RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-12-16

Study Completion:2030-01-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05097287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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): * 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:	* 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.

Inclusion Criteria

Exclusion 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):
* 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:

* 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.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610

Contact-US@sanofi.com

Study Locations (Sites)

Cullman Research Center, LLC- Site Number : 8400001

Cullman, Alabama, 35055

United States

Shoals Primary Care - Sheffield- Site Number : 8400015

Sheffield, Alabama, 35660

United States

Chandler Clinical Trials (Elite Clinical Network)- Site Number : 8400147

Chandler, Arizona, 85286

United States

Pulmonary Associates- Site Number : 8400155

Phoenix, Arizona, 85027

United States

MACOA- Site Number : 8400130

Tempe, Arizona, 85283

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

Children's Hospital of Orange County- Site Number : 8400137

Orange, California, 92868

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, INC- 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

Revival Research - Doral- Site Number : 8400097

Doral, Florida, 33122

United States

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

Kissimmee, Florida, 34746

United States

Floridian Clinical Research - Miami Lakes- Site Number : 8400091

Miami Lakes, Florida, 33016

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

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

Calhoun, Georgia, 30701

United States

Alpha Clinical Research Georgia- 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 HealthSystem - Skokie Hospital- Site Number : 8400138

Skokie, Illinois, 60076

United States

Brengle Family Medicine- Site Number : 8400157

Indianapolis, Indiana, 46260

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

Tandem Clinical Research, LLC- Site Number : 8400163

Metairie, Louisiana, 70006

United States

Javara Inc- Site Number : 8400087

Annapolis, Maryland, 21401

United States

Kur Research - Columbia Medical- 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

Revive Research Institute- 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- 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- Site Number : 8400143

Jersey City, New Jersey, 07304

United States

Urban Health Plan- Site Number : 8400144

Bronx, New York, 10459

United States

Clinical Research Of Gastonia- Site Number : 8400012

Gastonia, North Carolina, 28054

United States

Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400151

Hickory, North Carolina, 28601

United States

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

Huntersville, North Carolina, 28078

United States

Lapis Clinical Research- 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

Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400093

Tulsa, Oklahoma, 74136

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

ADAC Research, PA- 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- 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- Site Number : 8400135

Beaumont, Texas, 77701

United States

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

Boerne, Texas, 78006

United States

DCT-Baxter Research, LLC dba Discovery Clinical Trials- Site Number : 8400123

Dallas, Texas, 75225

United States

North Texas Allergy & Asthma Center- Site Number : 8400139

Denton, Texas, 76201

United States

C & R Research Services USA- 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

Texas Institute of Cardiology- Site Number : 8400003

McKinney, Texas, 75071

United States

Andante Research- Site Number : 8400140

San Antonio, Texas, 78229

United States

DM Clinical Research- 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

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-16

Study Completion Date2030-01-22

Study Record Updates

Study Start Date2021-12-16

Study Completion Date2030-01-22

Terms related to this study

Additional Relevant MeSH Terms

Asthma