Dupilumab for Asthma
Recruiting in Palo Alto (17 mi)
+98 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Sanofi
Must be taking: Inhaled corticosteroids
Must not be taking: Oral corticosteroids
Disqualifiers: Severe asthma, Anaphylaxis, Prematurity, others
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.
Study details include:
Part A:
The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).
Part B:
For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have been using a stable dose of inhaled corticosteroids (ICS) for at least one month before the screening, which suggests you may need to continue your current asthma medication.
What data supports the effectiveness of the drug Dupilumab for asthma?
Dupilumab has shown effectiveness in treating severe type-2 asthma by targeting specific pathways involved in inflammation, and its efficacy has been demonstrated in clinical trials. It is already used for other conditions like atopic dermatitis and chronic rhinitis, indicating its potential in managing asthma as well.
12345Is dupilumab safe for treating asthma?
Dupilumab is generally considered safe for treating moderate to severe asthma, with studies showing minimal adverse events compared to a placebo. 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 atopic dermatitis.
34678How is the drug Dupilumab unique for treating asthma?
Dupilumab is unique because it targets the IL-4 and IL-13 signaling pathways, which are involved in the inflammation process of asthma, and it may be effective for both eosinophilic and non-eosinophilic severe asthma types, unlike some other treatments that target only one type.
12347Eligibility Criteria
This trial is for children aged 2 to less than 6 with uncontrolled asthma or severe asthmatic wheeze, diagnosed with Atopic Dermatitis. They must have been on inhaled corticosteroids for at least a month and show allergic reactions to certain foods or airborne allergens. Parents need to understand study requirements and help their kids follow the protocol.Inclusion Criteria
Parents or guardians are able to bring the child to all clinic visits and follow study instructions.
The parent(s) or guardian(s) should be able to understand what is needed for the study.
Participants/parent(s)/caregiver(s)/legal guardian(s) must be able to understand and complete study-related questionnaires
+14 more
Exclusion Criteria
I have had severe asthma attacks that were life-threatening.
I have severe asthma and need to take steroids regularly.
History of a systemic hypersensitivity reaction or anaphylaxis to dupilumab or any other biologic therapy
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Treatment
Participants receive either dupilumab or placebo for 52 weeks in a double-blind manner
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment with dupilumab for an additional 52 weeks
52 weeks
Participant Groups
The study tests Dupilumab's effectiveness and safety against a placebo over a year (Part A), followed by an optional second year (Part B). It's double-blind, meaning neither participants nor researchers know who gets the real drug during Part A.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab (double-blind period)Experimental Treatment1 Intervention
Dupilumab subcutaneous injection as per protocol
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching dupilumab subcutaneous injection as per protocol
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:
UBMD Pediatrics, Oishei Childrens Hospital Site Number : 8400013Buffalo, NY
TTS Research Site Number : 8400022Boerne, TX
Newport Childrens Medical Group Site Number : 8400023Newport Beach, CA
Allervie Health - Destin (AllerVie Clinical Research) Site Number : 8400016Destin, FL
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
References
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.
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.
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 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.
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.
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.
Dupilumab in the treatment of asthma. [2020]Dupilumab is a fully human monoclonal IgG4 antibody that blocks IL-4 and IL-13 signaling. Its efficacy has been assessed across a range of atopic diseases, due to its ability to inhibit T helper cell 2 (Th2) mediated inflammation. It has already been approved in the USA and Europe for the treatment of atopic dermatitis. Recently, it also gained approval in the USA as add-on treatment for moderate-to-severe asthma in adolescents and adults. Phase II and III randomized controlled trials have demonstrated improvements in asthma exacerbation rates, FEV1, oral glucocorticoid use and a range of patient-reported outcomes, with a favorable safety profile. This article will review the available clinical trial data relating to the efficacy and safety of dupilumab in the management of asthma and related atopic respiratory conditions.