Dupilumab for Preventing Asthma Attacks in Children
(PANDA Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Fluticasone, LABA
Must not be taking: Immunotherapy, Biologic therapy
Disqualifiers: Pregnancy, Smoking, Cancer, others
Stay on Your Current Meds
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This is a multi-center, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for prevention of asthma exacerbations in urban children and adolescents with T2-high exacerbation-prone asthma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it does require that your asthma medications be managed by the study clinician. You may need to adjust your asthma medications to follow the study protocol.
What data supports the effectiveness of the drug Dupilumab for preventing asthma attacks in children?
Dupilumab has been shown to reduce severe asthma attacks and improve lung function in patients aged 12 and older with moderate-to-severe asthma, especially those with type 2 inflammation. It is already approved for use in adults and adolescents for asthma and other conditions like atopic dermatitis, indicating its potential effectiveness.12345
Is dupilumab generally safe for use in humans?
How is the drug dupilumab different from other asthma treatments?
Eligibility Criteria
This trial is for urban children and adolescents aged 6-17 with T2-high exacerbation-prone asthma. They must have had at least two asthma attacks in the past year, be on certain asthma medications, and not live in specific areas or have public health insurance. Participants need a diagnosis of asthma made over a year ago, meet certain blood test criteria, and can perform spirometry tests.Inclusion Criteria
I am 12 or older and use a specific asthma inhaler or its equivalent.
I am aged 6-11 and use a strong asthma inhaler or similar treatment.
You have high levels of eosinophils in your blood or FeNO in your breath.
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Exclusion Criteria
I am not pregnant, breastfeeding, nor planning to become pregnant and will use birth control during the study.
I do not have an active parasitic infection or am not currently being treated for one.
You have a known condition that weakens your immune system.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Run-in
Participants undergo a 4-week run-in period to ensure continued eligibility
4 weeks
1 visit (in-person)
Treatment
Participants receive dupilumab or placebo injections every 2 or 4 weeks for 12 months
12 months
Injections every 2 or 4 weeks, E&M visits every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Regular follow-up visits
Treatment Details
Interventions
- Dupilumab (Monoclonal Antibodies)
Trial OverviewThe study is testing Dupilumab as an additional treatment to prevent asthma flare-ups compared to a placebo (a substance with no therapeutic effect). It's conducted across multiple centers where participants are randomly assigned to either receive Dupilumab or placebo without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
Participants between 12-17 years of age will receive an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W).
Participants between 6-11 years of age will not complete a loading dose and will receive injections based on their body weight:
Those weighing 15 kg to less than 30 kg will receive 300 mg every four weeks (Q4W). Participants in this weight category who were randomized before July 1, 2024, were assigned to a 100mg Q2W and will not be transitioned to the Q4W dosing schedule.
Those with a body weight of 30 kg or more will receive 200 mg Q2W.
Group II: PlaceboPlacebo Group1 Intervention
Participants between 12-17 years of age will receive an initial dose of placebo (two injections) followed by a placebo injection given every other week (Q2W).
Participants between 6-11 years of age will not receive an initial loading dose of placebo and will receive injections Q2W or Q4W based on their body weight and date of randomization.:
The injection volume of placebo will be matched to the corresponding dupilumab dose based on participant body weight.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical Center: Asthma CenterCincinnati, OH
Children's National Medical Center: Children's Research InstituteWashington, United States
Washington University at St. LouisSaint Louis, MO
Boston Children's Hospital: Department of ImmunologyBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
Rho Federal Systems Division, Inc.Industry Sponsor
Childhood Asthma in Urban Settings (CAUSE)Collaborator
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.
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.
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 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.
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 Efficacy in Patients Stratified by Baseline Treatment Intensity and Lung Function. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">The Phase 3 LIBERTY ASTHMA QUEST study in patients aged ≥12 years with uncontrolled, moderate-to-severe asthma demonstrated the efficacy and safety of dupilumab 200 mg and 300 mg every 2 weeks (q2w) vs matched placebo in the overall population. This post hoc analysis assessed dupilumab efficacy by disease severity as evidenced by baseline % predicted forced expiratory volume in 1 second (FEV1) and dose of inhaled corticosteroids (ICS).
A review of dupilumab in the treatment of atopic diseases. [2020]Dupilumab is a fully human monoclonal IgG4 antibody directed against the alpha subunit of the IL-4 receptor and prevents the signaling of IL-4 and IL-13, two type 2 cytokines known to be important drivers of atopic diseases. In March of 2017, the United States Food and Drug Administration (FDA) approved dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults that is uncontrolled with topical medications, becoming the first biologic agent approved to treat this chronic skin condition. In October of 2018, Dupilumab received approval by the FDA as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years or older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. This review summarizes the characteristics of dupilumab and the clinical research that has been published to date, including treatment efficacy and adverse events.