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

March 11, 2024 updated by: Sanofi

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

Recruiting

Conditions

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1324

Phase

Phase 4

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

Belgium
- - Leuven, Belgium, 3000
    - Recruiting
    - Investigational Site Number : 0560001
  - Liège, Belgium, 4000
    - Recruiting
    - Investigational Site Number : 0560003
  - Sint-Lambrechts-Woluwe, Belgium, 1200
    - Recruiting
    - Investigational Site Number : 0560002
Brazil
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30150-221
    - Recruiting
    - Santa Casa de Belo Horizonte - Hospital Emygdio Germano Site Number : 0760006
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Recruiting
    - Hospital Sao Lucas da PUCRS Site Number : 0760005
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    - Recruiting
    - Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760003
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89030-100
    - Recruiting
    - HOSPITAL DIA DO PULMAO Site Number : 0760002
- São Paulo
  - Sao Paulo, São Paulo, Brazil, 01327-001
    - Recruiting
    - Hospital Alemao Oswaldo Cruz Site Number : 0760007
  - Sao Paulo, São Paulo, Brazil, 05403-000
    - Recruiting
    - Hospital das Clinicas de Sao Paulo Site Number : 0760008
  - Sorocaba, São Paulo, Brazil, 18040-425
    - Recruiting
    - Clinica de Alergia Martti Antila Site Number : 0760009
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Recruiting
    - Investigational Site Number : 1000005
  - Montana, Bulgaria, 3403
    - Recruiting
    - Investigational Site Number : 1000003
  - Plovdiv, Bulgaria, 4000
    - Recruiting
    - Investigational Site Number : 1000012
  - Ruse, Bulgaria, 7000
    - Recruiting
    - Investigational Site Number : 1000011
  - Sofia, Bulgaria, 1233
    - Recruiting
    - Investigational Site Number : 1000002
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Investigational Site Number : 1000008
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Investigational Site Number : 1000009
  - Sofia, Bulgaria, 1756
    - Recruiting
    - Investigational Site Number : 1000014
  - Vratsa, Bulgaria, 3000
    - Recruiting
    - Investigational Site Number : 1000013
Canada
- - Quebec, Canada, G1G 3Y8
    - Recruiting
    - Investigational Site Number : 1240002
  - Windsor, Canada, N8X 5A6
    - Recruiting
    - Investigational Site Number : 1240003
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 3H5
    - Recruiting
    - Investigational Site Number : 1240020
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Recruiting
    - Investigational Site Number : 1240004
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Recruiting
    - Investigational Site Number : 1240022
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 5C4
    - Recruiting
    - Investigational Site Number : 1240010
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Recruiting
    - Investigational Site Number : 1240015
  - Mississauga, Ontario, Canada, L4V 1P1
    - Recruiting
    - Investigational Site Number : 1240021
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Recruiting
    - Investigational Site Number : 1240018
  - Toronto, Ontario, Canada, M5G 1E2
    - Recruiting
    - Investigational Site Number : 1240011
  - Toronto, Ontario, Canada, M5T 3A9
    - Recruiting
    - Investigational Site Number : 1240001
  - Toronto, Ontario, Canada, M9V 4B4
    - Recruiting
    - Investigational Site Number : 1240007
- Quebec
  - Montreal, Quebec, Canada, H1M 1B1
    - Recruiting
    - Investigational Site Number : 1240014
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Investigational Site Number : 1240017
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Recruiting
    - Investigational Site Number : 1240025
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Investigational Site Number : 3000004
  - Athens, Greece, 10675
    - Recruiting
    - Investigational Site Number : 3000003
  - Athens, Greece, 115 27
    - Recruiting
    - Investigational Site Number : 3000006
  - Athens, Greece, 11521
    - Recruiting
    - Investigational Site Number : 3000010
  - Athens, Greece, 11525
    - Recruiting
    - Investigational Site Number : 3000007
  - Athens, Greece, 12462
    - Recruiting
    - Investigational Site Number : 3000005
  - Ioannina, Greece, 45500
    - Recruiting
    - Investigational Site Number : 3000002
  - N. Efkarpia, Greece, 56429
    - Recruiting
    - Investigational Site Number : 3000008
  - Palaio Faliro, Athens, Greece, 17562
    - Recruiting
    - Investigational Site Number : 3000009
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Investigational Site Number : 3000001
Hungary
- - Budapest, Hungary, 1106
    - Recruiting
    - Investigational Site Number : 3480011
  - Budapest, Hungary, 1203
    - Recruiting
    - Investigational Site Number : 3480012
  - Debrecen, Hungary, 4031
    - Recruiting
    - Investigational Site Number : 3480008
  - Edelény, Hungary, 3780
    - Recruiting
    - Investigational Site Number : 3480005
  - Hajdunánás, Hungary, 4080
    - Recruiting
    - Investigational Site Number : 3480004
  - Mosonmagyaróvár, Hungary, 9200
    - Recruiting
    - Investigational Site Number : 3480007
  - Puspokladany, Hungary, 4150
    - Recruiting
    - Investigational Site Number : 3480003
  - Szekszard, Hungary, 7100
    - Recruiting
    - Investigational Site Number : 3480013
  - Szombathely, Hungary, 9700
    - Recruiting
    - Investigational Site Number : 3480006
  - Százhalombatta, Hungary, 2440
    - Recruiting
    - Investigational Site Number : 3480001
India
- - Ahmedabad, India, 380060
    - Recruiting
    - Investigational Site Number : 3560011
  - Chandigarh, India, 160012
    - Recruiting
    - Investigational Site Number : 3560003
  - Coimbatore, India, 641028
    - Recruiting
    - Investigational Site Number : 3560008
  - Faridabad, India, 121001
    - Recruiting
    - Investigational Site Number : 3560016
  - Jaipur, India, 302023
    - Recruiting
    - Investigational Site Number : 3560001
  - Jodhpur, India, 342005
    - Recruiting
    - Investigational Site Number : 3560019
  - Kozhikode, India, 673008
    - Recruiting
    - Investigational Site Number : 3560002
  - Lucknow, India, 226006
    - Recruiting
    - Investigational Site Number : 3560014
  - Mangalore, India, 575003
    - Recruiting
    - Investigational Site Number : 3560006
  - Mysore, India, 570001
    - Recruiting
    - Investigational Site Number : 3560018
  - Mysore, India, 570004
    - Recruiting
    - Investigational Site Number : 3560005
  - Nagpur, India, 440012
    - Recruiting
    - Investigational Site Number : 3560009
  - Nagpur, India, 440012
    - Recruiting
    - Investigational Site Number : 3560012
  - New Delhi, India, 110025
    - Recruiting
    - Investigational Site Number : 3560015
  - Vadodara, India, 390021
    - Recruiting
    - Investigational Site Number : 3560004
Ireland
- Cork
  - Wilton, Cork, Ireland
    - Recruiting
    - Investigational Site Number : 3720001
- Dublin
  - Dublin 4, Dublin, Ireland
    - Recruiting
    - Investigational Site Number : 3720003
Korea, Republic of
- Busan-gwangyeoksi
  - Busan, Busan-gwangyeoksi, Korea, Republic of, 49241
    - Recruiting
    - Investigational Site Number : 4100007
- Daegu-gwangyeoksi
  - Daegu, Daegu-gwangyeoksi, Korea, Republic of, 705-717
    - Recruiting
    - Investigational Site Number : 4100006
- Gangwon-do
  - Wonju, Gangwon-do, Korea, Republic of, 26426
    - Recruiting
    - Investigational Site Number : 4100008
- Incheon-gwangyeoksi
  - Incheon, Incheon-gwangyeoksi, Korea, Republic of, 21431
    - Recruiting
    - Investigational Site Number : 4100010
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080
    - Recruiting
    - Investigational Site Number : 4100002
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03312
    - Recruiting
    - Investigational Site Number : 4100009
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05030
    - Recruiting
    - Investigational Site Number : 4100001
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 120-752
    - Recruiting
    - Investigational Site Number : 4100004
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 135-710
    - Recruiting
    - Investigational Site Number : 4100005
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 138-878
    - Recruiting
    - Investigational Site Number : 4100003
Mexico
- - Durango, Mexico, 34000
    - Recruiting
    - Investigational Site Number : 4840001
  - Mexico, Mexico, 06700
    - Recruiting
    - Investigational Site Number : 4840006
  - Veracruz, Mexico, 91910
    - Recruiting
    - Investigational Site Number : 4840003
- Ciudad De Mexico
  - Chihuahua, Ciudad De Mexico, Mexico, 31238
    - Recruiting
    - Investigational Site Number : 4840012
  - Oxaca, Ciudad De Mexico, Mexico, 68020
    - Recruiting
    - Investigational Site Number : 4840013
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Recruiting
    - Investigational Site Number : 4840002
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Recruiting
    - Investigational Site Number : 4840008
  - Monterrey, Nuevo León, Mexico, 66465
    - Recruiting
    - Investigational Site Number : 4840005
- Querétaro
  - San Juan del Rio, Querétaro, Mexico, 76800
    - Recruiting
    - Investigational Site Number : 4840014
Oman
- - Muscat, Oman
    - Recruiting
    - Investigational Site Number : 5120001
  - Muscat, Oman
    - Recruiting
    - Investigational Site Number : 5120002
Puerto Rico
- - Guaynabo, Puerto Rico, 00968
    - Recruiting
    - Cardiopulmonary Research Site Number : 8400126
  - San Juan, Puerto Rico, 00927
    - Recruiting
    - FDI Clinical Research Site Number : 8400121
  - San Juan, Puerto Rico, 00936
    - Recruiting
    - University of Puerto Rico Medical Sciences Campus Site Number : 8400128
Romania
- - Bragadiru, Romania, 769764
    - Recruiting
    - Investigational Site Number : 6420005
  - Brasov, Romania, 500283
    - Recruiting
    - Investigational Site Number : 6420002
  - Brasov, Romania, 500051
    - Recruiting
    - Investigational Site Number : 6420007
  - Codlea, Romania, 505100
    - Recruiting
    - Investigational Site Number : 6420004
  - Deva, Romania, 330162
    - Recruiting
    - Investigational Site Number : 6420001
  - Pitesti, Romania, 110117
    - Recruiting
    - Investigational Site Number : 6420008
  - Timisoara, Romania, 300134
    - Recruiting
    - Investigational Site Number : 6420009
Saudi Arabia
- - Riyadh, Saudi Arabia, 12746
    - Active, not recruiting
    - Investigational Site Number : 6820005
Slovakia
- - Levice, Slovakia, 93401
    - Recruiting
    - Investigational Site Number : 7030003
  - Poprad, Slovakia, 058 01
    - Recruiting
    - Investigational Site Number : 7030001
  - Spisska Nova Ves, Slovakia, 05201
    - Recruiting
    - Investigational Site Number : 7030002
  - Topolcany, Slovakia, 955 01
    - Recruiting
    - Investigational Site Number : 7030005
South Africa
- - Benoni, South Africa, 1500
    - Recruiting
    - Investigational Site Number : 7100006
  - Cape Town, South Africa, 7937
    - Recruiting
    - Investigational Site Number : 7100001
  - Cape Town, South Africa, 7130
    - Recruiting
    - Investigational Site Number : 7100008
  - Chatsworth, South Africa, 4091
    - Recruiting
    - Investigational Site Number : 7100012
  - Durban, South Africa, 4001
    - Recruiting
    - Investigational Site Number : 7100003
  - Durban, South Africa, 4302
    - Recruiting
    - Investigational Site Number : 7100009
  - Gatesville, South Africa, 4001
    - Recruiting
    - Investigational Site Number : 7100004
  - Gauteng, South Africa, 1935
    - Recruiting
    - Investigational Site Number : 7100007
  - Pretoria, South Africa, 0145
    - Recruiting
    - Investigational Site Number : 7100002
Taiwan
- - Kaohsiung, Taiwan, 807
    - Recruiting
    - Investigational Site Number : 1580001
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Investigational Site Number : 1580005
  - Taichung, Taiwan, 40447
    - Recruiting
    - Investigational Site Number : 1580004
  - Taipei, Taiwan, 110
    - Recruiting
    - Investigational Site Number : 1580002
  - Yunlin, Taiwan
    - Recruiting
    - Investigational Site Number : 1580003
Turkey
- - Ankara, Turkey, 06100
    - Recruiting
    - Investigational Site Number : 7920007
  - Ankara, Turkey, 06520
    - Completed
    - Investigational Site Number : 7920008
  - Balcali Adana, Turkey, 01330
    - Active, not recruiting
    - Investigational Site Number : 7920003
  - Istanbul, Turkey, 34098
    - Recruiting
    - Investigational Site Number : 7920001
  - Izmir, Turkey, 35100
    - Recruiting
    - Investigational Site Number : 7920006
  - Kayseri, Turkey, 38039
    - Recruiting
    - Investigational Site Number : 7920009
  - Kirikkale, Turkey, 71450
    - Recruiting
    - Investigational Site Number : 7920004
  - Mersin, Turkey, 33343
    - Active, not recruiting
    - Investigational Site Number : 7920002
United Arab Emirates
- - Abu Dhabi, United Arab Emirates, 000000
    - Recruiting
    - Investigational Site Number : 7840001
United Kingdom
- - Bradford, United Kingdom, BD9 6DA
    - Recruiting
    - Investigational Site Number : 8260002
  - Liverpool, United Kingdom, L7 8XP
    - Recruiting
    - Investigational Site Number : 8260005
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - Investigational Site Number : 8260001
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 OQQ
    - Recruiting
    - Investigational Site Number : 8260004
- Leeds
  - Wakefield, Leeds, United Kingdom, WF1 1PL
    - Recruiting
    - Investigational Site Number : 8260008
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX39DU
    - Recruiting
    - Investigational Site Number : 8260003
United States
- Alabama
  - Cullman, Alabama, United States, 35055
    - Recruiting
    - Cullman Research Center, LLC Site Number : 8400001
  - Sheffield, Alabama, United States, 35660
    - Recruiting
    - Syed Research Consultants, LLC Site Number : 8400015
- Arizona
  - Chandler, Arizona, United States, 85286
    - Recruiting
    - Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400147
  - Phoenix, Arizona, United States, 85027
    - Recruiting
    - Pulmonary Associates Site Number : 8400155
  - Tempe, Arizona, United States, 85283
    - Recruiting
    - MACOA Site Number : 8400130
  - Tucson, Arizona, United States, 85712
    - Recruiting
    - Del Sol Research Management, LLC Site Number : 8400017
- California
  - Bakersfield, California, United States, 93301
    - Recruiting
    - Kern Research, Inc Site Number : 8400037
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Vitality Clinical Research Site Number : 8400142
  - Fullerton, California, United States, 92835
    - Recruiting
    - ASCADA Research Site Number : 8400076
  - Huntington Beach, California, United States, 92647
    - Recruiting
    - Orange County Allergy & Asthma Specialists Site Number : 8400162
  - Newport Beach, California, United States, 92663
    - Recruiting
    - NewportNativeMD, Inc Site Number : 8400054
  - Orange, California, United States, 92868
    - Recruiting
    - Pediatric Subspecialty Faculty Site Number : 8400137
  - Rancho Cucamonga, California, United States, 91730
    - Recruiting
    - Prospective Research Innovations Inc. Site Number : 8400131
  - Sacramento, California, United States, 95816
    - Recruiting
    - Mercy Medical Group - Midtown, Primary and Specialty Care Site Number : 8400164
  - Upland, California, United States, 91786
    - Recruiting
    - Integrated Research of Inland, INC Site Number : 8400156
  - Westminster, California, United States, 92683
    - Recruiting
    - Allianz Research Institute Site Number : 8400018
  - Woodland, California, United States, 95695
    - Recruiting
    - WOODLAND CLINIC MEDICAL GROUP Site Number : 8400171
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Recruiting
    - Central Florida Pulmonary Group, PA Site Number : 8400035
  - Aventura, Florida, United States, 33180
    - Recruiting
    - Florida Center for Allergy and Asthma Research Site Number : 8400032
  - Cutler Bay, Florida, United States, 33157
    - Recruiting
    - Beautiful Minds Clinical Research Center Site Number : 8400141
  - DeBary, Florida, United States, 32713
    - Recruiting
    - Omega Research Site Number : 8400023
  - Kissimmee, Florida, United States, 34746
    - Recruiting
    - Florida Lung, Asthma, and Sleep Specialists Site Number : 8400098
  - Miami, Florida, United States, 33155
    - Recruiting
    - Biotech Pharmaceutical Group, LLC Site Number : 8400073
  - Miami, Florida, United States, 33155
    - Recruiting
    - Ivetmar Medical Group LLC Site Number : 8400063
  - Miami, Florida, United States, 33173
    - Recruiting
    - Research Institute of South Florida Site Number : 8400079
  - Miami Lakes, Florida, United States, 33016
    - Recruiting
    - Floridian Clinical Research Site Number : 8400091
  - Orlando, Florida, United States, 32819
    - Recruiting
    - HMD Research LLC Site Number : 8400024
  - Tampa, Florida, United States, 33634
    - Recruiting
    - JSV Clinical Research Study, Inc Site Number : 8400150
- Georgia
  - Adairsville, Georgia, United States, 30103
    - Recruiting
    - Appalachian Clinical Research Site Number : 8400129
  - Dunwoody, Georgia, United States, 30350
    - Recruiting
    - Alpha Clinical Research Georgia Site Number : 8400116
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Aeroallergy Research Laboratories Of Savannah Inc Site Number : 8400114
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Rush University Medical Center Site Number : 8400146
  - Skokie, Illinois, United States, 60077
    - Recruiting
    - NorthShore University HealthSystem Clinical Trials Center Site Number : 8400138
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Recruiting
    - Brengle Family Medicine Site Number : 8400157
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Recruiting
    - Allergy And Asthma Research Institute Site Number : 8400160
  - Owensboro, Kentucky, United States, 42301
    - Recruiting
    - Allergy & Asthma Specialists, PSC Site Number : 8400007
- Louisiana
  - Crowley, Louisiana, United States, 70526
    - Recruiting
    - Avant Research Associates LLC Site Number : 8400117
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Tandem Clinical Research, LLC Site Number : 8400163
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Recruiting
    - Javara Inc Site Number : 8400087
  - Columbia, Maryland, United States, 21045
    - Recruiting
    - Urgent Care Clinical Trials and KUR Research Site Number : 8400169
  - White Marsh, Maryland, United States, 21162
    - Recruiting
    - Allergy Asthma Specialists of Maryland Site Number : 8400119
- Massachusetts
  - Fall River, Massachusetts, United States, 02723
    - Recruiting
    - Genesis Clinical Research & Consulting Site Number : 8400050
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Site Number : 8400030
  - Dearborn, Michigan, United States, 48126
    - Recruiting
    - Revival Research Institute, LLC Site Number : 8400097
  - Lathrup Village, Michigan, United States, 48076
    - Recruiting
    - Revive Research Institute Site Number : 8400100
  - Rochester, Michigan, United States, 48307
    - Completed
    - Romedica, LLC Site Number : 8400043
  - Southfield, Michigan, United States, 48075-5400
    - Recruiting
    - Great Lakes Research Institute Site Number : 8400111
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - Respiratory Medicine Research Institute of Michigan, PLC Site Number : 8400107
- Nebraska
  - Bellevue, Nebraska, United States, 68123
    - Recruiting
    - Nebraska Medical Research Institute, Inc. Site Number : 8400055
- New Jersey
  - Jersey City, New Jersey, United States, 07304
    - Recruiting
    - Jersey City Breathing Center Site Number : 8400143
- New York
  - Bronx, New York, United States, 10459
    - Recruiting
    - Urban Health Plan Site Number : 8400144
- North Carolina
  - Gastonia, North Carolina, United States, 28054
    - Recruiting
    - Clinical Research of Gastonia Site Number : 8400012
  - Hickory, North Carolina, United States, 28601
    - Recruiting
    - Advanced Respiratory and Sleep Medicine Site Number : 8400151
  - Huntersville, North Carolina, United States, 28078
    - Recruiting
    - Advanced Respiratory and Sleep Medicine Site Number : 8400056
  - Mooresville, North Carolina, United States, 28117
    - Recruiting
    - Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400112
  - Winston-Salem, North Carolina, United States, 27103-4027
    - Recruiting
    - Southeastern Research Center Site Number : 8400153
- Ohio
  - Toledo, Ohio, United States, 43617
    - Recruiting
    - Toledo Institute of Clinical Research Site Number : 8400051
- Oklahoma
  - Tulsa, Oklahoma, United States, 74138
    - Recruiting
    - Vital Prospects Clinical Research Institute, P.C. Site Number : 8400093
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - Recruiting
    - St. Luke's University Health Network Site Number : 8400099
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Temple Lung Center Site Number : 8400038
  - Pittsburgh, Pennsylvania, United States, 15241
    - Recruiting
    - Allergy & Clinical Immunology Associates Site Number : 8400042
- South Carolina
  - Charleston, South Carolina, United States, 29420
    - Recruiting
    - National Allergy and ENT Site Number : 8400092
  - Columbia, South Carolina, United States, 29201
    - Recruiting
    - Bogan Sleep Consultants Site Number : 8400102
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - ADAC Research, PA Site Number : 8400026
  - Little River, South Carolina, United States, 29566
    - Completed
    - Main Street Physician's Care Site Number : 8400077
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Recruiting
    - Health Concepts Site Number : 8400006
- Texas
  - Beaumont, Texas, United States, 77701
    - Recruiting
    - REX Clinical Trials Site Number : 8400135
  - Boerne, Texas, United States, 78006
    - Recruiting
    - TTS Research Site Number : 8400009
  - Dallas, Texas, United States, 75225
    - Recruiting
    - DCT-Baxter Research, LLC dba Discovery Clinical Trials Site Number : 8400123
  - Denton, Texas, United States, 76201-4314
    - Recruiting
    - North Texas Allergy and Asthma Center Site Number : 8400139
  - Houston, Texas, United States, 77022
    - Recruiting
    - C & R Research Services USA Site Number : 8400067
  - Houston, Texas, United States, 77089
    - Completed
    - Clear Brook Medical Associates Site Number : 8400080
  - McKinney, Texas, United States, 75069
    - Recruiting
    - Metroplex Pulmonary and Sleep Center Site Number : 8400014
  - McKinney, Texas, United States, 75071
    - Recruiting
    - Texas Institute of Cardiology Site Number : 8400003
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Andante Research Site Number : 8400140
  - Tomball, Texas, United States, 77375
    - Recruiting
    - DM Clinical Research Site Number : 8400103
- Virginia
  - Burke, Virginia, United States, 22015
    - Recruiting
    - Burke Internal Medicine INC Site Number : 8400170
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - University of Virginia Site Number : 8400082

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

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

Number of Arms

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 Time Frame: Week 8 to Week 52	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 Time Frame: Week 8 to Week 52	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 Time Frame: Week 8 to Week 104	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 52	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 Time Frame: Week 8 to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 104	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 Time Frame: Baseline to Week 52	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 Time Frame: Baseline to Week 104	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 Time Frame: Week 8 to Week 156	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) Time Frame: Baseline to Week 168	Incidence of TEAEs and SAEs.	Baseline to Week 168
Incidence of adverse events of special interest (AESIs) Time Frame: Baseline to Week 168	Incidence of AESIs.	Baseline to Week 168

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

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.

Helpful Links

LPS16676 Asthma clinical study website

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, 2021

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

January 22, 2030

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)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LPS16676
2021-003903-16 (EudraCT Number)
U1111-1266-2849 (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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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