Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Objective:

Primary population (former smokers cohort):

• Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

Primary population (former smokers cohort):

• Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
• Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
• Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
• Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
• Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Secondary population (current smokers cohort)

• Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
• Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
• Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
• Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
• Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Itepekimab SAR440340; Drug: Placebo

Detailed Description

The study duration per participant:

• Screening period is 3-5 weeks
• Randomized investigational medicinal product (IMP) treatment period is 52 weeks for first cohort of randomized former smoker participants [approximately 930] and cohort of current smokers [approximately 280], and 24 to 52 weeks for potential additional randomized former smoker participants
• Post-IMP treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.

• Study Type: Interventional
• Enrollment (Actual): 1239
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, CP 1884
      • Investigational Site Number : 0320009
    • CABA, Buenos Aires, Argentina, C1023AAB
      • Investigational Site Number : 0320008
    • CABA, Buenos Aires, Argentina, C1414AIF
      • Investigational Site Number : 0320001
    • Pergamino, Buenos Aires, Argentina, B2700CPM
      • Investigational Site Number : 0320005
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1060
      • Investigational Site Number : 0320006
    • Vicente Lopez, Buenos Aires F.D., Argentina, B1602DQD
      • Investigational Site Number : 0320002
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320007
    • Rosario, Santa Fe Province, Argentina, S2000DBS
      • Investigational Site Number : 0320003
    • Rosario, Santa Fe Province, Argentina, S2000JKR
      • Investigational Site Number : 0320004
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigação Clínica- Site Number : 0760004
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055 450
      • CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • SER da Bahia- Site Number : 0760020
  • Federal District
    • Brasília, Federal District, Brazil, 70710-100
      • CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018
  • Maranhão
    • São Luís, Maranhão, Brazil, 65060-645
      • Hospital Sao Domingos- Site Number : 0760016
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014
  • Paraná
    • Curitiba, Paraná, Brazil, 80060-240
      • CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-020
      • Instituto Ceos Site Number : 0760021
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS- Site Number : 0760007
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618-687
      • Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005
    • Campinas, São Paulo, Brazil, 13059-900
      • PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila Site Number : 0760008
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015
    • São Paulo, São Paulo, Brazil, 04014-002
      • Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Investigational Site Number : 1000008
  • Dupnitsa, Bulgaria, 2600
    • Investigational Site Number : 1000013
  • Gabrovo, Bulgaria, 5300
    • Investigational Site Number : 1000004
  • Haskovo, Bulgaria, 6305
    • Investigational Site Number : 1000009
  • Montana, Bulgaria, 3403
    • Investigational Site Number : 1000005
  • Plovdiv, Bulgaria, 4002
    • Investigational Site Number : 1000002
  • Rousse, Bulgaria, 7000
    • Investigational Site Number : 1000012
  • Rousse, Bulgaria, 7002
    • Investigational Site Number : 1000003
  • Sofia, Bulgaria, 1142
    • Investigational Site Number : 1000001
  • Sofia, Bulgaria, 1680
    • Investigational Site Number : 1000006
• Canada
  • Québec, Canada, G1N 4V3
    • Investigational Site Number : 1240003
  • Alberta
    • Sherwood Park, Alberta, Canada, T8H 0N2
      • Investigational Site Number : 1240006
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 4N7
      • Investigational Site Number : 1240014
    • Penticton, British Columbia, Canada, V2A 5L5
      • Investigational Site Number : 1240016
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C2Z3
      • Investigational Site Number : 1240012
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Investigational Site Number : 1240021
    • Burlington, Ontario, Canada, L7N 3V2
      • Investigational Site Number : 1240020
    • Guelph, Ontario, Canada, N1H 6J2
      • Investigational Site Number : 1240023
    • Toronto, Ontario, Canada, M5T 3A9
      • Investigational Site Number : 1240009
    • Windsor, Ontario, Canada, N8X 1T3
      • Investigational Site Number : 1240022
    • Windsor, Ontario, Canada, N8X 5A6
      • Investigational Site Number : 1240018
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240004
    • St-charles Borrommee, Quebec, Canada, J6E 2B4
      • Investigational Site Number : 1240005
    • Terrebonne, Quebec, Canada, J6V 2H2
      • Investigational Site Number : 1240019
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Investigational Site Number : 1240001
    • Victoriaville, Quebec, Canada, G6P 3Z8
      • Investigational Site Number : 1240002
• Chile
  • Los Ríos Region
    • Valdivia, Los Ríos Region, Chile, 5110683
      • Investigational Site Number : 1520009
  • Maule Region
    • Talca, Maule Region, Chile
      • Investigational Site Number : 1520002
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500010
      • Investigational Site Number : 1520007
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500587
      • Investigational Site Number : 1520008
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500698
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana de Santiago, Chile, 8910131
      • Investigational Site Number : 1520005
  • Región de Valparaíso
    • Quillota, Región de Valparaíso, Chile, 2260877
      • Investigational Site Number : 1520006
• Czechia
  • Jindrichuv Hradec III, Czechia, 37701
    • Investigational Site Number : 2030001
  • Mladá Boleslav, Czechia, 29301
    • Investigational Site Number : 2030005
  • Měšice, Czechia, 250 64
    • Investigational Site Number : 2030009
  • Olomouc, Czechia, 779 00
    • Investigational Site Number : 2030008
  • Ostrava, Czechia, 70800
    • Investigational Site Number : 2030004
  • Prague, Czechia, 140 46
    • Investigational Site Number : 2030002
  • Teplice, Czechia, 415 01
    • Investigational Site Number : 2030006
  • Varnsdorf, Czechia, 40747
    • Investigational Site Number : 2030007
• Denmark
  • Hvidovre, Denmark, 2650
    • Investigational Site Number : 2080001
  • Vejle, Denmark, 7100
    • Investigational Site Number : 2080003
• Estonia
  • Tartu, Estonia, 50406
    • Investigational Site Number : 2330001
• France
  • Lyon, France, 69004
    • Investigational Site Number : 2500001
  • Montpellier, France
    • Investigational Site Number : 2500002
  • Pessac, France, 33600
    • Investigational Site Number : 2500003
  • Reims, France, 51090
    • Investigational Site Number : 2500004
• Georgia
  • Batumi, Georgia, 6010
    • Investigational Site Number : 2680003
  • Tbilisi, Georgia, 0160
    • Investigational Site Number : 2680001
  • Tbilisi, Georgia, 0168
    • Investigational Site Number : 2680002
• Germany
  • Bendorf, Germany, 56068
    • Investigational Site Number : 2760006
  • Berlin, Germany, 10787
    • Investigational Site Number : 2760004
  • Berlin, Germany, 10961
    • Investigational Site Number : 2760009
  • Berlin, Germany, 12159
    • Investigational Site Number : 2760010
  • Frankfurt am Main, Germany, 60596
    • Investigational Site Number : 2760005
  • Hamburg, Germany, 20354
    • Investigational Site Number : 2760002
  • Hanover, Germany, 30625
    • Investigational Site Number : 2760014
  • Leipzig, Germany, 04299
    • Investigational Site Number : 2760008
  • Leipzig, Germany, 04347
    • Investigational Site Number : 2760007
  • Lübeck, Germany, 23552
    • Investigational Site Number : 2760003
  • Mainz, Germany, 55128
    • Investigational Site Number : 2760001
  • Neu-Isenburg, Germany, 63263
    • Investigational Site Number : 2760012
  • Rosenheim, Germany, 83022
    • Investigational Site Number : 2760011
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Investigational Site Number : 3480002
  • Budapest, Hungary, 1106
    • Investigational Site Number : 3480009
  • Edelény, Hungary, 3780
    • Investigational Site Number : 3480005
  • Hajdunánás, Hungary, 4080
    • Investigational Site Number : 3480004
  • Püspökladány, Hungary, 4150
    • Investigational Site Number : 3480003
  • Szombathely, Hungary, 9700
    • Investigational Site Number : 3480012
  • Százhalombatta, Hungary, 2440
    • Investigational Site Number : 3480001
• India
  • Belagavi, India, 590010
    • Investigational Site Number : 3560016
  • Chandigarh, India, 160012
    • Investigational Site Number : 3560001
  • India, India, 440010
    • Investigational Site Number : 3560014
  • Jaipur, India, 302023
    • Investigational Site Number : 3560013
  • Kanpur, India, 208002
    • Investigational Site Number : 3560019
  • Kolkata, India, 700107
    • Investigational Site Number : 3560010
  • Nagpur, India, 440012
    • Investigational Site Number : 3560017
  • Nagpur, India, 440015
    • Investigational Site Number : 3560005
  • Nashik, India, 422007
    • Investigational Site Number : 3560009
  • Pune, India, 411004
    • Investigational Site Number : 3560012
  • Pune, India, 411057
    • Investigational Site Number : 3560018
• Israel
  • Jerusalem, Israel, 91120
    • Investigational Site Number : 3760002
  • Jerusalem, Israel, 91031
    • Investigational Site Number : 3760003
  • Petah Tikva, Israel, 49100
    • Investigational Site Number : 3760001
  • Ramat Gan, Israel, 5266202
    • Investigational Site Number : 3760009
  • Rehovot, Israel, 76100
    • Investigational Site Number : 3760004
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Investigational Site Number : 3920023
    • Nagoya, Aichi-ken, Japan, 457-8511
      • Investigational Site Number : 3920020
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 815-0032
      • Investigational Site Number : 3920005
    • Fukuoka, Fukuoka, Japan, 819-8555
      • Investigational Site Number : 3920027
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Investigational Site Number : 3920030
  • Gifu
    • Mizunami-shi, Gifu, Japan, 509-6134
      • Investigational Site Number : 3920015
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 734-8530
      • Investigational Site Number : 3920010
    • Kure-shi, Hiroshima, Japan, 737-0193
      • Investigational Site Number : 3920021
    • Kure-shi, Hiroshima, Japan, 737-8505
      • Investigational Site Number : 3920035
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 006-8555
      • Investigational Site Number : 3920038
    • Sapporo, Hokkaido, Japan, 064-0804
      • Investigational Site Number : 3920042
  • Hyōgo
    • Himeji-shi, Hyōgo, Japan, 670-0849
      • Investigational Site Number : 3920013
  • Kagawa-ken
    • Sakaide-shi, Kagawa-ken, Japan, 762-8550
      • Investigational Site Number : 3920009
    • Takamatsu, Kagawa-ken, Japan, 761-8073
      • Investigational Site Number : 3920014
  • Kanagawa
    • Konan-ku, Yokohama-shi, Kanagawa, Japan, 234-0054
      • Investigational Site Number : 3920011
    • Yokohama, Kanagawa, Japan, 223-0059
      • Investigational Site Number : 3920039
  • Mie-ken
    • Matsusaka-shi, Mie-ken, Japan, 515-8544
      • Investigational Site Number : 3920043
  • Osaka
    • Osaka, Osaka, Japan, 530-8480
      • Investigational Site Number : 3920003
    • Osaka, Osaka, Japan, 545-8586
      • Investigational Site Number : 3920026
    • Sakai-shi, Osaka, Japan, 591-8555
      • Investigational Site Number : 3920007
    • Yao-shi, Osaka, Japan, 581-0011
      • Investigational Site Number : 3920006
  • Tochigi
    • Sano-shi, Tochigi, Japan, 327-8511
      • Investigational Site Number : 3920036
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0022
      • Investigational Site Number : 3920040
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Investigational Site Number : 3920017
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Investigational Site Number : 3920024
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Investigational Site Number : 3920019
    • Kiyose, Tokyo, Japan, 204-8522
      • Investigational Site Number : 3920029
    • Shibuya-ku, Tokyo, Japan, 150-8935
      • Investigational Site Number : 3920025
    • Shinagawa-ku, Tokyo, Japan, 140-8522
      • Investigational Site Number : 3920016
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Investigational Site Number : 3920037
    • Toshima-ku, Tokyo, Japan, 170-0003
      • Investigational Site Number : 3920041
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Investigational Site Number : 4280002
  • Riga, Latvia, LV-1002
    • Investigational Site Number : 4280001
• Lithuania
  • Kaunas, Lithuania, 49449
    • Investigational Site Number : 4400002
  • Kaunas, Lithuania, 50161
    • Investigational Site Number : 4400001
  • Klaipėda, Lithuania, 92231
    • Investigational Site Number : 4400003
• Mexico
  • Aguascalientes, Mexico, 20230
    • Investigational Site Number : 4840010
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840003
  • Durango, Mexico, 34000
    • Investigational Site Number : 4840007
  • Durango, Durango, Mexico, 34080
    • Investigational Site Number : 4840012
  • Mexico City, Mexico, 14050
    • Investigational Site Number : 4840006
  • Monterrey, Nuevo León, Mexico, 64460
    • Investigational Site Number : 4840001
  • Veracruz, Mexico, 91910
    • Investigational Site Number : 4840004
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Investigational Site Number : 4840008
    • Monterrey, Nuevo León, Mexico, 64718
      • Investigational Site Number : 4840009
    • Monterrey, Nuevo León, Mexico, 66465
      • Investigational Site Number : 4840002
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Investigational Site Number : 5280005
  • Breda, Netherlands, 4818 CK
    • Investigational Site Number : 5280001
  • Zutphen, Netherlands, 7207 AE
    • Investigational Site Number : 5280008
• Norway
  • Lørenskog, Norway, 1478
    • Investigational Site Number : 5780001
• Poland
  • Masovian Voivodeship
    • Wołomin, Masovian Voivodeship, Poland, 05-200
      • Investigational Site Number : 6160005
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-044
      • Investigational Site Number : 6160008
  • Pomeranian Voivodeship
    • Malbork, Pomeranian Voivodeship, Poland, 82-200
      • Investigational Site Number : 6160003
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Investigational Site Number : 6160002
  • Świętokrzyskie Voivodeship
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • Investigational Site Number : 6160009
• Portugal
  • Almada, Portugal, 2801-951
    • Investigational Site Number : 6200009
  • Aveiro, Portugal, 3810-501
    • Investigational Site Number : 6200006
  • Braga, Portugal, 4710-243
    • Investigational Site Number : 6200002
  • Guimarães, Portugal, 4810-061
    • Investigational Site Number : 6200001
  • Matosinhos Municipality, Portugal, 4464-513
    • Investigational Site Number : 6200010
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Cardiopulmonary Research- Site Number : 8400040
  • Ponce, Puerto Rico, 00717-1322
    • BRCR Medical Center, Inc. Site Number : 8400190
  • San Juan, Puerto Rico, 00907
    • BRCR Medical Center Site Number : 8400180
  • Temecula, Puerto Rico, 92590
    • Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232
• Russia
  • Moscow, Russia, 105077
    • Investigational Site Number : 6430002
  • Moscow, Russia, 115093
    • Investigational Site Number : 6430001
  • Moscow, Russia, 115280
    • Investigational Site Number : 6430005
  • Saint Petersburg, Russia, 193231
    • Investigational Site Number : 6430004
  • Saint Petersburg, Russia, 194354
    • Investigational Site Number : 6430003
  • Ulyanovsk, Russia, 432017
    • Investigational Site Number : 6430006
• South Africa
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100013
  • Cape Town, South Africa, 7530
    • Investigational Site Number : 7100002
  • Cape Town, South Africa, 7130
    • Investigational Site Number : 7100019
  • Chatsworth, South Africa, 4091
    • Investigational Site Number : 7100015
  • Durban, South Africa, 4001
    • Investigational Site Number : 7100005
  • Durban, South Africa, 4001
    • Investigational Site Number : 7100017
  • Durban, South Africa, 4071
    • Investigational Site Number : 7100006
  • Durban, South Africa, 4302
    • Investigational Site Number : 7100016
  • Gatesville, South Africa, 7764
    • Investigational Site Number : 7100004
  • Middelburg, South Africa, 1055
    • Investigational Site Number : 7100012
  • Parow, South Africa, 7500
    • Investigational Site Number : 7100003
  • Pretoria, South Africa, 0145
    • Investigational Site Number : 7100009
• South Korea
  • Seoul, South Korea, 06591
    • Investigational Site Number : 4100001
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Investigational Site Number : 4100002
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 463-707
      • Investigational Site Number : 4100005
  • Incheon-gwangyeoksi
    • Incheon, Incheon-gwangyeoksi, South Korea, 21431
      • Investigational Site Number : 4100003
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 05030
      • Investigational Site Number : 4100004
• Spain
  • Cáceres, Spain, 10003
    • Investigational Site Number : 7240010
  • Madrid, Spain, 28007
    • Investigational Site Number : 7240003
  • Málaga, Spain, 29010
    • Investigational Site Number : 7240001
  • Zaragoza, Spain, 50009
    • Investigational Site Number : 7240012
  • Balears [Baleares]
    • Palma de Mallorca, Balears [Baleares], Spain, 07120
      • Investigational Site Number : 7240004
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08017
      • Investigational Site Number : 7240014
    • Sant Boi de Llobregat, Barcelona [Barcelona], Spain, 08830
      • Investigational Site Number : 7240006
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Investigational Site Number : 7240013
  • Extremadura
    • Mérida / Badajoz, Extremadura, Spain, 06800
      • Investigational Site Number : 7240002
  • Lleida [Lérida]
    • Lleida / Lleida, Lleida [Lérida], Spain, 25198
      • Investigational Site Number : 7240009
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240008
  • Madrid, Comunidad de
    • Madrid / Madrid, Madrid, Comunidad de, Spain, 28040
      • Investigational Site Number : 7240007
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Investigational Site Number : 7920007
  • Balcali Adana, Turkey (Türkiye), 01330
    • Investigational Site Number : 7920005
  • Istanbul, Turkey (Türkiye), 34303
    • Investigational Site Number : 7920001
  • Izmir, Turkey (Türkiye), 35040
    • Investigational Site Number : 7920003
  • Kırıkkale, Turkey (Türkiye), 71450
    • Investigational Site Number : 7920006
  • Mersin, Turkey (Türkiye), 33343
    • Investigational Site Number : 7920002
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Investigational Site Number : 8260003
  • Liverpool, United Kingdom, L143PE
    • Investigational Site Number : 8260005
  • Milton Keynes, United Kingdom, MK15 0DU
    • Investigational Site Number : 8260008
  • Newcastle upon Tyne, United Kingdom, NE4 6BE
    • Investigational Site Number : 8260001
  • Glasgow City
    • Wishaw, Glasgow City, United Kingdom, ML2 0DP
      • Investigational Site Number : 8260006
  • North Tyneside
    • Tyne and Wear, North Tyneside, United Kingdom, NE29 8NH
      • Investigational Site Number : 8260007
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Investigational Site Number : 8260002
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333
  • California
    • Fresno, California, United States, 93701
      • UCSF Fresno - Site Number : 8400030
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research Site Number : 8400184
  • Colorado
    • Denver, Colorado, United States, 80219
      • Allianz Research Institute Colorado Site Number : 8400061
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics, LLC - Site Number : 8400049
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc- Site Number : 8400041
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center Site Number : 8400352
    • DeBary, Florida, United States, 32713
      • Omega Research - Site Number : 8400031
    • Doral, Florida, United States, 33178
      • Sciences Connections, LLC Site Number : 8400045
    • Gainesville, Florida, United States, 32608
      • North Florida/South Georgia Veterans Health System Site Number : 8400176
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research- Site Number : 8400011
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Medical Center Inc- Site Number : 8400065
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc- Site Number : 8400044
    • Loxahatchee Groves, Florida, United States, 33470
      • Advanced Pulmonary Research Institute Site Number : 8400018
    • Miami, Florida, United States, 33126
      • Finlay Medical Research Site Number : 8400007
    • Miami, Florida, United States, 33126
      • MCR Research Site Number : 8400425
    • Miami, Florida, United States, 33155
      • My Community Research Center Site Number : 8400060
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services- Site Number : 8400054
    • Miami, Florida, United States, 33144
      • Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009
    • Miami, Florida, United States, 33165
      • Phoenix Medical Research- Site Number : 8400019
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research- Site Number : 8400015
    • Orlando, Florida, United States, 32819
      • Heuer M.D. Research Site Number : 8400016
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group, PA- Site Number : 8400192
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research Site Number : 8400026
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center- Site Number : 8400067
    • Pembroke Pines, Florida, United States, 33025
      • Pines Care Research Center LLC- Site Number : 8400056
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC Site Number : 8400182
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida, Inc- Site Number : 8400008
  • Georgia
    • Valdosta, Georgia, United States, 31605
      • Medster Research, LLC Site Number : 8400051
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research Site Number : 8400013
  • Illinois
    • Fairview Heights, Illinois, United States, 62208
      • Care Access Fairview Heights Site Number : 8400033
    • North Chicago, Illinois, United States, 60064
      • Captain James A. Lovell Federal Health Care Center Site Number : 8400032
    • Peoria, Illinois, United States, 61605
      • Illinois Lung Institute- Site Number : 8400024
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic Site Number : 8400034
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Garfield- Site Number : 8400063
  • Kentucky
    • Lexington, Kentucky, United States, 40502
      • Lexington VA Health Care System- Site Number : 8400036
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Pulmonary & Critical Care Site Number : 8400047
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Asthma and Allergy Center- Site Number : 8400055
  • Massachusetts
    • Boston, Massachusetts, United States, 02110
      • Care Access Site Number : 8400276
    • Boston, Massachusetts, United States, 02110
      • Care Access Site Number : 8400281
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital Site Number : 8400052
    • Lathrup Village, Michigan, United States, 48076
      • Revive Research Institute Site Number : 8400186
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine- Site Number : 8400035
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research- Site Number : 8400005
  • New York
    • Brooklyn, New York, United States, 11230
      • Smart Medical Research Site Number : 8400191
    • Buffalo, New York, United States, 14215
      • VA Western New York Healthcare System Site Number : 8400050
    • Flushing, New York, United States, 11355
      • New York - Presbyterian Queens- Site Number : 8400028
    • Schenectady, New York, United States, 12308
      • Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research- Site Number : 8400002
    • Huntersville, North Carolina, United States, 28078
      • Advanced Respiratory and Sleep Medicine- Site Number : 8400022
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati- Site Number : 8400042
    • Columbus, Ohio, United States, 43215
      • Remington-Davis Inc- Site Number : 8400004
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research- Site Number : 8400014
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research LLC- Site Number : 8400001
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research Site Number : 8400039
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network- Site Number : 8400187
    • Philadelphia, Pennsylvania, United States, 19140-5103
      • Temple University Hospital Site Number : 8400062
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network- Site Number : 8400058
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung & Critical Care- Site Number : 8400175
    • Columbia, South Carolina, United States, 29204
      • Medtrial, LLC Site Number : 8400048
    • Gaffney, South Carolina, United States, 29340
      • VitaLink Research- Gaffney- Site Number : 8400003
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Clinical Trials Center of Middle Tennessee Site Number : 8400025
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS Research- Site Number : 8400012
    • Houston, Texas, United States, 77091
      • United Memorial Medical Center (UMMC)- Site Number : 8400193
    • Lampasas, Texas, United States, 76550-1820
      • Radiance Clinical Research- Site Number : 8400037
    • Plano, Texas, United States, 75024
      • Clincove: Plano Primary Care Clinic Site Number : 8400424
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute - Site Number : 8400183
  • Utah
    • Murray, Utah, United States, 84123
      • AES Salt Lake City- Site Number : 8400332
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • The Rheumatology and Pulmonary Clinic- Site Number : 8400053
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center Site Number : 8400046

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria :

• Participant must be 40 to 85 years of age inclusive.
• Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).

• Smoking history of ≥10 pack-years:

  • For former smokers: participants who report that they are not currently smoking and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
  • For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period.
• Participants with moderate-to-severe COPD
• Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to Screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded).

• Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:

  • Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
  • Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
• Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the Screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
• Body mass index (BMI) ≥18.0 kg/m^2, or BMI ≥16.0 kg/m^2 for participants enrolled in East-Asian countries.

• Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:

  • not a women of child-bearing potential (WOCBP) OR
  • a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention. -

Exclusion criteria:

• Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred.
• For former smokers: Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A).
• For current smokers: vaping of any products (eg, nicotine, THC) within 6 months prior to Screening (Visit 1A).
• Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study.
• Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
• Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
• Hypercapnia requiring bilevel positive airway pressure (BiPAP).
• Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
• Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
• Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
• Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
• Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy).
• Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
• History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
• Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).
• Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis.
• History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
• Previous use of itepekimab.

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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Itepekimab Q2W in former smokers; Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks	Drug: Itepekimab SAR440340; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous; Other Names: REGN3500
Experimental: Itepekimab Q4W in former smokers; SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP	Drug: Itepekimab SAR440340; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous; Other Names: REGN3500; Drug: Placebo; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Placebo Comparator: Placebo in former smokers; SC administration of matching placebo Q2W for up to 52 weeks	Drug: Placebo; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Experimental: Itepekimab Q2W in current smokers; SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks	Drug: Itepekimab SAR440340; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous; Other Names: REGN3500
Placebo Comparator: Placebo in current smokers; SC administration of matching placebo Q2W for 52 weeks	Drug: Placebo; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers	Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.	Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 24
Change from baseline in post-BD FEV1 in former smokers	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 24 and Week 52
Change from baseline in pre-BD FEV1 in former smokers	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline to Week 52
Time to first moderate or severe AECOPD in former smokers	Time to first moderate or severe AECOPD over the placebo-controlled treatment period.	Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Annualized rate of severe AECOPD in former smokers	Annualized rate of severe AECOPD over the placebo-controlled treatment period.	Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Time to first severe AECOPD in former smokers	Time to first severe AECOPD over the placebo-controlled treatment period.	Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Annualized rate of corticosteroid-treated AECOPD in former smokers	Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.	Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score in former smokers	The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.	Baseline to Week 24 and Week 52
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) in former smokers		Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline to Week 24 and Week 52
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score in former smokers	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline to Week 24 and Week 52
Annualized rate of moderate or severe AECOPD in current smokers	Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period.	Baseline up to Week 52
Change from baseline in pre-BD FEV1 in current smokers	FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline up to Week 24 and Week 52
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation in former smokers		Baseline up to End-of-Study (EOS) (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Functional itepekimab concentrations in serum in former smokers		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers		Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers		Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers		Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Functional itepekimab concentrations in serum in current smokers		Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers		Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• EFC16819 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): April 21, 2025
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

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; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; itepekimab
• Other Study ID Numbers: EFC16819; 2020-001819-24 (EudraCT Number); U1111-1250-2843 (Registry Identifier: ICTRP); 2024-512012-21 (Registry Identifier: CTIS)

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
• product manufactured in and exported from the U.S.: Yes