Dupilumab for Eczema

(NEURADAD Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how dupilumab (a monoclonal antibody) affects cognitive functions in adolescents with moderate-to-severe atopic dermatitis (AD), a chronic skin condition. It examines whether the severity of AD relates to cognitive and sensory issues and whether these improve with treatment. Part A involves a single assessment, while Part B includes treatment and further evaluation. Adolescents who have had AD for at least a year and experience significant itching and skin coverage qualify as good candidates for this trial. Those who have recently used dupilumab or have certain other conditions, such as ADHD or substance abuse, are not eligible.

As a Phase 2 trial, this study measures how well dupilumab works in an initial, smaller group of adolescents, offering a chance to contribute to important research on improving AD treatment.

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.

Is there any evidence suggesting that dupilumab is likely to be safe for humans?

Research has shown that dupilumab is generally well-tolerated. In studies involving children as young as six months, those receiving dupilumab experienced fewer side effects compared to other treatments. Additionally, a large safety study in adults with atopic dermatitis (a skin condition) found serious allergic reactions were rare, occurring in only about 0.3% of patients. Another study tracked patients using dupilumab for up to five years and found that its safety remained stable, with no new concerns over time. Overall, the evidence suggests that dupilumab is safe for treating conditions like atopic dermatitis. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for AD?

Researchers are excited about dupilumab for treating moderate-to-severe atopic dermatitis in adolescents because it works differently from typical treatments like topical corticosteroids and calcineurin inhibitors. Unlike these standard options, which focus on managing symptoms, dupilumab targets the underlying cause by blocking specific proteins involved in the inflammation process, specifically IL-4 and IL-13. This unique approach not only has the potential to provide more effective relief but also reduces the risk of side effects associated with long-term steroid use.

What evidence suggests that dupilumab might be an effective treatment for cognitive functioning in adolescents with moderate-to-severe AD?

Research has shown that dupilumab effectively treats atopic dermatitis (AD), a skin condition causing redness and itching. Studies have found that people using dupilumab experienced lasting improvements in symptoms and quality of life, with some benefits persisting for years. Most people tolerated dupilumab well, experiencing no serious side effects. This suggests that dupilumab could be a promising treatment for teenagers with moderate-to-severe AD, addressing both skin problems and related mental health issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• dupilumab

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38653344/

Up to 5-year results from the daily practice BioDay registry Dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients' perspectives.

2. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/adult-real-world-results

Adult Real-World Data | DUPIXENT® (dupilumab) Long-term effectiveness of dupilumab in patients with atopic dermatitis: results up to 3 years from the RELIEVE-AD study. Dermatol Ther (Heidelb). 2023;13(9): ...

3. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2822203

Long-Term Effectiveness and Reasons for Discontinuation ... However, while dupilumab treatment was effective in most patients, 306 patients (23.8%) discontinued treatment after a median (IQR) of 54.0 ( ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224006418

Dupilumab provides sustained effectiveness on patient- ... Dupilumab treatment has demonstrated sustained improvements in patient-reported measures of severity, symptoms, quality of life, overall well-being, and work ...

5. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-cutaneous-immunology-and-allergy/articles/10.3389/jcia.2025.14794/full

Real-world safety and effectiveness of dupilumab for the ... Dupilumab was well tolerated and demonstrated an acceptable safety profile, and was associated with rapid and sustained improvements in AD signs ...

6. dupixenthcp.com dupixenthcp.com/asthma/efficacy/safety-data

Safety Data For Asthma | DUPIXENT® (dupilumab) DUPIXENT has been studied up to 1 year in nearly 3000 asthma patients. 1,a Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40993471/

The Safety Data of Dupilumab for the Treatment ... This study is the largest safety analysis of dupilumab to date. We found that children 6 months to 11 years receiving dupilumab had fewer side ...

8. dupixenthcp.com dupixenthcp.com/crswnp/efficacy/safety-data-and-design

safety data and study designs in adults The safety profile of DUPIXENT through Week 52 was generally consistent with the safety profile observed at Week 24.1. In subjects with CRSwNP, ...

9. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2820911

Dupilumab in Adults With Moderate to Severe Atopic ... Hypersensitivity and anaphylactic reactions were reported in 9 patients (0.3%; 0.154 events per 100 patient-years) and 6 patients (0.2%; 0.120 ...

10. jaad.org jaad.org/article/S0190-9622(24)01289-1/fulltext

52680 Long-Term Safety Data for Dupilumab in a 5-Year ... Conclusions: The safety profile observed in this OLE trial for up to 5 years is acceptable and consistent with the known safety profile of dupilumab observed in ...