Dupilumab + ICS/LABA for Asthma
(AIM4:Next Step Trial)
Trial Summary
What is the purpose of this trial?
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it requires that you continue using your current inhaled asthma medication (ICS/LABA) and possibly a LAMA if you are already on it. You cannot be on systemic corticosteroids from one month before the trial starts.
What data supports the effectiveness of the drug Dupilumab for asthma?
Dupilumab has been shown to reduce severe asthma attacks, improve lung function, and enhance asthma control in patients with moderate-to-severe asthma, especially those with type 2 inflammation. It is generally well tolerated and can help reduce the need for oral corticosteroids without worsening asthma control.12345
Is Dupilumab safe for treating asthma?
Dupilumab, used for asthma and other conditions, is generally considered safe with minimal side effects. However, it may cause an increase in blood eosinophils (a type of white blood cell) and has been associated with some eye-related side effects, mainly in patients treated for skin conditions.12367
How is the drug Dupilumab different from other asthma treatments?
Dupilumab is unique because it targets the IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation in asthma, and it can be effective for both eosinophilic and non-eosinophilic severe asthma. Unlike some other treatments, it is administered as a subcutaneous injection every two weeks and has shown benefits in reducing severe asthma attacks and improving lung function.12348
Research Team
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Eligibility Criteria
This trial is for adolescents and adults who have had asthma for at least a year, are currently on medium dose ICS/LABA, and still experience frequent symptoms. They should have had at least one severe asthma attack in the past year but not within the last 30 days. Participants must also meet certain lung function criteria and blood eosinophil levels.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dupilumab with ICS/LABA or a higher dose of ICS/LABA for asthma management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University