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

(NEURADAD Trial)

Recruiting at 9 trial locations

Overseen By Clinical Trials Administrator

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Regeneron Pharmaceuticals

Must be taking: Topical medications

Must not be taking: ADHD medications, Antihistamines

Disqualifiers: ADHD, Autism, Epilepsy, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

45 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

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

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

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

Group I: Part B Experimental Treatment 1 Intervention

Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.

Group II: Part A Experimental Treatment 0 Interventions

Assessed in a single visit and no study-related treatment will be given.

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

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

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

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease. Abadeh, A., Lee, JK.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Perception and Experience of Dupilumab in Atopic Dermatitis: A Real-Life Study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Seborrhoeic dermatitis and sebopsoriasis developing in patients on dupilumab: Two case reports. [2020]

5. Czech Republic pubmed.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]

6. England pubmed.ncbi.nlm.nih.gov

Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Reduced COVID-19 vaccine response in patient treated with dupilumab for IgG4-related disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Switching to Dupilumab from Other Biologics without a Treatment Interval in Patients with Severe Asthma: A Multi-Center Retrospective Study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. [2022]