Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Phase 2b/3, Randomized, Double-blind, Placebocontrolled, 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 (100) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a parallel, Phase 2/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
Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114
RECRUITING
Phoenix
Epic Medical Research - Surprise- Site Number : 8400096
RECRUITING
Surprise
California
IMAX Clinical Trials- Site Number : 8400109
RECRUITING
La Palma
Newport Native MD- Site Number : 8400003
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Newport Beach
Florida
Helix Biomedics- Site Number : 8400065
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Boynton Beach
Beautiful Minds Clinical Research Center- Site Number : 8400017
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Cutler Bay
Premier Medical Associates- Site Number : 8400012
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Lady Lake
MCR Research- Site Number : 8400004
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Miami
Nuren Medical & Research Center- Site Number : 8400030
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Miami
Deluxe Health Center- Site Number : 8400010
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Miami Lakes
Omega Research Consultants - Orlando - Forest City- Site Number : 8400015
RECRUITING
Orlando
Broward Research Center - Pembroke Pines- Site Number : 8400053
RECRUITING
Pembroke Pines
Clinical Research Trials of Florida- Site Number : 8400011
RECRUITING
Tampa
Deluxe Health Center-Tampa- Site Number : 8400056
RECRUITING
Tampa
Georgia
Private Practice - Dr. David Kavtaradze- Site Number : 8400006
RECRUITING
Cordele
Illinois
Avicenna Clinical Research- Site Number : 8400126
RECRUITING
Chicago Ridge
Indiana
Indy Clinical Research- Site Number : 8400071
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center- Site Number : 8400054
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Kansas City
Louisiana
Southern Clinical Research - Zachary- Site Number : 8400113
RECRUITING
Zachary
Michigan
Pulmonary and Medicine Associates- Site Number : 8400007
RECRUITING
Warren
North Carolina
Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013
RECRUITING
Hickory
Atrium Health Wake Forest Baptist Pulmonary, Sleep and Allergy- Site Number : 8400048
RECRUITING
Winston-salem
Nevada
Henderson Clinical Trials- Site Number : 8400026
RECRUITING
Henderson
Sierra Clinical Research - Las Vegas- Site Number : 8400028
RECRUITING
Las Vegas
New York
New York Hospital Queens- Site Number : 8400058
RECRUITING
Flushing
Ohio
Dayton Clinical Research- Site Number : 8400124
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Dayton
Oklahoma
Epic Medical Research - Chickasha- Site Number : 8400097
RECRUITING
Chickasha
Pennsylvania
Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092
RECRUITING
Pittsburgh
Texas
REX Clinical Trials - Beaumont- Site Number : 8400014
RECRUITING
Beaumont
South Texas Medical Research Institute - TTS Research- Site Number : 8400018
RECRUITING
Boerne
Texas Health Presbyterian Hospital Dallas- Site Number : 8400032
RECRUITING
Dallas
Epic Medical Research - De Soto- Site Number : 8400095
RECRUITING
Desoto
Gulf Coast Clinical Research- Site Number : 8400049
RECRUITING
Houston
HDH Research- Site Number : 8400104
RECRUITING
Houston
Trio Clinical Trials- Site Number : 8400106
RECRUITING
Houston
Lumi Research - Kingwood- Site Number : 8400120
RECRUITING
Kingwood
Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063
RECRUITING
Lampasas
Bandera Family Health Care - San Antonio- Site Number : 8400021
RECRUITING
San Antonio
Discovery Clinical Trials - San Antonio- Site Number : 8400031
RECRUITING
San Antonio
Other Locations
Argentina
Investigational Site Number : 0320001
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Buenos Aires
Investigational Site Number : 0320002
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Buenos Aires
Investigational Site Number : 0320005
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Buenos Aires
Investigational Site Number : 0320009
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Buenos Aires
Investigational Site Number : 0320010
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Buenos Aires
Investigational Site Number : 0320011
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Buenos Aires
Investigational Site Number : 0320004
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Rosario
Investigational Site Number : 0320012
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Rosario
Investigational Site Number : 0320003
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San Miguel De Tucumán
Investigational Site Number : 0320006
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San Miguel De Tucumán
Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
RECRUITING
Porto Alegre
Canada
Investigational Site Number : 1240010
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Ajax
Investigational Site Number : 1240004
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Guelph
Investigational Site Number : 1240012
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Ottawa
Investigational Site Number : 1240009
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Stoney Creek
Chile
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520003
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Santiago
Investigational Site Number : 1520004
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Santiago
Investigational Site Number : 1520007
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Santiago
Investigational Site Number : 1520006
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Talca
Investigational Site Number : 1520002
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Valdivia
Investigational Site Number : 1520005
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Viña Del Mar
China
Investigational Site Number : 1560054
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Changchun
Investigational Site Number : 1560010
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Changsha
Investigational Site Number : 1560032
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Changsha
Investigational Site Number : 1560004
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Chengdu
Investigational Site Number : 1560018
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Chengdu
Investigational Site Number : 1560001
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Guangzhou
Investigational Site Number : 1560021
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Guangzhou
Investigational Site Number : 1560030
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Hangzhou
Investigational Site Number : 1560012
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Hefei
Investigational Site Number : 1560044
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Huizhou
Investigational Site Number : 1560026
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Jiaozuo
Investigational Site Number : 1560039
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Jinan
Investigational Site Number : 1560049
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Jinhua
Investigational Site Number : 1560033
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Linhai
Investigational Site Number : 1560002
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Nanchang
Investigational Site Number : 1560017
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Ningbo
Investigational Site Number : 1560031
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Pingxiang
Investigational Site Number : 1560007
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Shanghai
Investigational Site Number : 1560037
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Shenzhen
Investigational Site Number : 1560022
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Taiyuan
Investigational Site Number : 1560034
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Taizhou
Investigational Site Number : 1560029
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Wenzhou
Investigational Site Number : 1560025
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Wuhan
Investigational Site Number : 1560011
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Xiangtan
Investigational Site Number : 1560040
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Xuzhou
Investigational Site Number : 1560041
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Yangzhou
Investigational Site Number : 1560060
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Yichang
Japan
Investigational Site Number : 3920026
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Fukuoka
Investigational Site Number : 3920040
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Kamakura
Investigational Site Number : 3920043
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Sakai
Investigational Site Number : 3920028
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Tokyo
Investigational Site Number : 3920020
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Ureshino
Investigational Site Number : 3920015
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Yokohama
United Kingdom
Investigational Site Number : 8260002
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Bradford
Investigational Site Number : 8260014
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Bristol
Investigational Site Number : 8260031
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Glasgow
Investigational Site Number : 8260009
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Harrow
Investigational Site Number : 8260003
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Leicester
Investigational Site Number : 8260032
RECRUITING
Worthing
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-09-16
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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