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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04751487
Other study ID # EFC16819
Secondary ID U1111-1250-28432
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 12, 2021
Est. completion date October 17, 2025

Study information

Verified date May 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email contact-us@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD


Description:

The study duration per participant: - Screening period is 3-5 weeks - Randomized investigational medicinal product (IMP) treatment period is 52 weeks for first cohort of randomized former smoker participants [approximately 930] and cohort of current smokers [approximately 280], and 24 to 52 weeks for potential additional randomized former smoker participants - Post-IMP treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.


Recruitment information / eligibility

Status Recruiting
Enrollment 1210
Est. completion date October 17, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion criteria : - Participant must be 40 to 85 years of age inclusive. - Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition). - Smoking history of =10 pack-years: - For former smokers: participants who report that they are not currently smoking and smoking cessation must have occurred =6 months prior to Screening (Visit 1A) with an intention to quit permanently. - For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period. - Participants with moderate-to-severe COPD - Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to Screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded). - Documented history of high exacerbation risk defined as having had =2 moderate or =1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy: - Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics. - Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility. - Participants with standard of care controller therapy, for =3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the Screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS. - Body mass index (BMI) =18.0 kg/m^2, or BMI =16.0 kg/m^2 for participants enrolled in East-Asian countries. - Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies: - not a women of child-bearing potential (WOCBP) OR - a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention. - Exclusion criteria: - Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred. - For former smokers: Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A). - For current smokers: vaping of any products (eg, nicotine, THC) within 6 months prior to Screening (Visit 1A). - Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study. - Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of a-1 anti-trypsin deficiency, or another diagnosed pulmonary disease. - Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension. - Hypercapnia requiring bilevel positive airway pressure (BiPAP). - Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A). - Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded. - Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A). - Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation. - Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy). - Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A). - History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A). - Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial. - Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment). - Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis. - History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin. - Previous use of itepekimab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Itepekimab SAR440340
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Placebo
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Locations

Country Name City State
Argentina Investigational Site Number : 0320009 Berazategui Buenos Aires
Argentina Investigational Site Number : 0320006 Buenos Aires Ciudad De Buenos Aires
Argentina Investigational Site Number : 0320001 Caba Buenos Aires
Argentina Investigational Site Number : 0320008 Caba Buenos Aires
Argentina Investigational Site Number : 0320005 Pergamino Buenos Aires
Argentina Investigational Site Number : 0320003 Rosario Santa Fe
Argentina Investigational Site Number : 0320004 Rosario Santa Fe
Argentina Investigational Site Number : 0320007 Rosario Santa Fe
Argentina Investigational Site Number : 0320002 Vicente Lopez Ciudad De Buenos Aires
Brazil Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760014 Belo Horizonte Minas Gerais
Brazil Faculdade de Medicina da Universidade Estadual Paulista Site Number : 0760005 Botucatu São Paulo
Brazil CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza Site Number : 0760018 Brasilia Distrito Federal
Brazil PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760010 Campinas São Paulo
Brazil CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760012 Curitiba Paraná
Brazil Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao Site Number : 0760006 Porto Alegre Rio Grande Do Sul
Brazil Hospital Sao Lucas da PUCRS Site Number : 0760007 Porto Alegre Rio Grande Do Sul
Brazil Instituto Ceos Site Number : 0760021 Porto Alegre Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760001 Porto Alegre Rio Grande Do Sul
Brazil Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017 Rio de Janeiro
Brazil SER da Bahia Site Number : 0760020 Salvador Bahia
Brazil CEMEC - Centro Multidisciplinar de Estudos Clinicos Site Number : 0760015 Sao Bernardo do Campo São Paulo
Brazil Hospital Sao Domingos Site Number : 0760016 Sao Luis Maranhão
Brazil CEPIC - Centro Paulista de Investigação Clínica Site Number : 0760004 Sao Paulo
Brazil Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760013 Sao Paulo São Paulo
Brazil Clinica de Alergia Martti Antila Site Number : 0760008 Sorocaba São Paulo
Brazil CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760009 Vitoria Espírito Santo
Bulgaria Investigational Site Number : 1000008 Blagoevgrad
Bulgaria Investigational Site Number : 1000013 Dupnitsa
Bulgaria Investigational Site Number : 1000004 Gabrovo
Bulgaria Investigational Site Number : 1000009 Haskovo
Bulgaria Investigational Site Number : 1000005 Montana
Bulgaria Investigational Site Number : 1000002 Plovdiv
Bulgaria Investigational Site Number : 1000003 Ruse
Bulgaria Investigational Site Number : 1000012 Ruse
Bulgaria Investigational Site Number : 1000001 Sofia
Bulgaria Investigational Site Number : 1000006 Sofia
Canada Investigational Site Number : 1240021 Ajax Ontario
Canada Investigational Site Number : 1240020 Burlington Ontario
Canada Investigational Site Number : 1240023 Guelph Ontario
Canada Investigational Site Number : 1240014 Kelowna British Columbia
Canada Investigational Site Number : 1240012 Moncton New Brunswick
Canada Investigational Site Number : 1240016 Penticton British Columbia
Canada Investigational Site Number : 1240003 Quebec
Canada Investigational Site Number : 1240004 Sherbrooke Quebec
Canada Investigational Site Number : 1240006 Sherwood Park Alberta
Canada Investigational Site Number : 1240005 St-charles Borrommee Quebec
Canada Investigational Site Number : 1240019 Terrebonne Quebec
Canada Investigational Site Number : 1240009 Toronto Ontario
Canada Investigational Site Number : 1240001 Trois-Rivieres Quebec
Canada Investigational Site Number : 1240002 Victoriaville Quebec
Canada Investigational Site Number : 1240018 Windsor Ontario
Canada Investigational Site Number : 1240022 Windsor Ontario
Chile Investigational Site Number : 1520006 Quillota Valparaíso
Chile Investigational Site Number : 1520001 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520003 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520005 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520007 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520008 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520002 Talca Maule
Chile Investigational Site Number : 1520009 Valdivia Los Ríos
Czechia Investigational Site Number : 2030001 Jindrichuv Hradec III
Czechia Investigational Site Number : 2030009 Mesice
Czechia Investigational Site Number : 2030005 Mlada Boleslav
Czechia Investigational Site Number : 2030008 Olomouc
Czechia Investigational Site Number : 2030004 Ostrava
Czechia Investigational Site Number : 2030002 Praha 4
Czechia Investigational Site Number : 2030006 Teplice
Czechia Investigational Site Number : 2030007 Varnsdorf
Denmark Investigational Site Number : 2080001 Hvidovre
Denmark Investigational Site Number : 2080003 Vejle
Estonia Investigational Site Number : 2330001 Tartu
France Investigational Site Number : 2500006 Angers
France Investigational Site Number : 2500001 Lyon
France Investigational Site Number : 2500002 Montpellier
France Investigational Site Number : 2500007 Paris
France Investigational Site Number : 2500003 Pessac
France Investigational Site Number : 2500004 Reims
Georgia Investigational Site Number : 2680003 Batumi
Georgia Investigational Site Number : 2680001 Tbilisi
Georgia Investigational Site Number : 2680002 Tbilisi
Germany Investigational Site Number : 2760004 Berlin
Germany Investigational Site Number : 2760009 Berlin
Germany Investigational Site Number : 2760010 Berlin
Germany Investigational Site Number : 2760005 Frankfurt am Main
Germany Investigational Site Number : 2760002 Hamburg
Germany Investigational Site Number : 2760014 Hannover
Germany Investigational Site Number : 2760006 Koblenz
Germany Investigational Site Number : 2760007 Leipzig
Germany Investigational Site Number : 2760008 Leipzig
Germany Investigational Site Number : 2760003 Lübeck
Germany Investigational Site Number : 2760001 Mainz
Germany Investigational Site Number : 2760012 Neu-Isenburg
Germany Investigational Site Number : 2760011 Rosenheim
Hungary Investigational Site Number : 3480002 Balassagyarmat
Hungary Investigational Site Number : 3480009 Budapest
Hungary Investigational Site Number : 3480013 Budapest
Hungary Investigational Site Number : 3480005 Edelény
Hungary Investigational Site Number : 3480004 Hajdunánás
Hungary Investigational Site Number : 3480003 Puspokladany
Hungary Investigational Site Number : 3480001 Százhalombatta
Hungary Investigational Site Number : 3480012 Szombathely
India Investigational Site Number : 3560016 Belgaum
India Investigational Site Number : 3560001 Chandigarh
India Investigational Site Number : 3560014 India
India Investigational Site Number : 3560013 Jaipur
India Investigational Site Number : 3560019 Kanpur
India Investigational Site Number : 3560010 Kolkata
India Investigational Site Number : 3560005 Nagpur
India Investigational Site Number : 3560017 Nagpur
India Investigational Site Number : 3560009 Nashik
India Investigational Site Number : 3560012 Pune
India Investigational Site Number : 3560018 Pune
Israel Investigational Site Number : 3760002 Jerusalem
Israel Investigational Site Number : 3760003 Jerusalem
Israel Investigational Site Number : 3760001 Petah-Tikva
Israel Investigational Site Number : 3760009 Ramat Gan
Israel Investigational Site Number : 3760004 Rehovot
Japan Investigational Site Number : 3920017 Chuo-ku Tokyo
Japan Investigational Site Number : 3920024 Chuo-ku Tokyo
Japan Investigational Site Number : 3920040 Chuo-ku Tokyo
Japan Investigational Site Number : 3920005 Fukuoka-shi Fukuoka
Japan Investigational Site Number : 3920027 Fukuoka-shi Fukuoka
Japan Investigational Site Number : 3920002 Hamamatsu-shi Shizuoka
Japan Investigational Site Number : 3920028 Hamamatsu-shi Shizuoka
Japan Investigational Site Number : 3920013 Himeji-shi Hyogo
Japan Investigational Site Number : 3920010 Hiroshima-shi Hiroshima
Japan Investigational Site Number : 3920034 Ikoma-shi Nara
Japan Investigational Site Number : 3920019 Itabashi-ku Tokyo
Japan Investigational Site Number : 3920033 Kawasaki-shi Kanagawa
Japan Investigational Site Number : 3920029 Kiyose-City Tokyo
Japan Investigational Site Number : 3920011 Konan-ku, Yokohama-shi Kanagawa
Japan Investigational Site Number : 3920021 Kure-shi Hiroshima
Japan Investigational Site Number : 3920035 Kure-shi Hiroshima
Japan Investigational Site Number : 3920030 Kurume-shi Fukuoka
Japan Investigational Site Number : 3920043 Matsusaka-shi Mie
Japan Investigational Site Number : 3920001 Meguro-ku Tokyo
Japan Investigational Site Number : 3920015 Mizunami-shi Gifu
Japan Investigational Site Number : 3920020 Nagoya-shi Aichi
Japan Investigational Site Number : 3920023 Nagoya-shi Aichi
Japan Investigational Site Number : 3920003 Osaka-shi Osaka
Japan Investigational Site Number : 3920026 Osaka-shi Osaka
Japan Investigational Site Number : 3920007 Sakai-shi Osaka
Japan Investigational Site Number : 3920009 Sakaide-shi Kagawa
Japan Investigational Site Number : 3920036 Sano-shi Tochigi
Japan Investigational Site Number : 3920038 Sapporo-shi Hokkaido
Japan Investigational Site Number : 3920042 Sapporo-shi Hokkaido
Japan Investigational Site Number : 3920025 Shibuya-ku Tokyo
Japan Investigational Site Number : 3920016 Shinagawa-ku Tokyo
Japan Investigational Site Number : 3920037 Shinagawa-ku Tokyo
Japan Investigational Site Number : 3920014 Takamatsu-shi Kagawa
Japan Investigational Site Number : 3920041 Toshima-ku Tokyo
Japan Investigational Site Number : 3920032 Yanagawa-shi Fukuoka
Japan Investigational Site Number : 3920006 Yao-shi Osaka
Japan Investigational Site Number : 3920039 Yokohama-shi Kanagawa
Korea, Republic of Investigational Site Number : 4100003 Incheon Incheon-gwangyeoksi
Korea, Republic of Investigational Site Number : 4100005 Seongnam Gyeonggi-do
Korea, Republic of Investigational Site Number : 4100001 Seoul
Korea, Republic of Investigational Site Number : 4100004 Seoul Seoul-teukbyeolsi
Korea, Republic of Investigational Site Number : 4100002 Wonju Gangwon-do
Latvia Investigational Site Number : 4280002 Daugavpils
Latvia Investigational Site Number : 4280001 Riga
Lithuania Investigational Site Number : 4400001 Kaunas
Lithuania Investigational Site Number : 4400002 Kaunas
Lithuania Investigational Site Number : 4400003 Klaipeda
Mexico Investigational Site Number : 4840010 Aguascalientes
Mexico Investigational Site Number : 4840003 Chihuahua
Mexico Investigational Site Number : 4840007 Durango
Mexico Investigational Site Number : 4840012 Durango, Durango
Mexico Investigational Site Number : 4840006 Mexico City
Mexico Investigational Site Number : 4840002 Monterrey Nuevo León
Mexico Investigational Site Number : 4840008 Monterrey Nuevo León
Mexico Investigational Site Number : 4840009 Monterrey Nuevo León
Mexico Investigational Site Number : 4840001 Monterrey, Nuevo León
Mexico Investigational Site Number : 4840004 Veracruz
Mexico Investigational Site Number : 4840015 Yucatan
Netherlands Investigational Site Number : 5280005 Arnhem
Netherlands Investigational Site Number : 5280001 Breda
Netherlands Investigational Site Number : 5280006 Nijmegen
Netherlands Investigational Site Number : 5280008 Zutphen
Netherlands Investigational Site Number : 5280004 Zwolle
Norway Investigational Site Number : 5780001 Lørenskog
Poland Investigational Site Number : 6160008 Bialystok Podlaskie
Poland Investigational Site Number : 6160002 Katowice Slaskie
Poland Investigational Site Number : 6160003 Malbork Pomorskie
Poland Investigational Site Number : 6160009 Ostrowiec Swietokrzyski Swietokrzyskie
Poland Investigational Site Number : 6160005 Wolomin Mazowieckie
Portugal Investigational Site Number : 6200009 Almada
Portugal Investigational Site Number : 6200006 Aveiro
Portugal Investigational Site Number : 6200002 Braga
Portugal Investigational Site Number : 6200004 Coimbra
Portugal Investigational Site Number : 6200011 Guarda
Portugal Investigational Site Number : 6200001 Guimarães
Portugal Investigational Site Number : 6200010 Matosinhos
Portugal Investigational Site Number : 6200003 Porto
Puerto Rico Cardiopulmonary Research Site Number : 8400040 Guaynabo
Puerto Rico BRCR Medical Center, Inc. Site Number : 8400190 Ponce
Puerto Rico BRCR Medical Center Site Number : 8400180 San Juan
Puerto Rico Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232 Temecula
Russian Federation Investigational Site Number : 6430001 Moscow
Russian Federation Investigational Site Number : 6430002 Moscow
Russian Federation Investigational Site Number : 6430005 Moscow
Russian Federation Investigational Site Number : 6430003 Saint-Petersburg
Russian Federation Investigational Site Number : 6430004 St-Petersburg
Russian Federation Investigational Site Number : 6430006 Ulyanovsk
South Africa Investigational Site Number : 7100013 Benoni
South Africa Investigational Site Number : 7100001 Cape Town
South Africa Investigational Site Number : 7100002 Cape Town
South Africa Investigational Site Number : 7100019 Cape Town
South Africa Investigational Site Number : 7100015 Chatsworth
South Africa Investigational Site Number : 7100005 Durban
South Africa Investigational Site Number : 7100006 Durban
South Africa Investigational Site Number : 7100016 Durban
South Africa Investigational Site Number : 7100017 Durban
South Africa Investigational Site Number : 7100004 Gatesville
South Africa Investigational Site Number : 7100012 Middelburg
South Africa Investigational Site Number : 7100003 Parow
South Africa Investigational Site Number : 7100009 Pretoria
Spain Investigational Site Number : 7240014 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 7240010 Cáceres
Spain Investigational Site Number : 7240009 Lleida / Lleida Lleida [Lérida]
Spain Investigational Site Number : 7240003 Madrid
Spain Investigational Site Number : 7240011 Madrid Madrid, Comunidad De
Spain Investigational Site Number : 7240007 Madrid / Madrid Madrid, Comunidad De
Spain Investigational Site Number : 7240001 Málaga
Spain Investigational Site Number : 7240002 Mérida / Badajoz Extremadura
Spain Investigational Site Number : 7240004 Palma de Mallorca Balears [Baleares]
Spain Investigational Site Number : 7240008 Pozuelo De Alarcón Madrid
Spain Investigational Site Number : 7240006 Sant Boi de Llobregat Barcelona [Barcelona]
Spain Investigational Site Number : 7240013 Santander Cantabria
Spain Investigational Site Number : 7240012 Zaragoza
Turkey Investigational Site Number : 7920007 Ankara
Turkey Investigational Site Number : 7920005 Balcali Adana
Turkey Investigational Site Number : 7920001 Istanbul
Turkey Investigational Site Number : 7920003 Izmir
Turkey Investigational Site Number : 7920006 Kirikkale
Turkey Investigational Site Number : 7920002 Mersin
United Kingdom Investigational Site Number : 8260003 Bradford
United Kingdom Investigational Site Number : 8260002 Chertsey Surrey
United Kingdom Investigational Site Number : 8260005 Liverpool
United Kingdom Investigational Site Number : 8260008 Milton Keynes
United Kingdom Investigational Site Number : 8260001 Newcastle upon Tyne
United Kingdom Investigational Site Number : 8260007 Tyne And Wear North Tyneside
United Kingdom Investigational Site Number : 8260006 Wishaw Glasgow City
United States Johns Hopkins Asthma and Allergy Center Site Number : 8400055 Baltimore Maryland
United States The Rheumatology and Pulmonary Clinic Site Number : 8400053 Beckley West Virginia
United States St. Luke's University Health Network Site Number : 8400187 Bethlehem Pennsylvania
United States TTS Research Site Number : 8400012 Boerne Texas
United States Care Access Site Number : 8400276 Boston Massachusetts
United States Care Access Site Number : 8400281 Boston Massachusetts
United States Helix Biomedics, LLC Site Number : 8400049 Boynton Beach Florida
United States Meris Clinical Research Site Number : 8400021 Brandon Florida
United States Smart Medical Research Site Number : 8400191 Brooklyn New York
United States VA Western New York Healthcare System Site Number : 8400050 Buffalo New York
United States Lowcountry Lung & Critical Care Site Number : 8400175 Charleston South Carolina
United States American Health Research Site Number : 8400002 Charlotte North Carolina
United States University of Cincinnati Site Number : 8400042 Cincinnati Ohio
United States Innovative Research of West Florida, Inc Site Number : 8400041 Clearwater Florida
United States Medtrial, LLC Site Number : 8400048 Columbia South Carolina
United States Remington-Davis Inc Site Number : 8400004 Columbus Ohio
United States Beautiful Minds Clinical Research Center Site Number : 8400352 Cutler Bay Florida
United States Omega Research Site Number : 8400031 DeBary Florida
United States Allianz Research Institute Colorado Site Number : 8400061 Denver Colorado
United States Henry Ford Hospital Site Number : 8400052 Detroit Michigan
United States Sciences Connections, LLC Site Number : 8400045 Doral Florida
United States OK Clinical Research LLC Site Number : 8400001 Edmond Oklahoma
United States Care Access Fairview Heights Site Number : 8400033 Fairview Heights Illinois
United States New York - Presbyterian Queens Site Number : 8400028 Flushing New York
United States Clinical Trials Center of Middle Tennessee Site Number : 8400025 Franklin Tennessee
United States UCSF Fresno Site Number : 8400030 Fresno California
United States VitaLink Research- Gaffney Site Number : 8400003 Gaffney South Carolina
United States North Florida/South Georgia Veterans Health System Site Number : 8400176 Gainesville Florida
United States Aurora BayCare Medical Center Site Number : 8400046 Green Bay Wisconsin
United States Finlay Medical Research Site Number : 8400011 Greenacres City Florida
United States Direct Helpers Medical Center Inc Site Number : 8400065 Hialeah Florida
United States United Memorial Medical Center (UMMC) Site Number : 8400193 Houston Texas
United States Advanced Respiratory and Sleep Medicine Site Number : 8400022 Huntersville North Carolina
United States Multi-Specialty Research Associates, Inc Site Number : 8400044 Lake City Florida
United States Radiance Clinical Research Site Number : 8400037 Lampasas Texas
United States Sierra Clinical Research Site Number : 8400005 Las Vegas Nevada
United States Revive Research Institute Site Number : 8400186 Lathrup Village Michigan
United States Lexington VA Health Care System Site Number : 8400036 Lexington Kentucky
United States Advanced Pulmonary Research Institute Site Number : 8400018 Loxahatchee Groves Florida
United States Columbus Clinical Services Site Number : 8400054 Miami Florida
United States Finlay Medical Research Site Number : 8400007 Miami Florida
United States MCR Research Site Number : 8400425 Miami Florida
United States My Community Research Center Site Number : 8400060 Miami Florida
United States Phoenix Medical Research Site Number : 8400019 Miami Florida
United States Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400009 Miami Florida
United States AES Salt Lake City Site Number : 8400332 Murray Utah
United States Rutgers Institute for Translational Medicine and Science/Rutgers University Site Number : 8400059 New Brunswick New Jersey
United States Captain James A. Lovell Federal Health Care Center Site Number : 8400032 North Chicago Illinois
United States Renstar Medical Research Site Number : 8400015 Ocala Florida
United States Central Florida Pulmonary Group, PA Site Number : 8400192 Orlando Florida
United States Heuer M.D. Research Site Number : 8400016 Orlando Florida
United States Oviedo Medical Research Site Number : 8400026 Oviedo Florida
United States Palmtree Clinical Research Site Number : 8400184 Palm Springs California
United States Innovation Medical Research Center Site Number : 8400067 Palmetto Bay Florida
United States Pines Care Research Center LLC Site Number : 8400056 Pembroke Pines Florida
United States Illinois Lung Institute Site Number : 8400024 Peoria Illinois
United States Temple University Hospital Site Number : 8400062 Philadelphia Pennsylvania
United States Synexus Phoenix Central (Central Phoenix Medical Clinic) Site Number : 8400333 Phoenix Arizona
United States Allegheny Health Network Site Number : 8400058 Pittsburgh Pennsylvania
United States Clincove: Plano Primary Care Clinic Site Number : 8400424 Plano Texas
United States Kaiser Permanente Center for Health Research Site Number : 8400039 Portland Oregon
United States Probe Clinical Research Corporation Site Number : 8400188 Riverside California
United States Washington University School of Medicine Site Number : 8400035 Saint Louis Missouri
United States Sun Research Institute Site Number : 8400183 San Antonio Texas
United States Sarasota Memorial Health Care System Clinical ResearchCenter Site Number : 8400178 Sarasota Florida
United States Schenectady Pulmonary and Critical Care Associates Site Number : 8400029 Schenectady New York
United States Pulmonary & Critical Care Site Number : 8400047 Shreveport Louisiana
United States Clinical Research of West Florida, Inc Site Number : 8400008 Tampa Florida
United States Genesis Clinical Research, LLC Site Number : 8400182 Tampa Florida
United States Toledo Institute of Clinical Research Site Number : 8400014 Toledo Ohio
United States Cotton O'Neil Garfield Site Number : 8400063 Topeka Kansas
United States Medster Research, LLC Site Number : 8400051 Valdosta Georgia
United States The Iowa Clinic Site Number : 8400034 West Des Moines Iowa
United States North Georgia Clinical Research Site Number : 8400013 Woodstock Georgia

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  Estonia,  France,  Georgia,  Germany,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period. Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline to Week 24
Secondary Change from baseline in post-BD FEV1 in former smokers FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline to Week 24 and Week 52
Secondary Change from baseline in pre-BD FEV1 in former smokers FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline to Week 52
Secondary Time to first moderate or severe AECOPD in former smokers Time to first moderate or severe AECOPD over the placebo-controlled treatment period. Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Annualized rate of severe AECOPD in former smokers Annualized rate of severe AECOPD over the placebo-controlled treatment period. Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Time to first severe AECOPD in former smokers Time to first severe AECOPD over the placebo-controlled treatment period. Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Annualized rate of corticosteroid-treated AECOPD in former smokers Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period. Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score in former smokers The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms. Baseline to Week 24 and Week 52
Secondary Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) in former smokers Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life. Baseline to Week 24 and Week 52
Secondary Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score in former smokers The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life. Baseline to Week 24 and Week 52
Secondary Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation in former smokers Baseline up to End-of-Study (EOS) (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary Functional itepekimab concentrations in serum in former smokers Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers Baseline up to EOS (Up to Week 72 for participants not transitioning to the extension study LTS18133; Up to Week 52 for participants transitioning to the extension study LTS18133)
Secondary Annualized rate of moderate or severe AECOPD in current smokers Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period. Baseline up to Week 52
Secondary Change from baseline in pre-BD FEV1 in current smokers FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline up to Week 24 and Week 52
Secondary Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Secondary Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Secondary Functional itepekimab concentrations in serum in current smokers Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
Secondary Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers Baseline up to EOS (Week 72 for participants not transitioning to the extension study LTS18133; Week 52 for participants transitioning to the extension study LTS18133)
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