Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma (ATLAS)

A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Dupilumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1339
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Investigational Site Number : 0560002
  • Liège, Belgium, 4000
    • Investigational Site Number : 0560003
• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
  • São Paulo, Brazil, 01323-020
    • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760007
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40060-330
      • Associacao Proar- Site Number : 0760004
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760006
  • Pará
    • Belém, Pará, Brazil, 66095-055
      • Health & Care - Consultancy, Research and HealthCare Management- Site Number : 0760010
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760003
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760005
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-101
      • Hospital Dia do Pulmão- Site Number : 0760002
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Clinica de Alergia Martti Antila- Site Number : 0760009
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Investigational Site Number : 1000005
  • Plovdiv, Bulgaria, 4023
    • Investigational Site Number : 1000012
  • Rousse, Bulgaria, 7000
    • Investigational Site Number : 1000011
  • Sofia, Bulgaria, 1407
    • Investigational Site Number : 1000008
  • Sofia, Bulgaria, 1233
    • Investigational Site Number : 1000002
  • Sofia, Bulgaria, 1431
    • Investigational Site Number : 1000009
  • Sofia, Bulgaria, 1756
    • Investigational Site Number : 1000014
  • Vratsa, Bulgaria, 3001
    • Investigational Site Number : 1000013
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 0M3
      • Investigational Site Number : 1240028
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 3H5
      • Investigational Site Number : 1240020
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Investigational Site Number : 1240004
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Investigational Site Number : 1240022
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 5C4
      • Investigational Site Number : 1240010
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Investigational Site Number : 1240015
    • Kingston, Ontario, Canada, K7M 7E4
      • Investigational Site Number : 1240029
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Investigational Site Number : 1240018
    • Toronto, Ontario, Canada, M5G 1E2
      • Investigational Site Number : 1240011
    • Toronto, Ontario, Canada, M5T 3A9
      • Investigational Site Number : 1240001
    • Toronto, Ontario, Canada, M9V 4B4
      • Investigational Site Number : 1240007
    • Windsor, Ontario, Canada, N8X 5A6
      • Investigational Site Number : 1240003
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3H5
      • Investigational Site Number : 1240014
    • Montreal, Quebec, Canada, H3T 1E2
      • Investigational Site Number : 1240017
    • Montreal, Quebec, Canada, H4A 3J1
      • Investigational Site Number : 1240023
    • Québec, Quebec, Canada, G1G 3Y8
      • Investigational Site Number : 1240002
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240025
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Investigational Site Number : 1240024
• China
  • Beijing, China, 100029
    • Investigational Site Number : 1560017
  • Beijing, China, 100029
    • Investigational Site Number : 1560022
  • Beijing, China, 100191
    • Investigational Site Number : 1560030
  • Dongguan, China, 523000
    • Investigational Site Number : 1560006
  • Guangzhou, China, 510000
    • Investigational Site Number : 1560007
  • Guiyang, China, 550002
    • Investigational Site Number : 1560019
  • Hebei, China, 050051
    • Investigational Site Number : 1560003
  • Hefei, China, 230022
    • Investigational Site Number : 1560023
  • Nanchang, China, 330006
    • Investigational Site Number : 1560002
  • Nanjing, China, 210008
    • Investigational Site Number : 1560014
  • Ningbo, China, 315010
    • Investigational Site Number : 1560008
  • Ningbo, China, 315041
    • Investigational Site Number : 1560031
  • Shanghai, China, 200080
    • Investigational Site Number : 1560001
  • Sichuan, China, 646000
    • Investigational Site Number : 1560029
  • Taiyuan, China, 030001
    • Investigational Site Number : 1560011
  • Taiyuan, China, 030032
    • Investigational Site Number : 1560012
  • Tianjin, China, 300052
    • Investigational Site Number : 1560004
  • Tianjin, China, 300192
    • Investigational Site Number : 1560025
  • Wuxi, China, 214023
    • Investigational Site Number : 1560009
  • Xi'an, China, 710004
    • Investigational Site Number : 1560028
  • Xiamen, China, 361004
    • Investigational Site Number : 1560020
  • Xiamen, China, 361004
    • Investigational Site Number : 1560024
  • Yichang, China, 443003
    • Investigational Site Number : 1560013
  • Yueyang, China, 414000
    • Investigational Site Number : 1560010
  • Zhengzhou, China, 450003
    • Investigational Site Number : 1560021
• Greece
  • Alexandroupoli, Greece, 681 00
    • Investigational Site Number : 3000011
  • Athens, Greece, 115 27
    • Investigational Site Number : 3000004
  • Athens, Greece, 106 76
    • Investigational Site Number : 3000003
  • Athens, Greece, 115 21
    • Investigational Site Number : 3000010
  • Athens, Greece, 115 25
    • Investigational Site Number : 3000007
  • Athens, Greece, 115 27
    • Investigational Site Number : 3000006
  • Athens, Greece, 124 62
    • Investigational Site Number : 3000005
  • Ioannina, Greece, 455 00
    • Investigational Site Number : 3000002
  • Palaió Fáliro, Greece, 175 62
    • Investigational Site Number : 3000009
  • Thessaloniki, Greece, 564 29
    • Investigational Site Number : 3000008
  • Thessaloniki, Greece, 570 10
    • Investigational Site Number : 3000001
• Hungary
  • Budapest, Hungary, 1204
    • Investigational Site Number : 3480012
  • Budapest, Hungary, 2200
    • Investigational Site Number : 3480011
  • Debrecen, Hungary, 4031
    • Investigational Site Number : 3480008
  • Edelény, Hungary, 3780
    • Investigational Site Number : 3480005
  • Hajdúnánás, Hungary, 4080
    • Investigational Site Number : 3480004
  • Mosonmagyaróvár, Hungary, 9200
    • Investigational Site Number : 3480007
  • Püspökladány, Hungary, 4150
    • Investigational Site Number : 3480003
  • Szekszárd, Hungary, 7100
    • Investigational Site Number : 3480013
  • Szombathely, Hungary, 9700
    • Investigational Site Number : 3480006
  • Százhalombatta, Hungary, 2440
    • Investigational Site Number : 3480001
• India
  • Ahmedabad, India, 380008
    • Investigational Site Number : 3560011
  • Chandigarh, India, 160012
    • Investigational Site Number : 3560003
  • Coimbatore, India, 641028
    • Investigational Site Number : 3560008
  • Jaipur, India, 302023
    • Investigational Site Number : 3560001
  • Jodhpur, India, 342005
    • Investigational Site Number : 3560019
  • Kozhikode, India, 673008
    • Investigational Site Number : 3560002
  • Lucknow, India, 226006
    • Investigational Site Number : 3560014
  • Mangaluru, India, 575003
    • Investigational Site Number : 3560006
  • Mysuru, India, 570001
    • Investigational Site Number : 3560018
  • Nagpur, India, 440012
    • Investigational Site Number : 3560009
  • Nagpur, India, 440012
    • Investigational Site Number : 3560012
  • New Delhi, India, 110025
    • Investigational Site Number : 3560015
  • Pune, India, 411004
    • Investigational Site Number : 3560020
  • Vadodara, India, 390021
    • Investigational Site Number : 3560004
• Ireland
  • Cork, Ireland, T12 E8YV
    • Investigational Site Number : 3720001
  • Dublin, Ireland, D04 T6F4
    • Investigational Site Number : 3720003
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840016
  • Chihuahua City, Mexico, 31217
    • Investigational Site Number : 4840012
  • Durango, Mexico, 34000
    • Investigational Site Number : 4840001
  • Oaxaca City, Mexico, 68020
    • Investigational Site Number : 4840013
  • Veracruz, Mexico, 91900
    • Investigational Site Number : 4840003
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Investigational Site Number : 4840002
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Investigational Site Number : 4840006
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64060
      • Investigational Site Number : 4840008
    • Monterrey, Nuevo León, Mexico, 64460
      • Investigational Site Number : 4840004
    • Monterrey, Nuevo León, Mexico, 66465
      • Investigational Site Number : 4840005
  • Querétaro
    • San Juan del Río, Querétaro, Mexico, 76800
      • Investigational Site Number : 4840014
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86035
      • Investigational Site Number : 4840010
• Oman
  • Muscat, Oman, 111
    • Investigational Site Number : 5120001
  • Muscat, Oman, 123
    • Investigational Site Number : 5120002
• Peru
  • Lima, Peru, 15001
    • Investigational Site Number : 6040001
  • Lima, Peru, 15102
    • Investigational Site Number : 6040002
  • Piura, Peru, 20000
    • Investigational Site Number : 6040003
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Cardio Pulmonary Research Center- Site Number : 8400126
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research- Site Number : 8400121
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico - Medical Sciences Campus- Site Number : 8400128
• Romania
  • Baia Mare, Romania, 430061
    • Investigational Site Number : 6420010
  • Bragadiru, Romania, 769764
    • Investigational Site Number : 6420005
  • Brasov, Romania, 500283
    • Investigational Site Number : 6420002
  • Brasov, Romania, 500051
    • Investigational Site Number : 6420007
  • Codlea, Romania, 505100
    • Investigational Site Number : 6420004
  • Craiova, Romania, 200515
    • Investigational Site Number : 6420011
  • Deva, Romania, 330162
    • Investigational Site Number : 6420001
  • Piteşti, Romania, 110117
    • Investigational Site Number : 6420008
  • Timișoara, Romania, 300134
    • Investigational Site Number : 6420009
• Saudi Arabia
  • Mecca, Saudi Arabia, 21955
    • Investigational Site Number : 6820008
• Slovakia
  • Levice, Slovakia, 934 01
    • Investigational Site Number : 7030003
  • Poprad, Slovakia, 058 01
    • Investigational Site Number : 7030001
  • Spišská Nová Ves, Slovakia, 052 01
    • Investigational Site Number : 7030002
  • Topoľčany, Slovakia, 955 01
    • Investigational Site Number : 7030005
• South Africa
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100006
  • Cape Town, South Africa, 7700
    • Investigational Site Number : 7100001
  • Cape Town, South Africa, 7505
    • Investigational Site Number : 7100013
  • Cape Town, South Africa, 7764
    • Investigational Site Number : 7100004
  • Chatsworth, South Africa, 4092
    • Investigational Site Number : 7100012
  • Durban, South Africa, 4001
    • Investigational Site Number : 7100003
  • Durban, South Africa, 4302
    • Investigational Site Number : 7100009
  • Kempton Park, South Africa, 1619
    • Investigational Site Number : 7100014
  • Pretoria, South Africa, 0009
    • Investigational Site Number : 7100002
  • Somerset West, South Africa, 7130
    • Investigational Site Number : 7100008
  • Vereeniging, South Africa, 1935
    • Investigational Site Number : 7100007
• South Korea
  • Busan
    • Busan, Busan, South Korea, 49241
      • Investigational Site Number : 4100007
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Investigational Site Number : 4100008
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, South Korea, 42415
      • Investigational Site Number : 4100006
  • Incheon-gwangyeoksi
    • Bupyeong-Gu, Incheon-gwangyeoksi, South Korea, 21431
      • Investigational Site Number : 4100010
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100002
    • Seoul, Seoul-teukbyeolsi, South Korea, 03722
      • Investigational Site Number : 4100004
    • Seoul, Seoul-teukbyeolsi, South Korea, 05505
      • Investigational Site Number : 4100003
    • Seoul, Seoul-teukbyeolsi, South Korea, 03312
      • Investigational Site Number : 4100009
    • Seoul, Seoul-teukbyeolsi, South Korea, 05030
      • Investigational Site Number : 4100001
    • Seoul, Seoul-teukbyeolsi, South Korea, 06351
      • Investigational Site Number : 4100005
• Taiwan
  • Douliu, Taiwan, 640
    • Investigational Site Number : 1580003
  • Kaohsiung City, Taiwan, 807
    • Investigational Site Number : 1580001
  • Taichung, Taiwan, 404
    • Investigational Site Number : 1580004
  • Taipei, Taiwan, 110
    • Investigational Site Number : 1580002
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01330
    • Investigational Site Number : 7920003
  • Ankara, Turkey (Türkiye), 06520
    • Investigational Site Number : 7920008
  • Ankara, Turkey (Türkiye), 06620
    • Investigational Site Number : 7920007
  • Istanbul, Turkey (Türkiye), 34098
    • Investigational Site Number : 7920001
  • Izmir, Turkey (Türkiye), 35100
    • Investigational Site Number : 7920006
  • Kayseri, Turkey (Türkiye), 38039
    • Investigational Site Number : 7920009
  • Kirikkale, Turkey (Türkiye), 71100
    • Investigational Site Number : 7920004
  • Mersin, Turkey (Türkiye), 33070
    • Investigational Site Number : 7920002
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 000000
    • Investigational Site Number : 7840001
  • Abu Dhabi, United Arab Emirates, 51900
    • Investigational Site Number : 7840002
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Investigational Site Number : 8260002
  • Liverpool, United Kingdom, L7 8XP
    • Investigational Site Number : 8260005
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Investigational Site Number : 8260001
  • Wakefield, United Kingdom, WF1 4DG
    • Investigational Site Number : 8260008
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Investigational Site Number : 8260004
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Investigational Site Number : 8260003
• United States
  • Alabama
    • Cullman, Alabama, United States, 35055
      • Cullman Research Center- Site Number : 8400001
    • Sheffield, Alabama, United States, 35660
      • Shoals Primary Care - Sheffield- Site Number : 8400015
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Clinical Research Trials- Site Number : 8400147
    • Phoenix, Arizona, United States, 85027
      • Pulmonary Associates - Deer Valley Office- Site Number : 8400155
    • Phoenix, Arizona, United States, 85051
      • Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management - Tucson- Site Number : 8400017
  • California
    • Bakersfield, California, United States, 93301
      • Kern Allergy and Medical Research- Site Number : 8400037
    • Beverly Hills, California, United States, 90211
      • Vitality Clinical Research- Site Number : 8400142
    • Fullerton, California, United States, 92835
      • Ascada Research - Fullerton- Site Number : 8400076
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists Medical Group- Site Number : 8400162
    • Newport Beach, California, United States, 92663
      • Newport Native MD- Site Number : 8400054
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations- Site Number : 8400131
    • Sacramento, California, United States, 95816
      • Mercy Medical Group - Midtown- Site Number : 8400164
    • Upland, California, United States, 91786
      • Integrated Research of Inland- Site Number : 8400156
    • Westminster, California, United States, 92683
      • Allianz Research Institute- Site Number : 8400018
    • Woodland, California, United States, 95695
      • Woodland Clinic - Woodland- Site Number : 8400171
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035
    • Aventura, Florida, United States, 33180
      • Florida Center for Allergy & Asthma Research- Site Number : 8400032
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center- Site Number : 8400141
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023
    • Kissimmee, Florida, United States, 34746
      • Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098
    • Miami, Florida, United States, 33155
      • Ivetmar Medical Group- Site Number : 8400063
    • Miami, Florida, United States, 33155
      • My Preferred Research- Site Number : 8400073
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida- Site Number : 8400079
    • Miami Lakes, Florida, United States, 33016
      • Floridian Clinical Research - Miami Lakes- Site Number : 8400091
    • Orlando, Florida, United States, 32819
      • Heuer M.D. Research- Site Number : 8400024
    • Tampa, Florida, United States, 33634
      • JSV Clinical Research- Site Number : 8400150
  • Georgia
    • Adairsville, Georgia, United States, 30103
      • Appalachian Clinical Research- Site Number : 8400129
    • Dunwoody, Georgia, United States, 30350
      • Alpha Clinical Research Group - Dunwoody- Site Number : 8400116
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratory- Site Number : 8400114
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center- Site Number : 8400146
    • Skokie, Illinois, United States, 60077
      • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160
    • Owensboro, Kentucky, United States, 42301
      • Allergy and Asthma Specialist- Site Number : 8400007
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Avant Research Associates - Crowley- Site Number : 8400117
    • Houma, Louisiana, United States, 70360-4413
      • Investigational Site Number : 3560016
    • Metairie, Louisiana, United States, 70006
      • Tandem Clinical Research - Metairie- Site Number : 8400163
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087
    • Columbia, Maryland, United States, 21045
      • Urgent Care Clinical Trials and KUR Research- Site Number : 8400169
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research - White Marsh- Site Number : 8400119
  • Massachusetts
    • Fall River, Massachusetts, United States, 02723
      • Genesis Clinical Research - Fall River- Site Number : 8400050
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - Ann Arbor- Site Number : 8400030
    • Dearborn, Michigan, United States, 48126
      • Revival Research Institute - Dearborn- Site Number : 8400097
    • Lathrup Village, Michigan, United States, 48076
      • Revive Research Institute - Lathrup Village- Site Number : 8400100
    • Rochester, Michigan, United States, 48307
      • Romedica- Site Number : 8400043
    • Southfield, Michigan, United States, 48075-5400
      • Great Lakes Research Institute Site Number : 8400111
    • Southfield, Michigan, United States, 48075
      • Great Lakes Research Institute - Southfield- Site Number : 8400111
    • Ypsilanti, Michigan, United States, 48197
      • Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • The Asthma and Allergy Center- Site Number : 8400055
  • New Jersey
    • Jersey City, New Jersey, United States, 07304
      • Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143
  • New York
    • The Bronx, New York, United States, 10459
      • Urban Health Plan- Site Number : 8400144
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • Clinical Research Of Gastonia- Site Number : 8400012
    • Huntersville, North Carolina, United States, 28078
      • Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056
    • Mooresville, North Carolina, United States, 28117
      • Lapis Clinical Research - Mooresville- Site Number : 8400112
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center- Site Number : 8400153
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Asthma & Allergy Center - Toledo- Site Number : 8400051
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital- Site Number : 8400099
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital- Site Number : 8400038
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants- Site Number : 8400102
    • Greenville, South Carolina, United States, 29607
      • Allergic Disease and Asthma Center (ADAC)- Site Number : 8400026
    • Little River, South Carolina, United States, 29566
      • Main Street Physician's Care- Site Number : 8400077
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts- Site Number : 8400006
  • Texas
    • Beaumont, Texas, United States, 77701
      • REX Clinical Trials - Beaumont- Site Number : 8400135
    • Boerne, Texas, United States, 78006
      • South Texas Medical Research Institute - TTS Research- Site Number : 8400009
    • Dallas, Texas, United States, 75225
      • Discovery Clinical Trials - Dallas- Site Number : 8400123
    • Dallas, Texas, United States, 75254
      • IntraCare- Site Number : 8400003
    • Houston, Texas, United States, 77022
      • C & R Research Services - Houston- Site Number : 8400067
    • Houston, Texas, United States, 77089
      • Clear Brook Medical Associates- Site Number : 8400080
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Center- Site Number : 8400014
    • San Antonio, Texas, United States, 78229
      • Andante Research- Site Number : 8400140
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - 710 Lawrence Street- Site Number : 8400103
  • Virginia
    • Burke, Virginia, United States, 22015
      • Burke Internal Medicine and Research- Site Number : 8400170
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia- Site Number : 8400082

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.
• Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
• Treatment with medium to high dose inhaled corticosteroids (ICS) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), leukotriene receptor antagonists (LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1. Patients requiring an additional controller as a fourth controller (Montelukast) for another type 2 comorbid condition such as allergic rhinitis will be considered eligible for this study, and should be on a stable dose for ≥1 month prior to Visit 1.
• Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization
• Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.

• Variable airflow obstruction as documented by one or more of the following (at least 1 needs to be met):

  i) Positive reversibility test: ≥12% and 200 mL improvement in FEV1 after SABA administration prior to randomization, or documented in the 24 months prior to Visit 1. OR, ii) Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine, or ≥15% with standardized hyperventilation, hypertonic saline or mannitol challenge prior to randomization or documented in the 24 months prior to Visit 1 OR, iii) Average daily diurnal Peak flow variability of >10% over a 2-week period, documented in the past 24 months prior to Screening Visit 1. OR, iv) Airflow variability in clinic FEV1 >12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Screening Visit 1. OR v) FEV1 increases by more than 12% and 200mL from baseline after 4 weeks of anti-inflammatory treatment.

• Reversibility test: Three attempts may be made during the Screening Period until the Baseline visit to meet the qualifying criteria for reversibility. This is only required if reversibility or other evidence of expiratory airflow limitation eligibility criteria was not performed within 24 months prior to Visit 1.
• FeNO ≥35 ppb at Visit 2, prior to randomization.

• History of ≥1 severe exacerbation(s) in the previous year before Visit1 defined as a deterioration of asthma requiring:

  i) Use of systemic corticosteroids for ≥3 days; or ii) Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).
• Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.
• Current acute bronchospasm or status asthmaticus.
• Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.
• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms [CRFs], etc).
• Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
• Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.
• Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.
• History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
• Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
• Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
• Previous smoker with a smoking history >10 pack-years.
• History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
• Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.
• Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab; Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1	Drug: Dupilumab; solution for injection subcutaneous
Placebo Comparator: Placebo; Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1	Drug: Placebo; solution for injection subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population	Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.	Week 8 to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population	Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.	Week 8 to Week 52
Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population	Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.	Week 8 to Week 104
Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations	Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.	Baseline to Week 52
Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations	Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.	Baseline to Week 52
Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations	Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	Baseline to Week 52
Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations	Change from baseline to week 52 in FeNO levels in FeNO and Total populations.	Baseline to Week 52
Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations	ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.	Baseline to Week 52
Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations	Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.	Baseline to Week 52
Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations	Change from baseline to week 52 in FVC in FeNO and Total populations.	Baseline to Week 52
Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population	Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.	Week 8 to Week 104
Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations	Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.	Baseline to Week 104
Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations	Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.	Baseline to Week 104
Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations	Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	Baseline to Week 104
Change from baseline to week 104 in FeNO levels in FeNO and Total populations	Change from baseline to week 104 in FeNO levels in FeNO and Total populations.	Baseline to Week 104
Change from baseline to week 104 in ACQ-7 in FeNO and Total populations	ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.	Baseline to Week 104
Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations	Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.	Baseline to Week 104
Change from baseline to week 104 FVC in FeNO and Total populations	Change from baseline to week 104 FVC in FeNO and Total populations.	Baseline to Week 104
Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations	The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.	Baseline to Week 52
Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations	The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.	Baseline to Week 104
Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations	Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.	Week 8 to Week 156
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Incidence of TEAEs and SAEs.	Baseline to Week 168
Incidence of adverse events of special interest (AESIs)	Incidence of AESIs.	Baseline to Week 168

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• De Prado Gomez L, Pavord I, Busse W, Brightling CE, Wechsler ME, Rabe KF, Zhang M, Xing J, Jacob-Nara JA, Rowe PJ. Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design. ERJ Open Res. 2023 Mar 6;9(2):00417-2022. doi: 10.1183/23120541.00417-2022. eCollection 2023 Mar.

Helpful Links

• LPS16676 Asthma clinical study website
• LPS16676 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): June 8, 2029

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; dupilumab
• Other Study ID Numbers: LPS16676; 2021-003903-16 (EudraCT Number); U1111-1266-2849 (Registry Identifier: ICTRP); 2024-513423-16 (Registry Identifier: CTIS)

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