Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05097287

PHASE4

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1324

Start Date

2021-12-16

Completion Date

2029-08-21

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Dupilumab

solution for injection subcutaneous

DRUG

Placebo

solution for injection subcutaneous

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.

Locations (249)

Cullman Research Center- Site Number : 8400001

Cullman, Alabama, United States

Shoals Primary Care - Sheffield- Site Number : 8400015

Sheffield, Alabama, United States

Chandler Clinical Research Trials- Site Number : 8400147

Chandler, Arizona, United States

Pulmonary Associates - Deer Valley Office- Site Number : 8400155

Phoenix, Arizona, United States

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

Phoenix, Arizona, United States

Del Sol Research Management - Tucson- Site Number : 8400017

Tucson, Arizona, United States

Kern Allergy and Medical Research- Site Number : 8400037

Bakersfield, California, United States

Vitality Clinical Research- Site Number : 8400142

Beverly Hills, California, United States

Ascada Research - Fullerton- Site Number : 8400076

Fullerton, California, United States

Allergy and Asthma Specialists Medical Group- Site Number : 8400162

Huntington Beach, California, United States

Newport Native MD- Site Number : 8400054

Newport Beach, California, United States

Prospective Research Innovations- Site Number : 8400131

Rancho Cucamonga, California, United States

Mercy Medical Group - Midtown- Site Number : 8400164

Sacramento, California, United States

Integrated Research of Inland- Site Number : 8400156

Upland, California, United States

Allianz Research Institute- Site Number : 8400018

Westminster, California, United States

Woodland Clinic - Woodland- Site Number : 8400171

Woodland, California, United States

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

Altamonte Springs, Florida, United States

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

Aventura, Florida, United States

Beautiful Minds Clinical Research Center- Site Number : 8400141

Cutler Bay, Florida, United States

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

DeBary, Florida, United States

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

Kissimmee, Florida, United States

Ivetmar Medical Group- Site Number : 8400063

Miami, Florida, United States

My Preferred Research- Site Number : 8400073

Miami, Florida, United States

Research Institute of South Florida- Site Number : 8400079

Miami, Florida, United States

Floridian Clinical Research - Miami Lakes- Site Number : 8400091

Miami Lakes, Florida, United States

Heuer M.D. Research- Site Number : 8400024

Orlando, Florida, United States

JSV Clinical Research- Site Number : 8400150

Tampa, Florida, United States

Appalachian Clinical Research- Site Number : 8400129

Adairsville, Georgia, United States

Alpha Clinical Research Group - Dunwoody- Site Number : 8400116

Dunwoody, Georgia, United States

Aeroallergy Research Laboratory- Site Number : 8400114

Savannah, Georgia, United States

Rush University Medical Center- Site Number : 8400146

Chicago, Illinois, United States

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

Skokie, Illinois, United States

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

Louisville, Kentucky, United States

Allergy and Asthma Specialist- Site Number : 8400007

Owensboro, Kentucky, United States

Avant Research Associates - Crowley- Site Number : 8400117

Crowley, Louisiana, United States

Investigational Site Number : 3560016

Houma, Louisiana, United States

Tandem Clinical Research - Metairie- Site Number : 8400163

Metairie, Louisiana, United States

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

Annapolis, Maryland, United States

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

Columbia, Maryland, United States

Chesapeake Clinical Research - White Marsh- Site Number : 8400119

White Marsh, Maryland, United States

Genesis Clinical Research - Fall River- Site Number : 8400050

Fall River, Massachusetts, United States

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

Ann Arbor, Michigan, United States

Revival Research Institute - Dearborn- Site Number : 8400097

Dearborn, Michigan, United States

Revive Research Institute - Lathrup Village- Site Number : 8400100

Lathrup Village, Michigan, United States

Romedica- Site Number : 8400043

Rochester, Michigan, United States

Great Lakes Research Institute Site Number : 8400111

Southfield, Michigan, United States

Great Lakes Research Institute - Southfield- Site Number : 8400111

Southfield, Michigan, United States

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

Ypsilanti, Michigan, United States

The Asthma and Allergy Center- Site Number : 8400055

Bellevue, Nebraska, United States

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

Jersey City, New Jersey, United States

Urban Health Plan- Site Number : 8400144

The Bronx, New York, United States

Clinical Research Of Gastonia- Site Number : 8400012

Gastonia, North Carolina, United States

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

Huntersville, North Carolina, United States

Lapis Clinical Research - Mooresville- Site Number : 8400112

Mooresville, North Carolina, United States

Southeastern Research Center- Site Number : 8400153

Winston-Salem, North Carolina, United States

Asthma & Allergy Center - Toledo- Site Number : 8400051

Toledo, Ohio, United States

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

Bethlehem, Pennsylvania, United States

Temple University Hospital- Site Number : 8400038

Philadelphia, Pennsylvania, United States

Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042

Pittsburgh, Pennsylvania, United States

Bogan Sleep Consultants- Site Number : 8400102

Columbia, South Carolina, United States

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

Greenville, South Carolina, United States

Main Street Physician's Care- Site Number : 8400077

Little River, South Carolina, United States

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

North Charleston, South Carolina, United States

Health Concepts- Site Number : 8400006

Rapid City, South Dakota, United States

REX Clinical Trials - Beaumont- Site Number : 8400135

Beaumont, Texas, United States

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

Boerne, Texas, United States

Discovery Clinical Trials - Dallas- Site Number : 8400123

Dallas, Texas, United States

IntraCare- Site Number : 8400003

Dallas, Texas, United States

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

Houston, Texas, United States

Clear Brook Medical Associates- Site Number : 8400080

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center- Site Number : 8400014

McKinney, Texas, United States

Andante Research- Site Number : 8400140

San Antonio, Texas, United States

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

Tomball, Texas, United States

Burke Internal Medicine and Research- Site Number : 8400170

Burke, Virginia, United States

University of Virginia- Site Number : 8400082

Charlottesville, Virginia, United States

Investigational Site Number : 0560002

Brussels, Belgium

Investigational Site Number : 0560003

Liège, Belgium

Associacao Proar- Site Number : 0760004

Salvador, Estado de Bahia, Brazil

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

Belo Horizonte, Minas Gerais, Brazil

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

Belém, Pará, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Dia do Pulmão- Site Number : 0760002

Blumenau, Santa Catarina, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760009

Sorocaba, São Paulo, Brazil

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

São Paulo, Brazil

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

São Paulo, Brazil

Investigational Site Number : 1000005

Dupnitsa, Bulgaria

Investigational Site Number : 1000012

Plovdiv, Bulgaria

Investigational Site Number : 1000011

Rousse, Bulgaria

Investigational Site Number : 1000002

Sofia, Bulgaria

Investigational Site Number : 1000008

Sofia, Bulgaria

Investigational Site Number : 1000009

Sofia, Bulgaria

Investigational Site Number : 1000014

Sofia, Bulgaria

Investigational Site Number : 1000013

Vratsa, Bulgaria

Investigational Site Number : 1240028

Calgary, Alberta, Canada

Investigational Site Number : 1240020

Kelowna, British Columbia, Canada

Investigational Site Number : 1240022

Vancouver, British Columbia, Canada

Investigational Site Number : 1240004

Vancouver, British Columbia, Canada

Investigational Site Number : 1240010

Moncton, New Brunswick, Canada

Investigational Site Number : 1240015

Ajax, Ontario, Canada

Investigational Site Number : 1240029

Kingston, Ontario, Canada

Investigational Site Number : 1240018

Niagara Falls, Ontario, Canada

Investigational Site Number : 1240011

Toronto, Ontario, Canada

Investigational Site Number : 1240001

Toronto, Ontario, Canada

Investigational Site Number : 1240007

Toronto, Ontario, Canada

Investigational Site Number : 1240003

Windsor, Ontario, Canada

Investigational Site Number : 1240014

Montreal, Quebec, Canada

Investigational Site Number : 1240017

Montreal, Quebec, Canada

Investigational Site Number : 1240023

Montreal, Quebec, Canada

Investigational Site Number : 1240002

Québec, Quebec, Canada

Investigational Site Number : 1240025

Sherbrooke, Quebec, Canada

Investigational Site Number : 1240024

Saskatoon, Saskatchewan, Canada

Investigational Site Number : 1560017

Beijing, China

Investigational Site Number : 1560022

Beijing, China

Investigational Site Number : 1560030

Beijing, China

Investigational Site Number : 1560006

Dongguan, China

Investigational Site Number : 1560007

Guangzhou, China

Investigational Site Number : 1560019

Guiyang, China

Investigational Site Number : 1560003

Hebei, China

Investigational Site Number : 1560023

Hefei, China

Investigational Site Number : 1560002

Nanchang, China

Investigational Site Number : 1560014

Nanjing, China

Investigational Site Number : 1560008

Ningbo, China

Investigational Site Number : 1560031

Ningbo, China

Investigational Site Number : 1560001

Shanghai, China

Investigational Site Number : 1560029

Sichuan, China

Investigational Site Number : 1560011

Taiyuan, China

Investigational Site Number : 1560012

Taiyuan, China

Investigational Site Number : 1560004

Tianjin, China

Investigational Site Number : 1560025

Tianjin, China

Investigational Site Number : 1560009

Wuxi, China

Investigational Site Number : 1560028

Xi'an, China

Investigational Site Number : 1560020

Xiamen, China

Investigational Site Number : 1560024

Xiamen, China

Investigational Site Number : 1560013

Yichang, China

Investigational Site Number : 1560010

Yueyang, China

Investigational Site Number : 1560021

Zhengzhou, China

Investigational Site Number : 3000011

Alexandroupoli, Greece

Investigational Site Number : 3000003

Athens, Greece

Investigational Site Number : 3000010

Athens, Greece

Investigational Site Number : 3000007

Athens, Greece

Investigational Site Number : 3000004

Athens, Greece

Investigational Site Number : 3000006

Athens, Greece

Investigational Site Number : 3000005

Athens, Greece

Investigational Site Number : 3000002

Ioannina, Greece

Investigational Site Number : 3000009

Palaió Fáliro, Greece

Investigational Site Number : 3000008

Thessaloniki, Greece

Investigational Site Number : 3000001

Thessaloniki, Greece

Investigational Site Number : 3480012

Budapest, Hungary

Investigational Site Number : 3480011

Budapest, Hungary

Investigational Site Number : 3480008

Debrecen, Hungary

Investigational Site Number : 3480005

Edelény, Hungary

Investigational Site Number : 3480004

Hajdúnánás, Hungary

Investigational Site Number : 3480007

Mosonmagyaróvár, Hungary

Investigational Site Number : 3480003

Püspökladány, Hungary

Investigational Site Number : 3480001

Százhalombatta, Hungary

Investigational Site Number : 3480013

Szekszárd, Hungary

Investigational Site Number : 3480006

Szombathely, Hungary

Investigational Site Number : 3560011

Ahmedabad, India

Investigational Site Number : 3560003

Chandigarh, India

Investigational Site Number : 3560008

Coimbatore, India

Investigational Site Number : 3560001

Jaipur, India

Investigational Site Number : 3560019

Jodhpur, India

Investigational Site Number : 3560002

Kozhikode, India

Investigational Site Number : 3560014

Lucknow, India

Investigational Site Number : 3560006

Mangaluru, India

Investigational Site Number : 3560018

Mysuru, India

Investigational Site Number : 3560009

Nagpur, India

Investigational Site Number : 3560012

Nagpur, India

Investigational Site Number : 3560015

New Delhi, India

Investigational Site Number : 3560020

Pune, India

Investigational Site Number : 3560004

Vadodara, India

Investigational Site Number : 3720001

Cork, Ireland

Investigational Site Number : 3720003

Dublin, Ireland

Investigational Site Number : 4840002

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840006

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840008

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4840004

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4840005

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4840014

San Juan del Río, Querétaro, Mexico

Investigational Site Number : 4840010

Villahermosa, Tabasco, Mexico

Investigational Site Number : 4840016

Chihuahua City, Mexico

Investigational Site Number : 4840012

Chihuahua City, Mexico

Investigational Site Number : 4840001

Durango, Mexico

Investigational Site Number : 4840013

Oaxaca City, Mexico

Investigational Site Number : 4840003

Veracruz, Mexico

Investigational Site Number : 5120001

Muscat, Oman

Investigational Site Number : 5120002

Muscat, Oman

Investigational Site Number : 6040001

Lima, Peru

Investigational Site Number : 6040002

Lima, Peru

Investigational Site Number : 6040003

Piura, Peru

Cardio Pulmonary Research Center- Site Number : 8400126

Guaynabo, Puerto Rico

FDI Clinical Research- Site Number : 8400121

San Juan, Puerto Rico

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

San Juan, Puerto Rico

Investigational Site Number : 6420010

Baia Mare, Romania

Investigational Site Number : 6420005

Bragadiru, Romania

Investigational Site Number : 6420007

Brasov, Romania

Investigational Site Number : 6420002

Brasov, Romania

Investigational Site Number : 6420004

Codlea, Romania

Investigational Site Number : 6420011

Craiova, Romania

Investigational Site Number : 6420001

Deva, Romania

Investigational Site Number : 6420008

Piteşti, Romania

Investigational Site Number : 6420009

Timișoara, Romania

Investigational Site Number : 6820008

Mecca, Saudi Arabia

Investigational Site Number : 7030003

Levice, Slovakia

Investigational Site Number : 7030001

Poprad, Slovakia

Investigational Site Number : 7030002

Spišská Nová Ves, Slovakia

Investigational Site Number : 7030005

Topoľčany, Slovakia

Investigational Site Number : 7100006

Benoni, South Africa

Investigational Site Number : 7100013

Cape Town, South Africa

Investigational Site Number : 7100001

Cape Town, South Africa

Investigational Site Number : 7100004

Cape Town, South Africa

Investigational Site Number : 7100012

Chatsworth, South Africa

Investigational Site Number : 7100003

Durban, South Africa

Investigational Site Number : 7100009

Durban, South Africa

Investigational Site Number : 7100014

Kempton Park, South Africa

Investigational Site Number : 7100002

Pretoria, South Africa

Investigational Site Number : 7100008

Somerset West, South Africa

Investigational Site Number : 7100007

Vereeniging, South Africa

Investigational Site Number : 4100007

Busan, Busan, South Korea

Investigational Site Number : 4100008

Wŏnju, Gangwon-do, South Korea

Investigational Site Number : 4100006

Daegu, Gyeongsangbuk-do, South Korea

Investigational Site Number : 4100010

Bupyeong-Gu, Incheon-gwangyeoksi, South Korea

Investigational Site Number : 4100002