Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Status: Recruiting
Location: See all (175) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2

Locations
United States
Arizona
Tucson Clinical Research Institute- Site Number : 8400006
RECRUITING
Tucson
California
Ark Clinical Research- Site Number : 8400113
RECRUITING
Long Beach
Alliance Clinical - West Hills- Site Number : 8400067
RECRUITING
Los Angeles
California Medical Research Associates - Northridge- Site Number : 8400089
RECRUITING
Northridge
Colorado
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005
RECRUITING
Boulder
Critical Care Pulmonary & Sleep Associates- Site Number : 8400081
RECRUITING
Lakewood
Florida
Hillcrest Medical Research- Site Number : 8400082
NOT_YET_RECRUITING
Deland
Finlay Medical Research - Greenacres- Site Number : 8400107
RECRUITING
Greenacres City
Direct Helpers Research Center- Site Number : 8400057
RECRUITING
Hialeah
Pulmonary Specialists of the Palm Beaches- Site Number : 8400017
RECRUITING
Loxahatchee Groves
DL Research Solutions- Site Number : 8400140
RECRUITING
Miami
Innovations Biotech- Site Number : 8400019
RECRUITING
Miami
Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027
RECRUITING
Miami
Professional Research Center- Site Number : 8400046
RECRUITING
Miami
Research Institute of South Florida- Site Number : 8400028
RECRUITING
Miami
Florida Institute for Clinical Research- Site Number : 8400001
RECRUITING
Orlando
Heuer M.D. Research- Site Number : 8400018
NOT_YET_RECRUITING
Orlando
Avanza Medical Research Center- Site Number : 8400015
RECRUITING
Pensacola
Hull and Hull Medical Specialists- Site Number : 8400002
RECRUITING
Plantation
Georgia
Appalachian Clinical Research- Site Number : 8400060
RECRUITING
Adairsville
Illinois
Christie Clinic in Champaign on University- Site Number : 8400023
RECRUITING
Champaign
Sneeze Wheeze & Itch Associates- Site Number : 8400020
RECRUITING
Normal
Indiana
Asha Clinical Research - Munster- Site Number : 8400115
RECRUITING
Hammond
Louisiana
Care Access - Shreveport - Youree Drive- Site Number : 8400007
RECRUITING
Shreveport
Massachusetts
Lucida Clinical Trials- Site Number : 8400101
RECRUITING
New Bedford
Michigan
Vitalis Clinical Research Center- Site Number : 8400040
RECRUITING
Allen Park
Bolt Clinical Research- Site Number : 8400086
RECRUITING
Brighton
Missouri
Hannibal Regional Healthcare System- Site Number : 8400035
RECRUITING
Hannibal
North Carolina
East Carolina University- Site Number : 8400102
RECRUITING
Greenville
Piedmont Healthcare - Family Medicine- Site Number : 8400022
RECRUITING
Statesville
All-Trials Clinical Research- Site Number : 8400008
RECRUITING
Winston-salem
New Jersey
Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037
RECRUITING
Hamilton
Nevada
AB Clinical Trials- Site Number : 8400075
RECRUITING
Las Vegas
Excel Clinical Research - Las Vegas- Site Number : 8400070
RECRUITING
Las Vegas
New York
Mid Hudson Medical Research - New Windsor- Site Number : 8400004
RECRUITING
New Windsor
Ohio
Asthma & Allergy Center - Toledo- Site Number : 8400110
RECRUITING
Toledo
Oklahoma
Layrek Clinical Research- Site Number : 8400066
RECRUITING
Tulsa
Oregon
The Oregon Clinic, PC- Site Number : 8400065
RECRUITING
Portland
South Carolina
MedTrial- Site Number : 8400010
RECRUITING
Columbia
Tennessee
Chattanooga Research and Medicine- Site Number : 8400026
RECRUITING
Chattanooga
Texas
IntraCare- Site Number : 8400034
RECRUITING
Dallas
Premier Pulmonary Critical Care and Sleep- Site Number : 8400111
RECRUITING
Denison
El Paso Pulmonary Association- Site Number : 8400033
RECRUITING
El Paso
Axsendo Clinical Research - Houston- Site Number : 8400054
RECRUITING
Houston
SE Houston- Site Number : 8400120
RECRUITING
Houston
Synergy Group US - Missouri City- Site Number : 8400119
RECRUITING
Missouri City
Synergy Group US - Missouri City- Site Number : 8400133
RECRUITING
Missouri City
Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053
RECRUITING
Sugar Land
Medrasa Clinical Research - Wylie- Site Number : 8400124
RECRUITING
Wylie
Virginia
Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154
ACTIVE_NOT_RECRUITING
Richmond
West Virginia
Rheumatology & Pulmonary Clinic- Site Number : 8400012
RECRUITING
Beckley
Other Locations
Argentina
Investigational Site Number : 0320011
RECRUITING
Berazategui
Investigational Site Number : 0320001
RECRUITING
Buenos Aires
Investigational Site Number : 0320002
RECRUITING
Buenos Aires
Investigational Site Number : 0320003
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
RECRUITING
Buenos Aires
Investigational Site Number : 0320005
RECRUITING
Buenos Aires
Investigational Site Number : 0320006
RECRUITING
Buenos Aires
Investigational Site Number : 0320012
RECRUITING
Buenos Aires
Investigational Site Number : 0320009
RECRUITING
Córdoba
Investigational Site Number : 0320007
RECRUITING
Mendoza
Investigational Site Number : 0320008
RECRUITING
Mendoza
Investigational Site Number : 0320010
RECRUITING
Santa Fe
Australia
Investigational Site Number : 5540004
RECRUITING
Dunedin
Investigational Site Number : 0360001
RECRUITING
Osborne Park
Investigational Site Number : 0360006
RECRUITING
South Brisbane
Investigational Site Number : 0360002
RECRUITING
Traralgon
Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004
RECRUITING
Belo Horizonte
Universidade Federal de Goias- Site Number : 0760002
RECRUITING
Goiânia
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
RECRUITING
Porto Alegre
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001
RECRUITING
São Bernardo Do Campo
IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005
RECRUITING
São Paulo
Canada
Investigational Site Number : 1240051
RECRUITING
Kelowna
Investigational Site Number : 1240049
RECRUITING
Longueuil
Investigational Site Number : 1240047
RECRUITING
Québec
Investigational Site Number : 1240053
RECRUITING
Québec
Investigational Site Number : 1240050
RECRUITING
Saint-charles-borromée
Investigational Site Number : 1240054
RECRUITING
Saint-charles-borromée
Investigational Site Number : 1240048
RECRUITING
Trois-rivières
Investigational Site Number : 1240042
RECRUITING
Victoriaville
Investigational Site Number : 1240052
RECRUITING
West Vancouver
Investigational Site Number : 1240041
RECRUITING
Windsor
Chile
Investigational Site Number : 1520007
RECRUITING
Chillán
Investigational Site Number : 1520004
RECRUITING
Recoleta
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520009
RECRUITING
Santiago
Investigational Site Number : 1520006
RECRUITING
Temuco
Investigational Site Number : 1520003
RECRUITING
Viña Del Mar
China
Investigational Site Number : 1560003
RECRUITING
Baotou
Investigational Site Number : 1560001
RECRUITING
Beijing
Investigational Site Number : 1560005
RECRUITING
Beijing
Investigational Site Number : 1560022
RECRUITING
Beijing
Investigational Site Number : 1560023
RECRUITING
Beijing
Investigational Site Number : 1560090
RECRUITING
Changde
Investigational Site Number : 1560057
RECRUITING
Changsha
Investigational Site Number : 1560032
RECRUITING
Chengdu
Investigational Site Number : 1560052
RECRUITING
Chengdu
Investigational Site Number : 1560037
RECRUITING
Chongqing
Investigational Site Number : 1560074
RECRUITING
Chongqing
Investigational Site Number : 1560051
RECRUITING
Foshan
Investigational Site Number : 1560042
RECRUITING
Ganzhou
Investigational Site Number : 1560015
RECRUITING
Guangzhou
Investigational Site Number : 1560034
RECRUITING
Guangzhou
Investigational Site Number : 1560038
RECRUITING
Guiyang
Investigational Site Number : 1560016
RECRUITING
Haikou
Investigational Site Number : 1560009
RECRUITING
Hangzhou
Investigational Site Number : 1560066
RECRUITING
Hangzhou
Investigational Site Number : 1560054
RECRUITING
Hebei
Investigational Site Number : 1560059
RECRUITING
Hefei
Investigational Site Number : 1560007
RECRUITING
Hohhot
Investigational Site Number : 1560050
RECRUITING
Honghehanizu
Investigational Site Number : 1560046
RECRUITING
Huaian City
Investigational Site Number : 1560004
RECRUITING
Huizhou
Investigational Site Number : 1560021
RECRUITING
Huzhou
Investigational Site Number : 1560065
RECRUITING
Jiangyin
Investigational Site Number : 1560013
RECRUITING
Jinan
Investigational Site Number : 1560028
RECRUITING
Jinan
Investigational Site Number : 1560055
RECRUITING
Jinan
Investigational Site Number : 1560079
RECRUITING
Jingzhou
Investigational Site Number : 1560040
RECRUITING
Jining
Investigational Site Number : 1560061
RECRUITING
Kunming
Investigational Site Number : 1560077
RECRUITING
Luoyang
Investigational Site Number : 1560063
RECRUITING
Meihekou
Investigational Site Number : 1560014
RECRUITING
Nanchang
Investigational Site Number : 1560047
RECRUITING
Nanjing
Investigational Site Number : 1560082
RECRUITING
Nanjing
Investigational Site Number : 1560018
RECRUITING
Nanyang
Investigational Site Number : 1560073
RECRUITING
Panjin
Investigational Site Number : 1560031
RECRUITING
Qiqihar
Investigational Site Number : 1560045
RECRUITING
Quzhou
Investigational Site Number : 1560008
RECRUITING
Shanghai
Investigational Site Number : 1560017
RECRUITING
Shanghai
Investigational Site Number : 1560072
RECRUITING
Shaoyang
Investigational Site Number : 1560035
RECRUITING
Shenyang
Investigational Site Number : 1560053
RECRUITING
Shijiazhuang
Investigational Site Number : 1560002
RECRUITING
Suzhou
Investigational Site Number : 1560024
RECRUITING
Taiyuan
Investigational Site Number : 1560075
RECRUITING
Ürümqi
Investigational Site Number : 1560033
RECRUITING
Weifang
Investigational Site Number : 1560036
RECRUITING
Wenzhou
Investigational Site Number : 1560019
RECRUITING
Wuhan
Investigational Site Number : 1560071
RECRUITING
Wuhan
Investigational Site Number : 1560020
RECRUITING
Xi'an
Investigational Site Number : 1560006
RECRUITING
Xinxiang
Investigational Site Number : 1560089
RECRUITING
Yinchuan
Investigational Site Number : 1560076
RECRUITING
Yiyang
Investigational Site Number : 1560044
RECRUITING
Zhangzhou
Investigational Site Number : 1560084
RECRUITING
Zigong
Investigational Site Number : 1560039
RECRUITING
Zunyi
New Zealand
Investigational Site Number : 5540001
RECRUITING
Auckland
Investigational Site Number : 5540003
RECRUITING
Christchurch
Investigational Site Number : 5540002
RECRUITING
Ebdentown
Republic of Korea
Investigational Site Number : 4100007
RECRUITING
Anyang-si
Investigational Site Number : 4100005
RECRUITING
Daegu
Investigational Site Number : 4100003
RECRUITING
Jeonju
Investigational Site Number : 4100001
RECRUITING
Seoul
Investigational Site Number : 4100002
RECRUITING
Seoul
Investigational Site Number : 4100004
RECRUITING
Seoul
Investigational Site Number : 4100006
RECRUITING
Seoul
South Africa
Investigational Site Number : 7100014
ACTIVE_NOT_RECRUITING
Durban
Taiwan
Investigational Site Number : 1580008
RECRUITING
Hsinchu
Investigational Site Number : 1580001
RECRUITING
Kaohsiung City
Investigational Site Number : 1580002
RECRUITING
Taipei
Investigational Site Number : 1580003
RECRUITING
Taipei
Investigational Site Number : 1580005
RECRUITING
Taipei
United Kingdom
Investigational Site Number : 8260013
RECRUITING
Chertsey
Investigational Site Number : 8260007
RECRUITING
London
Investigational Site Number : 8260008
RECRUITING
London
Investigational Site Number : 8260016
RECRUITING
London
Investigational Site Number : 8260035
RECRUITING
Milton Keynes
Investigational Site Number : 8260005
RECRUITING
Reading
Investigational Site Number : 8260017
RECRUITING
Rotherham
Investigational Site Number : 8260030
RECRUITING
Salford
Investigational Site Number : 8260006
RECRUITING
Southampton
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2030-01-22
Participants
Target number of participants: 942
Treatments
Experimental: Lunsekimig dose regimen A
Participants will receive lunsekimig dose regimen A.
Experimental: Lunsekimig dose regimen B
Participants will receive lunsekimig dose regimen B.
Placebo_comparator: Placebo
Participants will receive lunsekimig-matching placebo.
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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