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

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: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Dupilumab SAR231893; Drug: Inhaled Corticosteroid; Drug: Inhaled Long-Acting Beta Agonist; Drug: Inhaled Long-Acting Muscarinic Antagonist; Drug: Placebo

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

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
      • Radiance 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

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with a physician diagnosis of COPD who met 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 participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were 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: Participants 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. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: participants 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab; Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 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; Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period	Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.	Baseline (Day 1) to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12	The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Week 12
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52	The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had a unique empirically derived weight where lowest possible weight was 0 and the highest was 100. Total score was obtained by summing all positive responses in the questionnaire. The total score and domain score was derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating worse health status/health related quality of life. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Week 52
Percentage of Participants With Saint George's Respiratory Questionnaire Improvement ≥4 Points at Week 52	A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by ≥4 points. Percentage of participants who achieved a clinically meaningful response in SGRQ total score (improvement by ≥4 points)/responders are reported. SGRQ is a 50-item self-administered questionnaire. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had unique empirically derived weight where lowest possible weight was 0 and highest was 100. Total score was obtained by summing all positive responses in questionnaire. Total score and domain score was derived from relevant items and converted to a score of 0 to 100; higher score indicating worse health status/health related quality of life.	Baseline (Day 1) and Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52	The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 24, 36, and 44	The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Weeks 2, 4, 8, 24, 36 and 44
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 12, 24, 36, and 52	The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed consistent with the mechanism of action of reliever (30 minutes for albuterol or another short-acting beta agonists). Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36 and 52
Change From Baseline in Forced Expiratory Flow (FEF) 25 to 75 Percent (%) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52	FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the FEF at 25% to 75% of forced vital capacity (FVC), where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.	Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 44 and 52
Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period	Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.	Baseline (Day 1) to Week 52
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbation Event During the 52-week Treatment Period	The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. Moderate exacerbations were recorded by the Investigator and defined as AECOPD event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Median time as well as 95% confidence interval was calculated using Kaplan-Meier estimates.	Baseline (Day 1) and up to Weeks 12, 24, 36 and 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 98 days).	From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology	Blood samples were collected to determine PCSA in hematology. PCSA values were defined as abnormal values considered medically important by the Sponsor according to pre-defined criteria/thresholds based on literature review and defined by the Sponsor for clinical laboratory tests. Criteria for PCSA: Hemoglobin (Hb): ≤115 grams per liter (g/L) (Male[M]); ≤95 g/L (Female[F]), ≥185 g/L (M); ≥165 g/L (F), Decrease from baseline ≥20 g/L; Hematocrit: ≤0.37 volume per volume (v/v) (M); ≤0.32 v/v (F), ≥0.55 v/v (M); ≥0.5 v/v (F); Erythrocyte Count: ≥6 Tera/L; Platelet count: <100 Giga/L, ≥700 Giga/L; Leukocytes: <3 Giga/L (Non-Black [NB]); <2 Giga/L (Black [B]), ≥16 Giga/L; Neutrophils: <1.5 Giga/L (NB); <1 Giga/L (B); Lymphocytes: >4 Giga/L; Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN ≥0.5 Giga/L).	From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry	Blood samples were collected to determine PCSA in chemistry. PCSA criteria: Sodium: ≤129 millimoles (mmol)/L, ≥160 mmol/L; Potassium: <3 mmol/L, ≥5.5 mmol/L; Chloride: <80 mmol/L, >115 mmol/L; Glucose: ≤3.9 mmol/L and <lower limit of normal (LLN), ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted);Total cholesterol: ≥7.74 mmol/L; Creatinine kinase: >3 ULN, >10 ULN; Creatinine: ≥150 micromoles (µmol)/L (adults), ≥30% change from baseline, ≥100% change from baseline, Creatinine Clearance (CG): ≥60 - <90 milliliter per minute (mL/min), ≥30 - <60 mL/min, ≥15 - <30 mL/min, <15 mL/min; Urea nitrogen: ≥17 mmol/L; Uric acid: <120 μmol/L, >408 μmol/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST): >3 ULN, >5 ULN, >10 ULN; Alkaline phosphatase (ALP): >1.5 ULN; Total bilirubin (TB): >1.5 ULN, >2 ULN; ALT and TB: ALT >3 ULN and Bilirubin > 2 ULN; Direct bilirubin (DB) and TB: DB >35% Bilirubin and Bilirubin >1.5 ULN; Albumin: ≤25 g/L.	From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Abnormal Results for Urine Protein in Urinalysis	Urine dipstick samples were collected to determine the significant abnormalities in urine protein.	Baseline (Day 1), Weeks 4, 8, 12, 24, 36, 52 and 64
Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab	Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity is defined as an ADA positive response in the assay at baseline with all post-treatment ADA results negative, or an ADA positive response at baseline with all post-treatment ADA responses less than 4-fold over baseline titer levels. Treatment-emergent response is defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. Treatment-boosted response is defined as an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.	Up to Week 52

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• EFC15805 Plain language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Cholinergic Antagonists; Cholinergic Agents; Muscarinic Antagonists
• Other Study ID Numbers: EFC15805; 2018-001954-91 (EudraCT Number); U1111-1211-8837 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No