Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

Chronic Obstructive Pulmonary Disease Clinical Trial

— NOTUS  

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Inflammation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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

External Links

•   COPD Clinical Studies