AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3AERIFY-4NCT06208306

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

A Phase 3 study testing Itepekimab (SAR440340) in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 223 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Itepekimab (SAR440340)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
669 participants
Where
223 sitesin 32 countries
Study dates
11 Jan 2024to 10 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

223 sites in 32 countries.

223 sites in 32 countries

United States64 sites

  • Allianz Research Institute CO Site Number : 8402061

    Aurora, Colorado, 80014

  • Private Practice - Dr. Paul Shapero- Site Number : 8401016

    Bangor, Maine, 04401

  • REX Clinical Trials - Beaumont- Site Number : 8401371

    Beaumont, Texas, 77701

  • Rheumatology & Pulmonary Clinic- Site Number : 8402053

    Beckley, West Virginia, 25801

  • South Texas Medical Research Institute - TTS Research- Site Number : 8402012

    Boerne, Texas, 78006

  • Care Access - Boston- Site Number : 8402276

    Boston, Massachusetts, 02110

  • Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180

    Boulder, Colorado, 80301

  • Helix Biomedics- Site Number : 8402049

    Boynton Beach, Florida, 33435

  • VA Western New York Healthcare System Site Number : 8402050

    Buffalo, New York, 14215

  • Appalachian Clinical Research Site Number : 8400024

    Calhoun, Georgia, 30701

  • ClinRx Research - Carrollton- Site Number : 8401021

    Carrollton, Texas, 75007

  • Chandler Clinical Research Trials- Site Number : 8401034

    Chandler, Arizona, 85224

  • MedTrial- Site Number : 8402048

    Columbia, South Carolina, 29204

  • Private Practice - Dr. David Kavtaradze- Site Number : 8401029

    Cordele, Georgia, 31015

  • Corsicana Medical Research- Site Number : 8401018

    Corsicana, Texas, 75110

  • Benchmark Research - Covington- Site Number : 8401193

    Covington, Louisiana, 70433

  • Beautiful Minds Clinical Research Center Site Number : 8401201

    Cutler Bay, Florida, 33157

  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031

    DeBary, Florida, 32713

  • Science Connections, LLC Site Number : 8402045

    Doral, Florida, 33178

  • Clinical Research Associates of Central PA - Dubois- Site Number : 8401023

    DuBois, Pennsylvania, 15801

  • Alpha Clinical Research Group - Dunwoody- Site Number : 8401190

    Dunwoody, Georgia, 30350

  • Covenant Pulmonary Critical Care Site Number : 8401183

    East Point, Georgia, 30344

  • OK Clinical Research- Site Number : 8402001

    Edmond, Oklahoma, 73034

  • East Carolina University- Site Number : 8401022

    Greenville, North Carolina, 27858

  • Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383

    Hannibal, Missouri, 63401-6890

  • Henderson Clinical Trials Site Number : 8401365

    Henderson, Nevada, 89052

  • Direct Helpers Research Center- Site Number : 8402065

    Hialeah, Florida, 33012

  • The Methodist Hospital Research Institute Site Number : 8401194

    Houston, Texas, 77030

  • Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022

    Huntersville, North Carolina, 28078

  • IMAX Clinical Trials- Site Number : 8401419

    La Palma, California, 90623

  • Premier Medical Associates Site Number : 8401388

    Lady Lake, Florida, 32159

  • Antelope Valley Clinical Trials Site Number : 8401003

    Lancaster, California, 93534

  • Revive Research Institute - Lathrup Village- Site Number : 8402186

    Lathrup Village, Michigan, 48076

  • Downtown L.A. Research Center- Site Number : 8401027

    Los Angeles, California, 90017

  • Advanced Pulmonary Research Institute Site Number : 8402018

    Loxahatchee Groves, Florida, 33470

  • Metroplex Pulmonary and Sleep Center Site Number : 8401015

    McKinney, Texas, 75069

  • Finlay Medical Research- Site Number : 8402007

    Miami, Florida, 33126

  • Elite Clinical Research - Miami- Site Number : 8402009

    Miami, Florida, 33144

  • DL Research Solutions- Site Number : 8401033

    Miami, Florida, 33155

  • My Community Research Center Site Number : 8402060

    Miami, Florida, 33155

  • Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019

    Miami, Florida, 33165

  • Research Institute of South Florida- Site Number : 8401006

    Miami, Florida, 33173

  • Reed Medical Research Site Number : 8401032

    Miami, Florida, 33176

  • High Quality Research Site Number : 8401406

    Miami, Florida, 33184

  • Deluxe Health Center Site Number : 8401188

    Miami Lakes, Florida, 33014

  • Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015

    Ocala, Florida, 34470

  • Heuer M.D. Research- Site Number : 8402016

    Orlando, Florida, 32819

  • Florida Institute for Clinical Research Site Number : 8401013

    Orlando, Florida, 32825

  • Oviedo Medical Research Site Number : 8402026

    Oviedo, Florida, 32765

  • Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067

    Palmetto Bay, Florida, 33157

  • Pines Care Research Center- Site Number : 8402056

    Pembroke Pines, Florida, 33024

  • Tellabio International Research Services Site Number : 8401411

    Pembroke Pines, Florida, 33025

  • OSF Saint Fracis Medical Center- Site Number : 8402024

    Peoria, Illinois, 61637

  • Allegheny General Hospital- Site Number : 8402058

    Pittsburgh, Pennsylvania, 15212

  • Clinical Research of Rock Hill Site Number : 8401008

    Rock Hill, South Carolina, 29732

  • Midwest Chest Consultants- Site Number : 8401002

    Saint Charles, Missouri, 63301

  • Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029

    Schenectady, New York, 12308

  • Care Access - Shreveport- Site Number : 8402047

    Shreveport, Louisiana, 71105

  • Washington University- Site Number : 8402035

    St Louis, Missouri, 63110

  • Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008

    Tampa, Florida, 33606

  • Noble Clinical Research Site Number : 8401182

    Tucson, Arizona, 85704

  • Tucson Clinical Research Institute- Site Number : 8401431

    Tucson, Arizona, 85712

  • Pulmonary and Medicine Associates- Site Number : 8401403

    Warren, Michigan, 48088

  • Clear Lake Specialties Research Center, PLLC Site Number : 8401025

    Webster, Texas, 77598

Other trials in United States

China16 sites

  • Investigational Site Number : 1560012

    Beijing, 100038

  • Investigational Site Number : 1560004

    Changchun, 130021

  • Investigational Site Number : 1560001

    Chengdu, 610041

  • Investigational Site Number : 1560018

    Haikou, 570216

  • Investigational Site Number : 1560016

    Hefei, 230032

  • Investigational Site Number : 1560017

    Hohhot, 010050

  • Investigational Site Number : 1560002

    Jinan, 250014

  • Investigational Site Number : 1560014

    Nanchang, 330006

  • Investigational Site Number : 1560019

    Pingxiang, 337055

  • Investigational Site Number : 1560020

    Shanghai, 200025

  • Investigational Site Number : 1560006

    Shanghai, 200433

  • Investigational Site Number : 1560008

    Shenyang, 110004

  • Investigational Site Number : 1560005

    Wuhan, 430014

  • Investigational Site Number : 1560011

    Xiangtan, 411100

  • Investigational Site Number : 1560007

    Xuzhou, 221006

  • Investigational Site Number : 1560015

    Yangzhou, 225000

Other trials in China

Brazil13 sites

  • Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014

    Belo Horizonte, Minas Gerais, 30150-221

  • Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005

    Botucatu, São Paulo, 18618-970

  • Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018

    Brasília, Federal District, 70710-100

  • Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010

    Campinas, São Paulo, 13034-685

  • Centro de Estudos em Terapias Inovadoras- Site Number : 0760012

    Curitiba, Paraná, 80030-110

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Instituto Ceos Site Number : 0760021

    Porto Alegre, Rio Grande do Sul, 90480-020

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90610-000

  • WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 91010-006

  • Serviços Especializados em Reumatologia- Site Number : 0760020

    Salvador, Estado de Bahia, 40150-150

  • Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015

    São Bernardo do Campo, São Paulo, 09715-090

  • Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013

    São Paulo, 04014-002

  • Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Argentina12 sites

  • Investigational Site Number : 0320012

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320010

    Buenos Aires, 1023

  • Investigational Site Number : 0320005

    Buenos Aires, 1414

  • Investigational Site Number : 0320002

    Buenos Aires, 1425

  • Investigational Site Number : 0320006

    Buenos Aires, 1638

  • Investigational Site Number : 0320009

    Buenos Aires, 1650

  • Investigational Site Number : 0320013

    La Plata, Buenos Aires, B1900BNN

  • Investigational Site Number : 0320004

    Mendoza, 5500

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320008

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320011

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Bulgaria11 sites

  • Investigational Site Number : 1000004

    Gabrovo, 5300

  • Investigational Site Number : 1000007

    Haskovo, 6300

  • Investigational Site Number : 1000018

    Rousse, 7000

  • Investigational Site Number : 1000010

    Rousse, 7002

  • Investigational Site Number : 1000016

    Sofia, 1142

  • Investigational Site Number : 1000001

    Sofia, 1233

  • Investigational Site Number : 1000009

    Sofia, 1756

  • Investigational Site Number : 1000017

    Stara Zagora, 6000

  • Investigational Site Number : 1000003

    Stara Zagora, 6003

  • Investigational Site Number : 1000013

    Veliko Tarnovo, 5000

  • Investigational Site Number : 1000006

    Vidin, 3700

Other trials in Bulgaria

India11 sites

  • Investigational Site Number : 3560001

    Calicut, 673008

  • Investigational Site Number : 3560006

    Chandigarh, 160012

  • Investigational Site Number : 3560005

    Hyderabad, 500 084

  • Investigational Site Number : 3560009

    Jaipur, 302023

  • Investigational Site Number : 3560004

    Jaipur, 302039

  • Investigational Site Number : 3560012

    Kanpur, 208001

  • Investigational Site Number : 3560010

    Nagpur, 440010

  • Investigational Site Number : 3560011

    Nagpur, 440012

  • Investigational Site Number : 3560007

    Nagpur, 440015

  • Investigational Site Number : 3560003

    Nagpur, 441203

  • Investigational Site Number : 3560013

    Pune, 411057

Other trials in India

Japan9 sites

  • Investigational Site Number : 3920003

    Fukuoka, 819-0055

  • Investigational Site Number : 3920006

    Himeji, Hyōgo, 670-0849

  • Investigational Site Number : 3920005

    Kiyose, Tokyo, 204-8522

  • Investigational Site Number : 3920007

    Kure, Hiroshima, 737-0811

  • Investigational Site Number : 3920002

    Kurume, Fukuoka, 830-0011

  • Investigational Site Number : 3920001

    Matsusaka, Mie-ken, 515-0073

  • Investigational Site Number : 3920008

    Nagoya, Aichi-ken, 457-8511

  • Investigational Site Number : 3920004

    Tokyo, 140-8522

  • Investigational Site Number : 3920009

    Yokohama, Kanagawa, 234-0054

Other trials in Japan

Canada8 sites

  • Investigational Site Number : 1240021

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240004

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240006

    Sherwood Park, Alberta, T8H 0N2

  • Investigational Site Number : 1240009

    Toronto, Ontario, M5T 3A9

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1

  • Investigational Site Number : 1240002

    Victoriaville, Quebec, G6P 3Z8

  • Investigational Site Number : 1240022

    Windsor, Ontario, N8X 1T3

  • Investigational Site Number : 1240018

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Germany8 sites

  • Investigational Site Number : 2760006

    Bendorf, 56170

  • Investigational Site Number : 2760010

    Berlin, 12159

  • Investigational Site Number : 2760005

    Frankfurt, 60596

  • Investigational Site Number : 2760008

    Leipzig, 04299

  • Investigational Site Number : 2760007

    Leipzig, 04347

  • Investigational Site Number : 2760003

    Lübeck, 23552

  • Investigational Site Number : 2760001

    Mainz, 55128

  • Investigational Site Number : 2760011

    Rosenheim, 83022

Other trials in Germany

Israel8 sites

  • Investigational Site Number : 3760008

    Haifa, 3436212

  • Investigational Site Number : 3760003

    Jerusalem, 9103102

  • Investigational Site Number : 3760002

    Jerusalem, 9112001

  • Investigational Site Number : 3760006

    Kefar Sava, 4428164

  • Investigational Site Number : 3760001

    Petah Tikva, 4941492

  • Investigational Site Number : 3760009

    Ramat Gan, 5262100

  • Investigational Site Number : 3760004

    Rehovot, 7610001

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

Other trials in Israel

Spain8 sites

  • Investigational Site Number : 7240014

    Barcelona, Barcelona [Barcelona], 08017

  • Investigational Site Number : 7240003

    Madrid, 28007

  • Investigational Site Number : 7240007

    Madrid, 28040

  • Investigational Site Number : 7240001

    Málaga, 29010

  • Investigational Site Number : 7240004

    Palma, 07120

  • Investigational Site Number : 7240008

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7240006

    Sant Boi de Llobregat, Catalunya [Cataluña], 08830

  • Investigational Site Number : 7240012

    Zaragoza, 50009

Other trials in Spain

Chile7 sites

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7500010

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7750000

  • Investigational Site Number : 1520006

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520008

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

United Kingdom7 sites

  • Investigational Site Number : 8260003

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260002

    Chertsey, Surrey, KT16 0PZ

  • Investigational Site Number : 8260014

    Hounslow, TW5 9ER

  • Investigational Site Number : 8260005

    Liverpool, L14 3PE

  • Investigational Site Number : 8260010

    London, EC1M 6BQ

  • Investigational Site Number : 8260008

    Milton Keynes, MK15 0DU

  • Investigational Site Number : 8260004

    Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

Hungary5 sites

  • Investigational Site Number : 3480009

    Budapest, 1106

  • Investigational Site Number : 3480001

    Gödöllő, 2100

  • Investigational Site Number : 3480004

    Hajdúnánás, 4080

  • Investigational Site Number : 3480002

    Mosonmagyaróvár, 9200

  • Investigational Site Number : 3480003

    Püspökladány, 4150

Other trials in Hungary

Georgia4 sites

  • Investigational Site Number : 2680006

    Batumi, 6010

  • Investigational Site Number : 2680002

    Tbilisi, 0105

  • Investigational Site Number : 2680003

    Tbilisi, 0112

  • Investigational Site Number : 2680001

    Tbilisi, 0159

Other trials in Georgia

South Africa4 sites

  • Investigational Site Number : 7100004

    Benoni, 1500

  • Investigational Site Number : 7100001

    Durban, 4001

  • Investigational Site Number : 7100006

    Durban, 4001

  • Investigational Site Number : 7100005

    Durban, 4302

Other trials in South Africa

Turkey (Türkiye)4 sites

  • Investigational Site Number : 7920002

    Akdeniz, 33070

  • Investigational Site Number : 7920007

    Ankara, 06230

  • Investigational Site Number : 7920001

    Istanbul, 34098

  • Investigational Site Number : 7920006

    Kirikkale, 71100

Other trials in Turkey (Türkiye)

Slovakia3 sites

  • Investigational Site Number : 7030002

    Humenné, 066 01

  • Investigational Site Number : 7030004

    Prešov, 080 01

  • Investigational Site Number : 7030003

    Spišská Nová Ves, 052 01

Other trials in Slovakia

Taiwan3 sites

  • Investigational Site Number : 1580005

    Kaohsiung City, 807

  • Investigational Site Number : 1580006

    Taichung, 404

  • Investigational Site Number : 1580003

    Taipei, 110

Other trials in Taiwan

Czechia2 sites

  • Investigational Site Number : 2030003

    Havlíčkův Brod, 580 01

  • Investigational Site Number : 2030001

    Jindřichův Hradec, 377 01

Other trials in Czechia

France2 sites

  • Investigational Site Number : 2500001

    Lyon, 69004

  • Investigational Site Number : 2500004

    Reims, 51092

Other trials in France

Greece2 sites

  • Investigational Site Number : 3000008

    Palaió Fáliro, 175 62

  • Investigational Site Number : 3000002

    Thessaloniki, 570 10

Other trials in Greece

Poland2 sites

  • Investigational Site Number : 6160001

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160002

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

Other trials in Poland

South Korea2 sites

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100002

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Estonia1 site

  • Investigational Site Number : 2330001

    Tartu, 50406

Other trials in Estonia

Italy1 site

  • Investigational Site Number : 3800001

    Ferrara, 44100

Other trials in Italy

Lithuania1 site

  • Investigational Site Number : 4400002

    Kaunas, 49449

Other trials in Lithuania

Mexico1 site

  • Investigational Site Number : 4840007

    Durango, 34000

Other trials in Mexico

Netherlands1 site

  • Investigational Site Number : 5280001

    Breda, 4818 CK

Other trials in Netherlands

Norway1 site

  • Investigational Site Number : 5780001

    Lørenskog, 1478

Other trials in Norway

Portugal1 site

  • Investigational Site Number : 6200006

    Porto, 3814-501

Other trials in Portugal

Romania1 site

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400275

Other trials in Romania

About this study

Official title: 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.

Read more

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
Being tested
Itepekimab (SAR440340), Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Itepekimab (SAR440340)Drug

    Also called REGN3500

    Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

  • PlaceboDrug

    Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous

Study groups in NCT06208306
Study groupRoleWhat they receive
Itepekimab Q2WExperimentalSubcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Receives: Drug: Itepekimab (SAR440340)
Itepekimab Q4WExperimentalSC 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
Receives: Drug: Itepekimab (SAR440340); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation

    All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit

    Measured: Baseline up to Week 72

Secondary outcomes (11)

  1. Functional itepekimab concentrations in serum

    Measured: Baseline up to Week 52

  2. Incidence of treatment-emergent (TE) anti-drug antibody responses

    Measured: Baseline up to Week 72

  3. Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)

    Measured: Baseline up to Week 52

  4. Annualized rate of severe AECOPD

    Measured: Baseline up to Week 52

  5. Time to first moderate-to-severe AECOPD

    Measured: Baseline up to Week 52

  6. Time to first severe AECOPD

    Measured: Baseline up to Week 52

  7. Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1

    FEV1 is force expiratory volume in 1 second

    Measured: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

  8. Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores

    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.

    Measured: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

  9. Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score

    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).

    Measured: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

  10. Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS

    The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS.

    Measured: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52

  11. Change from Week 0 for CASA-Q

    The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients.

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start11 Jan 2024
  3. Primary completion10 Sep 2026
  4. Study completion10 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208306
Sponsor's protocol ID
LTS18133
Other IDs
U1111-1295-3333, 2023-508085-15-00, 2023
Acronym
AERIFY-4
Status last verified
Sep 2026
First submitted
5 Jan 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Itepekimab (SAR440340) in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 223 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, China, Brazil, Argentina, Bulgaria and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation (time frame: Baseline up to Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06208306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in