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
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
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.
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Phoenix, Arizona 85027, United States
Phoenix, Arizona 85051, United States
Bakersfield, California 93301, United States
Huntington Beach, California 92647, United States
Rancho Cucamonga, California 91730, United States
Altamonte Springs, Florida 32701, United States
Aventura, Florida 33180, United States
Cutler Bay, Florida 33157, United States
DeBary, Florida 32713, United States
Kissimmee, Florida 34746, United States
Miami Lakes, Florida 33016, United States
Dunwoody, Georgia 30350, United States
Skokie, Illinois 60077, United States
Louisville, Kentucky 40217, United States
Annapolis, Maryland 21401, United States
Columbia, Maryland 21045, United States
White Marsh, Maryland 21162, United States
Fall River, Massachusetts 02723, United States
Ann Arbor, Michigan 48109, United States
Lathrup Village, Michigan 48076, United States
Southfield, Michigan 48075, United States
Ypsilanti, Michigan 48197, United States
Jersey City, New Jersey 07304, United States
Huntersville, North Carolina 28078, United States
Mooresville, North Carolina 28117, United States
Winston-Salem, North Carolina 27103, United States
Pittsburgh, Pennsylvania 15241, United States
Greenville, South Carolina 29607, United States
Little River, South Carolina 29566, United States
North Charleston, South Carolina 29420, United States
Boerne, Texas 78006, United States
Tomball, Texas 77375, United States
Belo Horizonte, Minas Gerais 30150-221, Brazil
Belém, Pará 66095-055, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
São Paulo, 05403-000, Brazil
San Juan, 00936, Puerto Rico
Daegu, Gyeongsangbuk-do 42415, South Korea
Bupyeong-Gu, Incheon-gwangyeoksi 21431, South Korea