A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD (AERIFY-4)

May 14, 2026 updated by: Sanofi

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies

This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.

The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819.

Study details include:

  • The study duration will be up to 72 weeks
  • The treatment duration will be up to 52 weeks
  • A follow-up period of 20 weeks will be conducted
  • The number of on-site visits will be 7 and the number of phone contacts will be 5

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1023
        • Investigational Site Number : 0320010
      • Buenos Aires, Argentina, 1414
        • Investigational Site Number : 0320005
      • Buenos Aires, Argentina, 1638
        • Investigational Site Number : 0320006
      • Buenos Aires, Argentina, 1650
        • Investigational Site Number : 0320009
      • Mendoza, Argentina, 5500
        • Investigational Site Number : 0320004
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1886
        • Investigational Site Number : 0320012
      • La Plata, Buenos Aires, Argentina, B1900BNN
        • Investigational Site Number : 0320013
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320007
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320003
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320008
      • Rosario, Santa Fe Province, Argentina, 2000
        • Investigational Site Number : 0320011
  • Brazil
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Serviços Especializados em Reumatologia- Site Number : 0760020
    • Federal District
      • Brasília, Federal District, Brazil, 70710-100
        • Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • 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 São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007
      • Porto Alegre, Rio Grande do Sul, Brazil, 91010-006
        • WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005
      • Campinas, São Paulo, Brazil, 13034-685
        • Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Investigational Site Number : 1000004
      • Haskovo, Bulgaria, 6300
        • Investigational Site Number : 1000007
      • Rousse, Bulgaria, 7000
        • Investigational Site Number : 1000018
      • Rousse, Bulgaria, 7002
        • Investigational Site Number : 1000010
      • Sofia, Bulgaria, 1233
        • Investigational Site Number : 1000001
      • Sofia, Bulgaria, 1756
        • Investigational Site Number : 1000009
      • Sofia, Bulgaria, 1142
        • Investigational Site Number : 1000016
      • Stara Zagora, Bulgaria, 6000
        • Investigational Site Number : 1000017
      • Stara Zagora, Bulgaria, 6003
        • Investigational Site Number : 1000003
      • Veliko Tarnovo, Bulgaria, 5000
        • Investigational Site Number : 1000013
      • Vidin, Bulgaria, 3700
        • Investigational Site Number : 1000006
  • Canada
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 0N2
        • Investigational Site Number : 1240006
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Investigational Site Number : 1240021
      • 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
      • 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 : 1520008
    • Maule Region
      • Talca, Maule Region, Chile, 3465584
        • Investigational Site Number : 1520006
    • 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, 7500698
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 7750000
        • Investigational Site Number : 1520002
    • Valparaiso
      • Quillota, Valparaiso, Chile, 2260877
        • Investigational Site Number : 1520005
  • China
      • Beijing, China, 100038
        • Investigational Site Number : 1560012
      • Changchun, China, 130021
        • Investigational Site Number : 1560004
      • Chengdu, China, 610041
        • Investigational Site Number : 1560001
      • Haikou, China, 570216
        • Investigational Site Number : 1560018
      • Hefei, China, 230032
        • Investigational Site Number : 1560016
      • Hohhot, China, 010050
        • Investigational Site Number : 1560017
      • Jinan, China, 250014
        • Investigational Site Number : 1560002
      • Nanchang, China, 330006
        • Investigational Site Number : 1560014
      • Pingxiang, China, 337055
        • Investigational Site Number : 1560019
      • Shanghai, China, 200025
        • Investigational Site Number : 1560020
      • Shanghai, China, 200433
        • Investigational Site Number : 1560006
      • Shenyang, China, 110004
        • Investigational Site Number : 1560008
      • Wuhan, China, 430014
        • Investigational Site Number : 1560005
      • Xiangtan, China, 411100
        • Investigational Site Number : 1560011
      • Xuzhou, China, 221006
        • Investigational Site Number : 1560007
      • Yangzhou, China, 225000
        • Investigational Site Number : 1560015
  • Czechia
      • Havlíčkův Brod, Czechia, 580 01
        • Investigational Site Number : 2030003
      • Jindřichův Hradec, Czechia, 377 01
        • Investigational Site Number : 2030001
  • Estonia
      • Tartu, Estonia, 50406
        • Investigational Site Number : 2330001
  • France
      • Lyon, France, 69004
        • Investigational Site Number : 2500001
      • Reims, France, 51092
        • Investigational Site Number : 2500004
  • Georgia
      • Batumi, Georgia, 6010
        • Investigational Site Number : 2680006
      • Tbilisi, Georgia, 0112
        • Investigational Site Number : 2680003
      • Tbilisi, Georgia, 0105
        • Investigational Site Number : 2680002
      • Tbilisi, Georgia, 0159
        • Investigational Site Number : 2680001
  • Germany
      • Bendorf, Germany, 56170
        • Investigational Site Number : 2760006
      • Berlin, Germany, 12159
        • Investigational Site Number : 2760010
      • Frankfurt, Germany, 60596
        • Investigational Site Number : 2760005
      • 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
      • Rosenheim, Germany, 83022
        • Investigational Site Number : 2760011
  • Greece
      • Palaió Fáliro, Greece, 175 62
        • Investigational Site Number : 3000008
      • Thessaloniki, Greece, 570 10
        • Investigational Site Number : 3000002
  • Hungary
      • Budapest, Hungary, 1106
        • Investigational Site Number : 3480009
      • Gödöllő, Hungary, 2100
        • Investigational Site Number : 3480001
      • Hajdúnánás, Hungary, 4080
        • Investigational Site Number : 3480004
      • Mosonmagyaróvár, Hungary, 9200
        • Investigational Site Number : 3480002
      • Püspökladány, Hungary, 4150
        • Investigational Site Number : 3480003
  • India
      • Calicut, India, 673008
        • Investigational Site Number : 3560001
      • Chandigarh, India, 160012
        • Investigational Site Number : 3560006
      • Hyderabad, India, 500 084
        • Investigational Site Number : 3560005
      • Jaipur, India, 302039
        • Investigational Site Number : 3560004
      • Jaipur, India, 302023
        • Investigational Site Number : 3560009
      • Kanpur, India, 208001
        • Investigational Site Number : 3560012
      • Nagpur, India, 441203
        • Investigational Site Number : 3560003
      • Nagpur, India, 440010
        • Investigational Site Number : 3560010
      • Nagpur, India, 440012
        • Investigational Site Number : 3560011
      • Nagpur, India, 440015
        • Investigational Site Number : 3560007
      • Pune, India, 411057
        • Investigational Site Number : 3560013
  • Israel
      • Haifa, Israel, 3436212
        • Investigational Site Number : 3760008
      • Jerusalem, Israel, 9103102
        • Investigational Site Number : 3760003
      • Jerusalem, Israel, 9112001
        • Investigational Site Number : 3760002
      • Kefar Sava, Israel, 4428164
        • Investigational Site Number : 3760006
      • Petah Tikva, Israel, 4941492
        • Investigational Site Number : 3760001
      • Ramat Gan, Israel, 5262100
        • Investigational Site Number : 3760009
      • Rehovot, Israel, 7610001
        • Investigational Site Number : 3760004
      • Tel Aviv, Israel, 6423906
        • Investigational Site Number : 3760007
  • Italy
      • Ferrara, Italy, 44100
        • Investigational Site Number : 3800001
  • Japan
      • Fukuoka, Japan, 819-0055
        • Investigational Site Number : 3920003
      • Tokyo, Japan, 140-8522
        • Investigational Site Number : 3920004
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Investigational Site Number : 3920008
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Investigational Site Number : 3920002
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0811
        • Investigational Site Number : 3920007
    • Hyōgo
      • Himeji, Hyōgo, Japan, 670-0849
        • Investigational Site Number : 3920006
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 234-0054
        • Investigational Site Number : 3920009
    • Mie-ken
      • Matsusaka, Mie-ken, Japan, 515-0073
        • Investigational Site Number : 3920001
    • Tokyo
      • Kiyose, Tokyo, Japan, 204-8522
        • Investigational Site Number : 3920005
  • Lithuania
      • Kaunas, Lithuania, 49449
        • Investigational Site Number : 4400002
  • Mexico
      • Durango, Mexico, 34000
        • Investigational Site Number : 4840007
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Investigational Site Number : 5280001
  • Norway
      • Lørenskog, Norway, 1478
        • Investigational Site Number : 5780001
  • Poland
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-044
        • Investigational Site Number : 6160001
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
        • Investigational Site Number : 6160002
  • Portugal
      • Porto, Portugal, 3814-501
        • Investigational Site Number : 6200006
  • Romania
      • Cluj-Napoca, Romania, 400275
        • Investigational Site Number : 6420002
  • Slovakia
      • Humenné, Slovakia, 066 01
        • Investigational Site Number : 7030002
      • Prešov, Slovakia, 080 01
        • Investigational Site Number : 7030004
      • Spišská Nová Ves, Slovakia, 052 01
        • Investigational Site Number : 7030003
  • South Africa
      • Benoni, South Africa, 1500
        • Investigational Site Number : 7100004
      • Durban, South Africa, 4001
        • Investigational Site Number : 7100001
      • Durban, South Africa, 4001
        • Investigational Site Number : 7100006
      • Durban, South Africa, 4302
        • Investigational Site Number : 7100005
  • South Korea
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Investigational Site Number : 4100002
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05030
        • Investigational Site Number : 4100001
  • Spain
      • Madrid, Spain, 28007
        • Investigational Site Number : 7240003
      • Madrid, Spain, 28040
        • Investigational Site Number : 7240007
      • Málaga, Spain, 29010
        • Investigational Site Number : 7240001
      • Palma, Spain, 07120
        • Investigational Site Number : 7240004
      • Zaragoza, Spain, 50009
        • Investigational Site Number : 7240012
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08017
        • Investigational Site Number : 7240014
    • Catalunya [Cataluña]
      • Sant Boi de Llobregat, Catalunya [Cataluña], Spain, 08830
        • Investigational Site Number : 7240006
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Investigational Site Number : 7240008
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Investigational Site Number : 1580005
      • Taichung, Taiwan, 404
        • Investigational Site Number : 1580006
      • Taipei, Taiwan, 110
        • Investigational Site Number : 1580003
  • Turkey (Türkiye)
      • Akdeniz, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920002
      • Ankara, Turkey (Türkiye), 06230
        • Investigational Site Number : 7920007
      • Istanbul, Turkey (Türkiye), 34098
        • Investigational Site Number : 7920001
      • Kirikkale, Turkey (Türkiye), 71100
        • Investigational Site Number : 7920006
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Investigational Site Number : 8260003
      • Hounslow, United Kingdom, TW5 9ER
        • Investigational Site Number : 8260014
      • Liverpool, United Kingdom, L14 3PE
        • Investigational Site Number : 8260005
      • London, United Kingdom, EC1M 6BQ
        • Investigational Site Number : 8260010
      • Milton Keynes, United Kingdom, MK15 0DU
        • Investigational Site Number : 8260008
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Investigational Site Number : 8260004
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Investigational Site Number : 8260002
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Clinical Research Trials- Site Number : 8401034
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research Site Number : 8401182
      • Tucson, Arizona, United States, 85712
        • Tucson Clinical Research Institute- Site Number : 8401431
    • California
      • La Palma, California, United States, 90623
        • IMAX Clinical Trials- Site Number : 8401419
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials Site Number : 8401003
      • Los Angeles, California, United States, 90017
        • Downtown L.A. Research Center- Site Number : 8401027
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Allianz Research Institute CO Site Number : 8402061
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Helix Biomedics- Site Number : 8402049
      • Cutler Bay, Florida, United States, 33157
        • Beautiful Minds Clinical Research Center Site Number : 8401201
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
      • Doral, Florida, United States, 33178
        • Science Connections, LLC Site Number : 8402045
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center- Site Number : 8402065
      • Lady Lake, Florida, United States, 32159
        • Premier Medical Associates Site Number : 8401388
      • Loxahatchee Groves, Florida, United States, 33470
        • Advanced Pulmonary Research Institute Site Number : 8402018
      • Miami, Florida, United States, 33126
        • Finlay Medical Research- Site Number : 8402007
      • Miami, Florida, United States, 33144
        • Elite Clinical Research - Miami- Site Number : 8402009
      • Miami, Florida, United States, 33155
        • DL Research Solutions- Site Number : 8401033
      • Miami, Florida, United States, 33155
        • My Community Research Center Site Number : 8402060
      • Miami, Florida, United States, 33165
        • Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida- Site Number : 8401006
      • Miami, Florida, United States, 33176
        • Reed Medical Research Site Number : 8401032
      • Miami, Florida, United States, 33184
        • High Quality Research Site Number : 8401406
      • Miami Lakes, Florida, United States, 33014
        • Deluxe Health Center Site Number : 8401188
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
      • Orlando, Florida, United States, 32819
        • Heuer M.D. Research- Site Number : 8402016
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical Research Site Number : 8401013
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research Site Number : 8402026
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
      • Pembroke Pines, Florida, United States, 33024
        • Pines Care Research Center- Site Number : 8402056
      • Pembroke Pines, Florida, United States, 33025
        • Tellabio International Research Services Site Number : 8401411
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
    • Georgia
      • Calhoun, Georgia, United States, 30701
        • Appalachian Clinical Research Site Number : 8400024
      • Cordele, Georgia, United States, 31015
        • Private Practice - Dr. David Kavtaradze- Site Number : 8401029
      • Dunwoody, Georgia, United States, 30350
        • Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
      • East Point, Georgia, United States, 30344
        • Covenant Pulmonary Critical Care Site Number : 8401183
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Fracis Medical Center- Site Number : 8402024
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Benchmark Research - Covington- Site Number : 8401193
      • Shreveport, Louisiana, United States, 71105
        • Care Access - Shreveport- Site Number : 8402047
    • Maine
      • Bangor, Maine, United States, 04401
        • Private Practice - Dr. Paul Shapero- Site Number : 8401016
    • Massachusetts
      • Boston, Massachusetts, United States, 02110
        • Care Access - Boston- Site Number : 8402276
    • Michigan
      • Lathrup Village, Michigan, United States, 48076
        • Revive Research Institute - Lathrup Village- Site Number : 8402186
      • Warren, Michigan, United States, 48088
        • Pulmonary and Medicine Associates- Site Number : 8401403
    • Missouri
      • Hannibal, Missouri, United States, 63401-6890
        • Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
      • Saint Charles, Missouri, United States, 63301
        • Midwest Chest Consultants- Site Number : 8401002
      • St Louis, Missouri, United States, 63110
        • Washington University- Site Number : 8402035
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Henderson Clinical Trials Site Number : 8401365
    • New York
      • Buffalo, New York, United States, 14215
        • VA Western New York Healthcare System Site Number : 8402050
      • Schenectady, New York, United States, 12308
        • Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University- Site Number : 8401022
      • Huntersville, North Carolina, United States, 28078
        • Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research- Site Number : 8402001
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital- Site Number : 8402058
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • MedTrial- Site Number : 8402048
      • Rock Hill, South Carolina, United States, 29732
        • Clinical Research of Rock Hill Site Number : 8401008
    • Texas
      • Beaumont, Texas, United States, 77701
        • REX Clinical Trials - Beaumont- Site Number : 8401371
      • Boerne, Texas, United States, 78006
        • South Texas Medical Research Institute - TTS Research- Site Number : 8402012
      • Carrollton, Texas, United States, 75007
        • ClinRx Research - Carrollton- Site Number : 8401021
      • Corsicana, Texas, United States, 75110
        • Corsicana Medical Research- Site Number : 8401018
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute Site Number : 8401194
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center Site Number : 8401015
      • Webster, Texas, United States, 77598
        • Clear Lake Specialties Research Center, PLLC Site Number : 8401025
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic- Site Number : 8402053

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Exclusion Criteria:

  • Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
  • Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
  • Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
  • Any situation that led to a permanent premature IMP discontinuation in parent trials

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Itepekimab Q2W
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Time Frame: Baseline up to Week 72
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit
Baseline up to Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional itepekimab concentrations in serum
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Annualized rate of severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Time to first moderate-to-severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Time to first severe AECOPD
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1
Time Frame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
FEV1 is force expiratory volume in 1 second
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS
Time Frame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS.
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Change from Week 0 for CASA-Q
Time Frame: Baseline up to Week 52
The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients.
Baseline up to Week 52
Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores
Time Frame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation.
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score
Time Frame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
The European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L) is a standardized health-related quality-of-life (HRQoL) questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS).
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
Incidence of treatment-emergent (TE) anti-drug antibody responses
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)
Time Frame: Baseline up to Week 52
Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS18133
  • U1111-1295-3333 (Registry Identifier: ICTRP)
  • 2023-508085-15-00 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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