45 Participants Needed

Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

(NEURADAD Trial)

Recruiting at 9 trial locations
CT
Overseen ByClinical Trials Administrator
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Regeneron Pharmaceuticals
Must be taking: Topical medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This trial aimed to measure cognitive deficits in adolescents with moderate-to-severe eczema and see if these improved with a specific treatment. The study concluded after the initial phase, which only measured cognitive deficits without starting the treatment phase. The treatment is approved for patients over 12 years with conditions like atopic dermatitis and asthma.

Do I need to stop taking my current medications for this trial?

The trial requires that you stop taking certain medications, such as specific ADHD medications and systemic antihistamines, before participating. If you are using a stable prescription topical medication for AD, you should continue it for at least 2 weeks before the trial.

What safety data exists for dupilumab treatment?

Dupilumab is generally considered safe, but some people may experience side effects like injection site reactions, conjunctivitis (eye inflammation), headaches, and nasopharyngitis (cold-like symptoms). There may be differences in how men and women experience these side effects, with some being more common in one gender.12345

How is the drug dupilumab different from other treatments?

Dupilumab is unique because it is a monoclonal antibody that specifically blocks the signals of two proteins, interleukin-4 and interleukin-13, which are involved in inflammation. This makes it different from other treatments that may not target these specific pathways.678910

Research Team

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Adolescent (12 - 17 years of age) Part A: at time of visit Part B: at time of screening visit
EASI score ≥ 12 Part A: at time of visit Part B: at screening and baseline visits
BSA of AD involvement ≥ 10% Part A: at time visit Part B: at screening and baseline visits
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Exclusion Criteria

Systemic antihistamine or nicotine use Part A: within the week prior to the visit Part B: during the week prior to screening
Part B Only: Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
Part B Only: At baseline, presence of any conditions listed as criteria for study drug discontinuation
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants undergo neuropsychologic assessments using Conners' Continuous Performance Test 3rd Edition (CPT-3) and other measures

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

4 weeks

Treatment Details

Interventions

  • dupilumab
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.
Group II: Part AExperimental Treatment0 Interventions
Assessed in a single visit and no study-related treatment will be given.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Findings from Research

Dupilumab, a monoclonal antibody used to treat Th2 disorders, has a generally excellent safety profile, but some adverse effects like injection site reactions and conjunctivitis have been reported, with a higher incidence in male patients.
In a study analyzing 94,065 adverse drug reactions, it was found that while females reported more overall adverse reactions, certain immune-related adverse events were more strongly associated with dupilumab in males, indicating potential sex differences in safety responses.
Big data- and machine learning-based analysis of a global pharmacovigilance database enables the discovery of sex-specific differences in the safety profile of dual IL4/IL13 blockade.Sharif, K., Omar, M., Lahat, A., et al.[2023]
Dupilumab, a monoclonal antibody used to treat conditions like asthma and atopic dermatitis, can cause hypereosinophilia (high eosinophil levels) as a potential adverse effect, which poses a challenge for clinicians.
An algorithm has been proposed to help manage dupilumab-induced hypereosinophilia, allowing for proper investigation of related health issues while minimizing unnecessary discontinuation of the medication.
Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management.Caminati, M., Olivieri, B., Dama, A., et al.[2022]
Dupilumab is an innovative monoclonal antibody that blocks the IL-4 receptor-α, affecting the immune response pathways related to IL-4 and IL-13.
There is currently limited data on how well patients taking dupilumab respond to vaccinations against SARS-CoV-2, indicating a need for further research in this area.
Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease.Abadeh, A., Lee, JK.[2023]

References

Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. [2023]
Perception and Experience of Dupilumab in Atopic Dermatitis: A Real-Life Study. [2023]
Big data- and machine learning-based analysis of a global pharmacovigilance database enables the discovery of sex-specific differences in the safety profile of dual IL4/IL13 blockade. [2023]
Seborrhoeic dermatitis and sebopsoriasis developing in patients on dupilumab: Two case reports. [2020]
5.Czech Republicpubmed.ncbi.nlm.nih.gov
Real-life experience in the effectiveness, impact on quality of life and safety of dupilumab treatment in patients with moderate to severe atopic dermatitis in the Czech Republic. [2022]
Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management. [2022]
Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease. [2023]
Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. [2022]
Switching to Dupilumab from Other Biologics without a Treatment Interval in Patients with Severe Asthma: A Multi-Center Retrospective Study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. [2022]