AzTrials
AzTrials

AsthmaPhase 4ATLASNCT05097287

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

A Phase 4 study testing Dupilumab in people with Asthma, run by Sanofi at 249 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,339 participants
Where
249 sitesin 23 countries
Study dates
16 Dec 2021to 8 Jun 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

249 sites in 23 countries.

249 sites in 23 countries

United States75 sites

  • Appalachian Clinical Research- Site Number : 8400129

    Adairsville, Georgia, 30103

  • Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035

    Altamonte Springs, Florida, 32701

  • University of Michigan Health System - Ann Arbor- Site Number : 8400030

    Ann Arbor, Michigan, 48109

  • Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087

    Annapolis, Maryland, 21401

  • Florida Center for Allergy & Asthma Research- Site Number : 8400032

    Aventura, Florida, 33180

  • Kern Allergy and Medical Research- Site Number : 8400037

    Bakersfield, California, 93301

  • REX Clinical Trials - Beaumont- Site Number : 8400135

    Beaumont, Texas, 77701

  • The Asthma and Allergy Center- Site Number : 8400055

    Bellevue, Nebraska, 68123

  • St. Luke's University Hospital- Site Number : 8400099

    Bethlehem, Pennsylvania, 18015

  • Vitality Clinical Research- Site Number : 8400142

    Beverly Hills, California, 90211

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400009

    Boerne, Texas, 78006

  • Burke Internal Medicine and Research- Site Number : 8400170

    Burke, Virginia, 22015

  • Chandler Clinical Research Trials- Site Number : 8400147

    Chandler, Arizona, 85224

  • University of Virginia- Site Number : 8400082

    Charlottesville, Virginia, 22908

  • Rush University Medical Center- Site Number : 8400146

    Chicago, Illinois, 60612

  • Urgent Care Clinical Trials and KUR Research- Site Number : 8400169

    Columbia, Maryland, 21045

  • Bogan Sleep Consultants- Site Number : 8400102

    Columbia, South Carolina, 29201

  • Avant Research Associates - Crowley- Site Number : 8400117

    Crowley, Louisiana, 70526

  • Cullman Research Center- Site Number : 8400001

    Cullman, Alabama, 35055

  • Beautiful Minds Clinical Research Center- Site Number : 8400141

    Cutler Bay, Florida, 33157

  • Discovery Clinical Trials - Dallas- Site Number : 8400123

    Dallas, Texas, 75225

  • IntraCare- Site Number : 8400003

    Dallas, Texas, 75254

  • Revival Research Institute - Dearborn- Site Number : 8400097

    Dearborn, Michigan, 48126

  • Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023

    DeBary, Florida, 32713

  • Alpha Clinical Research Group - Dunwoody- Site Number : 8400116

    Dunwoody, Georgia, 30350

  • Genesis Clinical Research - Fall River- Site Number : 8400050

    Fall River, Massachusetts, 02723

  • Ascada Research - Fullerton- Site Number : 8400076

    Fullerton, California, 92835

  • Clinical Research Of Gastonia- Site Number : 8400012

    Gastonia, North Carolina, 28054

  • Allergic Disease and Asthma Center (ADAC)- Site Number : 8400026

    Greenville, South Carolina, 29607

  • Investigational Site Number : 3560016

    Houma, Louisiana, 70360-4413

  • C & R Research Services - Houston- Site Number : 8400067

    Houston, Texas, 77022

  • Clear Brook Medical Associates- Site Number : 8400080

    Houston, Texas, 77089

  • Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056

    Huntersville, North Carolina, 28078

  • Allergy and Asthma Specialists Medical Group- Site Number : 8400162

    Huntington Beach, California, 92647

  • Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143

    Jersey City, New Jersey, 07304

  • Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098

    Kissimmee, Florida, 34746

  • Revive Research Institute - Lathrup Village- Site Number : 8400100

    Lathrup Village, Michigan, 48076

  • Main Street Physician's Care- Site Number : 8400077

    Little River, South Carolina, 29566

  • Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160

    Louisville, Kentucky, 40217

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400014

    McKinney, Texas, 75069

  • Tandem Clinical Research - Metairie- Site Number : 8400163

    Metairie, Louisiana, 70006

  • Ivetmar Medical Group- Site Number : 8400063

    Miami, Florida, 33155

  • My Preferred Research- Site Number : 8400073

    Miami, Florida, 33155

  • Research Institute of South Florida- Site Number : 8400079

    Miami, Florida, 33173

  • Floridian Clinical Research - Miami Lakes- Site Number : 8400091

    Miami Lakes, Florida, 33016

  • Lapis Clinical Research - Mooresville- Site Number : 8400112

    Mooresville, North Carolina, 28117

  • Newport Native MD- Site Number : 8400054

    Newport Beach, California, 92663

  • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092

    North Charleston, South Carolina, 29420

  • Heuer M.D. Research- Site Number : 8400024

    Orlando, Florida, 32819

  • Allergy and Asthma Specialist- Site Number : 8400007

    Owensboro, Kentucky, 42301

  • Temple University Hospital- Site Number : 8400038

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates - Deer Valley Office- Site Number : 8400155

    Phoenix, Arizona, 85027

  • Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130

    Phoenix, Arizona, 85051

  • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042

    Pittsburgh, Pennsylvania, 15241

  • Prospective Research Innovations- Site Number : 8400131

    Rancho Cucamonga, California, 91730

  • Health Concepts- Site Number : 8400006

    Rapid City, South Dakota, 57702

  • Romedica- Site Number : 8400043

    Rochester, Michigan, 48307

  • Mercy Medical Group - Midtown- Site Number : 8400164

    Sacramento, California, 95816

  • Andante Research- Site Number : 8400140

    San Antonio, Texas, 78229

  • Aeroallergy Research Laboratory- Site Number : 8400114

    Savannah, Georgia, 31406

  • Shoals Primary Care - Sheffield- Site Number : 8400015

    Sheffield, Alabama, 35660

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138

    Skokie, Illinois, 60077

  • Great Lakes Research Institute Site Number : 8400111

    Southfield, Michigan, 48075-5400

  • Great Lakes Research Institute - Southfield- Site Number : 8400111

    Southfield, Michigan, 48075

  • JSV Clinical Research- Site Number : 8400150

    Tampa, Florida, 33634

  • Urban Health Plan- Site Number : 8400144

    The Bronx, New York, 10459

  • Asthma & Allergy Center - Toledo- Site Number : 8400051

    Toledo, Ohio, 43617

  • DM Clinical Research - 710 Lawrence Street- Site Number : 8400103

    Tomball, Texas, 77375

  • Del Sol Research Management - Tucson- Site Number : 8400017

    Tucson, Arizona, 85715

  • Integrated Research of Inland- Site Number : 8400156

    Upland, California, 91786

  • Allianz Research Institute- Site Number : 8400018

    Westminster, California, 92683

  • Chesapeake Clinical Research - White Marsh- Site Number : 8400119

    White Marsh, Maryland, 21162

  • Southeastern Research Center- Site Number : 8400153

    Winston-Salem, North Carolina, 27103

  • Woodland Clinic - Woodland- Site Number : 8400171

    Woodland, California, 95695

  • Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107

    Ypsilanti, Michigan, 48197

Other trials in United States

China25 sites

  • Investigational Site Number : 1560017

    Beijing, 100029

  • Investigational Site Number : 1560022

    Beijing, 100029

  • Investigational Site Number : 1560030

    Beijing, 100191

  • Investigational Site Number : 1560006

    Dongguan, 523000

  • Investigational Site Number : 1560007

    Guangzhou, 510000

  • Investigational Site Number : 1560019

    Guiyang, 550002

  • Investigational Site Number : 1560003

    Hebei, 050051

  • Investigational Site Number : 1560023

    Hefei, 230022

  • Investigational Site Number : 1560002

    Nanchang, 330006

  • Investigational Site Number : 1560014

    Nanjing, 210008

  • Investigational Site Number : 1560008

    Ningbo, 315010

  • Investigational Site Number : 1560031

    Ningbo, 315041

  • Investigational Site Number : 1560001

    Shanghai, 200080

  • Investigational Site Number : 1560029

    Sichuan, 646000

  • Investigational Site Number : 1560011

    Taiyuan, 030001

  • Investigational Site Number : 1560012

    Taiyuan, 030032

  • Investigational Site Number : 1560004

    Tianjin, 300052

  • Investigational Site Number : 1560025

    Tianjin, 300192

  • Investigational Site Number : 1560009

    Wuxi, 214023

  • Investigational Site Number : 1560028

    Xi'an, 710004

  • Investigational Site Number : 1560020

    Xiamen, 361004

  • Investigational Site Number : 1560024

    Xiamen, 361004

  • Investigational Site Number : 1560013

    Yichang, 443003

  • Investigational Site Number : 1560010

    Yueyang, 414000

  • Investigational Site Number : 1560021

    Zhengzhou, 450003

Other trials in China

Canada18 sites

  • Investigational Site Number : 1240015

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240028

    Calgary, Alberta, T3B 0M3

  • Investigational Site Number : 1240020

    Kelowna, British Columbia, V1W 3H5

  • Investigational Site Number : 1240029

    Kingston, Ontario, K7M 7E4

  • Investigational Site Number : 1240010

    Moncton, New Brunswick, E1G 5C4

  • Investigational Site Number : 1240014

    Montreal, Quebec, H1Y 3H5

  • Investigational Site Number : 1240017

    Montreal, Quebec, H3T 1E2

  • Investigational Site Number : 1240023

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number : 1240018

    Niagara Falls, Ontario, L2H 1H5

  • Investigational Site Number : 1240002

    Québec, Quebec, G1G 3Y8

  • Investigational Site Number : 1240024

    Saskatoon, Saskatchewan, S7N 0W8

  • Investigational Site Number : 1240025

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240011

    Toronto, Ontario, M5G 1E2

  • Investigational Site Number : 1240001

    Toronto, Ontario, M5T 3A9

  • Investigational Site Number : 1240007

    Toronto, Ontario, M9V 4B4

  • Investigational Site Number : 1240022

    Vancouver, British Columbia, V5Z 1M9

  • Investigational Site Number : 1240004

    Vancouver, British Columbia, V6Z 1Y6

  • Investigational Site Number : 1240003

    Windsor, Ontario, N8X 5A6

Other trials in Canada

India14 sites

  • Investigational Site Number : 3560011

    Ahmedabad, 380008

  • Investigational Site Number : 3560003

    Chandigarh, 160012

  • Investigational Site Number : 3560008

    Coimbatore, 641028

  • Investigational Site Number : 3560001

    Jaipur, 302023

  • Investigational Site Number : 3560019

    Jodhpur, 342005

  • Investigational Site Number : 3560002

    Kozhikode, 673008

  • Investigational Site Number : 3560014

    Lucknow, 226006

  • Investigational Site Number : 3560006

    Mangaluru, 575003

  • Investigational Site Number : 3560018

    Mysuru, 570001

  • Investigational Site Number : 3560009

    Nagpur, 440012

  • Investigational Site Number : 3560012

    Nagpur, 440012

  • Investigational Site Number : 3560015

    New Delhi, 110025

  • Investigational Site Number : 3560020

    Pune, 411004

  • Investigational Site Number : 3560004

    Vadodara, 390021

Other trials in India

Mexico12 sites

  • Investigational Site Number : 4840016

    Chihuahua City, 31000

  • Investigational Site Number : 4840012

    Chihuahua City, 31217

  • Investigational Site Number : 4840001

    Durango, 34000

  • Investigational Site Number : 4840002

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840006

    Mexico City, Mexico City, 06700

  • Investigational Site Number : 4840008

    Monterrey, Nuevo León, 64060

  • Investigational Site Number : 4840004

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840005

    Monterrey, Nuevo León, 66465

  • Investigational Site Number : 4840013

    Oaxaca City, 68020

  • Investigational Site Number : 4840014

    San Juan del Río, Querétaro, 76800

  • Investigational Site Number : 4840003

    Veracruz, 91900

  • Investigational Site Number : 4840010

    Villahermosa, Tabasco, 86035

Other trials in Mexico

Greece11 sites

  • Investigational Site Number : 3000011

    Alexandroupoli, 681 00

  • Investigational Site Number : 3000003

    Athens, 106 76

  • Investigational Site Number : 3000010

    Athens, 115 21

  • Investigational Site Number : 3000007

    Athens, 115 25

  • Investigational Site Number : 3000004

    Athens, 115 27

  • Investigational Site Number : 3000006

    Athens, 115 27

  • Investigational Site Number : 3000005

    Athens, 124 62

  • Investigational Site Number : 3000002

    Ioannina, 455 00

  • Investigational Site Number : 3000009

    Palaió Fáliro, 175 62

  • Investigational Site Number : 3000008

    Thessaloniki, 564 29

  • Investigational Site Number : 3000001

    Thessaloniki, 570 10

Other trials in Greece

South Africa11 sites

  • Investigational Site Number : 7100006

    Benoni, 1500

  • Investigational Site Number : 7100013

    Cape Town, 7505

  • Investigational Site Number : 7100001

    Cape Town, 7700

  • Investigational Site Number : 7100004

    Cape Town, 7764

  • Investigational Site Number : 7100012

    Chatsworth, 4092

  • Investigational Site Number : 7100003

    Durban, 4001

  • Investigational Site Number : 7100009

    Durban, 4302

  • Investigational Site Number : 7100014

    Kempton Park, 1619

  • Investigational Site Number : 7100002

    Pretoria, 0009

  • Investigational Site Number : 7100008

    Somerset West, 7130

  • Investigational Site Number : 7100007

    Vereeniging, 1935

Other trials in South Africa

Hungary10 sites

  • Investigational Site Number : 3480012

    Budapest, 1204

  • Investigational Site Number : 3480011

    Budapest, 2200

  • Investigational Site Number : 3480008

    Debrecen, 4031

  • Investigational Site Number : 3480005

    Edelény, 3780

  • Investigational Site Number : 3480004

    Hajdúnánás, 4080

  • Investigational Site Number : 3480007

    Mosonmagyaróvár, 9200

  • Investigational Site Number : 3480003

    Püspökladány, 4150

  • Investigational Site Number : 3480001

    Százhalombatta, 2440

  • Investigational Site Number : 3480013

    Szekszárd, 7100

  • Investigational Site Number : 3480006

    Szombathely, 9700

Other trials in Hungary

South Korea10 sites

  • Investigational Site Number : 4100010

    Bupyeong-Gu, Incheon-gwangyeoksi, 21431

  • Investigational Site Number : 4100007

    Busan, Busan, 49241

  • Investigational Site Number : 4100006

    Daegu, Gyeongsangbuk-do, 42415

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100009

    Seoul, Seoul-teukbyeolsi, 03312

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 06351

  • Investigational Site Number : 4100008

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Brazil9 sites

  • Health & Care - Consultancy, Research and HealthCare Management- Site Number : 0760010

    Belém, Pará, 66095-055

  • Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760006

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital Dia do Pulmão- Site Number : 0760002

    Blumenau, Santa Catarina, 89030-101

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760005

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Associacao Proar- Site Number : 0760004

    Salvador, Estado de Bahia, 40060-330

  • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760007

    São Paulo, 01323-020

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760009

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Romania9 sites

  • Investigational Site Number : 6420010

    Baia Mare, 430061

  • Investigational Site Number : 6420005

    Bragadiru, 769764

  • Investigational Site Number : 6420007

    Brasov, 500051

  • Investigational Site Number : 6420002

    Brasov, 500283

  • Investigational Site Number : 6420004

    Codlea, 505100

  • Investigational Site Number : 6420011

    Craiova, 200515

  • Investigational Site Number : 6420001

    Deva, 330162

  • Investigational Site Number : 6420008

    Piteşti, 110117

  • Investigational Site Number : 6420009

    Timișoara, 300134

Other trials in Romania

Bulgaria8 sites

  • Investigational Site Number : 1000005

    Dupnitsa, 2600

  • Investigational Site Number : 1000012

    Plovdiv, 4023

  • Investigational Site Number : 1000011

    Rousse, 7000

  • Investigational Site Number : 1000002

    Sofia, 1233

  • Investigational Site Number : 1000008

    Sofia, 1407

  • Investigational Site Number : 1000009

    Sofia, 1431

  • Investigational Site Number : 1000014

    Sofia, 1756

  • Investigational Site Number : 1000013

    Vratsa, 3001

Other trials in Bulgaria

Turkey (Türkiye)8 sites

  • Investigational Site Number : 7920003

    Adana, 01330

  • Investigational Site Number : 7920008

    Ankara, 06520

  • Investigational Site Number : 7920007

    Ankara, 06620

  • Investigational Site Number : 7920001

    Istanbul, 34098

  • Investigational Site Number : 7920006

    Izmir, 35100

  • Investigational Site Number : 7920009

    Kayseri, 38039

  • Investigational Site Number : 7920004

    Kirikkale, 71100

  • Investigational Site Number : 7920002

    Mersin, 33070

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Investigational Site Number : 8260002

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260004

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260005

    Liverpool, L7 8XP

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number : 8260003

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260008

    Wakefield, WF1 4DG

Other trials in United Kingdom

Slovakia4 sites

  • Investigational Site Number : 7030003

    Levice, 934 01

  • Investigational Site Number : 7030001

    Poprad, 058 01

  • Investigational Site Number : 7030002

    Spišská Nová Ves, 052 01

  • Investigational Site Number : 7030005

    Topoľčany, 955 01

Other trials in Slovakia

Taiwan4 sites

  • Investigational Site Number : 1580003

    Douliu, 640

  • Investigational Site Number : 1580001

    Kaohsiung City, 807

  • Investigational Site Number : 1580004

    Taichung, 404

  • Investigational Site Number : 1580002

    Taipei, 110

Other trials in Taiwan

Peru3 sites

  • Investigational Site Number : 6040001

    Lima, 15001

  • Investigational Site Number : 6040002

    Lima, 15102

  • Investigational Site Number : 6040003

    Piura, 20000

Other trials in Peru

Puerto Rico3 sites

  • Cardio Pulmonary Research Center- Site Number : 8400126

    Guaynabo, 00968

  • FDI Clinical Research- Site Number : 8400121

    San Juan, 00927

  • University of Puerto Rico - Medical Sciences Campus- Site Number : 8400128

    San Juan, 00936

Other trials in Puerto Rico

Belgium2 sites

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About this study

Official title: 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.

Conditions
Asthma
Being tested
Dupilumab, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    solution for injection subcutaneous

  • PlaceboDrug

    solution for injection subcutaneous

Study groups in NCT05097287
Study groupRoleWhat they receive
DupilumabExperimentalDupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1
Receives: Drug: Dupilumab
PlaceboPlacebo comparatorMatching placebo administered Q2W after an initial loading dose (2 injections) on Day 1
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: Week 8 to Week 52

Secondary outcomes (22)

  1. 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.

    Measured: Week 8 to Week 52

  2. 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.

    Measured: Week 8 to Week 104

  3. 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.

    Measured: Baseline to Week 52

  4. 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.

    Measured: Baseline to Week 52

  5. 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.

    Measured: Baseline to Week 52

  6. 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.

    Measured: Baseline to Week 52

  7. 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.

    Measured: Baseline to Week 52

  8. 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.

    Measured: Baseline to Week 52

  9. 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.

    Measured: Baseline to Week 52

  10. 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.

    Measured: Week 8 to Week 104

  11. 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.

    Measured: Baseline to Week 104

  12. 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.

    Measured: Baseline to Week 104

  13. 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.

    Measured: Baseline to Week 104

  14. 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.

    Measured: Baseline to Week 104

  15. 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.

    Measured: Baseline to Week 104

  16. 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.

    Measured: Baseline to Week 104

  17. Change from baseline to week 104 FVC in FeNO and Total populations

    Change from baseline to week 104 FVC in FeNO and Total populations.

    Measured: Baseline to Week 104

  18. 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.

    Measured: Baseline to Week 52

  19. 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.

    Measured: Baseline to Week 104

  20. 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.

    Measured: Week 8 to Week 156

  21. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Incidence of TEAEs and SAEs.

    Measured: Baseline to Week 168

  22. Incidence of adverse events of special interest (AESIs)

    Incidence of AESIs.

    Measured: Baseline to Week 168

Timeline

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

  1. First posted28 Oct 2021
  2. Study start16 Dec 2021
  3. Primary completion16 Mar 2027 (estimated)
  4. Study completion8 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05097287
Sponsor's protocol ID
LPS16676
Other IDs
U1111-1266-2849, 2024-513423-16, 2021-003903-16
Acronym
ATLAS
Status last verified
Apr 2026
First submitted
15 Oct 2021
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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.

    PubMed 36891077

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dupilumab in people with Asthma, run by Sanofi at 249 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, China, Canada, India, Mexico and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population (time frame: Week 8 to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05097287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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