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

NCT06208306 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: LTS18133U1111-1295-33332023-508085-15-00
• Study Type: interventional
• Target: 700
• Locations: 31 countries
• Sites: 222

Brief 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. 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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (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

  Baseline up to Week 72

Secondary Outcomes (11)

• Functional itepekimab concentrations in serum

  Baseline up to Week 52

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

  Baseline up to Week 72

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

  Baseline up to Week 52

• Annualized rate of severe AECOPD

  Baseline up to Week 52

• Time to first moderate-to-severe AECOPD

  Baseline up to Week 52

Study Arms (2)

Itepekimab Q2W

EXPERIMENTAL

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

Drug: Itepekimab (SAR440340)

Itepekimab Q4W

EXPERIMENTAL

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); Drug: Placebo

Interventions

Itepekimab (SAR440340) DRUG

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

Also known as: REGN3500

Itepekimab Q2W; Itepekimab Q4W

Placebo DRUG

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

Itepekimab Q4W

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (223)

Chandler Clinical Research Trials- Site Number : 8401034

Chandler, Arizona, 85224, United States

Location

Noble Clinical Research Site Number : 8401182

Tucson, Arizona, 85704, United States

Location

Tucson Clinical Research Institute- Site Number : 8401431

Tucson, Arizona, 85712, United States

Location

IMAX Clinical Trials- Site Number : 8401419

La Palma, California, 90623, United States

Location

Antelope Valley Clinical Trials Site Number : 8401003

Lancaster, California, 93534, United States

Location

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

Los Angeles, California, 90017, United States

Location

Allianz Research Institute CO Site Number : 8402061

Aurora, Colorado, 80014, United States

Location

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

Boulder, Colorado, 80301, United States

Location

Helix Biomedics- Site Number : 8402049

Boynton Beach, Florida, 33435, United States

Location

Beautiful Minds Clinical Research Center Site Number : 8401201

Cutler Bay, Florida, 33157, United States

Location

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

DeBary, Florida, 32713, United States

Location

Science Connections, LLC Site Number : 8402045

Doral, Florida, 33178, United States

Location

Direct Helpers Research Center- Site Number : 8402065

Hialeah, Florida, 33012, United States

Location

Premier Medical Associates Site Number : 8401388

Lady Lake, Florida, 32159, United States

Location

Advanced Pulmonary Research Institute Site Number : 8402018

Loxahatchee Groves, Florida, 33470, United States

Location

Finlay Medical Research- Site Number : 8402007

Miami, Florida, 33126, United States

Location

Elite Clinical Research - Miami- Site Number : 8402009

Miami, Florida, 33144, United States

Location

DL Research Solutions- Site Number : 8401033

Miami, Florida, 33155, United States

Location

My Community Research Center Site Number : 8402060

Miami, Florida, 33155, United States

Location

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

Miami, Florida, 33165, United States

Location

Research Institute of South Florida- Site Number : 8401006

Miami, Florida, 33173, United States

Location

Reed Medical Research Site Number : 8401032

Miami, Florida, 33176, United States

Location

High Quality Research Site Number : 8401406

Miami, Florida, 33184, United States

Location

Deluxe Health Center Site Number : 8401188

Miami Lakes, Florida, 33014, United States

Location

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

Ocala, Florida, 34470, United States

Location

Heuer M.D. Research- Site Number : 8402016

Orlando, Florida, 32819, United States

Location

Florida Institute for Clinical Research Site Number : 8401013

Orlando, Florida, 32825, United States

Location

Oviedo Medical Research Site Number : 8402026

Oviedo, Florida, 32765, United States

Location

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

Palmetto Bay, Florida, 33157, United States

Location

Pines Care Research Center- Site Number : 8402056

Pembroke Pines, Florida, 33024, United States

Location

Tellabio International Research Services Site Number : 8401411

Pembroke Pines, Florida, 33025, United States

Location

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

Tampa, Florida, 33606, United States

Location

Appalachian Clinical Research Site Number : 8400024

Calhoun, Georgia, 30701, United States

Location

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

Cordele, Georgia, 31015, United States

Location

Alpha Clinical Research Group - Dunwoody- Site Number : 8401190

Dunwoody, Georgia, 30350, United States

Location

Covenant Pulmonary Critical Care Site Number : 8401183

East Point, Georgia, 30344, United States

Location

OSF Saint Fracis Medical Center- Site Number : 8402024

Peoria, Illinois, 61637, United States

Location

Benchmark Research - Covington- Site Number : 8401193

Covington, Louisiana, 70433, United States

Location

Care Access - Shreveport- Site Number : 8402047

Shreveport, Louisiana, 71105, United States

Location

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

Bangor, Maine, 04401, United States

Location

Care Access - Boston- Site Number : 8402276

Boston, Massachusetts, 02110, United States

Location

Revive Research Institute - Lathrup Village- Site Number : 8402186

Lathrup Village, Michigan, 48076, United States

Location

Pulmonary and Medicine Associates- Site Number : 8401403

Warren, Michigan, 48088, United States

Location

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

Hannibal, Missouri, 63401-6890, United States

Location

Midwest Chest Consultants- Site Number : 8401002

Saint Charles, Missouri, 63301, United States

Location

Washington University- Site Number : 8402035

St Louis, Missouri, 63110, United States

Location

Henderson Clinical Trials Site Number : 8401365

Henderson, Nevada, 89052, United States

Location

VA Western New York Healthcare System Site Number : 8402050

Buffalo, New York, 14215, United States

Location

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

Schenectady, New York, 12308, United States

Location

East Carolina University- Site Number : 8401022

Greenville, North Carolina, 27858, United States

Location

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

Huntersville, North Carolina, 28078, United States

Location

OK Clinical Research- Site Number : 8402001

Edmond, Oklahoma, 73034, United States

Location

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

DuBois, Pennsylvania, 15801, United States

Location

Allegheny General Hospital- Site Number : 8402058

Pittsburgh, Pennsylvania, 15212, United States

Location

MedTrial- Site Number : 8402048

Columbia, South Carolina, 29204, United States

Location

Clinical Research of Rock Hill Site Number : 8401008

Rock Hill, South Carolina, 29732, United States

Location

REX Clinical Trials - Beaumont- Site Number : 8401371

Beaumont, Texas, 77701, United States

Location

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

Boerne, Texas, 78006, United States

Location

ClinRx Research - Carrollton- Site Number : 8401021

Carrollton, Texas, 75007, United States

Location

Corsicana Medical Research- Site Number : 8401018

Corsicana, Texas, 75110, United States

Location

The Methodist Hospital Research Institute Site Number : 8401194

Houston, Texas, 77030, United States

Location

Metroplex Pulmonary and Sleep Center Site Number : 8401015

McKinney, Texas, 75069, United States

Location

Clear Lake Specialties Research Center, PLLC Site Number : 8401025

Webster, Texas, 77598, United States

Location

Rheumatology & Pulmonary Clinic- Site Number : 8402053

Beckley, West Virginia, 25801, United States

Location

Investigational Site Number : 0320012

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320013

La Plata, Buenos Aires, B1900BNN, Argentina

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Investigational Site Number : 0320003

Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, 1023, Argentina

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Buenos Aires, 1414, Argentina

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Buenos Aires, 1425, Argentina

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Buenos Aires, 1638, Argentina

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Investigational Site Number : 0320009

Buenos Aires, 1650, Argentina

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Investigational Site Number : 0320004

Mendoza, 5500, Argentina

Location

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

Vitória, Espírito Santo, 29055-450, Brazil

Location

Serviços Especializados em Reumatologia- Site Number : 0760020

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018

Brasília, Federal District, 70710-100, Brazil

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

Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Centro de Estudos em Terapias Inovadoras- Site Number : 0760012

Curitiba, Paraná, 80030-110, Brazil

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

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Instituto Ceos Site Number : 0760021

Porto Alegre, Rio Grande do Sul, 90480-020, Brazil

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006

Porto Alegre, Rio Grande do Sul, 91010-006, Brazil

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

Botucatu, São Paulo, 18618-970, Brazil

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

Campinas, São Paulo, 13034-685, Brazil

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Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015

São Bernardo do Campo, São Paulo, 09715-090, Brazil

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

São Paulo, 04014-002, Brazil

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Investigational Site Number : 1000004

Gabrovo, 5300, Bulgaria

Location

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Haskovo, 6300, Bulgaria

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Rousse, 7000, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1142, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1756, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Vidin, 3700, Bulgaria

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Sherwood Park, Alberta, T8H 0N2, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Windsor, Ontario, N8X 1T3, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

Location

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Trois-Rivières, Quebec, G8T 7A1, Canada

Location

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Victoriaville, Quebec, G6P 3Z8, Canada

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Valdivia, Los Ríos Region, 5110683, Chile

Location

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Talca, Maule Region, 3465584, Chile

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Santiago, Reg Metropolitana de Santiago, 7500010, Chile

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Santiago, Reg Metropolitana de Santiago, 7500692, Chile

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Santiago, Reg Metropolitana de Santiago, 7500698, Chile

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Santiago, Reg Metropolitana de Santiago, 7750000, Chile

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Quillota, Región de Valparaíso, 2260877, Chile

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Beijing, 100038, China

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Changchun, 130021, China

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Chengdu, 610041, China

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Haikou, 570216, China

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Hefei, 230032, China

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Hohhot, 010050, China

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Jinan, 250014, China

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Nanchang, 330006, China

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Pingxiang, 337055, China

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Shanghai, 200025, China

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Shanghai, 200433, China

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Shenyang, 110004, China

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Wuhan, 430014, China

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Xiangtan, 411100, China

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Xuzhou, 221006, China

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Yangzhou, 225000, China

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Havlíčkův Brod, 580 01, Czechia

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Jindřichův Hradec, 377 01, Czechia

Location

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Tartu, 50406, Estonia

Location

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Lyon, 69004, France

Location

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Reims, 51092, France

Location

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Batumi, 6010, Georgia

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Tbilisi, 0105, Georgia

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Tbilisi, 0112, Georgia

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Tbilisi, 0159, Georgia

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Bendorf, 56170, Germany

Location

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Berlin, 12159, Germany

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Frankfurt, 60596, Germany

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Leipzig, 04299, Germany

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Leipzig, 04347, Germany

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Lübeck, 23552, Germany

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Mainz, 55128, Germany

Location

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Rosenheim, 83022, Germany

Location

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Palaió Fáliro, 175 62, Greece

Location

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Thessaloniki, 570 10, Greece

Location

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Budapest, 1106, Hungary

Location

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Gödöllő, 2100, Hungary

Location

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Hajdúnánás, 4080, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Püspökladány, 4150, Hungary

Location

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Calicut, 673008, India

Location

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Chandigarh, 160012, India

Location

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Hyderabad, 500 084, India

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Jaipur, 302023, India

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Jaipur, 302039, India

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Kanpur, 208001, India

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Nagpur, 440010, India

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Nagpur, 440012, India

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Nagpur, 440015, India

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Nagpur, 441203, India

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Pune, 411057, India

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Haifa, 3436212, Israel

Location

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Jerusalem, 9103102, Israel

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Jerusalem, 9112001, Israel

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Kefar Sava, 4428164, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5262100, Israel

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Rehovot, 7610001, Israel

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Tel Aviv, 6423906, Israel

Location

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Ferrara, 44100, Italy

Location

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Nagoya, Aichi-ken, 457-8511, Japan

Location

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Kurume, Fukuoka, 830-0011, Japan

Location

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Kure, Hiroshima, 737-0811, Japan

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Himeji, Hyōgo, 670-0849, Japan

Location

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Yokohama, Kanagawa, 234-0054, Japan

Location

Investigational Site Number : 3920001

Matsusaka, Mie-ken, 515-0073, Japan

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Kiyose, Tokyo, 204-8522, Japan

Location

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Fukuoka, 819-0055, Japan

Location

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Tokyo, 140-8522, Japan

Location

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Kaunas, 49449, Lithuania

Location

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Durango, 34000, Mexico

Location

Investigational Site Number : 5280001

Breda, 4818 CK, Netherlands

Location

Investigational Site Number : 5780001

Lørenskog, 1478, Norway

Location

Investigational Site Number : 6160001

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

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Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

Investigational Site Number : 6200006

Porto, 3814-501, Portugal

Location

Investigational Site Number : 6420002

Cluj-Napoca, 400275, Romania

Location

Investigational Site Number : 7030002

Humenné, 066 01, Slovakia

Location

Investigational Site Number : 7030004

Prešov, 080 01, Slovakia

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Investigational Site Number : 7030003

Spišská Nová Ves, 052 01, Slovakia

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Investigational Site Number : 7100004

Benoni, 1500, South Africa

Location

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Durban, 4001, South Africa

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Durban, 4001, South Africa

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Durban, 4302, South Africa

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Wŏnju, Gangwon-do, 26426, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 7240014

Barcelona, Barcelona [Barcelona], 08017, Spain

Location

Investigational Site Number : 7240006

Sant Boi de Llobregat, Catalunya [Cataluña], 08830, Spain

Location

Investigational Site Number : 7240008

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Investigational Site Number : 7240003

Madrid, 28007, Spain

Location

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Madrid, 28040, Spain

Location

Investigational Site Number : 7240001

Málaga, 29010, Spain

Location

Investigational Site Number : 7240004

Palma, 07120, Spain

Location

Investigational Site Number : 7240012

Zaragoza, 50009, Spain

Location

Investigational Site Number : 1580005

Kaohsiung City, 807, Taiwan

Location

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Taichung, 404, Taiwan

Location

Investigational Site Number : 1580003

Taipei, 110, Taiwan

Location

Investigational Site Number : 7920002

Akdeniz, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Ankara, 06230, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Kırıkkale, 71100, Turkey (Türkiye)

Location

Investigational Site Number : 8260004

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Investigational Site Number : 8260002

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Investigational Site Number : 8260003

Bradford, BD9 6RJ, United Kingdom

Location

Investigational Site Number : 8260014

Hounslow, TW5 9ER, United Kingdom

Location

Investigational Site Number : 8260005

Liverpool, L14 3PE, United Kingdom

Location

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London, EC1M 6BQ, United Kingdom

Location

Investigational Site Number : 8260008

Milton Keynes, MK15 0DU, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

itepekimab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GE (4); IN (11); CZ (2); CA (8); IL (8); TU (4); GB (7); ES (8); IT (1); PL (2); ME (1); FR (2); DE (8); RO (1); NO (1); BU (11); GR (2); US (64); CL (7); JP (9); TW (3); SL (3); ZA (4); AR (12); NL (1); PT (1); LI (1); HU (5); BR (13); CN (16); KR (2)