investigational Site Number : 0320010 La Plata Buenos Aires
Argentina Investigational Site Number : 0320012 Launs Este
Argentina Investigational Site Number : 0320013 Lobos Buenos Aires
Argentina Investigational Site Number : 0320005 Quilmes Ciudad De Buenos Aires
Argentina Investigational Site Number : 0320008 Rosario Santa Fe
Argentina Investigational Site Number : 0320009 Rosario Santa Fe
Australia Investigational Site Number : 0360005 Clayton Victoria
Australia Investigational Site Number : 0360008 Kent Town South Australia
Australia Investigational Site Number : 0360001 Spearwood Western Australia
Belgium Investigational Site Number : 0560002 Edegem
Belgium Investigational Site Number : 0560001 Leuven
Belgium Investigational Site Number : 0560003 Liege
Belgium Investigational Site Number : 0560004 Mechelen
Brazil HOSPITAL DIA DO PULMAO Site Number : 0760006 Blumenau Santa Catarina
Brazil PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015 Campinas São Paulo
Brazil UFSC - Hospital Universitário Site Number : 0760018 Florianópolis Santa Catarina
Brazil Instituto Mederi de Pesquisa e Saude Site Number : 0760008 Passo Fundo Rio Grande Do Sul
Brazil Hospital Sao Lucas Site Number : 0760001 Porto Alegre Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017 Porto Alegre Rio Grande Do Sul
Brazil SER da Bahia Site Number : 0760019 Salvador Bahia
Brazil FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007 Santo Andre São Paulo
Brazil CPQuali Pesquisa Clinica Site Number : 0760003 Sao Paulo São Paulo
Brazil InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002 Sao Paulo São Paulo
Brazil Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012 Sao Paulo São Paulo
Brazil Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021 Sao Paulo São Paulo
Brazil Clinica de Alergia Martti Antila Site Number : 0760009 Sorocaba São Paulo
Brazil CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020 Vitoria Espírito Santo
Bulgaria Investigational Site Number : 1005025 Burgas
Bulgaria Investigational Site Number : 1005021 Dupnitsa
Bulgaria Investigational Site Number : 1005012 Haskovo
Bulgaria Investigational Site Number : 1005011 Montana
Bulgaria Investigational Site Number : 1005008 Plovdiv
Bulgaria Investigational Site Number : 1005013 Ruse
Bulgaria Investigational Site Number : 1005015 Ruse
Bulgaria Investigational Site Number : 1005001 Sofia
Bulgaria Investigational Site Number : 1005002 Sofia
Bulgaria Investigational Site Number : 1005003 Sofia
Bulgaria Investigational Site Number : 1005006 Sofia
Bulgaria Investigational Site Number : 1005018 Sofia
Bulgaria Investigational Site Number : 1005026 Sofia
Bulgaria Investigational Site Number : 1005004 Stara Zagora
Bulgaria Investigational Site Number : 1005024 Stara Zagora
Bulgaria Investigational Site Number : 1005023 Veliko Tyrnovo
Bulgaria Investigational Site Number : 1005027 Veliko Tyrnovo
Bulgaria Investigational Site Number : 1005019 Vidin
Bulgaria Investigational Site Number : 1005020 Vratsa
Canada Investigational Site Number : 1240010 Ajax Ontario
Canada Investigational Site Number : 1240015 Calgary Alberta
Canada Investigational Site Number : 1240018 Kamloops British Columbia
Canada Investigational Site Number : 1240017 Kelowna British Columbia
Canada Investigational Site Number : 1240014 Moncton New Brunswick
Canada Investigational Site Number : 1240004 Montreal Quebec
Canada Investigational Site Number : 1240001 Quebec
Canada Investigational Site Number : 1240005 Quebec
Canada Investigational Site Number : 1240012 Québec Quebec
Canada Investigational Site Number : 1240009 Sarnia Ontario
Canada Investigational Site Number : 1240007 Windsor Ontario
Chile Investigational Site Number : 1520006 Curicó Maule
Chile Investigational Site Number : 1520004 Quillota Valparaíso
Chile Investigational Site Number : 1520002 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520003 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520007 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520001 Talca Maule
Chile Investigational Site Number : 1520009 Valdivia Los Ríos
Colombia Investigational Site Number : 1700002 Bogota
Colombia Investigational Site Number : 1700007 Bucaramanga
Colombia Investigational Site Number : 1700005 Manizales
Czechia Investigational Site Number : 2030009 Havlickuv Brod
Czechia Investigational Site Number : 2030004 Jihlava
Czechia Investigational Site Number : 2030001 Jindrichuv Hradec III
Czechia Investigational Site Number : 2030007 Kralupy nad Vltavou
Czechia Investigational Site Number : 2030003 Miroslav
Czechia Investigational Site Number : 2030010 Nymburk
Czechia Investigational Site Number : 2030002 Strakonice
France Investigational Site Number : 2500009 Bayonne
France Investigational Site Number : 2500002 Dijon
France Investigational Site Number : 2500005 Lyon
France Investigational Site Number : 2500003 Montpellier
France Investigational Site Number : 2500007 Paris
France Investigational Site Number : 2500008 Paris
France Investigational Site Number : 2500006 Pessac
France Investigational Site Number : 2500001 Saint Herblain
Germany Investigational Site Number : 2760024 Berlin
Germany Investigational Site Number : 2760025 Berlin
Germany Investigational Site Number : 2760017 Darmstadt
Germany Investigational Site Number : 2760009 Frankfurt am Main
Germany Investigational Site Number : 2760002 Hamburg
Germany Investigational Site Number : 2760003 Hannover
Germany Investigational Site Number : 2760007 Koblenz
Germany Investigational Site Number : 2760011 Leipzig
Germany Investigational Site Number : 2760023 Leipzig
Germany Investigational Site Number : 2760010 Lübeck
Germany Investigational Site Number : 2760012 Mainz
Germany Investigational Site Number : 2760008 Marburg
Germany Investigational Site Number : 2760020 Peine
Germany Investigational Site Number : 2760016 Rosenheim
Germany Investigational Site Number : 2760018 Wiesbaden
Greece Investigational Site Number : 3000001 Athens
Greece Investigational Site Number : 3000006 Athens
Greece Investigational Site Number : 3000003 Heraklion
Greece Investigational Site Number : 3000002 Ioannina
Greece Investigational Site Number : 3000007 Palaio Faliro, Athens
Greece Investigational Site Number : 3000004 Thessaloniki
Hungary Investigational Site Number : 3480003 Edelény
Hungary Investigational Site Number : 3480004 Gödöllö
Hungary Investigational Site Number : 3480002 Hajdunánás
Hungary Investigational Site Number : 3480006 Mosonmagyaróvár
Hungary Investigational Site Number : 3480001 Százhalombatta
Hungary Investigational Site Number : 3480005 Szombathely
Latvia Investigational Site Number : 4280008 Balvi
Latvia Investigational Site Number : 4280007 Rezekne
Latvia Investigational Site Number : 4280001 Riga
Latvia Investigational Site Number : 4280002 Riga
Latvia Investigational Site Number : 4280003 Riga
Latvia Investigational Site Number : 4280005 Riga
Latvia Investigational Site Number : 4280006 Riga
Lithuania Investigational Site Number : 4400001 Kaunas
Lithuania Investigational Site Number : 4400003 Kaunas
Lithuania Investigational Site Number : 4400008 Kaunas
Lithuania Investigational Site Number : 4400007 Klaipeda
Lithuania Investigational Site Number : 4400005 Vilnius
Mexico Investigational Site Number : 4840008 Benito Juarez Ciudad De Mexico
Mexico Investigational Site Number : 4840010 Chihuahua
Mexico Investigational Site Number : 4840006 Durango
Mexico Investigational Site Number : 4840002 Guadalajara Jalisco
Mexico Investigational Site Number : 4840013 Guadalajara Jalisco
Mexico Investigational Site Number : 4840007 Mexico City
Mexico Investigational Site Number : 4840009 Mexico City
Mexico Investigational Site Number : 4840003 Monterrey Nuevo León
Mexico Investigational Site Number : 4840004 Monterrey Nuevo León
Mexico Investigational Site Number : 4840005 Veracruz
Mexico Investigational Site Number : 4840011 Zapopan Jalisco
Netherlands Investigational Site Number : 5280005 Arnhem
Netherlands Investigational Site Number : 5280001 Breda
Netherlands Investigational Site Number : 5280010 Dordrecht
Netherlands Investigational Site Number : 5280009 Harderwijk
Netherlands Investigational Site Number : 5280002 Leeuwarden
Netherlands Investigational Site Number : 5280006 Nijmegen
Netherlands Investigational Site Number : 5280011 Roermond
Netherlands Investigational Site Number : 5280008 Zutphen
Netherlands Investigational Site Number : 5280004 Zwolle
Peru Investigational Site Number : 6040001 Lima
Peru Investigational Site Number : 6040004 Lima
Peru Investigational Site Number : 6040006 Lima
Peru Investigational Site Number : 6040002 Lima Lima
Peru Investigational Site Number : 6040005 Piura
Poland Investigational Site Number : 6160008 Bialystok Podlaskie
Poland Investigational Site Number : 6160014 Elblag Warminsko-mazurskie
Poland Investigational Site Number : 6160015 Grodzisk Mazowiecki Mazowieckie
Poland Investigational Site Number : 6160009 Grudziadz Kujawsko-pomorskie
Poland Investigational Site Number : 6160011 Katowice Slaskie
Poland Investigational Site Number : 6160018 Katowice Slaskie
Poland Investigational Site Number : 6160007 Krakow Malopolskie
Poland Investigational Site Number : 6160019 Krakow
Poland Investigational Site Number : 6160020 Nowa Sol
Poland Investigational Site Number : 6160022 Ostrowiec Swietokrzyski Swietokrzyskie
Poland Investigational Site Number : 6160010 Rzeszow Podkarpackie
Portugal Investigational Site Number : 6200007 Almada
Portugal Investigational Site Number : 6200006 Aveiro
Portugal Investigational Site Number : 6200002 Guimarães
Portugal Investigational Site Number : 6200009 Lisboa
Portugal Investigational Site Number : 6200012 Matosinhos
Romania Investigational Site Number : 6425004 Bacau
Romania Investigational Site Number : 6425003 Cluj-Napoca
Romania Investigational Site Number : 6425005 Constanta
Romania Investigational Site Number : 6425002 Iasi
Romania Investigational Site Number : 6425006 Pitesti
Romania Investigational Site Number : 6425001 Timisoara
Russian Federation Investigational Site Number : 6430001 Moscow
Russian Federation Investigational Site Number : 6430002 Moscow
Russian Federation Investigational Site Number : 6430003 Moscow
Russian Federation Investigational Site Number : 6430009 Nizhny Novgorod
Russian Federation Investigational Site Number : 6430010 Ryazan
Russian Federation Investigational Site Number : 6430013 Saint Petersburg
Russian Federation Investigational Site Number : 6430014 Saint Petersburg
Russian Federation Investigational Site Number : 6430004 St-Petersburg
Russian Federation Investigational Site Number : 6430012 Stavropol
Russian Federation Investigational Site Number : 6430006 Tomsk
Russian Federation Investigational Site Number : 6430008 Ulyanovsk
Russian Federation Investigational Site Number : 6430005 Voronezh
Serbia Investigational Site Number : 6880005 Belgrade
Serbia Investigational Site Number : 6880006 Belgrade
Serbia Investigational Site Number : 6880007 Belgrade
Serbia Investigational Site Number : 6880003 Kragujevac
Serbia Investigational Site Number : 6880001 Sremska Kamenica
Serbia Investigational Site Number : 6880002 Valjevo
Slovakia Investigational Site Number : 7030007 Banska Bystrica
Slovakia Investigational Site Number : 7030006 Humenne
Slovakia Investigational Site Number : 7030005 Kosice
Slovakia Investigational Site Number : 7030003 Levice
Slovakia Investigational Site Number : 7030001 Poprad
Slovakia Investigational Site Number : 7030002 Spisska Nova Ves
South Africa Investigational Site Number : 7100015 Benoni
South Africa Investigational Site Number : 7100004 Cape Town
South Africa Investigational Site Number : 7100014 Chatsworth
South Africa Investigational Site Number : 7100001 Durban
South Africa Investigational Site Number : 7100003 Durban
South Africa Investigational Site Number : 7100010 Durban
South Africa Investigational Site Number : 7100013 Durban
South Africa Investigational Site Number : 7100002 Gatesville
South Africa Investigational Site Number : 7100011 Gauteng
South Africa Investigational Site Number : 7100009 Johannesburg
South Africa Investigational Site Number : 7100012 Middelburg
South Africa Investigational Site Number : 7100006 Parow
South Africa Investigational Site Number : 7100005 Pretoria
South Africa Investigational Site Number : 7100008 Somerset West
Spain Investigational Site Number : 7240009 Badalona Catalunya [Cataluña]
Spain Investigational Site Number : 7240002 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 7240012 Caceres Cáceres
Spain Investigational Site Number : 7240003 Madrid Madrid, Comunidad De
Spain Investigational Site Number : 7240010 Málaga
Spain Investigational Site Number : 7240007 Oviedo Asturias
Spain Investigational Site Number : 7240008 Valencia Valenciana, Comunidad
Spain Investigational Site Number : 7240011 Zaragoza
Ukraine Investigational Site Number : 8040011 Chernivtsi
Ukraine Investigational Site Number : 8040002 Ivano-Frankivsk
Ukraine Investigational Site Number : 8040003 Ivano-Frankivsk
Ukraine Investigational Site Number : 8040001 Kharkiv
Ukraine Investigational Site Number : 8040004 Kyiv
Ukraine Investigational Site Number : 8040007 Kyiv
Ukraine Investigational Site Number : 8040006 Lviv
Ukraine Investigational Site Number : 8040010 Ternopil
Ukraine Investigational Site Number : 8040008 Zaporizhzhia
Ukraine Investigational Site Number : 8040009 Zaporizhzhya
United Kingdom Investigational Site Number : 8260012 Aylesbury
United Kingdom Investigational Site Number : 8260002 Blackpool Lancashire
United Kingdom Investigational Site Number : 8260001 Bradford
United Kingdom Investigational Site Number : 8260005 Bristol
United Kingdom Investigational Site Number : 8260003 Cambridge Cambridgeshire
United Kingdom Investigational Site Number : 8260011 Chippenham
United Kingdom Investigational Site Number : 8260015 Derby
United Kingdom Investigational Site Number : 8260007 North Shields Newcastle Upon Tyne
United Kingdom Investigational Site Number : 8260013 Nottingham Nottinghamshire
United Kingdom Investigational Site Number : 8260004 South Shields Newcastle Upon Tyne
United Kingdom Investigational Site Number : 8260006 Swansea Neath Port Talbot
United States Pulmonary Research of Abingdon, LLC Site Number : 8400030 Abingdon Virginia
United States Appalachian Clinical Research Site Number : 8400048 Adairsville Georgia
United States Northlake Medical Group Site Number : 8400099 Atlanta Georgia
United States Kern Research, Inc Site Number : 8400031 Bakersfield California
United States REX Clinical Trials Site Number : 8400143 Beaumont Texas
United States River Birch Research, LLC Site Number : 8400045 Blue Ridge Georgia
United States Helix Biomedics, LLC Site Number : 8400035 Boynton Beach Florida
United States Pioneer Clinical Research Site Number : 8400043 Boynton Beach Florida
United States Renaissance Research and Medical Group, Inc Site Number : 8400092 Cape Coral Florida
United States Clinrx Research Site Number : 8400059 Carrollton Texas
United States Onsite Clinical Solutions LLC Site Number : 8400042 Charlotte North Carolina
United States St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020 Clearwater Florida
United States Carolina Medical Research, LLC Site Number : 8400026 Clinton South Carolina
United States Optimed Research, LTD Site Number : 8400082 Columbus Ohio
United States Medical Centre of Conyers Site Number : 8400064 Conyers Georgia
United States David Kavtaradze MD, Inc. Site Number : 8400135 Cordele Georgia
United States Avant Research Associates LLC Site Number : 8400118 Crowley Louisiana
United States Cullman Research Center, LLC Site Number : 8400095 Cullman Alabama
United States Beautiful Minds Clinical Research Center Site Number : 8400081 Cutler Bay Florida
United States Houston Pulmonary and Sleep Associates Site Number : 8400011 Cypress Texas
United States Omega Research Consultants, LLC Site Number : 8400021 DeBary Florida
United States Henry Ford Health System Site Number : 8400053 Detroit Michigan
United States Pulmonary & Sleep Specialists Site Number : 8400136 Dickson Tennessee
United States Sciences Connections, LLC Site Number : 8400133 Doral Florida
United States Clinical Research of Central PA Site Number : 8400009 DuBois Pennsylvania
United States WellNow Urgent Care Site Number : 8400132 E. Amherst New York
United States Genesis Clinical Research & Consulting Site Number : 8400050 Fall River Massachusetts
United States InvesClinic, LLC Site Number : 8400039 Fort Lauderdale Florida
United States Clinical Trials Center of Middle Tennessee Site Number : 8400066 Franklin Tennessee
United States Clinical Research of Gastonia Site Number : 8400010 Gastonia North Carolina
United States Finlay Medical Research Site Number : 8400071 Greenacres City Florida
United States Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088 Greenfield Wisconsin
United States Direct Helpers Medical Center Inc Site Number : 8400079 Hialeah Florida
United States Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055 Houston Texas
United States Pioneer Research Solutions, Inc. Site Number : 8400070 Houston Texas
United States Prolato Clinical Research Center Site Number : 8400128 Houston Texas
United States Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090 Jasper Alabama
United States Jersey City Breathing Center Site Number : 8400137 Jersey City New Jersey
United States MultiSpecialty Clinical Research Site Number : 8400110 Johnson City Tennessee
United States Innovative Clinical Research Site Number : 8400018 Lafayette Colorado
United States Prestige Clinical Research Site Number : 8400029 Lampasas Texas
United States MD First Research Site Number : 8400105 Lancaster South Carolina
United States Revive Research Institute Site Number : 8400120 Lathrup Village Michigan
United States Gwinnett Biomedical Research Site Number : 8400052 Lawrenceville Georgia
United States Somnos Clinical Research Site Number : 8400016 Lincoln Nebraska
United States Asthma and Allergy Institute Site Number : 8400022 Little Rock Arkansas
United States DCOL Center for Clinical Research Site Number : 8400028 Longview Texas
United States Metroplex Pulmonary and Sleep Center Site Number : 8400131 McKinney Texas
United States Columbus Clinical Services Site Number : 8400062 Miami Florida
United States De La Cruz Research Center, LLC Site Number : 8400075 Miami Florida
United States DL Research Solutions Inc Site Number : 8400089 Miami Florida
United States Phoenix Medical Research, LLC Site Number : 8400012 Miami Florida
United States Reed Medical Research Site Number : 8400123 Miami Florida
United States Montana Medical Research Site Number : 8400019 Missoula Montana
United States Monroe Biomedical Research Site Number : 8400087 Monroe North Carolina
United States Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006 Mooresville North Carolina
United States Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117 Mooresville North Carolina
United States LLM Research Site Number : 8400125 Myrtle Beach South Carolina
United States Coastal Carolina Health Care, P.A. Site Number : 8400025 New Bern North Carolina
United States Northwell Health Site Number : 8400054 New Hyde Park New York
United States Mid Hudson Medical Research PLLC Site Number : 8400037 New Windsor New York
United States NewportNativeMD, Inc Site Number : 8400032 Newport Beach California
United States Allergy, Asthma and Clinical Research Center Site Number : 8400127 Oklahoma City Oklahoma
United States Quality Clinical Research, Inc. Site Number : 8400073 Omaha Nebraska
United States Central Florida Pulmonary Group, PA Site Number : 8400101 Orlando Florida
United States Florida Institute for Clinical Research Site Number : 8400129 Orlando Florida
United States Innovation Medical Research Center Site Number : 8400114 Palmetto Bay Florida
United States Phoenix Medical Group Site Number : 8400061 Peoria Arizona
United States Clinrx Research, LLC Site Number : 8400069 Plano Texas
United States Family Medical Specialists of Florida, PA Site Number : 8400077 Plant City Florida
United States Prospective Research Innovations, Inc. Site Number : 8400063 Rancho Cucamonga California
United States Health Concepts Site Number : 8400027 Rapid City South Dakota
United States Clinical Research Partners Site Number : 8400040 Richmond Virginia
United States Southeast Lung Associates Site Number : 8400003 Rincon Georgia
United States Romedica, LLC Site Number : 8400034 Rochester Michigan
United States Covenant Healthcare Site Number : 8400057 Saginaw Michigan
United States Coastal Pulmonary And Critical Care Site Number : 8400013 Saint Petersburg Florida
United States Diagnostics Research Group Site Number : 8400038 San Antonio Texas
United States ACRC Studies Site Number : 8400094 San Diego California
United States Institute of HealthCare Assessment, Inc. Site Number : 8400015 San Diego California
United States Frontier Clinical Research, LLC Site Number : 8400049 Scottdale Pennsylvania
United States Scottsboro Quick Care Clinic Site Number : 8400116 Scottsboro Alabama
United States Infinity Medical Research Site Number : 8400004 South Dartmouth Massachusetts
United States Great Lakes Research Institute Site Number : 8400096 Southfield Michigan
United States Mt. Olympus Medical Research Site Number : 8400115 Sugar Land Texas
United States Herman Clinical Research LLC Site Number : 8400078 Suwanee Georgia
United States Medical Advancement Center of Arizona Site Number : 8400107 Tempe Arizona
United States Toledo Institute of Clinical Research Site Number : 8400024 Toledo Ohio
United States Great Lakes Medical Research Site Number : 8400044 Westfield New York
United States Allianz Research Institute Site Number : 8400007 Westminster California
United States Southeastern Research Center Site Number : 8400068 Winston-Salem North Carolina
United States Florida Pulmonary Research Center Site Number : 8400001 Winter Park Florida

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  France,  Germany,  Greece,  Hungary,  Latvia,  Lithuania,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annual rate of acute COPD exacerbation (AECOPD) Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo Baseline to week 52
Secondary Change in pre-bronchodilator FEV1 Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo Baseline to week 12
Secondary Change in SGRQ Change from baseline to Week 52 in SGRQ total score compared to placebo Baseline to week 52
Secondary Improvement in SGRQ Proportion of patients with SGRQ improvement =4 points at Week 52 Baseline to week 52
Secondary Change in pre-bronchodilator FEV1 from baseline to Week 52 Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo Baseline to week 52
Secondary Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo Baseline to weeks 2, 4, 8, 24, 36, 44
Secondary Change in post-bronchodilator FEV1 lung function Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo Baseline to weeks 2, 4, 8, 12, 24, 36, 52
Secondary Change in forced expiratory flow (FEF) 25-75% Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52 Baseline to weeks 2, 4, 8, 12, 24, 36, 44, 52
Secondary Annualized rate of severe AECOPD Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period Baseline through week 52
Secondary Time to first AECOPD Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period Baseline through week 52
Secondary Adverse events Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs) Baseline through week 64
Secondary Potentially clinically significant abnormality (PCSA) in laboratory tests Percentage of patients with at least one incidence of PCSA Baseline through week 64
Secondary Anti-drug antibodies Incidence of anti-drug antibodies against dupilumab Baseline through week 64
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