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

NCT07190222 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: EFC182442024-518213-25-00U1111-1308-9980
• Study Type: interventional
• Target: 942
• Locations: 12 countries
• Sites: 175

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 (175)

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona, 85712, United States

RECRUITING

Ark Clinical Research- Site Number : 8400113

Long Beach, California, 90815, United States

RECRUITING

Alliance Clinical - West Hills- Site Number : 8400067

Los Angeles, California, 91307, United States

RECRUITING

California Medical Research Associates - Northridge- Site Number : 8400089

Northridge, California, 91324, United States

RECRUITING

Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005

Boulder, Colorado, 80301, United States

RECRUITING

Critical Care Pulmonary & Sleep Associates- Site Number : 8400081

Lakewood, Colorado, 80228, United States

RECRUITING

Hillcrest Medical Research- Site Number : 8400082

DeLand, Florida, 32720, United States

NOT YET RECRUITING

Finlay Medical Research - Greenacres- Site Number : 8400107

Greenacres City, Florida, 33467, United States

RECRUITING

Direct Helpers Research Center- Site Number : 8400057

Hialeah, Florida, 33012, United States

RECRUITING

Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

DL Research Solutions- Site Number : 8400140

Miami, Florida, 33155, United States

RECRUITING

Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027

Miami, Florida, 33165, United States

RECRUITING

Professional Research Center- Site Number : 8400046

Miami, Florida, 33172, United States

RECRUITING

Research Institute of South Florida- Site Number : 8400028

Miami, Florida, 33173, United States

RECRUITING

Innovations Biotech- Site Number : 8400019

Miami, Florida, 33186, United States

RECRUITING

Heuer M.D. Research- Site Number : 8400018

Orlando, Florida, 32819, United States

NOT YET RECRUITING

Florida Institute for Clinical Research- Site Number : 8400001

Orlando, Florida, 32825, United States

RECRUITING

Avanza Medical Research Center- Site Number : 8400015

Pensacola, Florida, 32503, United States

RECRUITING

Hull and Hull Medical Specialists- Site Number : 8400002

Plantation, Florida, 33324, United States

RECRUITING

Appalachian Clinical Research- Site Number : 8400060

Adairsville, Georgia, 30103, United States

RECRUITING

Christie Clinic in Champaign on University- Site Number : 8400023

Champaign, Illinois, 61820, United States

RECRUITING

Sneeze Wheeze & Itch Associates- Site Number : 8400020

Normal, Illinois, 61761, United States

RECRUITING

Asha Clinical Research - Munster- Site Number : 8400115

Hammond, Indiana, 46324, United States

RECRUITING

Care Access - Shreveport - Youree Drive- Site Number : 8400007

Shreveport, Louisiana, 71105, United States

RECRUITING

Lucida Clinical Trials- Site Number : 8400101

New Bedford, Massachusetts, 02740, United States

RECRUITING

Vitalis Clinical Research Center- Site Number : 8400040

Allen Park, Michigan, 48101, United States

RECRUITING

Bolt Clinical Research- Site Number : 8400086

Brighton, Michigan, 48116, United States

RECRUITING

Hannibal Regional Healthcare System- Site Number : 8400035

Hannibal, Missouri, 63401, United States

RECRUITING

Excel Clinical Research - Las Vegas- Site Number : 8400070

Las Vegas, Nevada, 89109, United States

RECRUITING

AB Clinical Trials- Site Number : 8400075

Las Vegas, Nevada, 89119, United States

RECRUITING

Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037

Hamilton, New Jersey, 08690, United States

RECRUITING

Mid Hudson Medical Research - New Windsor- Site Number : 8400004

New Windsor, New York, 12553, United States

RECRUITING

East Carolina University- Site Number : 8400102

Greenville, North Carolina, 27858, United States

RECRUITING

Piedmont Healthcare - Family Medicine- Site Number : 8400022

Statesville, North Carolina, 28625, United States

RECRUITING

All-Trials Clinical Research- Site Number : 8400008

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Asthma & Allergy Center - Toledo- Site Number : 8400110

Toledo, Ohio, 43617, United States

RECRUITING

Layrek Clinical Research- Site Number : 8400066

Tulsa, Oklahoma, 74133, United States

RECRUITING

The Oregon Clinic, PC- Site Number : 8400065

Portland, Oregon, 97232, United States

RECRUITING

MedTrial- Site Number : 8400010

Columbia, South Carolina, 29204, United States

RECRUITING

Chattanooga Research and Medicine- Site Number : 8400026

Chattanooga, Tennessee, 37404, United States

RECRUITING

IntraCare- Site Number : 8400034

Dallas, Texas, 75254, United States

RECRUITING

Premier Pulmonary Critical Care and Sleep- Site Number : 8400111

Denison, Texas, 75020, United States

RECRUITING

El Paso Pulmonary Association- Site Number : 8400033

El Paso, Texas, 79902, United States

RECRUITING

Axsendo Clinical Research - Houston- Site Number : 8400054

Houston, Texas, 77058, United States

RECRUITING

SE Houston- Site Number : 8400120

Houston, Texas, 77061, United States

RECRUITING

Synergy Group US - Missouri City- Site Number : 8400119

Missouri City, Texas, 77459, United States

RECRUITING

Synergy Group US - Missouri City- Site Number : 8400133

Missouri City, Texas, 77459, United States

RECRUITING

Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053

Sugar Land, Texas, 77478, United States

RECRUITING

Medrasa Clinical Research - Wylie- Site Number : 8400124

Wylie, Texas, 75098, United States

RECRUITING

Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154

Richmond, Virginia, 23219, United States

ACTIVE NOT RECRUITING

Rheumatology & Pulmonary Clinic- Site Number : 8400012

Beckley, West Virginia, 25801, United States

RECRUITING

Investigational Site Number : 0320011

Berazategui, Buenos Aires, 1886, Argentina

RECRUITING

Investigational Site Number : 0320004

Buenos Aires, 1006, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1023, Argentina

RECRUITING

Investigational Site Number : 0320005

Buenos Aires, 1121, Argentina

RECRUITING

Investigational Site Number : 0320006

Buenos Aires, 1280, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1414, Argentina

RECRUITING

Investigational Site Number : 0320012

Buenos Aires, 1638, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1650, Argentina

RECRUITING

Investigational Site Number : 0320009

Córdoba, 5003, Argentina

RECRUITING

Investigational Site Number : 0320007

Mendoza, 5500, Argentina

RECRUITING

Investigational Site Number : 0320008

Mendoza, 5500, Argentina

RECRUITING

Investigational Site Number : 0320010

Santa Fe, 3000, Argentina

RECRUITING

Investigational Site Number : 0360006

South Brisbane, Queensland, 4101, Australia

RECRUITING

Investigational Site Number : 0360002

Traralgon, Victoria, 3844, Australia

RECRUITING

Investigational Site Number : 0360001

Osborne Park, Western Australia, 6017, Australia

RECRUITING

Investigational Site Number : 5540004

Dunedin, 9016, Australia

RECRUITING

Universidade Federal de Goias- Site Number : 0760002

Goiânia, Goiás, 74605-020, Brazil

RECRUITING

Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004

Belo Horizonte, Minas Gerais, 30150-221, Brazil

RECRUITING

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

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

RECRUITING

Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001

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

RECRUITING

IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005

São Paulo, 04014-002, Brazil

RECRUITING

Investigational Site Number : 1240051

Kelowna, British Columbia, V1Y 4N7, Canada

RECRUITING

Investigational Site Number : 1240052

West Vancouver, British Columbia, V7T 2Z3, Canada

RECRUITING

Investigational Site Number : 1240041

Windsor, Ontario, N8X 1T3, Canada

RECRUITING

Investigational Site Number : 1240049

Longueuil, Quebec, J4K 1C8, Canada

RECRUITING

Investigational Site Number : 1240047

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Investigational Site Number : 1240053

Québec, Quebec, G2J 0C4, Canada

RECRUITING

Investigational Site Number : 1240050

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

RECRUITING

Investigational Site Number : 1240054

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

RECRUITING

Investigational Site Number : 1240048

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

Investigational Site Number : 1240042

Victoriaville, Quebec, G6P 3Z8, Canada

RECRUITING

Investigational Site Number : 1520006

Temuco, La Araucanía, 4810345, Chile

RECRUITING

Investigational Site Number : 1520004

Recoleta, Reg Metropolitana de Santiago, 8420000, Chile

RECRUITING

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500587, Chile

RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7750495, Chile

RECRUITING

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, 8380453, Chile

RECRUITING

Investigational Site Number : 1520003

Viña del Mar, Región de Valparaíso, 2540364, Chile

RECRUITING

Investigational Site Number : 1520007

Chillán, 3800761, Chile

RECRUITING

Investigational Site Number : 1560003

Baotou, 014010, China

RECRUITING

Investigational Site Number : 1560022

Beijing, 100020, China

RECRUITING

Investigational Site Number : 1560001

Beijing, 100029, China

RECRUITING

Investigational Site Number : 1560023

Beijing, 100038, China

RECRUITING

Investigational Site Number : 1560005

Beijing, 100191, China

RECRUITING

Investigational Site Number : 1560090

Changde, 415000, China

RECRUITING

Investigational Site Number : 1560057

Changsha, 410008, China

RECRUITING

Investigational Site Number : 1560052

Chengdu, 610000, China

RECRUITING

Investigational Site Number : 1560032

Chengdu, 610081, China

RECRUITING

Investigational Site Number : 1560037

Chongqing, 400010, China

RECRUITING

Investigational Site Number : 1560074

Chongqing, China

RECRUITING

Investigational Site Number : 1560051

Foshan, 528399, China

RECRUITING

Investigational Site Number : 1560042

Ganzhou, 341000, China

RECRUITING

Investigational Site Number : 1560015

Guangzhou, 510180, China

RECRUITING

Investigational Site Number : 1560034

Guangzhou, 511400, China

RECRUITING

Investigational Site Number : 1560038

Guiyang, 550004, China

RECRUITING

Investigational Site Number : 1560016

Haikou, 570216, China

RECRUITING

Investigational Site Number : 1560009

Hangzhou, 310009, China

RECRUITING

Investigational Site Number : 1560066

Hangzhou, 310009, China

RECRUITING

Investigational Site Number : 1560054

Hebei, 050051, China

RECRUITING

Investigational Site Number : 1560059

Hefei, 230011, China

RECRUITING

Investigational Site Number : 1560007

Hohhot, 010070, China

RECRUITING

Investigational Site Number : 1560050

Honghehanizu, 654400, China

RECRUITING

Investigational Site Number : 1560046

Huaian City, China

RECRUITING

Investigational Site Number : 1560004

Huizhou, 516002, China

RECRUITING

Investigational Site Number : 1560021

Huzhou, 313000, China

RECRUITING

Investigational Site Number : 1560065

Jiangyin, 214400, China

RECRUITING

Investigational Site Number : 1560055

Jinan, 250001, China

RECRUITING

Investigational Site Number : 1560028

Jinan, 250013, China

RECRUITING

Investigational Site Number : 1560013

Jinan, 250014, China

RECRUITING

Investigational Site Number : 1560079

Jingzhou, 434020, China

RECRUITING

Investigational Site Number : 1560040

Jining, 272029, China

RECRUITING

Investigational Site Number : 1560061

Kunming, 650011, China

RECRUITING

Investigational Site Number : 1560077

Luoyang, 471002, China

RECRUITING

Investigational Site Number : 1560063

Meihekou, 135022, China

RECRUITING

Investigational Site Number : 1560014

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560047

Nanjing, 210006, China

RECRUITING

Investigational Site Number : 1560082

Nanjing, 211100, China

RECRUITING

Investigational Site Number : 1560018

Nanyang, 473014, China

RECRUITING

Investigational Site Number : 1560073

Panjin, 422000, China

RECRUITING

Investigational Site Number : 1560031

Qiqihar, 161000, China

RECRUITING

Investigational Site Number : 1560045

Quzhou, 324000, China

RECRUITING

Investigational Site Number : 1560008

Shanghai, 200025, China

RECRUITING

Investigational Site Number : 1560017

Shanghai, 201200, China

RECRUITING

Investigational Site Number : 1560072

Shaoyang, 422000, China

RECRUITING

Investigational Site Number : 1560035

Shenyang, 110000, China

RECRUITING

Investigational Site Number : 1560053

Shijiazhuang, 050031, China

RECRUITING

Investigational Site Number : 1560002

Suzhou, 215006, China

RECRUITING

Investigational Site Number : 1560024

Taiyuan, 030032, China

RECRUITING

Investigational Site Number : 1560075

Ürümqi, 830001, China

RECRUITING

Investigational Site Number : 1560033

Weifang, 261041, China

RECRUITING

Investigational Site Number : 1560036

Wenzhou, 325027, China

RECRUITING

Investigational Site Number : 1560019

Wuhan, 430014, China

RECRUITING

Investigational Site Number : 1560071

Wuhan, 430022, China

RECRUITING

Investigational Site Number : 1560020

Xi'an, 710126, China

RECRUITING

Investigational Site Number : 1560006

Xinxiang, 453000, China

RECRUITING

Investigational Site Number : 1560089

Yinchuan, 750004, China

RECRUITING

Investigational Site Number : 1560076

Yiyang, 413000, China

RECRUITING

Investigational Site Number : 1560044

Zhangzhou, 363000, China

RECRUITING

Investigational Site Number : 1560084

Zigong, 643000, China

RECRUITING

Investigational Site Number : 1560039

Zunyi, 563002, China

RECRUITING

Investigational Site Number : 5540003

Christchurch, Canterbury, 8011, New Zealand

RECRUITING

Investigational Site Number : 5540002

Ebdentown, Wellington Region, 5018, New Zealand

RECRUITING

Investigational Site Number : 5540001

Auckland, 0622, New Zealand

RECRUITING

Investigational Site Number : 7100014

Durban, 4001, South Africa

ACTIVE NOT RECRUITING

Investigational Site Number : 4100007

Anyang-si, Gyeonggi-do, 14068, South Korea

RECRUITING

Investigational Site Number : 4100005

Daegu, Gyeongsangbuk-do, 42415, South Korea

RECRUITING

Investigational Site Number : 4100003

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, 05030, South Korea

RECRUITING

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 05355, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 06591, South Korea

RECRUITING

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 07061, South Korea

RECRUITING

Investigational Site Number : 1580008

Hsinchu, 300, Taiwan

RECRUITING

Investigational Site Number : 1580001

Kaohsiung City, 807, Taiwan

RECRUITING

Investigational Site Number : 1580005

Taipei, 100, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taipei, 110, Taiwan

RECRUITING

Investigational Site Number : 1580003

Taipei, 112, Taiwan

RECRUITING

Investigational Site Number : 8260035

Milton Keynes, Buckinghamshire, MK19 6FG, United Kingdom

RECRUITING

Investigational Site Number : 8260007

London, England, E11 1NR, United Kingdom

RECRUITING

Investigational Site Number : 8260008

London, Hammersmith and Fulham, W6 8RF, United Kingdom

RECRUITING

Investigational Site Number : 8260006

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Investigational Site Number : 8260016

London, London, City of, SW1P 2PF, United Kingdom

RECRUITING

Investigational Site Number : 8260030

Salford, Manchester, M6 8HD, United Kingdom

RECRUITING

Investigational Site Number : 8260013

Chertsey, Surrey, KT16 0PZ, United Kingdom

RECRUITING

Investigational Site Number : 8260005

Reading, RG1 5AN, United Kingdom

RECRUITING

Investigational Site Number : 8260017

Rotherham, S61 1AH, United Kingdom

RECRUITING

Related Links

• EFC18244 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 17, 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

KR (7); NZ (3); CN (61); GB (9); CA (10); BR (5); US (51); AR (12); TW (5); CL (7); AU (4); ZA (1)