AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3AERIFY-1NCT04701983

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 232 sites in 21 countries.

Completed

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

Official record

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Trial summary

Primary Objective: 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: Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with… 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
1,127 participants
Where
232 sitesin 21 countries
Study dates
16 Dec 2020to 27 Aug 2025
Phase
Phase 3

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, but who were not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently
  • 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:
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  • Moderate exacerbations were 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 were recorded by the Investigator and were 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 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 agrees 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
  • Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [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 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
  • Hypercapnia requiring bilevel positive airway pressure (BiPAP)
Show all 19Show fewer
  • 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 sScreening (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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

232 sites in 21 countries.

232 sites in 21 countries

United States75 sites

  • Appalachian Clinical Research Site Number : 8400024

    Adairsville, Georgia, 30103

  • Covenant Pulmonary Critical Care Site Number : 8400183

    Atlanta, Georgia, 30344

  • Paul Shapero, PC Site Number : 8400016

    Bangor, Maine, 04401

  • REX Clinical Trials Site Number : 8400371

    Beaumont, Texas, 77701

  • University of Alabama at Birmingham Site Number : 8400012

    Birmingham, Alabama, 34294

  • Care Access Site Number : 8400276

    Boston, Massachusetts, 02110

  • Care Access Site Number : 8400277

    Boston, Massachusetts, 02110

  • Care Access Site Number : 8400278

    Boston, Massachusetts, 02110

  • Care Access Site Number : 8400280

    Boston, Massachusetts, 02110

  • Care Access Site Number : 8400281

    Boston, Massachusetts, 02110

  • ~Alpine Clinical Research Center Site Number : 8400180

    Boulder, Colorado, 80301

  • Clinrx Research Site Number : 8400021

    Carrollton, Texas, 75007

  • Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034

    Chandler, Arizona, 85286

  • Bernstein Clinical Research Center Site Number : 8400014

    Cincinnati, Ohio, 45236

  • Clin Research W Florida Site Number : 8400004

    Clearwater, Florida, 33765

  • Bogan Sleep Consultants Site Number : 8400181

    Columbia, South Carolina, 29201

  • David Kavtaradze MD, Inc. Site Number : 8400029

    Cordele, Georgia, 31015

  • Corsicana Medical Research, LLC Site Number : 8400018

    Corsicana, Texas, 75110

  • Benchmark Research Site Number : 8400193

    Covington, Louisiana, 70433

  • Beautiful Minds Clinical Research Center Site Number : 8400037

    Cutler Bay, Florida, 33157

  • Revival Research Institute, LLC Site Number : 8400191

    Dearborn, Michigan, 48126

  • Clinical Research of Central PA Site Number : 8400023

    DuBois, Pennsylvania, 15801

  • Alpha Clinical Research Georgia Site Number : 8400190

    Dunwoody, Georgia, 30350

  • Texas Tech University Health Sciences Center Site Number : 8400189

    El Paso, Texas, 79911

  • Gastonia Pharmaceutical Research Site Number : 8400010

    Gastonia, North Carolina, 28054

  • East Carolina University Brody School Of Medicine Site Number : 8400022

    Greenville, North Carolina, 27834

  • Hannibal Clinic Site Number : 8400383

    Hannibal, Missouri, 63401

  • Hendeson Clinical Trials Site Number : 8400365

    Henderson, Nevada, 89052

  • Indago Research and Health Center Site Number : 8400187

    Hialeah, Florida, 33012

  • The Methodist Hospital Research Institute Site Number : 8400194

    Houston, Texas, 77030

  • Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038

    Houston, Texas, 77043-2742

  • Santa Clara Family Clinic Site Number : 8400398

    Houston, Texas, 77087

  • California Research Institute Site Number : 8400400

    Huntington Park, California, 90255

  • Jasper Summit Research Site Number : 8400178

    Jasper, Alabama, 35501

  • Advanced Clinical Research Site Number : 8400409

    Kendall, Florida, 33156

  • Modena Allergy + Asthma Site Number : 8400036

    La Jolla, California, 92037

  • Imax Clinical Trials LLC 1 Site Number : 8400419

    La Palma, California, 90623

  • Innovative Clinical Research Site Number : 8400017

    Lafayette, Colorado, 80026

  • Gwinnett Biomedical Research Site Number : 8400007

    Lawrenceville, Georgia, 30046

  • Downtown LA Research Center Inc. Site Number : 8400027

    Los Angeles, California, 90017

  • MACRO Trials Site Number : 8400030

    Los Angeles, California, 90048

  • Advanced Pulmonary Research Institute Site Number : 8400455

    Loxahatchee Groves, Florida, 33470

  • Metroplex Pulmonary and Sleep Center Site Number : 8400015

    McKinney, Texas, 75069

  • University of Miami/Miami VA Medical Center Site Number : 8400026

    Miami, Florida, 33125

  • DL Research Solutions Inc Site Number : 8400033

    Miami, Florida, 33155

  • Reliant Medical Research Site Number : 8400397

    Miami, Florida, 33165

  • Research Institute of South Florida,Inc Site Number : 8400006

    Miami, Florida, 33173

  • PROLIVE MEDICAL RESEARCH Site Number : 8400420

    Miami, Florida, 33175

  • Reed Medical Research Site Number : 8400032

    Miami, Florida, 33176

  • High Quality Research Site Number : 8400406

    Miami, Florida, 33184

  • Deluxe Health Center Site Number : 8400188

    Miami Lakes, Florida, 33014

  • Northwell Health Site Number : 8400019

    Mount Kisco, New York, 10549

  • Antelope Valley Clinical Trials Site Number : 8400003

    Northridge, California, 91325

  • Florida Institute for Clinical Research Site Number : 8400013

    Orlando, Florida, 32825-4454

  • Tellabio International Research Services Site Number : 8400411

    Pembroke Pines, Florida, 33025

  • Avanza Medical Research Center Site Number : 8400376

    Pensacola, Florida, 32503

  • Pulmonary Associates Site Number : 8400392

    Phoenix, Arizona, 85027

  • Broward Pulmonary and Sleep Specialists Site Number : 8400031

    Plantation, Florida, 33324

  • Clinical Research of Rock Hill Site Number : 8400008

    Rock Hill, South Carolina, 29732

  • Midwest Chest Consultants, P.C. Site Number : 8400002

    Saint Charles, Missouri, 63301

  • Carolina Research Center Site Number : 8400005

    Shelby, North Carolina, 28150

  • Advance Lung and Sleep Center Site Number : 8400040

    Sherman, Texas, 75092

  • Sherman Clinical Research Site Number : 8400009

    Sherman, Texas, 75092

  • WellNow Urgent Care and Research Site Number : 8400039

    Springdale, Ohio, 45215

  • Coastal Medical Research Institute Site Number : 8400044

    St. Petersburg, Florida, 33707

  • Pasadena Center for Medical Research Site Number : 8400043

    St. Petersburg, Florida, 33710

  • AdtreMed Site Number : 8400442

    Tampa, Florida, 33607

  • Premier Medical Associates Site Number : 8400388

    The Villages, Florida, 32159

  • DM Clinical Research Site Number : 8400179

    Tomball, Texas, 77375

  • Noble Clinical Research Site Number : 8400182

    Tucson, Arizona, 85704-7876

  • Tucson Clinical Research Institute Site Number : 8400431

    Tucson, Arizona, 85712

  • Advanced Pulmonary Research Institute of Michigan Site Number : 8400403

    Warren, Michigan, 48088

  • Clearlake Specialties Site Number : 8400025

    Webster, Texas, 77598

  • Accellacare Site Number : 8400001

    Wilmington, North Carolina, 28401

  • Southeastern Research Center Site Number : 8400011

    Winston-Salem, North Carolina, 27103

Other trials in United States

China42 sites

  • Investigational Site Number : 1560003

    Baotou, 014010

  • Investigational Site Number : 1560004

    Beijing, 100020

  • Investigational Site Number : 1560030

    Beijing, 100038

  • Investigational Site Number : 1560014

    Beijing

  • Investigational Site Number : 1560002

    Changchun, 130021

  • Investigational Site Number : 1560012

    Changsha, 410011

  • Investigational Site Number : 1560013

    Changsha, 410013

  • Investigational Site Number : 1560047

    Changsha, 410023

  • Investigational Site Number : 1560001

    Chengdu, 610041

  • Investigational Site Number : 1560040

    Chengdu, 611130

  • Investigational Site Number : 1560032

    Chongqing, 400038

  • Investigational Site Number : 1560006

    Guangzhou, 510150

  • Investigational Site Number : 1560025

    Guangzhou, 510163

  • Investigational Site Number : 1560036

    Haikou, 570216

  • Investigational Site Number : 1560022

    Hangzhou, 310014

  • Investigational Site Number : 1560039

    Hangzhou

  • Investigational Site Number : 1560017

    Hefei

  • Investigational Site Number : 1560008

    Hohhot, 010017

  • Investigational Site Number : 1560010

    Hohhot, 010050

  • Investigational Site Number : 1560044

    Jinan, 250013

  • Investigational Site Number : 1560027

    Jinan, 250014

  • Investigational Site Number : 1560031

    Nanchang, 330006

  • Investigational Site Number : 1560035

    Nanjing, 210009

  • Investigational Site Number : 1560023

    Nanning, 530021

  • Investigational Site Number : 1560015

    Pingxiang, 337055

  • Investigational Site Number : 1560043

    Shanghai, 200025

  • Investigational Site Number : 1560034

    Shanghai, 200240

  • Investigational Site Number : 1560009

    Shanghai, 200433

  • Investigational Site Number : 1560045

    Shanghai

  • Investigational Site Number : 1560005

    Shenyang, 110004

  • Investigational Site Number : 1560020

    Shenzhen, 518020

  • Investigational Site Number : 1560028

    Shijiazhuang, 050000

  • Investigational Site Number : 1560024

    Tianjin, 300052

  • Investigational Site Number : 1560019

    Wenzhou, 325000

  • Investigational Site Number : 1560029

    Wuhan, 430014

  • Investigational Site Number : 1560016

    Xi'an

  • Investigational Site Number : 1560046

    Xiangtan, 411100

  • Investigational Site Number : 1560007

    Xuzhou, 221002

  • Investigational Site Number : 1560026

    Yangzhou, 225001

  • Investigational Site Number : 1560041

    Zhanjiang, 524001

  • Investigational Site Number : 1560042

    Zhengzhou, 450008

  • Investigational Site Number : 1560048

    Zhongshan, 528403

Other trials in China

Bulgaria9 sites

  • Investigational Site Number : 1000005

    Dimitrovgrad, 6400

  • Investigational Site Number : 1000001

    Sofia, 1233

  • Investigational Site Number : 1000004

    Sofia, 1233

  • Investigational Site Number : 1000002

    Sofia, 1407

  • Investigational Site Number : 1000009

    Sofia, 1756

  • Investigational Site Number : 1000006

    Stara Zagora, 6000

  • Investigational Site Number : 1000003

    Stara Zagora, 6001

  • Investigational Site Number : 1000007

    Veliko Tarnovo, 5000

  • Investigational Site Number : 1000008

    Vidin, 3700

Other trials in Bulgaria

Chile9 sites

  • Investigational Site Number : 1520007

    Curicó, Maule Region, 3341643

  • Investigational Site Number : 1520005

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana de Santiago, 7500010

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500571

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520002

    Talca, Maule Region

  • Investigational Site Number : 1520008

    Temuco, La Araucanía, 4781173

Other trials in Chile

Romania9 sites

  • Investigational Site Number : 6420005

    Bragadiru, 769764

  • Investigational Site Number : 6420006

    Brasov, 500450

  • Investigational Site Number : 6420012

    Bucaresti, 010192

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400275

  • Investigational Site Number : 6420007

    Codlea, 505100

  • Investigational Site Number : 6420010

    Deva, 330162

  • Investigational Site Number : 6420001

    Iași, 700732

  • Investigational Site Number : 6420009

    Oradea, 410155

  • Investigational Site Number : 6420003

    Timișoara, 300134

Other trials in Romania

Israel8 sites

  • Investigational Site Number : 3760008

    Haifa, 34362

  • Investigational Site Number : 3760003

    Jerusalem, 91031

  • Investigational Site Number : 3760002

    Jerusalem, 91120

  • Investigational Site Number : 3760006

    Kfar Saba, 44281

  • Investigational Site Number : 3760001

    Petah Tikva, 49100

  • Investigational Site Number : 3760009

    Ramat Gan, 5266202

  • Investigational Site Number : 3760004

    Rehovot, 76100

  • Investigational Site Number : 3760007

    Tel Aviv, 64239

Other trials in Israel

Mexico8 sites

  • Investigational Site Number : 4840004

    Benito Juárez, 03100

  • Investigational Site Number : 4840007

    Cuernavaca, Morelos, 62250

  • Investigational Site Number : 4840001

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840011

    Guadalajara, Jalisco, 44130

  • Investigational Site Number : 4840010

    Guadalajara, Jalisco, 44210

  • Investigational Site Number : 4840002

    Mexico City, Mexico City, 06700

  • Investigational Site Number : 4840014

    Oaxaca City, 68000

  • Investigational Site Number : 4840003

    San Juan del Río, Querétaro, 76800

Other trials in Mexico

Ukraine8 sites

  • Investigational Site Number : 8040003

    Ivano-Frankivsk, 76018

  • Investigational Site Number : 8040007

    Ivano-Frankivsk, 76018

  • Investigational Site Number : 8040008

    Kharkiv, 61039

  • Investigational Site Number : 8040006

    Kharkiv, 61166

  • Investigational Site Number : 8040004

    Kyiv, 01023

  • Investigational Site Number : 8040001

    Kyiv, 01033

  • Investigational Site Number : 8040005

    Kyiv, 02091

  • Investigational Site Number : 8040011

    Kyiv, 04050

Other trials in Ukraine

Slovakia7 sites

  • Investigational Site Number : 7030009

    Bardejov, 08501

  • Investigational Site Number : 7030007

    Humenné, 066 01

  • Investigational Site Number : 7030003

    Levice, 93401

  • Investigational Site Number : 7030011

    Martin, 03659

  • Investigational Site Number : 7030002

    Poprad, 058 01

  • Investigational Site Number : 7030010

    Prešov, 08001

  • Investigational Site Number : 7030001

    Spišská Nová Ves, 05201

Other trials in Slovakia

Czechia6 sites

  • Investigational Site Number : 2030006

    Havlíčkův Brod, 580 01

  • Investigational Site Number : 2030001

    Jindrichuv Hradec III, 37701

  • Investigational Site Number : 2030004

    Ostrava, 70800

  • Investigational Site Number : 2030002

    Prague, 140 46

  • Investigational Site Number : 2030003

    Prague, 18200

  • Investigational Site Number : 2030005

    Praha 5 - Radotin, 15300

Other trials in Czechia

Greece6 sites

  • Investigational Site Number : 3000005

    Athens, 106 76

  • Investigational Site Number : 3000006

    Athens, 11527

  • Investigational Site Number : 3000004

    Heraklion, 71500

  • Investigational Site Number : 3000001

    Ioannina, 455 00

  • Investigational Site Number : 3000008

    Palaio Faliro, Athens, 17562

  • Investigational Site Number : 3000002

    Thessaloniki, 57010

Other trials in Greece

India6 sites

  • Investigational Site Number : 3560002

    Coimbatore, 641028

  • Investigational Site Number : 3560005

    Hyderabad, 500 084

  • Investigational Site Number : 3560004

    Jaipur, 302039

  • Investigational Site Number : 3560001

    Kozhikode, 673008

  • Investigational Site Number : 3560007

    Mumbai, 400078

  • Investigational Site Number : 3560003

    Nagpur, 441203

Other trials in India

Taiwan6 sites

  • Investigational Site Number : 1580005

    Kaohsiung City, 807

  • Investigational Site Number : 1580002

    New Taipei City, 220

  • Investigational Site Number : 1580006

    Taichung, 40447

  • Investigational Site Number : 1580004

    Taipei, 10002

  • Investigational Site Number : 1580003

    Taipei, 11031

  • Investigational Site Number : 1580008

    Yunlin

Other trials in Taiwan

United Kingdom6 sites

  • Investigational Site Number : 8260003

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260014

    Heston, TW5 9ER

  • Investigational Site Number : 8260001

    London, EC1M 6BQ

  • Investigational Site Number : 8260004

    Portsmouth, Hampshire, PO6 3LY

  • Investigational Site Number : 8260013

    Redruth, TR16 4ET

  • Investigational Site Number : 8260010

    Wigan, Lancashire, WN6 9EP

Other trials in United Kingdom

Argentina5 sites

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1425BEN

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1425FVH

  • Investigational Site Number : 0320005

    La Plata, Buenos Aires, B1900BNN

  • Investigational Site Number : 0320004

    Mendoza, 5500

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, S2000DEJ

Other trials in Argentina

Italy5 sites

  • Investigational Site Number : 3800005

    Catania, 95123

  • Investigational Site Number : 3800001

    Ferrara, 44124

  • Investigational Site Number : 3800004

    Foggia, Apulia, 71122

  • Investigational Site Number : 3800003

    Rozzano, Milano, 20089

  • Investigational Site Number : 3800007

    Verona, 37134

Other trials in Italy

Russia5 sites

  • Investigational Site Number : 6430001

    Moscow, 115093

  • Investigational Site Number : 6430003

    Moscow, 115280

  • Investigational Site Number : 6430002

    Moscow, 117546

  • Investigational Site Number : 6430005

    Saint Petersburg, 194354

  • Investigational Site Number : 6430006

    Saint Petersburg, 194354

Other trials in Russia

Hungary4 sites

  • Investigational Site Number : 3480004

    Debrecen, 4031

  • Investigational Site Number : 3480001

    Gödöllö, 2100

  • Investigational Site Number : 3480002

    Mosonmagyaróvár, 9200

  • Investigational Site Number : 3480003

    Pécs, 7635

Other trials in Hungary

Poland4 sites

  • Investigational Site Number : 6160001

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160002

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 02-777

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 53-673

Other trials in Poland

Georgia3 sites

  • Investigational Site Number : 2680002

    Tbilisi, 0112

  • Investigational Site Number : 2680003

    Tbilisi, 0112

  • Investigational Site Number : 2680001

    Tbilisi, 159

Other trials in Georgia

Mauritius1 site

  • Investigational Site Number : 4800001

    Quatre Bornes, 72218

Other trials in Mauritius

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:

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

Read more

Secondary Objectives:

  • 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
Read the detailed description

The study duration per participant:

  • Screening period was 3-5 weeks
  • Placebo-controlled treatment period was 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants
  • Post-investigational medicinal product (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 had been 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 was 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 NCT04701983
Study groupRoleWhat they receive
Itepekimab Q2WExperimentalParticipants received itepekimab 300 mg as an SC injection every 2 weeks (Q2W) for up to 52 weeks.
Receives: Drug: Itepekimab SAR440340
Itepekimab Q4WExperimentalParticipants received Itepekimab 300 mg as an SC injection every 4 weeks (Q4W) with alternating placebo matching Itepekimab administration at the 2-week interval between active study drug for up to 52 weeks.
Receives: Drug: Itepekimab SAR440340; Drug: Placebo
PlaceboPlacebo comparatorParticipants received placebo matching Itepekimab as subcutaneous (SC) injection every 2 weeks (Q2W) for up to 52 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Annualized Rate of Adjudicated Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) Events 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 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 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 for initial randomized participants; Baseline (Day 1) up to Week 24 to 52 for additional randomized participants

Secondary outcomes (18)

  1. Annualized Rate of Adjudicated Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease Events Over the Placebo-Controlled 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 Week 24 to 52 for additional randomized participants

  2. 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 wash out period of BD according to their action duration. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

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

    The E-RS: COPD scale was a patient-reported outcome (PRO) that measured the severity of respiratory symptoms in COPD such as breathlessness, cough and sputum, and chest symptoms. It was derivative of the EXACT tool, which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD utilized 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking the sum of the scores for the 11 items comprising the instrument. Total score ranged from 0 (no symptoms) to 40 (severe symptoms), higher values indicated more severe respiratory symptoms. Baseline was defined as the last available value before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

  4. 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 before the first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

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

    SGRQ was 50-item PRO instrument developed to measure the health status of participants with airflow obstruction diseases. Questionnaire 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. Total SGRQ score indicated impact of disease on overall health status. 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 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) to Week 24

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

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 consisted of 8 items pertaining to the severity of respiratory symptoms in preceding 4 weeks; part 2 consisted of 42 items related to daily activity and psychosocial impacts of the individual's respiratory condition. The total SGRQ score indicated the impact of disease on overall health status. 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 to 100; 100 represented the worst possible health status and 0 indicated the best possible health status. Baseline was defined as the last available value before the first dose of study drug. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) and Week 24

  7. 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 the last available value before the first dose of study drug.

    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. 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 before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  9. 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 before the first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

  10. 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: acute worsening of respiratory symptoms that required either systemic corticosteroids (such as IM, IV, or oral) and/or antibiotics. Severe exacerbations: 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. 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. 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: acute worsening of respiratory symptoms that required either systemic corticosteroids (IM,IV, or oral) and/or antibiotics. Severe exacerbations: 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 Week 24 to 52 for additional randomized participants

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

    E-RS: COPD scale was PRO that measured severity of respiratory symptoms in COPD: breathlessness,cough and sputum,chest symptoms. It was derivative of EXACT tool which was daily symptom diary that quantified and measured exacerbations of COPD and assessed symptomatic manifestations of COPD exacerbations. E-RS: COPD used 11 respiratory symptom items contained in 14-item EXACT instrument. Daily E-RS: COPD RS-Total score was computed by taking sum of scores for 11 items comprising instrument. Total score:0 (no symptoms) to 40 (severe symptoms); higher values=more severe respiratory symptoms. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

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

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire had 2 parts: part 1 had 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 had 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Total score was calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire; ranged 0 to 100;100=worst possible health status;0=best possible health status. Baseline: last available value before first dose of study drug. Model-based average change from baseline to Week 52 is presented.

    Measured: Baseline (Day 1) to Week 52

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

    SGRQ was 50-item PRO instrument developed to measure health status of participants with airflow obstruction diseases. Questionnaire 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 daily activity and psychosocial impacts of individual's respiratory condition. 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 to 100; 100=worst possible health status; 0=best possible health status. Baseline: last available value before first dose of study drug. Percentages rounded off to tenth decimal place.

    Measured: Baseline (Day 1) and Week 52

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

    AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE (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. 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 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)

  17. 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)

  18. 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 78 weeks); up to EOT (considering maximum treatment exposure) for who entered LTS18133 (approximately 58 weeks)

Timeline

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

  1. First posted8 Jan 2021
  2. Study start16 Dec 2020
  3. Primary completion11 Apr 2025
  4. Study completion27 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
1,127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04701983
Sponsor's protocol ID
EFC16750
Other IDs
U1111-1250-2787, 2024-512013-41, 2020-001818-38
Acronym
AERIFY-1
Status last verified
Sep 2026
First submitted
30 Dec 2020
Last updated
15 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

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