Atlas
Come and Explore Better Asthma Treatment!
Purpose
The purpose of this randomized, double-blind, placebo-controlled study, is to learn more about Dupilumab (the study drug). The study will investigate if Dupilumab can prevent loss in lung function decline and improve asthma symptoms and quality of life by looking at whether it works when taken for a longer period in patients with moderate to severe asthma that is not well controlled.
Study Design
Those eligible to participate, will be randomly assigned on Day 1 (Week 0) of the treatment period to receive the study medication (study drug or placebo) once every 2 weeks. The treatment period will last for 3 years and 3 months. Participants will attend 14 total study visits, during this period until the end of the treatment period and EOT end-of-treatment, Visit 15.
This time can be broken down into three parts:
A 3-5 week run in/screening period where eligibility and safety to participate will be evaluated.
3 years (36 months) of active treatment.
A 2-month (8-week) follow up period.
The study provider will perform some tests (such as blood tests for hepatitis B, eosinophil count) and assessments (spirometry, FeNO test).
Participants will receive the study medication and be given a supply of the study medication for home injections every 2 weeks.
Participants will also continue to record their symptoms and medications daily in the diaries and complete questionnaires in an eDevice as instructed by the study coordinator.
Participant will return the eDevice to the study center at your end-of-treatment or EOT visit (Visit 15).
Key Inclusion Criteria
Are at least 18 years old with a physician diagnosis of asthma for at least the past 12 months.
Are currently being treated with established inhaled corticosteroid background therapy [called ICS] in combination with a second controller (i.e. an inhaled long-acting 2 adrenergic agonist [called LABA]). If they are treated with a third controller medication, this is also acceptable (i.e. a long-acting muscarinic antagonist [called LAMA]).
Be on a stable dose for at least one month prior to Visit 1.
Have had one or more severe exacerbations in the 12 months prior to visit 1.
4 controllers are not allowed.
Key Exclusion Criteria
History or clinical evidence of COPD including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease.
Severe asthma exacerbation requiring treatment with OCS in the past month before V1 or during the screening period.
Diagnosed pulmonary (other than asthma).
Active malignancy or history of malignancy within 5 years before Visit 1. Except completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
Any biologic therapy (including experimental treatments and Dupixent 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.
Compensation
All study medications and tests are included at no charge to participants. Additional travel reimbursement and compensation will be discussed at the screening visit.