Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-1)

March 14, 2024 updated by: Sanofi

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

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

Study Overview

Status

Recruiting

Detailed Description

The study duration per participant:

  • Screening period is 3-5 weeks
  • Placebo-controlled treatment period is 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 is 20 weeks for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free number for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

      • Mendoza, Argentina, 5500
        • Recruiting
        • Investigational Site Number : 0320004
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1425BEN
        • Recruiting
        • Investigational Site Number : 0320001
      • Caba, Buenos Aires, Argentina, C1425FVH
        • Recruiting
        • Investigational Site Number : 0320002
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Recruiting
        • Investigational Site Number : 0320003
      • Dimitrovgrad, Bulgaria, 6400
        • Recruiting
        • Investigational Site Number : 1000005
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Investigational Site Number : 1000002
      • Sofia, Bulgaria, 1233
        • Recruiting
        • Investigational Site Number : 1000001
      • Sofia, Bulgaria, 1233
        • Recruiting
        • Investigational Site Number : 1000004
      • Sofia, Bulgaria, 1756
        • Recruiting
        • Investigational Site Number : 1000009
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • Investigational Site Number : 1000006
      • Stara Zagora, Bulgaria, 6001
        • Recruiting
        • Investigational Site Number : 1000003
      • Veliko Tyrnovo, Bulgaria, 5000
        • Recruiting
        • Investigational Site Number : 1000007
      • Vidin, Bulgaria, 3700
        • Recruiting
        • Investigational Site Number : 1000008
    • La Araucanía
      • Temuco, La Araucanía, Chile, 4781173
        • Recruiting
        • Investigational Site Number : 1520008
    • Maule
      • Curicó, Maule, Chile, 3341643
        • Completed
        • Investigational Site Number : 1520007
      • Talca, Maule, Chile
        • Recruiting
        • Investigational Site Number : 1520002
    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500010
        • Recruiting
        • Investigational Site Number : 1520009
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500571
        • Recruiting
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500692
        • Recruiting
        • Investigational Site Number : 1520001
      • Santiago, Reg Metropolitana De Santiago, Chile, 7500698
        • Recruiting
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana De Santiago, Chile, 8910131
        • Recruiting
        • Investigational Site Number : 1520004
    • Valparaíso
      • Quillota, Valparaíso, Chile, 2260877
        • Recruiting
        • Investigational Site Number : 1520005
      • Baotou, China, 014010
        • Recruiting
        • Investigational Site Number : 1560003
      • Beijing, China, 100020
        • Recruiting
        • Investigational Site Number : 1560004
      • Beijing, China, 100038
        • Recruiting
        • Investigational Site Number : 1560030
      • Beijing, China
        • Recruiting
        • Investigational Site Number : 1560014
      • Changchun, China, 130021
        • Recruiting
        • Investigational Site Number : 1560002
      • Changsha, China, 410011
        • Recruiting
        • Investigational Site Number : 1560012
      • Changsha, China, 410013
        • Recruiting
        • Investigational Site Number : 1560013
      • Changsha, China, 410023
        • Recruiting
        • Investigational Site Number : 1560047
      • Chengdu, China, 610041
        • Recruiting
        • Investigational Site Number : 1560001
      • Chengdu, China, 611130
        • Recruiting
        • Investigational Site Number : 1560040
      • Chongqing, China, 400038
        • Recruiting
        • Investigational Site Number : 1560032
      • Guangzhou, China, 510150
        • Recruiting
        • Investigational Site Number : 1560006
      • Guangzhou, China, 510163
        • Recruiting
        • Investigational Site Number : 1560025
      • Haikou, China, 570216
        • Recruiting
        • Investigational Site Number : 1560036
      • Hangzhou, China, 310014
        • Recruiting
        • Investigational Site Number : 1560022
      • Hangzhou, China
        • Recruiting
        • Investigational Site Number : 1560039
      • Hefei, China
        • Recruiting
        • Investigational Site Number : 1560017
      • Hohhot, China, 010017
        • Recruiting
        • Investigational Site Number : 1560008
      • Hohhot, China, 010050
        • Recruiting
        • Investigational Site Number : 1560010
      • Jinan, China, 250013
        • Recruiting
        • Investigational Site Number : 1560044
      • Jinan, China, 250014
        • Recruiting
        • Investigational Site Number : 1560027
      • Nanchang, China, 330006
        • Recruiting
        • Investigational Site Number : 1560031
      • Nanjing, China, 210009
        • Recruiting
        • Investigational Site Number : 1560035
      • Nanning, China, 530021
        • Recruiting
        • Investigational Site Number : 1560023
      • Pingxiang, China, 337055
        • Recruiting
        • Investigational Site Number : 1560015
      • Shanghai, China, 200025
        • Recruiting
        • Investigational Site Number : 1560043
      • Shanghai, China, 200240
        • Recruiting
        • Investigational Site Number : 1560034
      • Shanghai, China, 200433
        • Recruiting
        • Investigational Site Number : 1560009
      • Shanghai, China
        • Recruiting
        • Investigational Site Number : 1560045
      • Shenyang, China, 110004
        • Recruiting
        • Investigational Site Number : 1560005
      • Shenzhen, China, 518020
        • Recruiting
        • Investigational Site Number : 1560020
      • Shijiazhuang, China, 050000
        • Recruiting
        • Investigational Site Number : 1560028
      • Tianjin, China, 300052
        • Recruiting
        • Investigational Site Number : 1560024
      • Wenzhou, China, 325000
        • Recruiting
        • Investigational Site Number : 1560019
      • Wuhan, China, 430014
        • Recruiting
        • Investigational Site Number : 1560029
      • Xi'an, China
        • Recruiting
        • Investigational Site Number : 1560016
      • Xiangtan, China, 411100
        • Recruiting
        • Investigational Site Number : 1560046
      • Xuzhou, China, 221002
        • Recruiting
        • Investigational Site Number : 1560007
      • Yangzhou, China, 225001
        • Recruiting
        • Investigational Site Number : 1560026
      • Zhanjiang, China, 524001
        • Recruiting
        • Investigational Site Number : 1560041
      • Zhengzhou, China, 450008
        • Recruiting
        • Investigational Site Number : 1560042
      • Zhongshan, China, 528403
        • Recruiting
        • Investigational Site Number : 1560048
      • Havlickuv Brod, Czechia, 580 01
        • Recruiting
        • Investigational Site Number : 2030006
      • Jindrichuv Hradec III, Czechia, 37701
        • Recruiting
        • Investigational Site Number : 2030001
      • Ostrava, Czechia, 70800
        • Recruiting
        • Investigational Site Number : 2030004
      • Praha 4, Czechia, 140 46
        • Recruiting
        • Investigational Site Number : 2030002
      • Praha 5 - Radotin, Czechia, 15300
        • Recruiting
        • Investigational Site Number : 2030005
      • Praha 8, Czechia, 18200
        • Recruiting
        • Investigational Site Number : 2030003
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Investigational Site Number : 2680002
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Investigational Site Number : 2680003
      • Tbilisi, Georgia, 159
        • Recruiting
        • Investigational Site Number : 2680001
      • Athens, Greece, 106 76
        • Recruiting
        • Investigational Site Number : 3000005
      • Athens, Greece, 11527
        • Recruiting
        • Investigational Site Number : 3000006
      • Heraklion, Greece, 71500
        • Recruiting
        • Investigational Site Number : 3000004
      • Ioannina, Greece, 455 00
        • Recruiting
        • Investigational Site Number : 3000001
      • Larisa, Greece, 41110
        • Recruiting
        • Investigational Site Number : 3000007
      • Palaio Faliro, Athens, Greece, 17562
        • Recruiting
        • Investigational Site Number : 3000008
      • Thessaloniki, Greece, 57010
        • Recruiting
        • Investigational Site Number : 3000002
      • Debrecen, Hungary, 4031
        • Recruiting
        • Investigational Site Number : 3480004
      • Gödöllö, Hungary, 2100
        • Recruiting
        • Investigational Site Number : 3480001
      • Mosonmagyaróvár, Hungary, 9200
        • Recruiting
        • Investigational Site Number : 3480002
      • Pécs, Hungary, 7635
        • Recruiting
        • Investigational Site Number : 3480003
      • Coimbatore, India, 641028
        • Recruiting
        • Investigational Site Number : 3560002
      • Hyderabad, India, 500 084
        • Recruiting
        • Investigational Site Number : 3560005
      • Jaipur, India, 302039
        • Recruiting
        • Investigational Site Number : 3560004
      • Kozhikode, India, 673008
        • Recruiting
        • Investigational Site Number : 3560001
      • Mumbai, India, 400078
        • Active, not recruiting
        • Investigational Site Number : 3560007
      • Nagpur, India, 441203
        • Recruiting
        • Investigational Site Number : 3560003
      • Haifa, Israel, 34362
        • Recruiting
        • Investigational Site Number : 3760008
      • Jerusalem, Israel, 91031
        • Recruiting
        • Investigational Site Number : 3760003
      • Jerusalem, Israel, 91120
        • Recruiting
        • Investigational Site Number : 3760002
      • Kfar-Saba, Israel, 44281
        • Recruiting
        • Investigational Site Number : 3760006
      • Petah-Tikva, Israel, 49100
        • Recruiting
        • Investigational Site Number : 3760001
      • Ramat Gan, Israel, 5266202
        • Recruiting
        • Investigational Site Number : 3760009
      • Rehovot, Israel, 76100
        • Recruiting
        • Investigational Site Number : 3760004
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Investigational Site Number : 3760007
      • Catania, Italy, 95123
        • Recruiting
        • Investigational Site Number : 3800005
      • Ferrara, Italy, 44124
        • Recruiting
        • Investigational Site Number : 3800001
      • Verona, Italy, 37134
        • Recruiting
        • Investigational Site Number : 3800007
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Investigational Site Number : 3800003
    • Puglia
      • Foggia, Puglia, Italy, 71122
        • Recruiting
        • Investigational Site Number : 3800004
      • Quatre Bornes, Mauritius, 72218
        • Recruiting
        • Investigational Site Number : 4800001
      • Benito Juarez, Mexico, 03100
        • Recruiting
        • Investigational Site Number : 4840004
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Recruiting
        • Investigational Site Number : 4840001
      • Guadalajara, Jalisco, Mexico, 44130
        • Recruiting
        • Investigational Site Number : 4840011
      • Guadalajara, Jalisco, Mexico, 44210
        • Recruiting
        • Investigational Site Number : 4840010
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Recruiting
        • Investigational Site Number : 4840007
    • México
      • Cdmx, México, Mexico, 06700
        • Recruiting
        • Investigational Site Number : 4840002
    • Querétaro
      • San Juan del Rio, Querétaro, Mexico, 76800
        • Recruiting
        • Investigational Site Number : 4840003
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 53-673
        • Recruiting
        • Investigational Site Number : 6160004
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-777
        • Recruiting
        • Investigational Site Number : 6160003
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-044
        • Recruiting
        • Investigational Site Number : 6160001
    • Swietokrzyskie
      • Ostrowiec Swietokrzyski, Swietokrzyskie, Poland, 27-400
        • Recruiting
        • Investigational Site Number : 6160002
      • Bragadiru, Romania, 769764
        • Recruiting
        • Investigational Site Number : 6420005
      • Brasov, Romania, 500283
        • Recruiting
        • Investigational Site Number : 6420006
      • Bucaresti, Romania, 010192
        • Recruiting
        • Investigational Site Number : 6420012
      • Cluj-Napoca, Romania, 400275
        • Recruiting
        • Investigational Site Number : 6420002
      • Codlea, Romania, 505100
        • Recruiting
        • Investigational Site Number : 6420007
      • Deva, Romania, 330162
        • Recruiting
        • Investigational Site Number : 6420010
      • Iasi, Romania, 700732
        • Recruiting
        • Investigational Site Number : 6420001
      • Oradea, Romania, 410155
        • Recruiting
        • Investigational Site Number : 6420009
      • Timisoara, Romania, 300134
        • Recruiting
        • Investigational Site Number : 6420003
      • Moscow, Russian Federation, 115093
        • Completed
        • Investigational Site Number : 6430001
      • Moscow, Russian Federation, 115280
        • Completed
        • Investigational Site Number : 6430003
      • Moscow, Russian Federation, 117546
        • Completed
        • Investigational Site Number : 6430002
      • Saint-Petersburg, Russian Federation, 194354
        • Completed
        • Investigational Site Number : 6430005
      • St-Petersburg, Russian Federation, 194354
        • Completed
        • Investigational Site Number : 6430006
      • Bardejov, Slovakia, 08501
        • Recruiting
        • Investigational Site Number : 7030009
      • Humenne, Slovakia, 066 01
        • Recruiting
        • Investigational Site Number : 7030007
      • Levice, Slovakia, 93401
        • Recruiting
        • Investigational Site Number : 7030003
      • Martin, Slovakia, 03659
        • Recruiting
        • Investigational Site Number : 7030011
      • Poprad, Slovakia, 058 01
        • Recruiting
        • Investigational Site Number : 7030002
      • Presov, Slovakia, 08001
        • Recruiting
        • Investigational Site Number : 7030010
      • Spisska Nova Ves, Slovakia, 05201
        • Recruiting
        • Investigational Site Number : 7030001
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Investigational Site Number : 1580005
      • New Taipei City, Taiwan, 220
        • Recruiting
        • Investigational Site Number : 1580002
      • Taichung, Taiwan, 40447
        • Recruiting
        • Investigational Site Number : 1580006
      • Taipei, Taiwan, 10002
        • Recruiting
        • Investigational Site Number : 1580004
      • Taipei, Taiwan, 11031
        • Recruiting
        • Investigational Site Number : 1580003
      • Yunlin, Taiwan
        • Recruiting
        • Investigational Site Number : 1580008
      • Ivano-Frankivsk, Ukraine, 76018
        • Completed
        • Investigational Site Number : 8040007
      • Ivano-Frankivsk, Ukraine, 76018
        • Completed
        • Investigational Site Number : 8040003
      • Kharkiv, Ukraine, 61039
        • Completed
        • Investigational Site Number : 8040008
      • Kharkiv, Ukraine, 61166
        • Completed
        • Investigational Site Number : 8040006
      • Kyiv, Ukraine, 01023
        • Completed
        • Investigational Site Number : 8040004
      • Kyiv, Ukraine, 01033
        • Completed
        • Investigational Site Number : 8040001
      • Kyiv, Ukraine, 02091
        • Completed
        • Investigational Site Number : 8040005
      • Kyiv, Ukraine, 04050
        • Recruiting
        • Investigational Site Number : 8040011
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • Investigational Site Number : 8260003
      • London, United Kingdom, EC1M 6BQ
        • Recruiting
        • Investigational Site Number : 8260001
      • Redruth, United Kingdom, TR16 4ET
        • Recruiting
        • Investigational Site Number : 8260013
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Recruiting
        • Investigational Site Number : 8260004
    • Alabama
      • Birmingham, Alabama, United States, 34294
        • Recruiting
        • University of Alabama at Birmingham Site Number : 8400012
      • Jasper, Alabama, United States, 35501
        • Recruiting
        • Jasper Summit Research Site Number : 8400178
    • Arizona
      • Chandler, Arizona, United States, 85286
        • Recruiting
        • Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034
      • Phoenix, Arizona, United States, 85027
        • Recruiting
        • Pulmonary Associates Site Number : 8400392
      • Tucson, Arizona, United States, 85704-7876
        • Recruiting
        • Noble Clinical Research Site Number : 8400182
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Clinical Research Institute Site Number : 8400431
    • California
      • Huntington Park, California, United States, 90255
        • Recruiting
        • California Research Institute Site Number : 8400400
      • La Jolla, California, United States, 92037
        • Completed
        • Modena Allergy + Asthma Site Number : 8400036
      • La Palma, California, United States, 90623
        • Recruiting
        • Imax Clinical Trials LLC Site Number : 8400419
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Downtown LA Research Center Inc. Site Number : 8400027
      • Los Angeles, California, United States, 90048
        • Recruiting
        • MACRO Trials Site Number : 8400030
      • Northridge, California, United States, 91325
        • Recruiting
        • Antelope Valley Clinical Trials Site Number : 8400003
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center Site Number : 8400180
      • Lafayette, Colorado, United States, 80026
        • Completed
        • Innovative Clinical Research Site Number : 8400017
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clin Research W Florida Site Number : 8400004
      • Cutler Bay, Florida, United States, 33157
        • Recruiting
        • Beautiful Minds Clinical Research Center Site Number : 8400037
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Indago Research and Health Center Site Number : 8400187
      • Kendall, Florida, United States, 33156
        • Recruiting
        • Advanced Clinical Research Site Number : 8400409
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of Miami/Miami VA Medical Center Site Number : 8400026
      • Miami, Florida, United States, 33155
        • Recruiting
        • DL Research Solutions Inc Site Number : 8400033
      • Miami, Florida, United States, 33173
        • Recruiting
        • Research Institute of South Florida,Inc Site Number : 8400006
      • Miami, Florida, United States, 33176
        • Recruiting
        • Reed Medical Research Site Number : 8400032
      • Miami, Florida, United States, 33184
        • Recruiting
        • High Quality Research Site Number : 8400406
      • Miami, Florida, United States, 33165
        • Recruiting
        • Reliant Medical Research Site Number : 8400397
      • Miami, Florida, United States, 33175
        • Recruiting
        • PROLIVE MEDICAL RESEARCH Site Number : 8400420
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Deluxe Health Center Site Number : 8400188
      • Orlando, Florida, United States, 32825-4454
        • Recruiting
        • Florida Institute for Clinical Research Site Number : 8400013
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Avanza Medical Research Center Site Number : 8400376
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Broward Pulmonary and Sleep Specialists Site Number : 8400031
      • Saint Petersburg, Florida, United States, 33707
        • Recruiting
        • Coastal Medical Research Institute Site Number : 8400044
      • Saint Petersburg, Florida, United States, 33710
        • Recruiting
        • Pasadena Center for Medical Research Site Number : 8400043
      • The Villages, Florida, United States, 32159
        • Recruiting
        • Premier Medical Associates Site Number : 8400388
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Recruiting
        • Appalachian Clinical Research Site Number : 8400024
      • Atlanta, Georgia, United States, 30311
        • Recruiting
        • Alpha Clinical Research Georgia Site Number : 8400190
      • Atlanta, Georgia, United States, 30344
        • Recruiting
        • Covenant Pulmonary Critical Care Site Number : 8400183
      • Cordele, Georgia, United States, 31015
        • Recruiting
        • David Kavtaradze MD, Inc. Site Number : 8400029
      • Lawrenceville, Georgia, United States, 30046
        • Completed
        • Gwinnett Biomedical Research Site Number : 8400007
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Recruiting
        • GenHarp Clinical Solutions Site Number : 8400028
    • Indiana
      • Hammond, Indiana, United States, 46324
        • Recruiting
        • ASHA Clinical Research Site Number : 8400408
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Benchmark Research Site Number : 8400193
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Paul Shapero, PC Site Number : 8400016
    • Massachusetts
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Care Access Site Number : 8400276
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Care Access Site Number : 8400277
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Care Access Site Number : 8400278
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Care Access Site Number : 8400280
      • Boston, Massachusetts, United States, 02110
        • Recruiting
        • Care Access Site Number : 8400281
      • Fall River, Massachusetts, United States, 02723
        • Recruiting
        • Exordia Medical Research, Inc. Site Number : 8400041
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute, LLC Site Number : 8400191
      • Warren, Michigan, United States, 48088
        • Recruiting
        • Advanced Pulmonary Research Institute of Michigan Site Number : 8400403
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Recruiting
        • Hannibal Clinic Site Number : 8400383
      • Saint Charles, Missouri, United States, 63301
        • Recruiting
        • Midwest Chest Consultants, P.C. Site Number : 8400002
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Hendeson Clinical Trials Site Number : 8400365
    • New York
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northwell Health Site Number : 8400019
      • Schenectady, New York, United States, 12304
        • Recruiting
        • WellNow Urgent Care and Clinical Research Site Number : 8400378
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Completed
        • Gastonia Pharmaceutical Research Site Number : 8400010
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University Brody School Of Medicine Site Number : 8400022
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Carolina Research Center Site Number : 8400005
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Accellacare Site Number : 8400001
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Southeastern Research Center Site Number : 8400011
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Bernstein Clinical Research Center Site Number : 8400014
      • Springdale, Ohio, United States, 45215
        • Recruiting
        • WellNow Urgent Care and Research Site Number : 8400039
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • Clinical Research of Central PA Site Number : 8400023
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Bogan Sleep Consultants Site Number : 8400181
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill Site Number : 8400008
    • Texas
      • Beaumont, Texas, United States, 77701
        • Recruiting
        • REX Clinical Trials Site Number : 8400371
      • Carrollton, Texas, United States, 75007
        • Recruiting
        • Clinrx Research Site Number : 8400021
      • Cedar Park, Texas, United States, 78641
        • Recruiting
        • Austin Pulmonary Consultants Site Number : 8400035
      • Corsicana, Texas, United States, 75110
        • Recruiting
        • Corsicana Medical Research, LLC Site Number : 8400018
      • El Paso, Texas, United States, 79911
        • Recruiting
        • Texas Tech University Health Sciences Center Site Number : 8400189
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute Site Number : 8400194
      • Houston, Texas, United States, 77043-2742
        • Recruiting
        • Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038
      • Houston, Texas, United States, 77087
        • Recruiting
        • Santa Clara Family Clinic Site Number : 8400398
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Metroplex Pulmonary and Sleep Center Site Number : 8400015
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • PRX Research Site Number : 8400380
      • Plano, Texas, United States, 75093
        • Recruiting
        • EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Advance Lung and Sleep Center Site Number : 8400040
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Sherman Clinical Research Site Number : 8400009
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research Site Number : 8400179
      • Webster, Texas, United States, 77598
        • Recruiting
        • Clearlake Specialties Site Number : 8400025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  • Participant must be 40 to 85 years of age inclusive.
  • Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
  • Smoking history of ≥10 pack-years, but who are 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:

    • Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.
    • Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
  • Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
  • Body mass index (BMI) ≥18.0 kg/m^2, or BMI ≥16.0 kg/m^2 for participants enrolled in East-Asian countries.
  • Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    • not a women of child-bearing potential (WOCBP) OR
    • a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.

Exclusion criteria:

  • Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred.
  • 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).
  • Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).
  • Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.
  • Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).
  • Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.
  • Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of anti-hypertensive therapy).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
  • History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).
  • Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Itepekimab Q2W
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Other Names:
  • REGN3500
Experimental: Itepekimab Q4W
SC 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
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Other Names:
  • REGN3500
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Placebo Comparator: Placebo
SC administration of matching placebo Q2W for up to 52 weeks
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Time Frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Estimated)

June 27, 2025

Study Completion (Estimated)

November 28, 2025

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EFC16750
  • 2020-001818-38 (EudraCT Number)
  • U1111-1250-2787 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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