Dupilumab for Allergic Asthma
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen BySunil K Ahuja, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
How is the drug Dupilumab different from other asthma treatments?
Dupilumab is unique because it is a monoclonal antibody that targets the interleukin-4 and interleukin-13 signaling pathways, which are involved in type 2 inflammation, making it effective for both eosinophilic and non-eosinophilic severe asthma. This mechanism of action is different from other biologics like omalizumab, mepolizumab, and reslizumab, which target different pathways.
14578Is dupilumab generally safe for humans?
Dupilumab is generally considered safe for treating moderate to severe asthma, with minimal adverse events reported. However, it may cause increased blood eosinophils (a type of white blood cell) and ocular adverse events, especially in patients treated for atopic dermatitis.
12456Will I have to stop taking my current medications?
The trial requires participants to stop using certain medications, including intranasal steroids, asthma medications, systemic glucocorticosteroids, and JAK-1 inhibitors, for specific times before and during the study. If you are taking any of these, you may need to stop them to participate.
What data supports the effectiveness of the drug Dupilumab for treating allergic 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.
12357Eligibility Criteria
Adults aged 18-65 with perennial nasal allergy for at least 2 years, positive skin test to house dust mites, and asthma can join. They must use reliable birth control if applicable, not smoke currently or heavily in the past, have COVID-19 vaccination or recent infection proof, and test negative for SARS-CoV-2 before visits.Participant Groups
The trial tests dupilumab's effects on allergic reactions by exposing participants to house dust mites in a controlled setting. Some will receive dupilumab while others get a placebo to compare outcomes.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Maladaptive Phenotypes randomized to study drugExperimental Treatment2 Interventions
This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug.
Group II: Adaptive Phenotypes randomized to study drugActive Control2 Interventions
This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug.
Group III: Adaptive Phenotype randomized to placeboPlacebo Group2 Interventions
This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo.
Group IV: Maladaptive Phenotype randomized to placeboPlacebo Group2 Interventions
This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo.
Dupilumab is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Dupixent for:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
๐ช๐บ 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:
Biogenics Research ChamberSan Antonio, TX
University of Texas Health Science Center at San AntonioSan Antonio, TX
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
Regeneron PharmaceuticalsIndustry Sponsor
References
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 ฮฑ-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.
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: 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.
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.
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 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.
Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. [2023]Dupilumab is a new biological drug approved for the treatment of type 2 inflammatory diseases, such as asthma. Dupilumab is a fully humanized monoclonal antibody that acts against both interleukin-4 and interleukin-13 receptors. This study evaluated the time--dependent effect of dupilumab on asthma exacerbations and quality of life in adolescents with uncontrolled severe asthma.
Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study. [2023]Dupilumab is approved for the treatment of severe type 2 (T2) asthma; however, the characteristics of patients receiving dupilumab in routine clinical practice are incompletely understood. This study describes the characteristics of patients with severe asthma before dupilumab treatment in a real-world setting.