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
4 other identifiers
interventional
1,339
23 countries
249
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Dec 2021
Longer than P75 for phase_4 asthma
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedStudy Start
First participant enrolled
December 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 8, 2029
April 16, 2026
April 1, 2026
5.2 years
October 15, 2021
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
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
Week 8 to Week 104
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
Baseline to Week 52
Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations
Baseline to Week 52
- +17 more secondary outcomes
Study Arms (2)
Dupilumab
EXPERIMENTALDupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1
Placebo
PLACEBO COMPARATORMatching placebo administered Q2W after an initial loading dose (2 injections) on Day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (249)
Cullman Research Center- Site Number : 8400001
Cullman, Alabama, 35055, United States
Shoals Primary Care - Sheffield- Site Number : 8400015
Sheffield, Alabama, 35660, United States
Chandler Clinical Research Trials- Site Number : 8400147
Chandler, Arizona, 85224, United States
Pulmonary Associates - Deer Valley Office- Site Number : 8400155
Phoenix, Arizona, 85027, United States
Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130
Phoenix, Arizona, 85051, United States
Del Sol Research Management - Tucson- Site Number : 8400017
Tucson, Arizona, 85715, United States
Kern Allergy and Medical Research- Site Number : 8400037
Bakersfield, California, 93301, United States
Vitality Clinical Research- Site Number : 8400142
Beverly Hills, California, 90211, United States
Ascada Research - Fullerton- Site Number : 8400076
Fullerton, California, 92835, United States
Allergy and Asthma Specialists Medical Group- Site Number : 8400162
Huntington Beach, California, 92647, United States
Newport Native MD- Site Number : 8400054
Newport Beach, California, 92663, United States
Prospective Research Innovations- Site Number : 8400131
Rancho Cucamonga, California, 91730, United States
Mercy Medical Group - Midtown- Site Number : 8400164
Sacramento, California, 95816, United States
Integrated Research of Inland- Site Number : 8400156
Upland, California, 91786, United States
Allianz Research Institute- Site Number : 8400018
Westminster, California, 92683, United States
Woodland Clinic - Woodland- Site Number : 8400171
Woodland, California, 95695, United States
Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035
Altamonte Springs, Florida, 32701, United States
Florida Center for Allergy & Asthma Research- Site Number : 8400032
Aventura, Florida, 33180, United States
Beautiful Minds Clinical Research Center- Site Number : 8400141
Cutler Bay, Florida, 33157, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023
DeBary, Florida, 32713, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098
Kissimmee, Florida, 34746, United States
Ivetmar Medical Group- Site Number : 8400063
Miami, Florida, 33155, United States
My Preferred Research- Site Number : 8400073
Miami, Florida, 33155, United States
Research Institute of South Florida- Site Number : 8400079
Miami, Florida, 33173, United States
Floridian Clinical Research - Miami Lakes- Site Number : 8400091
Miami Lakes, Florida, 33016, United States
Heuer M.D. Research- Site Number : 8400024
Orlando, Florida, 32819, United States
JSV Clinical Research- Site Number : 8400150
Tampa, Florida, 33634, United States
Appalachian Clinical Research- Site Number : 8400129
Adairsville, Georgia, 30103, United States
Alpha Clinical Research Group - Dunwoody- Site Number : 8400116
Dunwoody, Georgia, 30350, United States
Aeroallergy Research Laboratory- Site Number : 8400114
Savannah, Georgia, 31406, United States
Rush University Medical Center- Site Number : 8400146
Chicago, Illinois, 60612, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138
Skokie, Illinois, 60077, United States
Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160
Louisville, Kentucky, 40217, United States
Allergy and Asthma Specialist- Site Number : 8400007
Owensboro, Kentucky, 42301, United States
Avant Research Associates - Crowley- Site Number : 8400117
Crowley, Louisiana, 70526, United States
Investigational Site Number : 3560016
Houma, Louisiana, 70360-4413, United States
Tandem Clinical Research - Metairie- Site Number : 8400163
Metairie, Louisiana, 70006, United States
Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087
Annapolis, Maryland, 21401, United States
Urgent Care Clinical Trials and KUR Research- Site Number : 8400169
Columbia, Maryland, 21045, United States
Chesapeake Clinical Research - White Marsh- Site Number : 8400119
White Marsh, Maryland, 21162, United States
Genesis Clinical Research - Fall River- Site Number : 8400050
Fall River, Massachusetts, 02723, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400030
Ann Arbor, Michigan, 48109, United States
Revival Research Institute - Dearborn- Site Number : 8400097
Dearborn, Michigan, 48126, United States
Revive Research Institute - Lathrup Village- Site Number : 8400100
Lathrup Village, Michigan, 48076, United States
Romedica- Site Number : 8400043
Rochester, Michigan, 48307, United States
Great Lakes Research Institute Site Number : 8400111
Southfield, Michigan, 48075-5400, United States
Great Lakes Research Institute - Southfield- Site Number : 8400111
Southfield, Michigan, 48075, United States
Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107
Ypsilanti, Michigan, 48197, United States
The Asthma and Allergy Center- Site Number : 8400055
Bellevue, Nebraska, 68123, United States
Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143
Jersey City, New Jersey, 07304, United States
Urban Health Plan- Site Number : 8400144
The Bronx, New York, 10459, United States
Clinical Research Of Gastonia- Site Number : 8400012
Gastonia, North Carolina, 28054, United States
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056
Huntersville, North Carolina, 28078, United States
Lapis Clinical Research - Mooresville- Site Number : 8400112
Mooresville, North Carolina, 28117, United States
Southeastern Research Center- Site Number : 8400153
Winston-Salem, North Carolina, 27103, United States
Asthma & Allergy Center - Toledo- Site Number : 8400051
Toledo, Ohio, 43617, United States
St. Luke's University Hospital- Site Number : 8400099
Bethlehem, Pennsylvania, 18015, United States
Temple University Hospital- Site Number : 8400038
Philadelphia, Pennsylvania, 19140, United States
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042
Pittsburgh, Pennsylvania, 15241, United States
Bogan Sleep Consultants- Site Number : 8400102
Columbia, South Carolina, 29201, United States
Allergic Disease and Asthma Center (ADAC)- Site Number : 8400026
Greenville, South Carolina, 29607, United States
Main Street Physician's Care- Site Number : 8400077
Little River, South Carolina, 29566, United States
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092
North Charleston, South Carolina, 29420, United States
Health Concepts- Site Number : 8400006
Rapid City, South Dakota, 57702, United States
REX Clinical Trials - Beaumont- Site Number : 8400135
Beaumont, Texas, 77701, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400009
Boerne, Texas, 78006, United States
Discovery Clinical Trials - Dallas- Site Number : 8400123
Dallas, Texas, 75225, United States
IntraCare- Site Number : 8400003
Dallas, Texas, 75254, United States
C & R Research Services - Houston- Site Number : 8400067
Houston, Texas, 77022, United States
Clear Brook Medical Associates- Site Number : 8400080
Houston, Texas, 77089, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400014
McKinney, Texas, 75069, United States
Andante Research- Site Number : 8400140
San Antonio, Texas, 78229, United States
DM Clinical Research - 710 Lawrence Street- Site Number : 8400103
Tomball, Texas, 77375, United States
Burke Internal Medicine and Research- Site Number : 8400170
Burke, Virginia, 22015, United States
University of Virginia- Site Number : 8400082
Charlottesville, Virginia, 22908, United States
Investigational Site Number : 0560002
Brussels, 1200, Belgium
Investigational Site Number : 0560003
Liège, 4000, Belgium
Associacao Proar- Site Number : 0760004
Salvador, Estado de Bahia, 40060-330, Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760006
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Health & Care - Consultancy, Research and HealthCare Management- Site Number : 0760010
Belém, Pará, 66095-055, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760005
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital Dia do Pulmão- Site Number : 0760002
Blumenau, Santa Catarina, 89030-101, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760009
Sorocaba, São Paulo, 18040-425, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760007
São Paulo, 01323-020, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008
São Paulo, 05403-000, Brazil
Investigational Site Number : 1000005
Dupnitsa, 2600, Bulgaria
Investigational Site Number : 1000012
Plovdiv, 4023, Bulgaria
Investigational Site Number : 1000011
Rousse, 7000, Bulgaria
Investigational Site Number : 1000002
Sofia, 1233, Bulgaria
Investigational Site Number : 1000008
Sofia, 1407, Bulgaria
Investigational Site Number : 1000009
Sofia, 1431, Bulgaria
Investigational Site Number : 1000014
Sofia, 1756, Bulgaria
Investigational Site Number : 1000013
Vratsa, 3001, Bulgaria
Investigational Site Number : 1240028
Calgary, Alberta, T3B 0M3, Canada
Investigational Site Number : 1240020
Kelowna, British Columbia, V1W 3H5, Canada
Investigational Site Number : 1240022
Vancouver, British Columbia, V5Z 1M9, Canada
Investigational Site Number : 1240004
Vancouver, British Columbia, V6Z 1Y6, Canada
Investigational Site Number : 1240010
Moncton, New Brunswick, E1G 5C4, Canada
Investigational Site Number : 1240015
Ajax, Ontario, L1S 2J5, Canada
Investigational Site Number : 1240029
Kingston, Ontario, K7M 7E4, Canada
Investigational Site Number : 1240018
Niagara Falls, Ontario, L2H 1H5, Canada
Investigational Site Number : 1240011
Toronto, Ontario, M5G 1E2, Canada
Investigational Site Number : 1240001
Toronto, Ontario, M5T 3A9, Canada
Investigational Site Number : 1240007
Toronto, Ontario, M9V 4B4, Canada
Investigational Site Number : 1240003
Windsor, Ontario, N8X 5A6, Canada
Investigational Site Number : 1240014
Montreal, Quebec, H1Y 3H5, Canada
Investigational Site Number : 1240017
Montreal, Quebec, H3T 1E2, Canada
Investigational Site Number : 1240023
Montreal, Quebec, H4A 3J1, Canada
Investigational Site Number : 1240002
Québec, Quebec, G1G 3Y8, Canada
Investigational Site Number : 1240025
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240024
Saskatoon, Saskatchewan, S7N 0W8, Canada
Investigational Site Number : 1560017
Beijing, 100029, China
Investigational Site Number : 1560022
Beijing, 100029, China
Investigational Site Number : 1560030
Beijing, 100191, China
Investigational Site Number : 1560006
Dongguan, 523000, China
Investigational Site Number : 1560007
Guangzhou, 510000, China
Investigational Site Number : 1560019
Guiyang, 550002, China
Investigational Site Number : 1560003
Hebei, 050051, China
Investigational Site Number : 1560023
Hefei, 230022, China
Investigational Site Number : 1560002
Nanchang, 330006, China
Investigational Site Number : 1560014
Nanjing, 210008, China
Investigational Site Number : 1560008
Ningbo, 315010, China
Investigational Site Number : 1560031
Ningbo, 315041, China
Investigational Site Number : 1560001
Shanghai, 200080, China
Investigational Site Number : 1560029
Sichuan, 646000, China
Investigational Site Number : 1560011
Taiyuan, 030001, China
Investigational Site Number : 1560012
Taiyuan, 030032, China
Investigational Site Number : 1560004
Tianjin, 300052, China
Investigational Site Number : 1560025
Tianjin, 300192, China
Investigational Site Number : 1560009
Wuxi, 214023, China
Investigational Site Number : 1560028
Xi'an, 710004, China
Investigational Site Number : 1560020
Xiamen, 361004, China
Investigational Site Number : 1560024
Xiamen, 361004, China
Investigational Site Number : 1560013
Yichang, 443003, China
Investigational Site Number : 1560010
Yueyang, 414000, China
Investigational Site Number : 1560021
Zhengzhou, 450003, China
Investigational Site Number : 3000011
Alexandroupoli, 681 00, Greece
Investigational Site Number : 3000003
Athens, 106 76, Greece
Investigational Site Number : 3000010
Athens, 115 21, Greece
Investigational Site Number : 3000007
Athens, 115 25, Greece
Investigational Site Number : 3000004
Athens, 115 27, Greece
Investigational Site Number : 3000006
Athens, 115 27, Greece
Investigational Site Number : 3000005
Athens, 124 62, Greece
Investigational Site Number : 3000002
Ioannina, 455 00, Greece
Investigational Site Number : 3000009
Palaió Fáliro, 175 62, Greece
Investigational Site Number : 3000008
Thessaloniki, 564 29, Greece
Investigational Site Number : 3000001
Thessaloniki, 570 10, Greece
Investigational Site Number : 3480012
Budapest, 1204, Hungary
Investigational Site Number : 3480011
Budapest, 2200, Hungary
Investigational Site Number : 3480008
Debrecen, 4031, Hungary
Investigational Site Number : 3480005
Edelény, 3780, Hungary
Investigational Site Number : 3480004
Hajdúnánás, 4080, Hungary
Investigational Site Number : 3480007
Mosonmagyaróvár, 9200, Hungary
Investigational Site Number : 3480003
Püspökladány, 4150, Hungary
Investigational Site Number : 3480001
Százhalombatta, 2440, Hungary
Investigational Site Number : 3480013
Szekszárd, 7100, Hungary
Investigational Site Number : 3480006
Szombathely, 9700, Hungary
Investigational Site Number : 3560011
Ahmedabad, 380008, India
Investigational Site Number : 3560003
Chandigarh, 160012, India
Investigational Site Number : 3560008
Coimbatore, 641028, India
Investigational Site Number : 3560001
Jaipur, 302023, India
Investigational Site Number : 3560019
Jodhpur, 342005, India
Investigational Site Number : 3560002
Kozhikode, 673008, India
Investigational Site Number : 3560014
Lucknow, 226006, India
Investigational Site Number : 3560006
Mangaluru, 575003, India
Investigational Site Number : 3560018
Mysuru, 570001, India
Investigational Site Number : 3560009
Nagpur, 440012, India
Investigational Site Number : 3560012
Nagpur, 440012, India
Investigational Site Number : 3560015
New Delhi, 110025, India
Investigational Site Number : 3560020
Pune, 411004, India
Investigational Site Number : 3560004
Vadodara, 390021, India
Investigational Site Number : 3720001
Cork, T12 E8YV, Ireland
Investigational Site Number : 3720003
Dublin, D04 T6F4, Ireland
Investigational Site Number : 4840002
Guadalajara, Jalisco, 44100, Mexico
Investigational Site Number : 4840006
Mexico City, Mexico City, 06700, Mexico
Investigational Site Number : 4840008
Monterrey, Nuevo León, 64060, Mexico
Investigational Site Number : 4840004
Monterrey, Nuevo León, 64460, Mexico
Investigational Site Number : 4840005
Monterrey, Nuevo León, 66465, Mexico
Investigational Site Number : 4840014
San Juan del Río, Querétaro, 76800, Mexico
Investigational Site Number : 4840010
Villahermosa, Tabasco, 86035, Mexico
Investigational Site Number : 4840016
Chihuahua City, 31000, Mexico
Investigational Site Number : 4840012
Chihuahua City, 31217, Mexico
Investigational Site Number : 4840001
Durango, 34000, Mexico
Investigational Site Number : 4840013
Oaxaca City, 68020, Mexico
Investigational Site Number : 4840003
Veracruz, 91900, Mexico
Investigational Site Number : 5120001
Muscat, 111, Oman
Investigational Site Number : 5120002
Muscat, 123, Oman
Investigational Site Number : 6040001
Lima, 15001, Peru
Investigational Site Number : 6040002
Lima, 15102, Peru
Investigational Site Number : 6040003
Piura, 20000, Peru
Cardio Pulmonary Research Center- Site Number : 8400126
Guaynabo, 00968, Puerto Rico
FDI Clinical Research- Site Number : 8400121
San Juan, 00927, Puerto Rico
University of Puerto Rico - Medical Sciences Campus- Site Number : 8400128
San Juan, 00936, Puerto Rico
Investigational Site Number : 6420010
Baia Mare, 430061, Romania
Investigational Site Number : 6420005
Bragadiru, 769764, Romania
Investigational Site Number : 6420007
Brasov, 500051, Romania
Investigational Site Number : 6420002
Brasov, 500283, Romania
Investigational Site Number : 6420004
Codlea, 505100, Romania
Investigational Site Number : 6420011
Craiova, 200515, Romania
Investigational Site Number : 6420001
Deva, 330162, Romania
Investigational Site Number : 6420008
Piteşti, 110117, Romania
Investigational Site Number : 6420009
Timișoara, 300134, Romania
Investigational Site Number : 6820008
Mecca, 21955, Saudi Arabia
Investigational Site Number : 7030003
Levice, 934 01, Slovakia
Investigational Site Number : 7030001
Poprad, 058 01, Slovakia
Investigational Site Number : 7030002
Spišská Nová Ves, 052 01, Slovakia
Investigational Site Number : 7030005
Topoľčany, 955 01, Slovakia
Investigational Site Number : 7100006
Benoni, 1500, South Africa
Investigational Site Number : 7100013
Cape Town, 7505, South Africa
Investigational Site Number : 7100001
Cape Town, 7700, South Africa
Investigational Site Number : 7100004
Cape Town, 7764, South Africa
Investigational Site Number : 7100012
Chatsworth, 4092, South Africa
Investigational Site Number : 7100003
Durban, 4001, South Africa
Investigational Site Number : 7100009
Durban, 4302, South Africa
Investigational Site Number : 7100014
Kempton Park, 1619, South Africa
Investigational Site Number : 7100002
Pretoria, 0009, South Africa
Investigational Site Number : 7100008
Somerset West, 7130, South Africa
Investigational Site Number : 7100007
Vereeniging, 1935, South Africa
Investigational Site Number : 4100007
Busan, Busan, 49241, South Korea
Investigational Site Number : 4100008
Wŏnju, Gangwon-do, 26426, South Korea
Investigational Site Number : 4100006
Daegu, Gyeongsangbuk-do, 42415, South Korea
Investigational Site Number : 4100010
Bupyeong-Gu, Incheon-gwangyeoksi, 21431, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100009
Seoul, Seoul-teukbyeolsi, 03312, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 05030, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 05505, South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, 06351, South Korea
Investigational Site Number : 1580003
Douliu, 640, Taiwan
Investigational Site Number : 1580001
Kaohsiung City, 807, Taiwan
Investigational Site Number : 1580004
Taichung, 404, Taiwan
Investigational Site Number : 1580002
Taipei, 110, Taiwan
Investigational Site Number : 7920003
Adana, 01330, Turkey (Türkiye)
Investigational Site Number : 7920008
Ankara, 06520, Turkey (Türkiye)
Investigational Site Number : 7920007
Ankara, 06620, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, 34098, Turkey (Türkiye)
Investigational Site Number : 7920006
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number : 7920009
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number : 7920004
Kirikkale, 71100, Turkey (Türkiye)
Investigational Site Number : 7920002
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 7840001
Abu Dhabi, 000000, United Arab Emirates
Investigational Site Number : 7840002
Abu Dhabi, 51900, United Arab Emirates
Investigational Site Number : 8260004
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Investigational Site Number : 8260003
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Investigational Site Number : 8260002
Bradford, BD9 6RJ, United Kingdom
Investigational Site Number : 8260005
Liverpool, L7 8XP, United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, NE7 7DN, United Kingdom
Investigational Site Number : 8260008
Wakefield, WF1 4DG, United Kingdom
Related Publications (1)
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.
PMID: 36891077DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 28, 2021
Study Start
December 16, 2021
Primary Completion (Estimated)
March 16, 2027
Study Completion (Estimated)
June 8, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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