Dupilumab + ICS/LABA for Asthma
(AIM4:Next Step Trial)
Recruiting in Palo Alto (17 mi)
+67 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Regeneron Pharmaceuticals
Must be taking: ICS/LABA
Must not be taking: Systemic corticosteroids
Disqualifiers: COPD, Lung diseases, Smoking, others
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
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.
12345Is 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.
12367How 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.
12348Eligibility 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
Key
I use up to 3 medications to control my asthma.
I have been diagnosed with asthma for at least a year.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Dupilumab with ICS/LABA or a higher dose of ICS/LABA for asthma management
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares two treatments: adding dupilumab to an existing medium dose of ICS/LABA versus increasing the ICS/LABA dosage alone. The goal is to determine which approach better controls asthma symptoms.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab + ICS/LABAExperimental Treatment2 Interventions
Randomized 1:1
Group II: Placebo + ICS/LABAPlacebo Group2 Interventions
Randomized 1:1
Dupilumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
🇪🇺 Approved in European Union as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ark Clinical Research - Long BeachLong Beach, CA
Newport Native Md, Inc.Newport Beach, CA
Allianz Research InstituteWestminster, CA
St Francis Medical InstituteClearwater, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Regeneron PharmaceuticalsLead Sponsor
SanofiIndustry Sponsor
References
Dupixent, a New Entrant In the Asthma Lists. [2019]Sanofi and Regeneron's Dupixent (dupilumab)-which is already approved for atopic dermatitis-has an FDA action date of October 20 for its asthma indication. It will join Nucala, (mepolizumab), Cinqair (reslizumab), and Fasenra (benralizumab) as a monoclonal antibody approved as a treatment for the type 2 inflammation phenotype in severe asthma.
Dupilumab for the treatment of asthma. [2019]Dupilumab (REGN668/SAR231893), produced by a collaboration between Regeneron and Sanofi, is a monoclonal antibody currently in phase III for moderate-to-severe asthma. Dupilumab is directed against the α-subunit of the interleukin (IL)-4 receptor and blocks the IL-4 and IL-13 signal transduction. Areas covered: Pathophysiological role of IL-4 and IL-13 in asthma; mechanism of action of dupilumab; pharmacology of IL-4 receptor; phase I and phase II studies with dupilumab; regulatory affairs. Expert opinion: Patients with severe asthma who are not sufficiently controlled with standard-of-care represent the target asthma population for dupilumab. If confirmed, efficacy of dupilumab in both eosinophilic and non-eosinophilic severe asthma phenotype might represent an advantage over approved biologics for asthma, including omalizumab, mepolizumab, and reslizumab. Head-to-head studies to compare dupilumab versus other biologics with different mechanism of action are required. Pediatric studies with dupilumab are currently lacking and should be undertaken to assess efficacy and safety of this drug in children with severe asthma. The lack of preclinical data and published results of the completed four phase I studies precludes a complete assessment of the pharmacological profile of dupilumab. Dupilumab seems to be generally well tolerated, but large studies are required to establish its long-term safety and tolerability.
Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. [2022]Dupilumab is a humanized monoclonal antibody targeting the IL4/IL13 signaling pathway, already used for atopic dermatitis and chronic rhinitis with nasal polyps, recently approved for severe type-2 asthma. Its efficacy has been demonstrated in randomized control trials. The aim of our study is to evaluate possible early clinical improvement and type 2 biomarkers modifications in severe asthmatic patients treated with dupilumab in a real-life setting.
Dupilumab: A Review in Moderate to Severe Asthma. [2020]Dupilumab (Dupixent®) is a fully human monoclonal antibody against the interleukin (IL)-4 receptor α subunit of IL-4 and IL-4/IL-13 receptor complexes. IL-4 and IL-13 are key cytokines in driving type 2 inflammation, a dominant and largely eosinophilic inflammatory pathway in asthma. Trials evaluating the efficacy of dupilumab in asthma include three pivotal, placebo-controlled, phase 3 or 2b trials of 24-52 weeks' treatment duration in patients aged ≥ 12 years with moderate-to-severe asthma (inadequately controlled with medium-to-high dose inhaled corticosteroids) or severe asthma [dependent on oral corticosteroids (OCS) for control]. In these studies, adding subcutaneous dupilumab (200 or 300 mg every 2 weeks) to background therapy was generally well tolerated and reduced the rate of severe asthma exacerbations, improved lung function, as well as asthma control and, where specified, health-related quality of life (HR-QOL), and enabled OCS maintenance doses to be reduced without impacting asthma control. Dupilumab displayed efficacy across various patient subgroups, although those with heightened type 2 immune activity, including elevated eosinophils and fractional exhaled nitric oxide, tended to have a more prominent treatment benefit. Dupilumab is consequently widely indicated (and a valuable treatment option) as an add-on therapy in patients aged ≥ 12 years who have severe/moderate-to-severe asthma with a type 2 inflammation/eosinophilic phenotype despite conventional treatments or have OCS-dependent asthma.
Real-World Experience with Dupilumab in Severe Asthma: One-Year Data from an Italian Named Patient Program. [2022]Dupilumab is a monoclonal antibody targeting IL-4Rα recently licensed for severe asthma (SA). A Named Patients Program (NPP) was created in Italy before its commercial availability for SA patients with no other available therapeutic options. We aimed to assess the real-world effectiveness of dupilumab in patients with SA and unmet needs.
Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. [2022]Background: Dupilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-4 receptor and inhibits the signaling of IL-4 and IL-13. It is approved for treating asthma and other type-2 inflammatory diseases. There is a conflict in the literature regarding the safety and efficacy of dupilumab. Thus, we aimed to assess the safety and efficacy of dupilumab in patients with moderate to severe asthma. Methods: Six databases (PubMed, Embase, Scopus, Web of Science, Cochrane library, and clinicaltrials.gov registry) were searched until January 2022. We included randomized controlled trials that compared dupilumab with the placebo in moderate to severe asthma patients. We extracted the data at 12 and 24 weeks and analyzed them using review manager 5.4. Findings: Thirteen trials were included. Dupilumab significantly improved the forced expiratory volume in 1 s, asthma control questionnaire score, the fraction of exhaled nitric oxide level, and immunoglobulin E level at 12 and 24 weeks (p < 0.05). However, it was associated with increased blood eosinophils at 12 and 24 weeks. Dupilumab was generally a safe agent for asthmatic patients. It showed no significant difference compared with the placebo regarding most adverse events. Conclusion: Dupilumab improves pulmonary function and reduces local and systemic inflammatory markers with minimal adverse events in patients with moderate to severe asthma.
Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]Dupilumab is approved for use in moderate-to-severe atopic dermatitis (AD) and as an add-on maintenance treatment in patients suffering from severe asthma with type 2 inflammation. Ocular adverse events (OAEs) have been reported with dupilumab almost exclusively in patients treated for AD.
Real-world effectiveness of dupilumab in patients with asthma: Findings from the US ADVANTAGE study. [2023]Dupilumab is approved as an add-on maintenance therapy for patients (≥6 years) with moderate-to-severe asthma. Better understanding of real-world effectiveness is needed.