AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3AERIFY-2NCT04751487

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Itepekimab SAR440340 in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 238 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Itepekimab SAR440340
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,234 participants
Where
238 sitesin 29 countries
Study dates
12 Feb 2021to 28 Aug 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 reported that they were not currently smoking and smoking cessation must had occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
  • For current smokers: participants who reported that they were currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who were 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
Show all 15Show fewer
  • 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] had 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 had occurred while participants were on their current controller therapy:
  • Moderate exacerbations would be recorded by the Investigator and were defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
  • Severe exacerbations would be recorded by the Investigator and were defined as AECOPD that required 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 was 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 agreed to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention. -

Who cannot join

  • 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 might 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 α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.
  • Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.
Show all 20Show fewer
  • 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 were 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 had 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 might 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

238 sites in 29 countries.

238 sites in 29 countries

United States59 sites

  • Johns Hopkins Asthma and Allergy Center- Site Number : 8400055

    Baltimore, Maryland, 21224

  • The Rheumatology and Pulmonary Clinic- Site Number : 8400053

    Beckley, West Virginia, 25801

  • St. Luke's University Health Network- Site Number : 8400187

    Bethlehem, Pennsylvania, 18015

  • TTS Research- Site Number : 8400012

    Boerne, Texas, 78006

  • Care Access Site Number : 8400276

    Boston, Massachusetts, 02110

  • Care Access Site Number : 8400281

    Boston, Massachusetts, 02110

  • Helix Biomedics, LLC - Site Number : 8400049

    Boynton Beach, Florida, 33435

  • Smart Medical Research Site Number : 8400191

    Brooklyn, New York, 11230

  • VA Western New York Healthcare System Site Number : 8400050

    Buffalo, New York, 14215

  • Lowcountry Lung & Critical Care- Site Number : 8400175

    Charleston, South Carolina, 29406

  • University of Cincinnati- Site Number : 8400042

    Cincinnati, Ohio, 45267

  • Innovative Research of West Florida, Inc- Site Number : 8400041

    Clearwater, Florida, 33756

  • Medtrial, LLC Site Number : 8400048

    Columbia, South Carolina, 29204

  • Beautiful Minds Clinical Research Center Site Number : 8400352

    Cutler Bay, Florida, 33157

  • Omega Research - Site Number : 8400031

    DeBary, Florida, 32713

  • Allianz Research Institute Colorado Site Number : 8400061

    Denver, Colorado, 80219

  • Sciences Connections, LLC Site Number : 8400045

    Doral, Florida, 33178

  • Care Access Fairview Heights Site Number : 8400033

    Fairview Heights, Illinois, 62208

  • New York - Presbyterian Queens- Site Number : 8400028

    Flushing, New York, 11355

  • UCSF Fresno - Site Number : 8400030

    Fresno, California, 93701

  • North Florida/South Georgia Veterans Health System Site Number : 8400176

    Gainesville, Florida, 32608

  • Finlay Medical Research- Site Number : 8400011

    Greenacres City, Florida, 33467

  • Direct Helpers Medical Center Inc- Site Number : 8400065

    Hialeah, Florida, 33012

  • United Memorial Medical Center (UMMC)- Site Number : 8400193

    Houston, Texas, 77091

  • Advanced Respiratory and Sleep Medicine- Site Number : 8400022

    Huntersville, North Carolina, 28078

  • Multi-Specialty Research Associates, Inc- Site Number : 8400044

    Lake City, Florida, 32055

  • Radiance Clinical Research- Site Number : 8400037

    Lampasas, Texas, 76550-1820

  • Revive Research Institute Site Number : 8400186

    Lathrup Village, Michigan, 48076

  • Advanced Pulmonary Research Institute Site Number : 8400018

    Loxahatchee Groves, Florida, 33470

  • Columbus Clinical Services- Site Number : 8400054

    Miami, Florida, 33125

  • Finlay Medical Research Site Number : 8400007

    Miami, Florida, 33126

  • MCR Research Site Number : 8400425

    Miami, Florida, 33126

  • Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009

    Miami, Florida, 33144

  • My Community Research Center Site Number : 8400060

    Miami, Florida, 33155

  • Phoenix Medical Research- Site Number : 8400019

    Miami, Florida, 33165

  • AES Salt Lake City- Site Number : 8400332

    Murray, Utah, 84123

  • Captain James A. Lovell Federal Health Care Center Site Number : 8400032

    North Chicago, Illinois, 60064

  • Renstar Medical Research- Site Number : 8400015

    Ocala, Florida, 34470

  • Central Florida Pulmonary Group, PA- Site Number : 8400192

    Orlando, Florida, 32803

  • Oviedo Medical Research Site Number : 8400026

    Oviedo, Florida, 32765

  • Palmtree Clinical Research Site Number : 8400184

    Palm Springs, California, 92262

  • Innovation Medical Research Center- Site Number : 8400067

    Palmetto Bay, Florida, 33157

  • Pines Care Research Center LLC- Site Number : 8400056

    Pembroke Pines, Florida, 33025

  • Illinois Lung Institute- Site Number : 8400024

    Peoria, Illinois, 61605

  • Temple University Hospital Site Number : 8400062

    Philadelphia, Pennsylvania, 19140-5103

  • Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333

    Phoenix, Arizona, 85020

  • Allegheny Health Network- Site Number : 8400058

    Pittsburgh, Pennsylvania, 15212

  • Sun Research Institute - Site Number : 8400183

    San Antonio, Texas, 78215

  • Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178

    Sarasota, Florida, 34239

  • Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029

    Schenectady, New York, 12308

  • Pulmonary & Critical Care Site Number : 8400047

    Shreveport, Louisiana, 71105

  • Washington University School of Medicine- Site Number : 8400035

    St Louis, Missouri, 63110

  • Genesis Clinical Research, LLC Site Number : 8400182

    Tampa, Florida, 33603

  • Clinical Research of West Florida, Inc- Site Number : 8400008

    Tampa, Florida, 33606

  • Toledo Institute of Clinical Research- Site Number : 8400014

    Toledo, Ohio, 43617

  • Cotton O'Neil Garfield- Site Number : 8400063

    Topeka, Kansas, 66606

  • Medster Research, LLC Site Number : 8400051

    Valdosta, Georgia, 31605

  • The Iowa Clinic Site Number : 8400034

    West Des Moines, Iowa, 50266

  • North Georgia Clinical Research Site Number : 8400013

    Woodstock, Georgia, 30189

Other trials in United States

Japan26 sites

  • Investigational Site Number : 3920040

    Chuo-ku, Tokyo, 103-0022

  • Investigational Site Number : 3920017

    Chuo-ku, Tokyo, 104-0031

  • Investigational Site Number : 3920005

    Fukuoka, Fukuoka, 815-0032

  • Investigational Site Number : 3920027

    Fukuoka, Fukuoka, 819-8555

  • Investigational Site Number : 3920013

    Himeji-shi, Hyōgo, 670-0849

  • Investigational Site Number : 3920010

    Hiroshima, Hiroshima, 734-8530

  • Investigational Site Number : 3920029

    Kiyose, Tokyo, 204-8522

  • Investigational Site Number : 3920011

    Konan-ku, Yokohama-shi, Kanagawa, 234-0054

  • Investigational Site Number : 3920021

    Kure-shi, Hiroshima, 737-0193

  • Investigational Site Number : 3920035

    Kure-shi, Hiroshima, 737-8505

  • Investigational Site Number : 3920030

    Kurume-shi, Fukuoka, 830-0011

  • Investigational Site Number : 3920043

    Matsusaka-shi, Mie-ken, 515-8544

  • Investigational Site Number : 3920015

    Mizunami-shi, Gifu, 509-6134

  • Investigational Site Number : 3920023

    Nagoya, Aichi-ken, 455-8530

  • Investigational Site Number : 3920020

    Nagoya, Aichi-ken, 457-8511

  • Investigational Site Number : 3920009

    Sakaide-shi, Kagawa-ken, 762-8550

  • Investigational Site Number : 3920038

    Sapporo, Hokkaido, 006-8555

  • Investigational Site Number : 3920042

    Sapporo, Hokkaido, 064-0804

  • Investigational Site Number : 3920025

    Shibuya-ku, Tokyo, 150-8935

  • Investigational Site Number : 3920016

    Shinagawa-ku, Tokyo, 140-8522

  • Investigational Site Number : 3920037

    Shinagawa-ku, Tokyo, 142-8666

  • Investigational Site Number : 3920019

    tabashi City, Tokyo, 173-8610

  • Investigational Site Number : 3920014

    Takamatsu, Kagawa-ken, 761-8073

  • Investigational Site Number : 3920041

    Toshima-ku, Tokyo, 170-0003

  • Investigational Site Number : 3920006

    Yao-shi, Osaka, 581-0011

  • Investigational Site Number : 3920039

    Yokohama, Kanagawa, 223-0059

Other trials in Japan

Brazil16 sites

  • Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014

    Belo Horizonte, Minas Gerais, 30150-221

  • Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005

    Botucatu, São Paulo, 18618-687

  • CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018

    Brasília, Federal District, 70710-100

  • PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010

    Campinas, São Paulo, 13059-900

  • CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012

    Curitiba, Paraná, 80060-240

  • Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Instituto Ceos Site Number : 0760021

    Porto Alegre, Rio Grande do Sul, 90480-020

  • Hospital Sao Lucas da PUCRS- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017

    Rio de Janeiro, 20241-180

  • SER da Bahia- Site Number : 0760020

    Salvador, Estado de Bahia, 40150-150

  • CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015

    São Bernardo do Campo, São Paulo, 09715-090

  • Hospital Sao Domingos- Site Number : 0760016

    São Luís, Maranhão, 65060-645

  • Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013

    São Paulo, São Paulo, 04014-002

  • Clinica de Alergia Martti Antila Site Number : 0760008

    Sorocaba, São Paulo, 18040-425

  • CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009

    Vitória, Espírito Santo, 29055 450

Other trials in Brazil

India11 sites

  • Investigational Site Number : 3560016

    Belagavi, 590010

  • Investigational Site Number : 3560001

    Chandigarh, 160012

  • Investigational Site Number : 3560014

    India, 440010

  • Investigational Site Number : 3560013

    Jaipur, 302023

  • Investigational Site Number : 3560019

    Kanpur, 208002

  • Investigational Site Number : 3560010

    Kolkata, 700107

  • Investigational Site Number : 3560017

    Nagpur, 440012

  • Investigational Site Number : 3560005

    Nagpur, 440015

  • Investigational Site Number : 3560009

    Nashik, 422007

  • Investigational Site Number : 3560012

    Pune, 411004

  • Investigational Site Number : 3560018

    Pune, 411057

Other trials in India

Spain11 sites

  • Investigational Site Number : 7240014

    Barcelona, Barcelona [Barcelona], 08017

  • Investigational Site Number : 7240010

    Cáceres, 10003

  • Investigational Site Number : 7240009

    Lleida / Lleida, Lleida [Lérida], 25198

  • Investigational Site Number : 7240003

    Madrid, 28007

  • Investigational Site Number : 7240007

    Madrid / Madrid, Madrid, Comunidad de, 28040

  • Investigational Site Number : 7240001

    Málaga, 29010

  • Investigational Site Number : 7240002

    Mérida / Badajoz, Extremadura, 06800

  • Investigational Site Number : 7240008

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7240006

    Sant Boi de Llobregat, Barcelona [Barcelona], 08830

  • Investigational Site Number : 7240013

    Santander, Cantabria, 39008

  • Investigational Site Number : 7240012

    Zaragoza, 50009

Other trials in Spain

Bulgaria10 sites

  • Investigational Site Number : 1000008

    Blagoevgrad, 2700

  • Investigational Site Number : 1000013

    Dupnitsa, 2600

  • Investigational Site Number : 1000004

    Gabrovo, 5300

  • Investigational Site Number : 1000009

    Haskovo, 6305

  • Investigational Site Number : 1000005

    Montana, 3403

  • Investigational Site Number : 1000002

    Plovdiv, 4002

  • Investigational Site Number : 1000012

    Rousse, 7000

  • Investigational Site Number : 1000003

    Rousse, 7002

  • Investigational Site Number : 1000001

    Sofia, 1142

  • Investigational Site Number : 1000006

    Sofia, 1680

Other trials in Bulgaria

South Africa10 sites

  • Investigational Site Number : 7100013

    Benoni, 1500

  • Investigational Site Number : 7100019

    Cape Town, 7130

  • Investigational Site Number : 7100015

    Chatsworth, 4091

  • Investigational Site Number : 7100005

    Durban, 4001

  • Investigational Site Number : 7100017

    Durban, 4001

  • Investigational Site Number : 7100006

    Durban, 4071

  • Investigational Site Number : 7100016

    Durban, 4302

  • Investigational Site Number : 7100004

    Gatesville, 7764

  • Investigational Site Number : 7100012

    Middelburg, 1055

  • Investigational Site Number : 7100009

    Pretoria, 0145

Other trials in South Africa

Argentina9 sites

  • Investigational Site Number : 0320009

    Berazategui, Buenos Aires, CP 1884

  • Investigational Site Number : 0320006

    Buenos Aires, Buenos Aires F.D., 1060

  • Investigational Site Number : 0320008

    CABA, Buenos Aires, C1023AAB

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1414AIF

  • Investigational Site Number : 0320005

    Pergamino, Buenos Aires, B2700CPM

  • Investigational Site Number : 0320007

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, S2000DBS

  • Investigational Site Number : 0320004

    Rosario, Santa Fe Province, S2000JKR

  • Investigational Site Number : 0320002

    Vicente Lopez, Buenos Aires F.D., B1602DQD

Other trials in Argentina

Canada8 sites

  • Investigational Site Number : 1240021

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240020

    Burlington, Ontario, L7N 3V2

  • Investigational Site Number : 1240014

    Kelowna, British Columbia, V1Y 4N7

  • Investigational Site Number : 1240012

    Moncton, New Brunswick, E1C2Z3

  • Investigational Site Number : 1240016

    Penticton, British Columbia, V2A 5L5

  • Investigational Site Number : 1240019

    Terrebonne, Quebec, J6V 2H2

  • Investigational Site Number : 1240022

    Windsor, Ontario, N8X 1T3

  • Investigational Site Number : 1240018

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Chile8 sites

  • Investigational Site Number : 1520006

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7500010

  • Investigational Site Number : 1520008

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8910131

  • Investigational Site Number : 1520002

    Talca, Maule Region

  • Investigational Site Number : 1520009

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Czechia8 sites

  • Investigational Site Number : 2030001

    Jindrichuv Hradec III, 37701

  • Investigational Site Number : 2030009

    Měšice, 250 64

  • Investigational Site Number : 2030005

    Mladá Boleslav, 29301

  • Investigational Site Number : 2030008

    Olomouc, 779 00

  • Investigational Site Number : 2030004

    Ostrava, 70800

  • Investigational Site Number : 2030002

    Prague, 140 46

  • Investigational Site Number : 2030006

    Teplice, 415 01

  • Investigational Site Number : 2030007

    Varnsdorf, 40747

Other trials in Czechia

Hungary7 sites

  • Investigational Site Number : 3480002

    Balassagyarmat, 2660

  • Investigational Site Number : 3480009

    Budapest, 1106

  • Investigational Site Number : 3480005

    Edelény, 3780

  • Investigational Site Number : 3480004

    Hajdunánás, 4080

  • Investigational Site Number : 3480003

    Püspökladány, 4150

  • Investigational Site Number : 3480001

    Százhalombatta, 2440

  • Investigational Site Number : 3480012

    Szombathely, 9700

Other trials in Hungary

United Kingdom6 sites

  • Investigational Site Number : 8260003

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260002

    Chertsey, Surrey, KT16 0PZ

  • Investigational Site Number : 8260005

    Liverpool, L143PE

  • Investigational Site Number : 8260008

    Milton Keynes, MK15 0DU

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE4 6BE

  • Investigational Site Number : 8260007

    Tyne and Wear, North Tyneside, NE29 8NH

Other trials in United Kingdom

Israel5 sites

  • Investigational Site Number : 3760003

    Jerusalem, 91031

  • Investigational Site Number : 3760002

    Jerusalem, 91120

  • Investigational Site Number : 3760001

    Petah Tikva, 49100

  • Investigational Site Number : 3760009

    Ramat Gan, 5266202

  • Investigational Site Number : 3760004

    Rehovot, 76100

Other trials in Israel

Poland5 sites

  • Investigational Site Number : 6160008

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160002

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6160003

    Malbork, Pomeranian Voivodeship, 82-200

  • Investigational Site Number : 6160009

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Investigational Site Number : 6160005

    Wołomin, Masovian Voivodeship, 05-200

Other trials in Poland

Portugal5 sites

  • Investigational Site Number : 6200009

    Almada, 2801-951

  • Investigational Site Number : 6200006

    Aveiro, 3810-501

  • Investigational Site Number : 6200002

    Braga, 4710-243

  • Investigational Site Number : 6200001

    Guimarães, 4810-061

  • Investigational Site Number : 6200010

    Matosinhos Municipality, 4464-513

Other trials in Portugal

South Korea5 sites

  • Investigational Site Number : 4100003

    Incheon, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100005

    Seongnam-si, Gyeonggi-do, 463-707

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100001

    Seoul, 06591

  • Investigational Site Number : 4100002

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

France4 sites

  • Investigational Site Number : 2500001

    Lyon, 69004

  • Investigational Site Number : 2500002

    Montpellier

  • Investigational Site Number : 2500003

    Pessac, 33600

  • Investigational Site Number : 2500004

    Reims, 51090

Other trials in France

Germany4 sites

  • Investigational Site Number : 2760009

    Berlin, 10961

  • Investigational Site Number : 2760010

    Berlin, 12159

  • Investigational Site Number : 2760008

    Leipzig, 04299

  • Investigational Site Number : 2760011

    Rosenheim, 83022

Other trials in Germany

Georgia3 sites

  • Investigational Site Number : 2680003

    Batumi, 6010

  • Investigational Site Number : 2680001

    Tbilisi, 0160

  • Investigational Site Number : 2680002

    Tbilisi, 0168

Other trials in Georgia

Netherlands3 sites

  • Investigational Site Number : 5280005

    Arnhem, 6815 AD

  • Investigational Site Number : 5280001

    Breda, 4818 CK

  • Investigational Site Number : 5280008

    Zutphen, 7207 AE

Other trials in Netherlands

Puerto Rico3 sites

  • Cardiopulmonary Research- Site Number : 8400040

    Guaynabo, 00968

  • BRCR Medical Center, Inc. Site Number : 8400190

    Ponce, 00717-1322

  • BRCR Medical Center Site Number : 8400180

    San Juan, 00907

Other trials in Puerto Rico

Denmark2 sites

  • Investigational Site Number : 2080001

    Hvidovre, 2650

  • Investigational Site Number : 2080003

    Vejle, 7100

Other trials in Denmark

Latvia2 sites

  • Investigational Site Number : 4280002

    Daugavpils, LV-5417

  • Investigational Site Number : 4280001

    Riga, LV-1002

Other trials in Latvia

Lithuania2 sites

  • Investigational Site Number : 4400002

    Kaunas, 49449

  • Investigational Site Number : 4400003

    Klaipėda, 92231

Other trials in Lithuania

Mexico2 sites

  • Investigational Site Number : 4840010

    Aguascalientes, 20230

  • Investigational Site Number : 4840012

    Durango, Durango, 34080

Other trials in Mexico

Turkey (Türkiye)2 sites

  • Investigational Site Number : 7920007

    Ankara, 06100

  • Investigational Site Number : 7920006

    Kirikkale, 71450

Other trials in Turkey (Türkiye)

Estonia1 site

  • Investigational Site Number : 2330001

    Tartu, 50406

Other trials in Estonia

Norway1 site

  • Investigational Site Number : 5780001

    Lørenskog, 1478

Other trials in Norway

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Objective:

Primary population (former smokers cohort):

Read more
  • 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
Read the detailed description

The study duration per participant:

  • Screening period was 3-5 weeks
  • Randomized investigational medicinal product (IMP) treatment period was 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 was 20 weeks for participants not transitioning to the extension study LTS18133 (NCT06208306)

Note: A long-term, double-blinded extension study would 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 would be offered to participate in the LTS18133 study (NCT06208306).

Being tested
Itepekimab SAR440340, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Itepekimab SAR440340Drug

    Also called REGN3500

    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

  • PlaceboDrug

    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Study groups in NCT04751487
Study groupRoleWhat they receive
Itepekimab Q2W in former smokersExperimentalSubcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Receives: Drug: Itepekimab SAR440340
Itepekimab Q4W in former smokersExperimentalSC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
Receives: Drug: Itepekimab SAR440340; Drug: Placebo
Placebo in former smokersPlacebo comparatorSC administration of matching placebo Q2W for up to 52 weeks
Receives: Drug: Placebo
Itepekimab Q2W in current smokersExperimentalSC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks
Receives: Drug: Itepekimab SAR440340
Placebo in current smokersPlacebo comparatorSC administration of matching placebo Q2W for 52 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Former Smoker Cohort: Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the 52-Week Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as intramuscular [IM], intravenous [IV], or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was total number of moderate or severe exacerbation events divided by total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

    Measured: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Weeks 24 to 52 for additional randomized participants

Secondary outcomes (23)

  1. Former Smoker Cohort: Annualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Planned Treatment Period

    Exacerbations were recorded by the Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in an emergency department/urgent care facility, or resulted in death. Annualized rate was the total number of severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

    Measured: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Weeks 24 to 52 for additional randomized participants

  2. Former Smoker Cohort: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a washout period of BD according to their action duration. Baseline was defined as the last available value collected prior to the first study treatment administration. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

  3. Former Smoker Cohort: Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) Total Score at Week 24

    E-RS:COPD scale was patient-reported outcome (PRO) and derivative of Exacerbations of Chronic pulmonary Disease Tool (EXACT) tool. It comprised of 11 respiratory symptom items contained in 14-item of EXACT instrument: breathlessness (2 items scored from 0-4 and 3 items scored from 0-3); cough and sputum (2 items scored from 0-4 and 1 item scored from 0-3); chest symptoms (3 items scored from 0-4); difficulty bringing up sputum; tired or weak; sleep disturbance and scared or worried (each contained 1 item scored from 0-3). Total score was the sum of scores for 11 items comprising instrument and ranged from 0 to 40; higher values indicated more severe respiratory symptoms. Baseline was defined as the last available value collected prior to first study treatment administration. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

  4. Former Smoker Cohort: Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of short-acting beta-agonist (SABA; albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value collected prior to the first study treatment administration. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

  5. Former Smoker Cohort: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24

    SGRQ had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. Scores by dimension were calculated for 3 domains: symptoms, activity and impacts (psychosocial) which ranged from 0 to 100; higher scores indicated greater impairment. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 (best possible health status) to 100 (worst possible health status); lower scores indicated better health status. Baseline was defined as the last available value collected prior to first study treatment administration. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

  6. Former Smoker Cohort: Percentage of Participants With a Decrease of at Least 4 Points From Baseline in St. George's Respiratory Questionnaire Total Score at Week 24

    SGRQ had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. Scores by dimension were calculated for 3 domains: symptoms, activity and impacts (psychosocial) which ranged from 0 to 100; higher scores indicated greater impairment. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 (best possible health status) to 100 (worst possible health status); lower scores indicated better health status. Baseline was defined as last available value collected prior to first study treatment administration. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) and Week 24

  7. Former Smoker Cohort: Rate of Change in Post-Bronchodilator Forced Expiratory Volume in One Second From Baseline (Post-Bronchodilator Forced Expiratory Volume in One Second Slope) After Week 4

    The rate of change from baseline in post-BD FEV1 (or post-BD FEV1 slope) after a period of initial BD effect (after Week 4) were estimated to assess the rate of decline in lung function over time, commonly observed in participants with inadequately controlled COPD. The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as last available value collected prior to first study treatment administration.

    Measured: Baseline (Day 1) and from Week 8 up to Week 52 for initial randomized participants; Baseline (Day 1) and from Week 8 up to a variable study treatment period (i.e., 24 weeks minimum and 52 weeks maximum) for additional randomized participants

  8. Former Smoker Cohort: Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of SABA (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value collected prior to the first study treatment administration. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  9. Former Smoker Cohort: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Week 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a wash out period of BD according to their action duration. Baseline was defined as the last available value collected prior to the first study treatment administration. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  10. Former Smoker Cohort: Probability of Participants With First Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as IM, IV, or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated moderate or severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

    Measured: Baseline (Day 1) up to Weeks 12, 24, 36 and 52

  11. Former Smoker Cohort: Probability of Participants With First Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Weeks 12, 24, 36 and 52 Over the Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in an emergency department/urgent care facility, or resulted in death. Probability of participants with first adjudicated severe AECOPD in Weeks 12, 24, 36, and 52 was based on Kaplan-Meier estimates. Events were adjudicated by third party.

    Measured: Baseline (Day 1) up to Weeks 12, 24, 36 and 52

  12. Former Smoker Cohort: Annualized Rate of Corticosteroid-Treated Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate/severe AECOPD events which were treated with regimen containing systemic corticosteroids for AECOPD; at time of AECOPD were considered. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (IM, IV, or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in emergency department/urgent care facility or resulted in death. For moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events). Annualized rate: total number of corticosteroid-treated AECOPD events divided by total observation duration and was estimated based on negative binomial regression.

    Measured: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Weeks 24 to 52 for additional randomized participants

  13. Former Smoker Cohort: Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease Total Score at Week 52

    E-RS:COPD scale was PRO and derivative of EXACT tool. It comprised of 11 respiratory symptom items contained in 14-item of EXACT instrument: breathlessness (2 items scored from 0-4 and 3 items scored from 0-3); cough and sputum (2 items scored from 0-4 and 1 item scored from 0-3); chest symptoms (3 items scored from 0-4); difficulty bringing up sputum; tired or weak; sleep disturbance and scared or worried (each contained 1 item scored from 0-3). Total score was the sum of scores for 11 items comprising instrument and ranged from 0 to 40; higher values indicated more severe respiratory symptoms. Baseline was defined as the last available value collected prior to first study treatment administration. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  14. Former Smoker Cohort: Change From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52

    SGRQ had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. Scores by dimension calculated for 3 domains: symptoms, activity and impacts (psychosocial) which ranged from 0 to 100; higher scores indicated greater impairment. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 (best possible health status) to 100 (worst possible health status); lower scores indicated better health status. Baseline was defined as the last available value collected prior to first study treatment administration. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  15. Former Smoker Cohort: Percentage of Participants With a Decrease of at Least 4 Points From Baseline in St. George's Respiratory Questionnaire Total Score at Week 52

    SGRQ had 2 parts: part 1 consisted of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. Scores by dimension calculated for 3 domains: symptoms, activity and impacts (psychosocial) which ranged from 0 to 100; higher scores indicated greater impairment. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire and ranged from 0 (best possible health status) to 100 (worst possible health status); lower scores indicated better health status. Baseline was defined as the last available value collected prior to first study treatment administration. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) and Week 52

  16. Former Smoker Cohort: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), TE Adverse Events of Special Interest (TEAESIs) and TEAEs Leading to Permanent Treatment Discontinuation

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to study treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. An AESI was any AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.

    Measured: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 75 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 55 weeks)

  17. Former Smoker Cohort: Functional Itepekimab Concentrations in Serum

    Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.

    Measured: Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (End of study [EOS]) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)

  18. Former Smoker Cohort: Number of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response

    Blood samples were collected to evaluate antibodies to itepekimab. Treatment-emergent response was defined as a positive response in the anti-drug antibody (ADA) assay post first dose when baseline results were negative or missing.

    Measured: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 75 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 55 weeks)

  19. Current Smoker Cohort: Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the 52-Week Placebo-Controlled Treatment Period

    Exacerbations were recorded by Investigator. Moderate exacerbations were defined as acute worsening of respiratory symptoms that required either systemic corticosteroids (such as IM, IV, or oral) and/or antibiotics. Severe exacerbations were defined as AECOPD that required hospitalization, observation for >24 hours in an emergency department/urgent care facility, or resulted in death. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of systemic steroids/antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate was the total number of moderate or severe exacerbation events divided by the total observation duration and was estimated based on negative binomial regression. Events were adjudicated by third party.

    Measured: Baseline (Day 1) up to Week 52

  20. Current Smoker Cohort: Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second at Weeks 24 and 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a washout period of BD according to their action duration. Baseline was defined as the last available value collected prior to the first study treatment administration. Model-based average change from baseline to Weeks 24 and 52 are presented.

    Measured: Baseline (Day 1) and Weeks 24 and 52

  21. Current Smoker Cohort: Number of Participants With Treatment-Emergent Adverse Events, Treatment-Emergent Serious Adverse Events, Treatment-Emergent Adverse Events of Special Interest and TEAEs Leading to Permanent Treatment Discontinuation

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. An AESI was any AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. TEAEs were AEs that developed, worsened or became serious during the treatment-emergent period.

    Measured: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 74 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 54 weeks)

  22. Current Smoker Cohort: Functional Itepekimab Concentrations in Serum

    Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.

    Measured: Baseline (Day 1), Weeks 2, 4, 8, 12, 24, 36, 52 (EOT), 58 and 72 (EOS) (Weeks 58 and 72 applicable for participants not transitioning to the LTS18133 study)

  23. Current Smoker Cohort: Number of Participants With Treatment-Emergent Anti-Itepekimab Antibodies Response

    Blood samples were collected to evaluate antibodies to itepekimab. Treatment-emergent response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing.

    Measured: 1st dose (Day 1) up to 22 weeks post last dose (considering maximum treatment exposure) for who did not enter LTS18133 (approximately 74 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 54 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start12 Feb 2021
  3. Primary completion21 Apr 2025
  4. Study completion28 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751487
Sponsor's protocol ID
EFC16819
Other IDs
U1111-1250-2843, 2024-512012-21, 2020-001819-24
Acronym
AERIFY-2
Status last verified
Oct 2026
First submitted
8 Feb 2021
Last updated
9 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Itepekimab SAR440340 in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 238 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 238 sites in United States, Japan, Brazil, India, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Former Smoker Cohort: Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events Over the 52-Week Placebo-Controlled Treatment Period (time frame: Baseline (Day 1) up to Week 52 for initial randomized participants; Baseline (Day 1) up to Weeks 24 to 52 for additional randomized participants). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04751487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in