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Active, not recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT05097287

Public ClinicalTrials.gov record NCT05097287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 7:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

Study identification

NCT ID
NCT05097287
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sanofi
Industry
Enrollment
1,339 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 16, 2021 (Actual)
Primary completion
Mar 16, 2027 (Estimated)
Completion
Jun 8, 2029 (Estimated)
Last update posted
Apr 16, 2026

2021 – 2029

United States locations

U.S. sites
75
U.S. states
21
U.S. cities
69
Facility City State ZIP Site status
Cullman Research Center- Site Number : 8400001 Cullman Alabama 35055 —
Shoals Primary Care - Sheffield- Site Number : 8400015 Sheffield Alabama 35660 —
Chandler Clinical Research Trials- Site Number : 8400147 Chandler Arizona 85224 —
Pulmonary Associates - Deer Valley Office- Site Number : 8400155 Phoenix Arizona 85027 —
Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130 Phoenix Arizona 85051 —
Del Sol Research Management - Tucson- Site Number : 8400017 Tucson Arizona 85715 —
Kern Allergy and Medical Research- Site Number : 8400037 Bakersfield California 93301 —
Vitality Clinical Research- Site Number : 8400142 Beverly Hills California 90211 —
Ascada Research - Fullerton- Site Number : 8400076 Fullerton California 92835 —
Allergy and Asthma Specialists Medical Group- Site Number : 8400162 Huntington Beach California 92647 —
Newport Native MD- Site Number : 8400054 Newport Beach California 92663 —
Prospective Research Innovations- Site Number : 8400131 Rancho Cucamonga California 91730 —
Mercy Medical Group - Midtown- Site Number : 8400164 Sacramento California 95816 —
Integrated Research of Inland- Site Number : 8400156 Upland California 91786 —
Allianz Research Institute- Site Number : 8400018 Westminster California 92683 —
Woodland Clinic - Woodland- Site Number : 8400171 Woodland California 95695 —
Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035 Altamonte Springs Florida 32701 —
Florida Center for Allergy & Asthma Research- Site Number : 8400032 Aventura Florida 33180 —
Beautiful Minds Clinical Research Center- Site Number : 8400141 Cutler Bay Florida 33157 —
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023 DeBary Florida 32713 —
Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098 Kissimmee Florida 34746 —
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 —
Heuer M.D. Research- Site Number : 8400024 Orlando Florida 32819 —
JSV Clinical Research- Site Number : 8400150 Tampa Florida 33634 —
Appalachian Clinical Research- Site Number : 8400129 Adairsville Georgia 30103 —
Alpha Clinical Research Group - Dunwoody- Site Number : 8400116 Dunwoody Georgia 30350 —
Aeroallergy Research Laboratory- Site Number : 8400114 Savannah Georgia 31406 —
Rush University Medical Center- Site Number : 8400146 Chicago Illinois 60612 —
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138 Skokie Illinois 60077 —
Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160 Louisville Kentucky 40217 —
Allergy and Asthma Specialist- Site Number : 8400007 Owensboro Kentucky 42301 —
Avant Research Associates - Crowley- Site Number : 8400117 Crowley Louisiana 70526 —
Investigational Site Number : 3560016 Houma Louisiana 70360-4413 —
Tandem Clinical Research - Metairie- Site Number : 8400163 Metairie Louisiana 70006 —
Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087 Annapolis Maryland 21401 —
Urgent Care Clinical Trials and KUR Research- Site Number : 8400169 Columbia Maryland 21045 —
Chesapeake Clinical Research - White Marsh- Site Number : 8400119 White Marsh Maryland 21162 —
Genesis Clinical Research - Fall River- Site Number : 8400050 Fall River Massachusetts 02723 —
University of Michigan Health System - Ann Arbor- Site Number : 8400030 Ann Arbor Michigan 48109 —
Revival Research Institute - Dearborn- Site Number : 8400097 Dearborn Michigan 48126 —
Revive Research Institute - Lathrup Village- Site Number : 8400100 Lathrup Village Michigan 48076 —
Romedica- Site Number : 8400043 Rochester Michigan 48307 —
Great Lakes Research Institute Site Number : 8400111 Southfield Michigan 48075-5400 —
Great Lakes Research Institute - Southfield- Site Number : 8400111 Southfield Michigan 48075 —
Allergy & Immunology Associates of Ann Arbor- Site Number : 8400107 Ypsilanti Michigan 48197 —
The Asthma and Allergy Center- Site Number : 8400055 Bellevue Nebraska 68123 —
Jersey City Breathing Center: Elamir Mazhar- Site Number : 8400143 Jersey City New Jersey 07304 —
Urban Health Plan- Site Number : 8400144 The Bronx New York 10459 —
Clinical Research Of Gastonia- Site Number : 8400012 Gastonia North Carolina 28054 —
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400056 Huntersville North Carolina 28078 —
Lapis Clinical Research - Mooresville- Site Number : 8400112 Mooresville North Carolina 28117 —
Southeastern Research Center- Site Number : 8400153 Winston-Salem North Carolina 27103 —
Asthma & Allergy Center - Toledo- Site Number : 8400051 Toledo Ohio 43617 —
St. Luke's University Hospital- Site Number : 8400099 Bethlehem Pennsylvania 18015 —
Temple University Hospital- Site Number : 8400038 Philadelphia Pennsylvania 19140 —
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400042 Pittsburgh Pennsylvania 15241 —
Bogan Sleep Consultants- Site Number : 8400102 Columbia South Carolina 29201 —
Allergic Disease and Asthma Center (ADAC)- Site Number : 8400026 Greenville South Carolina 29607 —
Main Street Physician's Care- Site Number : 8400077 Little River South Carolina 29566 —
National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400092 North Charleston South Carolina 29420 —
Health Concepts- Site Number : 8400006 Rapid City South Dakota 57702 —
REX Clinical Trials - Beaumont- Site Number : 8400135 Beaumont Texas 77701 —
South Texas Medical Research Institute - TTS Research- Site Number : 8400009 Boerne Texas 78006 —
Discovery Clinical Trials - Dallas- Site Number : 8400123 Dallas Texas 75225 —
IntraCare- Site Number : 8400003 Dallas Texas 75254 —
C & R Research Services - Houston- Site Number : 8400067 Houston Texas 77022 —
Clear Brook Medical Associates- Site Number : 8400080 Houston Texas 77089 —
Metroplex Pulmonary and Sleep Center- Site Number : 8400014 McKinney Texas 75069 —
Andante Research- Site Number : 8400140 San Antonio Texas 78229 —
DM Clinical Research - 710 Lawrence Street- Site Number : 8400103 Tomball Texas 77375 —
Burke Internal Medicine and Research- Site Number : 8400170 Burke Virginia 22015 —
University of Virginia- Site Number : 8400082 Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 174 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05097287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05097287 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →