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

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT05097287

Run by

Sanofi

People needed

1339

Starts

2021-12-16

Expected to finish

2029-06-08

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Cullman Research Center- Site Number : 8400001 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.