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

March 21, 2024 updated by: Sanofi

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

935

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1121ABE
    - Investigational Site Number : 0320002
  - Launs Este, Argentina, B1824KAJ
    - Investigational Site Number : 0320012
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, CP 1884
    - Investigational Site Number : 0320007
  - Caba, Buenos Aires, Argentina, C1425BEN
    - Investigational Site Number : 0320001
  - Caba, Buenos Aires, Argentina, C1122AAK
    - Investigational Site Number : 0320006
  - Caba, Buenos Aires, Argentina, C1425FVH
    - Investigational Site Number : 0320003
  - Caba, Buenos Aires, Argentina, C1414AIF
    - Investigational Site Number : 0320004
  - La Plata, Buenos Aires, Argentina, B1900BNN
    - Investigational Site Number : 0320010
  - Lobos, Buenos Aires, Argentina, 7240
    - Investigational Site Number : 0320013
- Ciudad De Buenos Aires
  - Quilmes, Ciudad De Buenos Aires, Argentina, B1878FNR
    - Investigational Site Number : 0320005
- Córdoba
  - Cordoba, Córdoba, Argentina, X5003DCE
    - Investigational Site Number : 0320011
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DEJ
    - Investigational Site Number : 0320008
  - Rosario, Santa Fe, Argentina, S2002OJP
    - Investigational Site Number : 0320009
Australia
- South Australia
  - Kent Town, South Australia, Australia, 5067
    - Investigational Site Number : 0360008
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Investigational Site Number : 0360005
- Western Australia
  - Spearwood, Western Australia, Australia, 6163
    - Investigational Site Number : 0360001
Belgium
- - Edegem, Belgium, 2650
    - Investigational Site Number : 0560002
  - Leuven, Belgium, 3000
    - Investigational Site Number : 0560001
  - Liege, Belgium, 4000
    - Investigational Site Number : 0560003
  - Mechelen, Belgium, 2800
    - Investigational Site Number : 0560004
Brazil
- Bahia
  - Salvador, Bahia, Brazil, 40150-150
    - SER da Bahia Site Number : 0760019
- Espírito Santo
  - Vitoria, Espírito Santo, Brazil, 29055 450
    - CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020
- Rio Grande Do Sul
  - Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
    - Instituto Mederi de Pesquisa e Saude Site Number : 0760008
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    - Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90160-090
    - Hospital Sao Lucas Site Number : 0760001
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89030-100
    - HOSPITAL DIA DO PULMAO Site Number : 0760006
  - Florianópolis, Santa Catarina, Brazil, 88040-970
    - UFSC - Hospital Universitário Site Number : 0760018
- São Paulo
  - Campinas, São Paulo, Brazil, 13059-900
    - PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015
  - Santo Andre, São Paulo, Brazil, 09060-870
    - FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007
  - Sao Paulo, São Paulo, Brazil, 01228-000
    - CPQuali Pesquisa Clinica Site Number : 0760003
  - Sao Paulo, São Paulo, Brazil, 01229-010
    - Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012
  - Sao Paulo, São Paulo, Brazil, 04014-002
    - Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021
  - Sao Paulo, São Paulo, Brazil, 05403-900
    - InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Clinica de Alergia Martti Antila Site Number : 0760009
Bulgaria
- - Burgas, Bulgaria, 8000
    - Investigational Site Number : 1005025
  - Dupnitsa, Bulgaria, 2600
    - Investigational Site Number : 1005021
  - Haskovo, Bulgaria, 6305
    - Investigational Site Number : 1005012
  - Montana, Bulgaria, 3403
    - Investigational Site Number : 1005011
  - Plovdiv, Bulgaria, 4002
    - Investigational Site Number : 1005008
  - Ruse, Bulgaria, 70000
    - Investigational Site Number : 1005015
  - Ruse, Bulgaria, 7002
    - Investigational Site Number : 1005013
  - Sofia, Bulgaria, 1000
    - Investigational Site Number : 1005018
  - Sofia, Bulgaria, 1142
    - Investigational Site Number : 1005003
  - Sofia, Bulgaria, 1233
    - Investigational Site Number : 1005001
  - Sofia, Bulgaria, 1233
    - Investigational Site Number : 1005006
  - Sofia, Bulgaria, 1407
    - Investigational Site Number : 1005002
  - Sofia, Bulgaria, 1618
    - Investigational Site Number : 1005026
  - Stara Zagora, Bulgaria, 6000
    - Investigational Site Number : 1005024
  - Stara Zagora, Bulgaria, 6001
    - Investigational Site Number : 1005004
  - Veliko Tyrnovo, Bulgaria, 5000
    - Investigational Site Number : 1005023
  - Veliko Tyrnovo, Bulgaria, 5000
    - Investigational Site Number : 1005027
  - Vidin, Bulgaria, 3700
    - Investigational Site Number : 1005019
  - Vratsa, Bulgaria, 3000
    - Investigational Site Number : 1005020
Canada
- - Quebec, Canada, G1G 3Y8
    - Investigational Site Number : 1240001
  - Quebec, Canada, G2J 0C4
    - Investigational Site Number : 1240005
- Alberta
  - Calgary, Alberta, Canada, T3L 3E6
    - Investigational Site Number : 1240015
- British Columbia
  - Kamloops, British Columbia, Canada, V2C 5T1
    - Investigational Site Number : 1240018
  - Kelowna, British Columbia, Canada, V1Y 4N7
    - Investigational Site Number : 1240017
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 5C4
    - Investigational Site Number : 1240014
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Investigational Site Number : 1240010
  - Sarnia, Ontario, Canada, N7T 4X3
    - Investigational Site Number : 1240009
  - Windsor, Ontario, Canada, N8X 1T3
    - Investigational Site Number : 1240007
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Investigational Site Number : 1240004
  - Québec, Quebec, Canada, G1V 4W2
    - Investigational Site Number : 1240012
Chile
- Los Ríos
  - Valdivia, Los Ríos, Chile, 5110683
    - Investigational Site Number : 1520009
- Maule
  - Curicó, Maule, Chile, 3341643
    - Investigational Site Number : 1520006
  - Talca, Maule, Chile
    - Investigational Site Number : 1520001
- Reg Metropolitana De Santiago
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500571
    - Investigational Site Number : 1520007
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500692
    - Investigational Site Number : 1520003
  - Santiago, Reg Metropolitana De Santiago, Chile, 8910131
    - Investigational Site Number : 1520002
- Valparaíso
  - Quillota, Valparaíso, Chile, 2260877
    - Investigational Site Number : 1520004
Colombia
- - Bogota, Colombia, 11001000
    - Investigational Site Number : 1700002
  - Bucaramanga, Colombia
    - Investigational Site Number : 1700007
  - Manizales, Colombia, 170004
    - Investigational Site Number : 1700005
Czechia
- - Havlickuv Brod, Czechia, 580 01
    - Investigational Site Number : 2030009
  - Jihlava, Czechia, 58633
    - Investigational Site Number : 2030004
  - Jindrichuv Hradec III, Czechia, 37701
    - Investigational Site Number : 2030001
  - Kralupy nad Vltavou, Czechia, 278 01
    - Investigational Site Number : 2030007
  - Miroslav, Czechia, 67172
    - Investigational Site Number : 2030003
  - Nymburk, Czechia, 288 01
    - Investigational Site Number : 2030010
  - Strakonice, Czechia, 38601
    - Investigational Site Number : 2030002
France
- - Bayonne, France, 64100
    - Investigational Site Number : 2500009
  - Dijon, France, 21079
    - Investigational Site Number : 2500002
  - Lyon, France, 69004
    - Investigational Site Number : 2500005
  - Montpellier, France, 34295
    - Investigational Site Number : 2500003
  - Paris, France, 75014
    - Investigational Site Number : 2500007
  - Paris, France, 75015
    - Investigational Site Number : 2500008
  - Pessac, France, 33600
    - Investigational Site Number : 2500006
  - Saint Herblain, France, 44800
    - Investigational Site Number : 2500001
Germany
- - Berlin, Germany, 10961
    - Investigational Site Number : 2760024
  - Berlin, Germany, 12159
    - Investigational Site Number : 2760025
  - Darmstadt, Germany, 64283
    - Investigational Site Number : 2760017
  - Frankfurt am Main, Germany, 60596
    - Investigational Site Number : 2760009
  - Hamburg, Germany, 20354
    - Investigational Site Number : 2760002
  - Hannover, Germany, 30173
    - Investigational Site Number : 2760003
  - Koblenz, Germany, 56068
    - Investigational Site Number : 2760007
  - Leipzig, Germany, 04299
    - Investigational Site Number : 2760023
  - Leipzig, Germany, 04347
    - Investigational Site Number : 2760011
  - Lübeck, Germany, 23552
    - Investigational Site Number : 2760010
  - Mainz, Germany, 55128
    - Investigational Site Number : 2760012
  - Marburg, Germany, 35043
    - Investigational Site Number : 2760008
  - Peine, Germany, 31224
    - Investigational Site Number : 2760020
  - Rosenheim, Germany, 83022
    - Investigational Site Number : 2760016
  - Wiesbaden, Germany, 65183
    - Investigational Site Number : 2760018
Greece
- - Athens, Greece, 11527
    - Investigational Site Number : 3000001
  - Athens, Greece, 10675
    - Investigational Site Number : 3000006
  - Heraklion, Greece, 71500
    - Investigational Site Number : 3000003
  - Ioannina, Greece, 455 00
    - Investigational Site Number : 3000002
  - Palaio Faliro, Athens, Greece, 17562
    - Investigational Site Number : 3000007
  - Thessaloniki, Greece, 57010
    - Investigational Site Number : 3000004
Hungary
- - Edelény, Hungary, 3780
    - Investigational Site Number : 3480003
  - Gödöllö, Hungary, 2100
    - Investigational Site Number : 3480004
  - Hajdunánás, Hungary, 4080
    - Investigational Site Number : 3480002
  - Mosonmagyaróvár, Hungary, 9200
    - Investigational Site Number : 3480006
  - Szombathely, Hungary, 9700
    - Investigational Site Number : 3480005
  - Százhalombatta, Hungary, 2440
    - Investigational Site Number : 3480001
Latvia
- - Balvi, Latvia, LV-4501
    - Investigational Site Number : 4280008
  - Rezekne, Latvia, LV - 4601
    - Investigational Site Number : 4280007
  - Riga, Latvia, LV-1002
    - Investigational Site Number : 4280002
  - Riga, Latvia, LV -1010
    - Investigational Site Number : 4280001
  - Riga, Latvia, LV -1010
    - Investigational Site Number : 4280005
  - Riga, Latvia, LV -1021
    - Investigational Site Number : 4280006
  - Riga, Latvia, LV-1038
    - Investigational Site Number : 4280003
Lithuania
- - Kaunas, Lithuania, 44320
    - Investigational Site Number : 4400001
  - Kaunas, Lithuania, 49449
    - Investigational Site Number : 4400003
  - Kaunas, Lithuania, 50161
    - Investigational Site Number : 4400008
  - Klaipeda, Lithuania, 92231
    - Investigational Site Number : 4400007
  - Vilnius, Lithuania, 04130
    - Investigational Site Number : 4400005
Mexico
- - Chihuahua, Mexico, 31000
    - Investigational Site Number : 4840010
  - Durango, Mexico, 34000
    - Investigational Site Number : 4840006
  - Mexico City, Mexico, 14050
    - Investigational Site Number : 4840007
  - Mexico City, Mexico, 67000
    - Investigational Site Number : 4840009
  - Veracruz, Mexico, 91910
    - Investigational Site Number : 4840005
- Ciudad De Mexico
  - Benito Juarez, Ciudad De Mexico, Mexico, 03100
    - Investigational Site Number : 4840008
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Investigational Site Number : 4840002
  - Guadalajara, Jalisco, Mexico, 44670
    - Investigational Site Number : 4840013
  - Zapopan, Jalisco, Mexico, 45070
    - Investigational Site Number : 4840011
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Investigational Site Number : 4840004
  - Monterrey, Nuevo León, Mexico, 66465
    - Investigational Site Number : 4840003
Netherlands
- - Arnhem, Netherlands, 6815 AD
    - Investigational Site Number : 5280005
  - Breda, Netherlands, 4818 CK
    - Investigational Site Number : 5280001
  - Dordrecht, Netherlands, 3318 AT
    - Investigational Site Number : 5280010
  - Harderwijk, Netherlands, 3844 DG
    - Investigational Site Number : 5280009
  - Leeuwarden, Netherlands, 8934 AD
    - Investigational Site Number : 5280002
  - Nijmegen, Netherlands, 6532 SZ
    - Investigational Site Number : 5280006
  - Roermond, Netherlands, 6043 CV
    - Investigational Site Number : 5280011
  - Zutphen, Netherlands, 7207 AE
    - Investigational Site Number : 5280008
  - Zwolle, Netherlands, 8025 AB
    - Investigational Site Number : 5280004
Peru
- - Lima, Peru, 021
    - Investigational Site Number : 6040006
  - Lima, Peru, 15004
    - Investigational Site Number : 6040004
  - Lima, Peru, LIMA 31
    - Investigational Site Number : 6040001
  - Lima Lima, Peru, Lima 01
    - Investigational Site Number : 6040002
  - Piura, Peru, 20000
    - Investigational Site Number : 6040005
Poland
- - Krakow, Poland, 30-033
    - Investigational Site Number : 6160019
  - Nowa Sol, Poland, 67-100
    - Investigational Site Number : 6160020
- Kujawsko-pomorskie
  - Grudziadz, Kujawsko-pomorskie, Poland, 86-300
    - Investigational Site Number : 6160009
- Malopolskie
  - Krakow, Malopolskie, Poland, 31-559
    - Investigational Site Number : 6160007
- Mazowieckie
  - Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
    - Investigational Site Number : 6160015
- Podkarpackie
  - Rzeszow, Podkarpackie, Poland, 35-205
    - Investigational Site Number : 6160010
- Podlaskie
  - Bialystok, Podlaskie, Poland, 15-044
    - Investigational Site Number : 6160008
- Slaskie
  - Katowice, Slaskie, Poland, 40-611
    - Investigational Site Number : 6160018
  - Katowice, Slaskie, Poland, 40-648
    - Investigational Site Number : 6160011
- Swietokrzyskie
  - Ostrowiec Swietokrzyski, Swietokrzyskie, Poland, 27-400
    - Investigational Site Number : 6160022
- Warminsko-mazurskie
  - Elblag, Warminsko-mazurskie, Poland, 82-300
    - Investigational Site Number : 6160014
Portugal
- - Almada, Portugal, 2801-951
    - Investigational Site Number : 6200007
  - Aveiro, Portugal, 3810-501
    - Investigational Site Number : 6200006
  - Guimarães, Portugal, 4810-061
    - Investigational Site Number : 6200002
  - Lisboa, Portugal, 1769
    - Investigational Site Number : 6200009
  - Matosinhos, Portugal, 4464-513
    - Investigational Site Number : 6200012
Romania
- - Bacau, Romania, 600252
    - Investigational Site Number : 6425004
  - Cluj-Napoca, Romania, 400275
    - Investigational Site Number : 6425003
  - Constanta, Romania, 900002
    - Investigational Site Number : 6425005
  - Iasi, Romania, 700732
    - Investigational Site Number : 6425002
  - Pitesti, Romania, 110117
    - Investigational Site Number : 6425006
  - Timisoara, Romania, 300134
    - Investigational Site Number : 6425001
Russian Federation
- - Moscow, Russian Federation, 115093
    - Investigational Site Number : 6430001
  - Moscow, Russian Federation, 115280
    - Investigational Site Number : 6430003
  - Moscow, Russian Federation, 125284
    - Investigational Site Number : 6430002
  - Nizhny Novgorod, Russian Federation, 603126
    - Investigational Site Number : 6430009
  - Ryazan, Russian Federation
    - Investigational Site Number : 6430010
  - Saint Petersburg, Russian Federation, 198328
    - Investigational Site Number : 6430013
  - Saint Petersburg, Russian Federation, 928260
    - Investigational Site Number : 6430014
  - St-Petersburg, Russian Federation, 194354
    - Investigational Site Number : 6430004
  - Stavropol, Russian Federation, 355020
    - Investigational Site Number : 6430012
  - Tomsk, Russian Federation, 634034
    - Investigational Site Number : 6430006
  - Ulyanovsk, Russian Federation, 432017
    - Investigational Site Number : 6430008
  - Voronezh, Russian Federation, 394066
    - Investigational Site Number : 6430005
Serbia
- - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880005
  - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880006
  - Belgrade, Serbia, 11000
    - Investigational Site Number : 6880007
  - Kragujevac, Serbia, 34000
    - Investigational Site Number : 6880003
  - Sremska Kamenica, Serbia, 21204
    - Investigational Site Number : 6880001
  - Valjevo, Serbia, 14000
    - Investigational Site Number : 6880002
Slovakia
- - Banska Bystrica, Slovakia, 97401
    - Investigational Site Number : 7030007
  - Humenne, Slovakia, 066 01
    - Investigational Site Number : 7030006
  - Kosice, Slovakia, 040 01
    - Investigational Site Number : 7030005
  - Levice, Slovakia, 93401
    - Investigational Site Number : 7030003
  - Poprad, Slovakia, 058 01
    - Investigational Site Number : 7030001
  - Spisska Nova Ves, Slovakia, 05201
    - Investigational Site Number : 7030002
South Africa
- - Benoni, South Africa, 1500
    - Investigational Site Number : 7100015
  - Cape Town, South Africa, 7500
    - Investigational Site Number : 7100004
  - Chatsworth, South Africa, 4091
    - Investigational Site Number : 7100014
  - Durban, South Africa, 4071
    - Investigational Site Number : 7100003
  - Durban, South Africa, 4001
    - Investigational Site Number : 7100001
  - Durban, South Africa, 4001
    - Investigational Site Number : 7100013
  - Durban, South Africa, 4302
    - Investigational Site Number : 7100010
  - Gatesville, South Africa, 7764
    - Investigational Site Number : 7100002
  - Gauteng, South Africa, 1935
    - Investigational Site Number : 7100011
  - Johannesburg, South Africa, 0157
    - Investigational Site Number : 7100009
  - Middelburg, South Africa, 1050
    - Investigational Site Number : 7100012
  - Parow, South Africa, 7500
    - Investigational Site Number : 7100006
  - Pretoria, South Africa, 0157
    - Investigational Site Number : 7100005
  - Somerset West, South Africa, 7130
    - Investigational Site Number : 7100008
Spain
- - Málaga, Spain, 29010
    - Investigational Site Number : 7240010
  - Zaragoza, Spain, 50009
    - Investigational Site Number : 7240011
- Asturias
  - Oviedo, Asturias, Spain, 33011
    - Investigational Site Number : 7240007
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spain, 08023
    - Investigational Site Number : 7240002
- Catalunya [Cataluña]
  - Badalona, Catalunya [Cataluña], Spain, 08916
    - Investigational Site Number : 7240009
- Cáceres
  - Caceres, Cáceres, Spain, 10002
    - Investigational Site Number : 7240012
- Madrid, Comunidad De
  - Madrid, Madrid, Comunidad De, Spain, 28046
    - Investigational Site Number : 7240003
- Valenciana, Comunidad
  - Valencia, Valenciana, Comunidad, Spain, 46017
    - Investigational Site Number : 7240008
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Investigational Site Number : 8040011
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number : 8040002
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number : 8040003
  - Kharkiv, Ukraine, 61124
    - Investigational Site Number : 8040001
  - Kyiv, Ukraine, 01033
    - Investigational Site Number : 8040007
  - Kyiv, Ukraine, 03049
    - Investigational Site Number : 8040004
  - Lviv, Ukraine, 79011
    - Investigational Site Number : 8040006
  - Ternopil, Ukraine, 46000
    - Investigational Site Number : 8040010
  - Zaporizhzhia, Ukraine, 69076
    - Investigational Site Number : 8040008
  - Zaporizhzhya, Ukraine, 69600
    - Investigational Site Number : 8040009
United Kingdom
- - Aylesbury, United Kingdom, HP218AL
    - Investigational Site Number : 8260012
  - Bradford, United Kingdom, BD9 6RJ
    - Investigational Site Number : 8260001
  - Bristol, United Kingdom, BS10 5NB
    - Investigational Site Number : 8260005
  - Chippenham, United Kingdom, SN15 2SB
    - Investigational Site Number : 8260011
  - Derby, United Kingdom, DE223NE
    - Investigational Site Number : 8260015
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
    - Investigational Site Number : 8260003
- Lancashire
  - Blackpool, Lancashire, United Kingdom, FY3 7DQ
    - Investigational Site Number : 8260002
- Neath Port Talbot
  - Swansea, Neath Port Talbot, United Kingdom, SA2 8QA
    - Investigational Site Number : 8260006
- Newcastle Upon Tyne
  - North Shields, Newcastle Upon Tyne, United Kingdom, NE29 8NH
    - Investigational Site Number : 8260007
  - South Shields, Newcastle Upon Tyne, United Kingdom, NE34 0PL
    - Investigational Site Number : 8260004
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    - Investigational Site Number : 8260013
United States
- Alabama
  - Cullman, Alabama, United States, 35055
    - Cullman Research Center, LLC Site Number : 8400095
  - Jasper, Alabama, United States, 35501
    - Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090
  - Scottsboro, Alabama, United States, 35768
    - Scottsboro Quick Care Clinic Site Number : 8400116
- Arizona
  - Peoria, Arizona, United States, 85381
    - Phoenix Medical Group Site Number : 8400061
  - Tempe, Arizona, United States, 85283
    - Medical Advancement Center of Arizona Site Number : 8400107
- Arkansas
  - Little Rock, Arkansas, United States, 72209
    - Asthma and Allergy Institute Site Number : 8400022
- California
  - Bakersfield, California, United States, 93301
    - Kern Research, Inc Site Number : 8400031
  - Newport Beach, California, United States, 92663
    - NewportNativeMD, Inc Site Number : 8400032
  - Rancho Cucamonga, California, United States, 91730
    - Prospective Research Innovations, Inc. Site Number : 8400063
  - San Diego, California, United States, 92119
    - ACRC Studies Site Number : 8400094
  - San Diego, California, United States, 92120
    - Institute of HealthCare Assessment, Inc. Site Number : 8400015
  - Westminster, California, United States, 92683
    - Allianz Research Institute Site Number : 8400007
- Colorado
  - Lafayette, Colorado, United States, 80026
    - Innovative Clinical Research Site Number : 8400018
- Florida
  - Boynton Beach, Florida, United States, 33435
    - Helix Biomedics, LLC Site Number : 8400035
  - Boynton Beach, Florida, United States, 33437
    - Pioneer Clinical Research Site Number : 8400043
  - Cape Coral, Florida, United States, 33991
    - Renaissance Research and Medical Group, Inc Site Number : 8400092
  - Clearwater, Florida, United States, 33765
    - St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020
  - Cutler Bay, Florida, United States, 33157
    - Beautiful Minds Clinical Research Center Site Number : 8400081
  - DeBary, Florida, United States, 32713
    - Omega Research Consultants, LLC Site Number : 8400021
  - Doral, Florida, United States, 33178
    - Sciences Connections, LLC Site Number : 8400133
  - Fort Lauderdale, Florida, United States, 33308
    - InvesClinic, LLC Site Number : 8400039
  - Greenacres City, Florida, United States, 33467
    - Finlay Medical Research Site Number : 8400071
  - Hialeah, Florida, United States, 33012
    - Direct Helpers Medical Center Inc Site Number : 8400079
  - Miami, Florida, United States, 33155
    - DL Research Solutions Inc Site Number : 8400089
  - Miami, Florida, United States, 33165
    - Phoenix Medical Research, LLC Site Number : 8400012
  - Miami, Florida, United States, 33174
    - Columbus Clinical Services Site Number : 8400062
  - Miami, Florida, United States, 33176
    - Reed Medical Research Site Number : 8400123
  - Miami, Florida, United States, 33184
    - De La Cruz Research Center, LLC Site Number : 8400075
  - Orlando, Florida, United States, 32825-4454
    - Florida Institute for Clinical Research Site Number : 8400129
  - Orlando, Florida, United States, 32825
    - Central Florida Pulmonary Group, PA Site Number : 8400101
  - Palmetto Bay, Florida, United States, 33157
    - Innovation Medical Research Center Site Number : 8400114
  - Plant City, Florida, United States, 33563
    - Family Medical Specialists of Florida, PA Site Number : 8400077
  - Saint Petersburg, Florida, United States, 33704
    - Coastal Pulmonary And Critical Care Site Number : 8400013
  - Winter Park, Florida, United States, 32789
    - Florida Pulmonary Research Center Site Number : 8400001
- Georgia
  - Adairsville, Georgia, United States, 30103
    - Appalachian Clinical Research Site Number : 8400048
  - Atlanta, Georgia, United States, 30345
    - Northlake Medical Group Site Number : 8400099
  - Blue Ridge, Georgia, United States, 30513
    - River Birch Research, LLC Site Number : 8400045
  - Conyers, Georgia, United States, 30094
    - Medical Centre of Conyers Site Number : 8400064
  - Cordele, Georgia, United States, 31015
    - David Kavtaradze MD, Inc. Site Number : 8400135
  - Lawrenceville, Georgia, United States, 30046
    - Gwinnett Biomedical Research Site Number : 8400052
  - Rincon, Georgia, United States, 31326
    - Southeast Lung Associates Site Number : 8400003
  - Suwanee, Georgia, United States, 30024
    - Herman Clinical Research LLC Site Number : 8400078
- Louisiana
  - Crowley, Louisiana, United States, 70526
    - Avant Research Associates LLC Site Number : 8400118
- Massachusetts
  - Fall River, Massachusetts, United States, 02723
    - Genesis Clinical Research & Consulting Site Number : 8400050
  - South Dartmouth, Massachusetts, United States, 02747
    - Infinity Medical Research Site Number : 8400004
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System Site Number : 8400053
  - Lathrup Village, Michigan, United States, 48076
    - Revive Research Institute Site Number : 8400120
  - Rochester, Michigan, United States, 48307
    - Romedica, LLC Site Number : 8400034
  - Saginaw, Michigan, United States, 48638
    - Covenant Healthcare Site Number : 8400057
  - Southfield, Michigan, United States, 48075-5400
    - Great Lakes Research Institute Site Number : 8400096
- Montana
  - Missoula, Montana, United States, 59808
    - Montana Medical Research Site Number : 8400019
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Somnos Clinical Research Site Number : 8400016
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research, Inc. Site Number : 8400073
- New Jersey
  - Jersey City, New Jersey, United States, 07304
    - Jersey City Breathing Center Site Number : 8400137
- New York
  - E. Amherst, New York, United States, 14051
    - WellNow Urgent Care Site Number : 8400132
  - New Hyde Park, New York, United States, 11040
    - Northwell Health Site Number : 8400054
  - New Windsor, New York, United States, 12553-7754
    - Mid Hudson Medical Research PLLC Site Number : 8400037
  - Westfield, New York, United States, 14787
    - Great Lakes Medical Research Site Number : 8400044
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Onsite Clinical Solutions LLC Site Number : 8400042
  - Gastonia, North Carolina, United States, 28054
    - Clinical Research of Gastonia Site Number : 8400010
  - Monroe, North Carolina, United States, 28112
    - Monroe Biomedical Research Site Number : 8400087
  - Mooresville, North Carolina, United States, 28117
    - Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006
  - Mooresville, North Carolina, United States, 28117
    - Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117
  - New Bern, North Carolina, United States, 28562
    - Coastal Carolina Health Care, P.A. Site Number : 8400025
  - Winston-Salem, North Carolina, United States, 27103
    - Southeastern Research Center Site Number : 8400068
- Ohio
  - Columbus, Ohio, United States, 43235
    - Optimed Research, LTD Site Number : 8400082
  - Toledo, Ohio, United States, 43617
    - Toledo Institute of Clinical Research Site Number : 8400024
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Allergy, Asthma and Clinical Research Center Site Number : 8400127
- Pennsylvania
  - DuBois, Pennsylvania, United States, 15801
    - Clinical Research of Central PA Site Number : 8400009
  - Scottdale, Pennsylvania, United States, 15683
    - Frontier Clinical Research, LLC Site Number : 8400049
- South Carolina
  - Clinton, South Carolina, United States, 29325
    - Carolina Medical Research, LLC Site Number : 8400026
  - Lancaster, South Carolina, United States, 29720
    - MD First Research Site Number : 8400105
  - Myrtle Beach, South Carolina, United States, 29577
    - LLM Research Site Number : 8400125
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts Site Number : 8400027
- Tennessee
  - Dickson, Tennessee, United States, 37055
    - Pulmonary & Sleep Specialists Site Number : 8400136
  - Franklin, Tennessee, United States, 37067
    - Clinical Trials Center of Middle Tennessee Site Number : 8400066
  - Johnson City, Tennessee, United States, 37601
    - MultiSpecialty Clinical Research Site Number : 8400110
- Texas
  - Beaumont, Texas, United States, 77701
    - REX Clinical Trials Site Number : 8400143
  - Carrollton, Texas, United States, 75007
    - Clinrx Research Site Number : 8400059
  - Cypress, Texas, United States, 77429
    - Houston Pulmonary and Sleep Associates Site Number : 8400011
  - Houston, Texas, United States, 77043-2742
    - Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055
  - Houston, Texas, United States, 77054
    - Prolato Clinical Research Center Site Number : 8400128
  - Houston, Texas, United States, 77099
    - Pioneer Research Solutions, Inc. Site Number : 8400070
  - Lampasas, Texas, United States, 76550-1820
    - Prestige Clinical Research Site Number : 8400029
  - Longview, Texas, United States, 75605
    - DCOL Center for Clinical Research Site Number : 8400028
  - McKinney, Texas, United States, 75069
    - Metroplex Pulmonary and Sleep Center Site Number : 8400131
  - Plano, Texas, United States, 75024
    - Clinrx Research, LLC Site Number : 8400069
  - San Antonio, Texas, United States, 78229
    - Diagnostics Research Group Site Number : 8400038
  - Sugar Land, Texas, United States, 77479
    - Mt. Olympus Medical Research Site Number : 8400115
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Pulmonary Research of Abingdon, LLC Site Number : 8400030
  - Richmond, Virginia, United States, 23236
    - Clinical Research Partners Site Number : 8400040
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 α-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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab Dupilumab administered every 2 weeks	Drug: Dupilumab SAR231893 Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Other Names: Dupixent Drug: Inhaled Corticosteroid Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Beta Agonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Muscarinic Antagonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo Comparator: Placebo Placebo dose administered every 2 weeks	Drug: Inhaled Corticosteroid Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Beta Agonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Muscarinic Antagonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Placebo Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Participant Group / Arm

Intervention / Treatment

Experimental: Dupilumab

Dupilumab administered every 2 weeks

Drug: Dupilumab SAR231893

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Other Names:

Dupixent

Drug: Inhaled Corticosteroid

Pharmaceutical form: Inhaled Powder