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Clinical Trials in the UK / NCT05097287
Active, not recruiting Phase 4

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

NCT05097287 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 4
Started
2021-12-16
Last updated
2026-04-16

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

DupilumabPlacebo

Dupilumab: solution for injection subcutaneous

Placebo: solution for injection subcutaneous

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (249)

FacilityCityRegionStatus
Cullman Research Center- Site Number : 8400001 Cullman Alabama
Shoals Primary Care - Sheffield- Site Number : 8400015 Sheffield Alabama
Chandler Clinical Research Trials- Site Number : 8400147 Chandler Arizona
Pulmonary Associates - Deer Valley Office- Site Number : 8400155 Phoenix Arizona
Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130 Phoenix Arizona
Del Sol Research Management - Tucson- Site Number : 8400017 Tucson Arizona
Kern Allergy and Medical Research- Site Number : 8400037 Bakersfield California
Vitality Clinical Research- Site Number : 8400142 Beverly Hills California
Ascada Research - Fullerton- Site Number : 8400076 Fullerton California
Allergy and Asthma Specialists Medical Group- Site Number : 8400162 Huntington Beach California
Newport Native MD- Site Number : 8400054 Newport Beach California
Prospective Research Innovations- Site Number : 8400131 Rancho Cucamonga California
Mercy Medical Group - Midtown- Site Number : 8400164 Sacramento California
Integrated Research of Inland- Site Number : 8400156 Upland California
Allianz Research Institute- Site Number : 8400018 Westminster California
Woodland Clinic - Woodland- Site Number : 8400171 Woodland California
Central Florida Pulmonary Group - Altamonte Springs- Site Number : 8400035 Altamonte Springs Florida
Florida Center for Allergy & Asthma Research- Site Number : 8400032 Aventura Florida
Beautiful Minds Clinical Research Center- Site Number : 8400141 Cutler Bay Florida
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400023 DeBary Florida
Florida Lung, Asthma and Sleep Specialists (FLASS) - Polynesian- Site Number : 8400098 Kissimmee Florida
Ivetmar Medical Group- Site Number : 8400063 Miami Florida
My Preferred Research- Site Number : 8400073 Miami Florida
Research Institute of South Florida- Site Number : 8400079 Miami Florida
Floridian Clinical Research - Miami Lakes- Site Number : 8400091 Miami Lakes Florida
Heuer M.D. Research- Site Number : 8400024 Orlando Florida
JSV Clinical Research- Site Number : 8400150 Tampa Florida
Appalachian Clinical Research- Site Number : 8400129 Adairsville Georgia
Alpha Clinical Research Group - Dunwoody- Site Number : 8400116 Dunwoody Georgia
Aeroallergy Research Laboratory- Site Number : 8400114 Savannah Georgia
Rush University Medical Center- Site Number : 8400146 Chicago Illinois
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400138 Skokie Illinois
Family Allergy & Asthma - Louisville - Goss Avenue- Site Number : 8400160 Louisville Kentucky
Allergy and Asthma Specialist- Site Number : 8400007 Owensboro Kentucky
Avant Research Associates - Crowley- Site Number : 8400117 Crowley Louisiana
Investigational Site Number : 3560016 Houma Louisiana
Tandem Clinical Research - Metairie- Site Number : 8400163 Metairie Louisiana
Javara Privia Mid-Atlantic - Annapolis- Site Number : 8400087 Annapolis Maryland
Urgent Care Clinical Trials and KUR Research- Site Number : 8400169 Columbia Maryland
Chesapeake Clinical Research - White Marsh- Site Number : 8400119 White Marsh Maryland

+ 209 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05097287 on ClinicalTrials.gov ↗ ← All trials in the UK