Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

NCT07190209 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC182432024-518016-39-00U1111-1308-9892
• Study Type: interventional
• Target: 942
• Locations: 9 countries
• Sites: 153

Brief Summary

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods:

• Screening period of up to 4 weeks
• Randomized intervention period of approximately 48 weeks
• Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations

  The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo

  From Baseline up to 48 weeks

Secondary Outcomes (15)

• Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)

  From Baseline up to 48 weeks

• Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)

  From Baseline up to 48 weeks

• Change from baseline in the SGRQ-C total score

  From Baseline up to 48 weeks

• SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score

  From Baseline up to 48 weeks

• Change from baseline in the Chronic airways assessment Test (CAAT) score

  From Baseline up to 48 weeks

Study Arms (3)

Lunsekimig dose regimen A

EXPERIMENTAL

Participants will receive lunsekimig dose regimen A.

Drug: Lunsekimig

Lunsekimig dose regimen B

EXPERIMENTAL

Participants will receive lunsekimig dose regimen B

Drug: Lunsekimig

Placebo

PLACEBO COMPARATOR

Participants will receive lunsekimig-matching placebo

Drug: Placebo

Interventions

Lunsekimig DRUG

Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection

Also known as: SAR443765

Lunsekimig dose regimen A; Lunsekimig dose regimen B

Placebo DRUG

Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 40 to 80 years of age
• Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
• Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70
• Former or current smokers ≥10 pack-years
• Chronic Airways Assessment Test (CAAT) ≥10
• ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
• Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
• EOS (blood eosinophil count) ≥ 150 cells/μL
• ≤ Body Mass Index ≤ 40.0 kg/m2

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
• Significant pulmonary disease other than COPD
• Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
• Unstable disorder that can impact participants safety or study outcomes
• Active or incompletely treated tuberculosis
• Current or past malignancies
• Concomitant therapies:
• long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \>6 months
• any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
• 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

Study Sites (153)

Chandler Clinical Research Trials- Site Number : 8400025

Chandler, Arizona, 85224, United States

RECRUITING

Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114

Phoenix, Arizona, 85032, United States

RECRUITING

Epic Medical Research - Surprise- Site Number : 8400096

Surprise, Arizona, 85378, United States

RECRUITING

IMAX Clinical Trials- Site Number : 8400109

La Palma, California, 90623, United States

RECRUITING

Long Beach Research Institute- Site Number : 8400027

Long Beach, California, 90805, United States

RECRUITING

Downtown L.A. Research Center- Site Number : 8400009

Los Angeles, California, 90017, United States

RECRUITING

Newport Native MD- Site Number : 8400003

Newport Beach, California, 92663, United States

RECRUITING

Paradigm Research - Redding- Site Number : 8400108

Redding, California, 96001, United States

RECRUITING

Amicis Research Center - Valencia- Site Number : 8400119

Valencia, California, 91355, United States

RECRUITING

Helix Biomedics- Site Number : 8400065

Boynton Beach, Florida, 33435, United States

RECRUITING

Beautiful Minds Clinical Research Center- Site Number : 8400017

Cutler Bay, Florida, 33157, United States

RECRUITING

Eastern Medical Group Research- Site Number : 8400020

Fort Myers, Florida, 33908, United States

RECRUITING

Premier Medical Associates- Site Number : 8400012

Lady Lake, Florida, 32159, United States

RECRUITING

MCR Research- Site Number : 8400004

Miami, Florida, 33126, United States

RECRUITING

Nuren Medical & Research Center- Site Number : 8400030

Miami, Florida, 33144, United States

RECRUITING

Deluxe Health Center- Site Number : 8400010

Miami Lakes, Florida, 33014, United States

RECRUITING

Omega Research Consultants - Orlando - Forest City- Site Number : 8400015

Orlando, Florida, 32810, United States

RECRUITING

Broward Research Center - Pembroke Pines- Site Number : 8400053

Pembroke Pines, Florida, 33024, United States

RECRUITING

Clinical Research Trials of Florida- Site Number : 8400011

Tampa, Florida, 33607, United States

RECRUITING

Deluxe Health Center-Tampa- Site Number : 8400056

Tampa, Florida, 33607, United States

RECRUITING

Private Practice - Dr. David Kavtaradze- Site Number : 8400006

Cordele, Georgia, 31015, United States

RECRUITING

Primeway Clinical Research- Site Number : 8400121

Fayetteville, Georgia, 30214, United States

RECRUITING

Avicenna Clinical Research- Site Number : 8400126

Chicago Ridge, Illinois, 60415, United States

RECRUITING

Indy Clinical Research- Site Number : 8400071

Indianapolis, Indiana, 46268, United States

RECRUITING

University of Kansas Medical Center- Site Number : 8400054

Kansas City, Kansas, 66160, United States

RECRUITING

Southern Clinical Research - Zachary- Site Number : 8400113

Zachary, Louisiana, 70791, United States

RECRUITING

Pulmonary and Medicine Associates- Site Number : 8400007

Warren, Michigan, 48088, United States

RECRUITING

Henderson Clinical Trials- Site Number : 8400026

Henderson, Nevada, 89052, United States

RECRUITING

Sierra Clinical Research - Las Vegas- Site Number : 8400028

Las Vegas, Nevada, 89106, United States

RECRUITING

New York Hospital Queens- Site Number : 8400058

Flushing, New York, 11355, United States

RECRUITING

Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013

Hickory, North Carolina, 28601, United States

RECRUITING

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Dayton Clinical Research- Site Number : 8400124

Dayton, Ohio, 45409, United States

RECRUITING

Epic Medical Research - Chickasha- Site Number : 8400097

Chickasha, Oklahoma, 73018, United States

RECRUITING

Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092

Pittsburgh, Pennsylvania, 15236, United States

RECRUITING

AnMed Oglesby Center- Site Number : 8400074

Anderson, South Carolina, 29621, United States

RECRUITING

REX Clinical Trials - Beaumont- Site Number : 8400014

Beaumont, Texas, 77701, United States

RECRUITING

South Texas Medical Research Institute - TTS Research- Site Number : 8400018

Boerne, Texas, 78006, United States

RECRUITING

Ten20 Clinical Research- Site Number : 8400141

Carrollton, Texas, 75010, United States

RECRUITING

Texas Health Presbyterian Hospital Dallas- Site Number : 8400032

Dallas, Texas, 75231, United States

RECRUITING

Epic Medical Research - De Soto- Site Number : 8400095

DeSoto, Texas, 75115, United States

RECRUITING

Trio Clinical Trials- Site Number : 8400106

Houston, Texas, 77008, United States

RECRUITING

HDH Research- Site Number : 8400104

Houston, Texas, 77022, United States

RECRUITING

Gulf Coast Clinical Research - Houston- Site Number : 8400049

Houston, Texas, 77070, United States

RECRUITING

Lumi Research - Kingwood- Site Number : 8400120

Kingwood, Texas, 77339, United States

RECRUITING

Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063

Lampasas, Texas, 76550, United States

RECRUITING

Discovery Clinical Trials - San Antonio- Site Number : 8400031

San Antonio, Texas, 78229, United States

RECRUITING

Bandera Family Health Care - San Antonio- Site Number : 8400021

San Antonio, Texas, 78249, United States

RECRUITING

Investigational Site Number : 0320007

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Investigational Site Number : 0320008

Lobos, Buenos Aires, 7240, Argentina

RECRUITING

Investigational Site Number : 0320004

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Investigational Site Number : 0320012

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Investigational Site Number : 0320006

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Investigational Site Number : 0320011

Buenos Aires, 1012, Argentina

RECRUITING

Investigational Site Number : 0320005

Buenos Aires, 1122, Argentina

RECRUITING

Investigational Site Number : 0320010

Buenos Aires, 1128, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1425, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1425, Argentina

RECRUITING

Investigational Site Number : 0320009

Buenos Aires, 1427, Argentina

RECRUITING

Chronos Pesquisa Clínica- Site Number : 0760012

Brasília, Federal District, 72145-450, Brazil

RECRUITING

Centro de Estudos em Terapias Inovadoras- Site Number : 0760013

Curitiba, Paraná, 80030-110, Brazil

RECRUITING

Hospital Universitário Onofre Lopes- Site Number : 0760016

Natal, Rio Grande do Norte, 59012-300, Brazil

RECRUITING

LMK Servicos Medicos- Site Number : 0760018

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

RECRUITING

Instituto Ceos- Site Number : 0760005

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

RECRUITING

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

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

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008

São José dos Campos, São Paulo, 12230-001, Brazil

RECRUITING

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010

São Paulo, 01323-001, Brazil

RECRUITING

Investigational Site Number : 1240010

Ajax, Ontario, L1S 2J5, Canada

RECRUITING

Investigational Site Number : 1240004

Guelph, Ontario, N1H 6J2, Canada

RECRUITING

Investigational Site Number : 1240012

Ottawa, Ontario, K1G 6C6, Canada

RECRUITING

Investigational Site Number : 1240009

Stoney Creek, Ontario, L8G 2V6, Canada

RECRUITING

Investigational Site Number : 1240001

Toronto, Ontario, M5T 3A9, Canada

RECRUITING

Investigational Site Number : 1520002

Valdivia, Los Ríos Region, 5110683, Chile

RECRUITING

Investigational Site Number : 1520006

Talca, Maule Region, 3465584, Chile

RECRUITING

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7500010, Chile

RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

RECRUITING

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7500698, Chile

RECRUITING

Investigational Site Number : 1520007

Santiago, Reg Metropolitana de Santiago, 8320325, Chile

RECRUITING

Investigational Site Number : 1520005

Viña del Mar, Región de Valparaíso, 2531172, Chile

RECRUITING

Investigational Site Number : 1560054

Changchun, 130021, China

RECRUITING

Investigational Site Number : 1560010

Changsha, 410011, China

RECRUITING

Investigational Site Number : 1560032

Changsha, 410015, China

RECRUITING

Investigational Site Number : 1560018

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560004

Chengdu, 610072, China

RECRUITING

Investigational Site Number : 1560005

Chengdu, 611130, China

RECRUITING

Investigational Site Number : 1560062

Foshan, 528041, China

RECRUITING

Investigational Site Number : 1560021

Guangzhou, 510150, China

RECRUITING

Investigational Site Number : 1560001

Guangzhou, 510163, China

RECRUITING

Investigational Site Number : 1560030

Hangzhou, 310006, China

RECRUITING

Investigational Site Number : 1560012

Hefei, 230032, China

RECRUITING

Investigational Site Number : 1560046

Hefei, 231220, China

RECRUITING

Investigational Site Number : 1560044

Huizhou, 516001, China

RECRUITING

Investigational Site Number : 1560026

Jiaozuo, 454001, China

RECRUITING

Investigational Site Number : 1560039

Jinan, 250014, China

RECRUITING

Investigational Site Number : 1560049

Jinhua, 321000, China

RECRUITING

Investigational Site Number : 1560056

Jining, 272011, China

RECRUITING

Investigational Site Number : 1560023

Langfang, 065000, China

RECRUITING

Investigational Site Number : 1560033

Linhai, 317000, China

RECRUITING

Investigational Site Number : 1560002

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560003

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560051

Nanning, 530021, China

RECRUITING

Investigational Site Number : 1560017

Ningbo, 315041, China

RECRUITING

Investigational Site Number : 1560031

Pingxiang, 337055, China

RECRUITING

Investigational Site Number : 1560007

Shanghai, 200240, China

RECRUITING

Investigational Site Number : 1560037

Shenzhen, 518020, China

RECRUITING

Investigational Site Number : 1560027

Shihezi, 832008, China

RECRUITING

Investigational Site Number : 1560015

Suining, 629000, China

RECRUITING

Investigational Site Number : 1560022

Taiyuan, 030001, China

RECRUITING

Investigational Site Number : 1560034

Taizhou, 318000, China

RECRUITING

Investigational Site Number : 1560016

Ürümqi, 830054, China

RECRUITING

Investigational Site Number : 1560029

Wenzhou, 325035, China

RECRUITING

Investigational Site Number : 1560025

Wuhan, 430030, China

RECRUITING

Investigational Site Number : 1560050

Wuxi, 214023, China

RECRUITING

Investigational Site Number : 1560052

Xi'an, 710004, China

RECRUITING

Investigational Site Number : 1560020

Xiamen, 361004, China

RECRUITING

Investigational Site Number : 1560011

Xiangtan, 411100, China

RECRUITING

Investigational Site Number : 1560055

Xianyang, 712000, China

RECRUITING

Investigational Site Number : 1560040

Xuzhou, 221006, China

RECRUITING

Investigational Site Number : 1560041

Yangzhou, 225000, China

RECRUITING

Investigational Site Number : 1560060

Yichang, 443003, China

RECRUITING

Investigational Site Number : 1560059

Zhanjiang, 524004, China

RECRUITING

Investigational Site Number : 3920042

Kōnan, Aichi-ken, 483-8704, Japan

RECRUITING

Investigational Site Number : 3920009

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Investigational Site Number : 3920008

Kita, Kagawa-ken, 761-0701, Japan

RECRUITING

Investigational Site Number : 3920040

Kamakura, Kanagawa, 247-8533, Japan

RECRUITING

Investigational Site Number : 3920015

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Investigational Site Number : 3920012

Okayama, Okayama-ken, 701-1192, Japan

RECRUITING

Investigational Site Number : 3920043

Sakai, Osaka, 591-8555, Japan

RECRUITING

Investigational Site Number : 3920020

Ureshino, Saga-ken, 843-0393, Japan

RECRUITING

Investigational Site Number : 3920033

Hachiōji, Tokyo, 193-0998, Japan

RECRUITING

Investigational Site Number : 3920003

Ube, Yamaguchi, 755-8505, Japan

RECRUITING

Investigational Site Number : 3920021

Chiba, 260-0852, Japan

RECRUITING

Investigational Site Number : 3920026

Fukuoka, 819-0055, Japan

RECRUITING

Investigational Site Number : 3920029

Hiroshima, 734-0004, Japan

RECRUITING

Investigational Site Number : 3920039

Kagoshima, 892-0847, Japan

RECRUITING

Investigational Site Number : 3920018

Kumamoto, 862-0909, Japan

RECRUITING

Investigational Site Number : 3920028

Tokyo, 150-8935, Japan

RECRUITING

Investigational Site Number : 7920002

Adana, 01330, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920006

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920003

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920004

Gaziantep, 27310, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920005

Istanbul, 34020, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920007

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 7920001

Mersin, 33070, Turkey (Türkiye)

RECRUITING

Investigational Site Number : 8260014

Bristol, Bristol, City of, BS37 4AX, United Kingdom

RECRUITING

Investigational Site Number : 8260031

Glasgow, Glasgow City, G12 8QQ, United Kingdom

RECRUITING

Investigational Site Number : 8260015

London, Hammersmith and Fulham, W6 7HY, United Kingdom

RECRUITING

Investigational Site Number : 8260003

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Investigational Site Number : 8260009

Harrow, London, City of, HA1 3UJ, United Kingdom

RECRUITING

Investigational Site Number : 8260032

Worthing, West Sussex, BN11 2DH, United Kingdom

RECRUITING

Investigational Site Number : 8260002

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Related Links

• EFC18243 Plain Language Results Summary

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

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

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): November 27, 2029
• Study Completion (Estimated): January 22, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); JP (16); BR (9); TU (7); AR (12); GB (7); CL (7); US (48); CN (42)