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
Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07190209
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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.
Interventions
-
Lunsekimig
(Drug)
Pharmaceutical form: solution for injection in prefilled syringe. Route of administration: Subcutaneous injection
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Placebo
(Drug)
Pharmaceutical form: solution for injection. Route of administration: Subcutaneous injection
Eligibility criteria
Conditions
Locations
- Chandler Clinical Research Trials- Site Number : 8400025 — Chandler, Arizona, United States
- Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114 — Phoenix, Arizona, United States
- Epic Medical Research - Surprise- Site Number : 8400096 — Surprise, Arizona, United States
- IMAX Clinical Trials- Site Number : 8400109 — La Palma, California, United States
- Long Beach Research Institute- Site Number : 8400027 — Long Beach, California, United States
- Downtown L.A. Research Center- Site Number : 8400009 — Los Angeles, California, United States
- Newport Native MD- Site Number : 8400003 — Newport Beach, California, United States
- Paradigm Research - Redding- Site Number : 8400108 — Redding, California, United States
- Amicis Research Center - Valencia- Site Number : 8400119 — Valencia, California, United States
- Helix Biomedics- Site Number : 8400065 — Boynton Beach, Florida, United States
- Beautiful Minds Clinical Research Center- Site Number : 8400017 — Cutler Bay, Florida, United States
- Solution Clinical Research- Site Number : 8400039 — Doral, Florida, United States
- Eastern Medical Group Research- Site Number : 8400020 — Fort Myers, Florida, United States
- Premier Medical Associates- Site Number : 8400012 — Lady Lake, Florida, United States
- University of Miami Dermatology Clinical Trials Unit- Site Number : 8400078 — Miami, Florida, United States
- MCR Research- Site Number : 8400004 — Miami, Florida, United States
- Nuren Medical & Research Center- Site Number : 8400030 — Miami, Florida, United States
- My Community Research Center- Site Number : 8400164 — Miami, Florida, United States
- Reed Medical Research Corp- Site Number : 8400167 — Miami, Florida, United States
- Deluxe Health Center- Site Number : 8400010 — Miami Lakes, Florida, United States
- Omega Research Consultants - Orlando - Forest City- Site Number : 8400015 — Orlando, Florida, United States
- Pharmakon Medical Research- Site Number : 8400156 — Palm Beach Gardens, Florida, United States
- Broward Research Center - Pembroke Pines- Site Number : 8400053 — Pembroke Pines, Florida, United States
- Clinical Research Trials of Florida- Site Number : 8400011 — Tampa, Florida, United States
- Deluxe Health Center-Tampa- Site Number : 8400056 — Tampa, Florida, United States
- Private Practice - Dr. David Kavtaradze- Site Number : 8400006 — Cordele, Georgia, United States
- Primeway Clinical Research- Site Number : 8400121 — Fayetteville, Georgia, United States
- University of Illinois-Chicago - College of Medicine- Site Number : 8400055 — Chicago, Illinois, United States
- Avicenna Clinical Research- Site Number : 8400126 — Chicago Ridge, Illinois, United States
- NorthShore Medical Group - Evanston ( Endeavor Health)- Site Number : 8400073 — Evanston, Illinois, United States
- Indy Clinical Research- Site Number : 8400071 — Indianapolis, Indiana, United States
- University of Kansas Medical Center- Site Number : 8400054 — Kansas City, Kansas, United States
- Southern Clinical Research - Zachary- Site Number : 8400113 — Zachary, Louisiana, United States
- Brigham & Women's Hospital- Site Number : 8400148 — Boston, Massachusetts, United States
- University of Michigan Health System - Ann Arbor- Site Number : 8400090 — Ann Arbor, Michigan, United States
- Veritas Clinical Research- Site Number : 8400007 — Madison Heights, Michigan, United States
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400005 — Rochester, Minnesota, United States
- Henderson Clinical Trials- Site Number : 8400026 — Henderson, Nevada, United States
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400144 — East Orange, New Jersey, United States
- New York Hospital Queens- Site Number : 8400058 — Flushing, New York, United States
- Duke Asthma, Allergy and Airway Center- Site Number : 8400047 — Durham, North Carolina, United States
- Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013 — Hickory, North Carolina, United States
- Science 37, Llc- Site Number : 8400154 — Morrisville, North Carolina, United States
- Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048 — Winston-Salem, North Carolina, United States
- Plains Clinical Research Center- Site Number : 8400140 — Fargo, North Dakota, United States
- Dayton Clinical Research- Site Number : 8400124 — Dayton, Ohio, United States
- Epic Medical Research - Chickasha- Site Number : 8400097 — Chickasha, Oklahoma, United States
- Oregon Health & Science University (OHSU)- Site Number : 8400155 — Portland, Oregon, United States
- Temple University Hospital- Site Number : 8400059 — Philadelphia, Pennsylvania, United States
- Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092 — Pittsburgh, Pennsylvania, United States
- AnMed Oglesby Center- Site Number : 8400074 — Anderson, South Carolina, United States
- MD First Research - Lancaster- Site Number : 8400102 — Lancaster, South Carolina, United States
- Circle Clinical Research- Site Number : 8400139 — Sioux Falls, South Dakota, United States
- Meharry Medical College- Site Number : 8400133 — Nashville, Tennessee, United States
- Wellness Clinical Research - Allen- Site Number : 8400085 — Allen, Texas, United States
- REX Clinical Trials - Beaumont- Site Number : 8400014 — Beaumont, Texas, United States
- Novel Research - Bellaire- Site Number : 8400116 — Bellaire, Texas, United States
- South Texas Medical Research Institute - TTS Research- Site Number : 8400018 — Boerne, Texas, United States
- TEN20 Clinical Research - Carrollton- Site Number : 8400141 — Carrollton, Texas, United States
- Corsicana Medical Research- Site Number : 8400134 — Corsicana, Texas, United States
- Syri Research Center- Site Number : 8400069 — Cypress, Texas, United States
- Texas Health Presbyterian Hospital Dallas- Site Number : 8400032 — Dallas, Texas, United States
- Epic Medical Research - De Soto- Site Number : 8400095 — DeSoto, Texas, United States
- Valley Institute of Research- Site Number : 8400118 — Harlingen, Texas, United States
- Trio Clinical Trials- Site Number : 8400106 — Houston, Texas, United States
- HDH Research, Inc.- Site Number : 8400104 — Houston, Texas, United States
- Baylor College of Medicine- Site Number : 8400076 — Houston, Texas, United States
- Gulf Coast Clinical Research - Houston- Site Number : 8400049 — Houston, Texas, United States
- Lumi Research - Kingwood- Site Number : 8400120 — Kingwood, Texas, United States
- Syri Research Center- Site Number : 8400136 — Kingwood, Texas, United States
- Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063 — Lampasas, Texas, United States
- Discovery Clinical Trials - San Antonio- Site Number : 8400031 — San Antonio, Texas, United States
- Bandera Family Health Care - San Antonio- Site Number : 8400021 — San Antonio, Texas, United States
- Element Research Group- Site Number : 8400115 — San Antonio, Texas, United States
- Tidewater Physicians Multispecialty Group Clinical Research - Williamsburg- Site Number : 8400081 — Williamsburg, Virginia, United States
- Investigational Site Number : 0320007 — La Plata, Buenos Aires, Argentina
- Investigational Site Number : 0320008 — Lobos, Buenos Aires, Argentina
- Investigational Site Number : 0320004 — Rosario, Santa Fe Province, Argentina
- Investigational Site Number : 0320012 — Rosario, Santa Fe Province, Argentina
- Investigational Site Number : 0320006 — San Miguel de Tucumán, Tucumán Province, Argentina
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- Chronos Pesquisa Clínica- Site Number : 0760012 — Brasília, Federal District, Brazil
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- Instituto Ceos- Site Number : 0760005 — Porto Alegre, Rio Grande do Sul, Brazil
- LMK Servicos Medicos- Site Number : 0760018 — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001 — Porto Alegre, Rio Grande do Sul, Brazil
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- Investigational Site Number : 2080005 — Aalborg, Denmark
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- Investigational Site Number : 2330003 — Tallinn, Estonia
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- Investigational Site Number : 2500012 — Brest, France
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- Investigational Site Number : 2680004 — Kutaisi, Georgia
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- Investigational Site Number : 2760006 — Ahrensburg, Germany
- Investigational Site Number : 2760011 — Augsburg, Germany
- Investigational Site Number : 2760002 — Bendorf, Germany
- Investigational Site Number : 2760009 — Berlin, Germany
- Investigational Site Number : 2760007 — Berlin, Germany
- Investigational Site Number : 2760013 — Darmstadt, Germany
- Investigational Site Number : 2760004 — Frankfurt, Germany
- Investigational Site Number : 2760008 — Frankfurt, Germany
- Investigational Site Number : 2760003 — Frankfurt am Main, Germany
- Investigational Site Number : 2760012 — Hamburg, Germany
- Investigational Site Number : 2760001 — Leipzig, Germany
- Investigational Site Number : 2760010 — Lübeck, Germany
- Investigational Site Number : 2760005 — Mainz, Germany
- Investigational Site Number : 2760018 — Munich, Germany
- Investigational Site Number : 3480006 — Debrecen, Hungary
- Investigational Site Number : 3480005 — Edelény, Hungary
- Investigational Site Number : 3480001 — Gödöllő, Hungary
- Investigational Site Number : 3480011 — Gyöngyös, Hungary
- Investigational Site Number : 3480004 — Hajdúnánás, Hungary
- Investigational Site Number : 3480002 — Mosonmagyaróvár, Hungary
- Investigational Site Number : 3480009 — Pécs, Hungary
- Investigational Site Number : 3480003 — Püspökladány, Hungary
- Investigational Site Number : 3800004 — Telese Terme, Benevento, Italy
- Investigational Site Number : 3800013 — Cona, Ferrara, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Site Number : 3800001 — Milan, Lombardy, Italy
- Investigational Site Number : 3800007 — Rozzano, Milano, Italy
- Azienda Ospedale Università di Padova Site Number : 3800011 — Padova, Veneto, Italy
- Investigational Site Number : 3800005 — Pavia, Italy
- Investigational Site Number : 3800010 — Reggio Emilia, Italy
- Investigational Site Number : 3800008 — Tradate (Va), Italy
- Investigational Site Number : 3920042 — Kōnan, Aichi-ken, Japan
- Investigational Site Number : 3920032 — Nagoya, Aichi-ken, Japan
- Investigational Site Number : 3920057 — Toyota, Aichi-ken, Japan
- Investigational Site Number : 3920047 — Matsuyama, Ehime, Japan
- Investigational Site Number : 3920026 — Fukuoka, Fukuoka, Japan
- Investigational Site Number : 3920058 — Iizuka, Fukuoka, Japan
- Investigational Site Number : 3920006 — Kurume, Fukuoka, Japan
- Investigational Site Number : 3920053 — Kure, Hiroshima, Japan
- Investigational Site Number : 3920049 — Sapporo, Hokkaido, Japan
- Investigational Site Number : 3920024 — Himeji-Shi, Hyōgo, Japan
- Investigational Site Number : 3920009 — Kobe, Hyōgo, Japan
- Investigational Site Number : 3920008 — Kita, Kagawa-ken, Japan
- Investigational Site Number : 3920030 — Sakaidechō, Kagawa-ken, Japan
- Investigational Site Number : 3920060 — Takamatsu, Kagawa-ken, Japan
- Investigational Site Number : 3920040 — Kamakura, Kanagawa, Japan
- Investigational Site Number : 3920051 — Kawasaki, Kanagawa, Japan
- Investigational Site Number : 3920035 — Yokohama, Kanagawa, Japan
- Investigational Site Number : 3920054 — Yokohama, Kanagawa, Japan
- Investigational Site Number : 3920015 — Yokohama, Kanagawa, Japan
- Investigational Site Number : 3920045 — Matsusaka, Mie-ken, Japan
- Investigational Site Number : 3920005 — Sendai, Miyagi, Japan
- Investigational Site Number : 3920001 — Kashihara, Nara, Japan
- Investigational Site Number : 3920012 — Okayama, Okayama-ken, Japan
- Investigational Site Number : 3920043 — Sakai, Osaka, Japan
- Investigational Site Number : 3920020 — Ureshino-Shi, Saga-ken, Japan
- Investigational Site Number : 3920046 — Fujieda, Shizuoka, Japan
- Investigational Site Number : 3920033 — Hachiōji, Tokyo, Japan
- Investigational Site Number : 3920062 — Yonezawa, Yamagata, Japan
- Investigational Site Number : 3920003 — Ube, Yamaguchi, Japan
- Investigational Site Number : 3920021 — Chiba, Japan
- Investigational Site Number : 3920002 — Fukushima, Japan
- Investigational Site Number : 3920029 — Hiroshima, Japan
- Investigational Site Number : 3920039 — Kagoshima, Japan
- Investigational Site Number : 3920059 — Kiyose, Japan
- Investigational Site Number : 3920036 — Kumamoto, Japan
- Investigational Site Number : 3920018 — Kumamoto, Japan
- Investigational Site Number : 3920056 — Kyoto, Japan
- Investigational Site Number : 3920004 — Osaka, Japan
- Investigational Site Number : 3920007 — Saga, Japan
- Investigational Site Number : 3920028 — Tokyo, Japan
- Investigational Site Number : 3920017 — Tokyo, Japan
- Investigational Site Number : 3920023 — Tokyo, Japan
- Investigational Site Number : 4280001 — Daugavpils, Latvia
- Investigational Site Number : 4280003 — Riga, Latvia
- Investigational Site Number : 4280002 — Riga, Latvia
- Investigational Site Number : 4840001 — Monterrey, Nuevo León, Mexico
- Investigational Site Number : 4840009 — San Juan del Río, Querétaro, Mexico
- Investigational Site Number : 4840008 — Durango, Mexico
- Investigational Site Number : 4840004 — Mexico City, Mexico
- Investigational Site Number : 4840003 — Veracruz, Mexico
- Investigational Site Number : 6160002 — Wroclaw, Lower Silesian Voivodeship, Poland
- Investigational Site Number : 6160006 — Piaseczno, Masovian Voivodeship, Poland
- Investigational Site Number : 6160001 — Bialystok, Podlaskie Voivodeship, Poland
- Investigational Site Number : 6160009 — Katowice, Silesian Voivodeship, Poland
- Investigational Site Number : 6160010 — Elblag, Poland
- Investigational Site Number : 6160003 — Katowice, Poland
- Investigational Site Number : 6160004 — Sosnowiec, Poland
- Investigational Site Number : 6200002 — Almada, Portugal
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- Investigational Site Number : 6200005 — Guimarães, Portugal
- Investigational Site Number : 6200003 — Matosinhos Municipality, Portugal
- Investigational Site Number : 6200001 — Porto, Portugal
- Investigational Site Number : 6820003 — Jeddah, Saudi Arabia
- Investigational Site Number : 6820001 — Riyadh, Saudi Arabia
- Investigational Site Number : 6820002 — Riyadh, Saudi Arabia
- Investigational Site Number : 7240003 — Málaga, Andalusia, Spain
- Investigational Site Number : 7240001 — Mérida, Badajoz, Spain
- Investigational Site Number : 7240007 — L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
- Investigational Site Number : 7240008 — Jerez de la Frontera, Cádiz, Spain
- Investigational Site Number : 7240005 — Cáceres, Extremadura, Spain
- Investigational Site Number : 7240006 — Benalmádena, Málaga, Spain
- Investigational Site Number : 7240004 — Palma, Spain
- Investigational Site Number : 7240002 — Seville, Spain
- Investigational Site Number : 7520002 — Solna, Sweden
- Investigational Site Number : 7520004 — Umeå, Sweden
- Investigational Site Number : 7920002 — Adana, Turkey (Türkiye)
- Investigational Site Number : 7920006 — Ankara, Turkey (Türkiye)
- Investigational Site Number : 7920003 — Ankara, Turkey (Türkiye)
- Investigational Site Number : 7920004 — Gaziantep, Turkey (Türkiye)
- Investigational Site Number : 7920005 — Istanbul, Turkey (Türkiye)
- Investigational Site Number : 7920007 — Izmir, Turkey (Türkiye)
- Investigational Site Number : 7920001 — Mersin, Turkey (Türkiye)
- Investigational Site Number : 8260014 — Bristol, Bristol, City of, United Kingdom
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- Investigational Site Number : 8260031 — London, London, City of, United Kingdom
- Investigational Site Number : 8260034 — Oxford, Oxfordshire, United Kingdom
- Investigational Site Number : 8260032 — Worthing, West Sussex, United Kingdom
- Investigational Site Number : 8260002 — Bradford, United Kingdom
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