Dupilumab for Atopic Dermatitis

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Anna B Fishbein, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: Inhaled corticosteroids, topical steroids

Must not be taking: Systemic immunosuppressants

Disqualifiers: Poorly controlled asthma, major medical condition, active sleep-affecting condition, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be on a stable regimen of inhaled corticosteroids, topical steroids, and antihistamines for at least 14 days before starting the study. You cannot use systemic immunosuppressants within 30 days of the first sleep study.

What data supports the effectiveness of the drug Dupilumab for treating atopic dermatitis?

Dupilumab has been shown to be effective and safe for treating moderate to severe atopic dermatitis in both clinical trials and real-world settings, with significant improvements observed in many patients.

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Is dupilumab safe for humans?

Dupilumab is generally considered safe for treating atopic dermatitis, but some patients may experience side effects like eye issues and local skin infections. It has a better safety profile compared to some other treatments, but injection-site reactions and conjunctivitis (eye inflammation) are noted as common side effects.

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What makes the drug Dupilumab unique for treating atopic dermatitis?

Dupilumab is unique because it is the first biologic drug specifically approved for moderate-to-severe atopic dermatitis, working by blocking the IL-4/IL-13 receptor to reduce type 2 inflammation, which helps improve the skin barrier and immune response.

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Eligibility Criteria

Children aged 6-17 with moderate to severe atopic dermatitis (AD) that isn't well-controlled by topical treatments can join. They must have a history of sleep disturbances due to AD and be on stable medication regimens. Kids who've used certain meds recently, have other conditions affecting sleep, or cannot communicate in English are excluded.

Inclusion Criteria

You have trouble sleeping, as assessed by a specific test, or if you're under 8 years old, your parent has reported that you have trouble sleeping.

I have been on a stable dose of inhaled or topical steroids and antihistamines for at least 14 days.

I am between 6 and 17 years old.

Exclusion Criteria

Pregnancy

You are taking a medication that makes you feel itchy.

I can communicate in English.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab treatment for 12 weeks with weekly subcutaneous injections

12 weeks

2 overnight visits (in-person) for sleep studies, weekly home administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing Dupilumab's effects over 12 weeks on improving circadian function, sleep quality, and itchiness in children with AD. It's an open-label study where all participants know they're receiving the drug and their sleep and itching symptoms are monitored before and after treatment.

Group I: Dupilumab administration Experimental Treatment 1 Intervention

dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.

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 Nearby Select from list below to view details:

Lurie Children's Hospital Chicago, IL

Northwestern University Chicago, IL

Lurie Children's Hospital/Northwestern University Chicago, IL

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago Lead Sponsor

Northwestern University Lead Sponsor

Regeneron Pharmaceuticals Industry Sponsor

References

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

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020] Dupilumab (Dupixent) for atopic dermatitis.

2. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021] Dupilumab is the first human monoclonal antibody approved for the treatment of atopic dermatitis (AD). Clinical trials have reported an increase of ocular side effects in patients who receive dupilumab, with a prevalence of 5-37%.

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

Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. [2019] Dupilumab is the first biologic available to treat atopic dermatitis (AD). Its effectiveness and safety were demonstrated in clinical trials.

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

Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. [2021] Dupilumab, the first biological drug to be approved for the treatment of moderate to severe atopic dermatitis in adolescents and adults, has shown good efficacy and safety in clinical trials.

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. [2021] Dupilumab is the first biologic registered for the treatment of moderate-to-severe atopic dermatitis (AD), and efficacy was shown in phase III clinical trials (primary outcome at week 16 was reached in 38% of patients). Currently, there are limited daily practice data available for dupilumab, especially when it is combined with systemic immunosuppressants.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Case report: Dupilumab leads to an increased chance of head and neck Staphylococcus aureus infection in atopic dermatitis patients. [2023] Dupilumab was the first biological medication licensed to treat atopic dermatitis (AD), and it has shown remarkable effectiveness and safety in the treatment of moderate-to-severe atopic dermatitis. There are limited drug-related adverse events associated with dupilumab in atopic dermatitis (AD) treatment. Here, we present two cases of local Staphylococcus aureus infection during the treatment of atopic dermatitis with dupilumab.

7. England pubmed.ncbi.nlm.nih.gov

Dupilumab for treatment of atopic dermatitis. [2019] Dupilumab is a new treatment option for patients with moderate-to-severe atopic dermatitis. It blocks IL-4/IL13-signaling and thereby inhibits receptor signaling downstream the JAK-STAT-pathway. Three of the main disease mechanisms of atopic dermatitis are affected by blocking this pathway; the decrease of skin barrier function, the class switch to IgE and the TH2-differentiation. Areas Covered: Dupilumab showed promising results in clinical trials of phase I-III. Clinical outcome parameters such as SCORAD, EASI, IGA and BSA improved with dupilumab. A positive effect on patient-reported outcomes like DLQI or pruritus-rating-scales was also demonstrated. The safety profile of dupilumab is superior to conventional immunosuppressive drugs, such as cyclosporine or methotrexate. Injection-site reactions and conjunctivitis were the most relevant side-effects. Skin infections were less frequently observed compared to placebo. Data on the use of dupilumab during pregnancy or in children are not published to date. Expert Commentary: Dupilumab was approved by the FDA in April 2017 for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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

Dupilumab and the risk of conjunctivitis and serious infection in patients with atopic dermatitis: A propensity score-matched cohort study. [2021] Dupilumab is an effective treatment for moderate to severe atopic dermatitis (AD) with limited safety data in clinical practice.

9. England pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023] Dupilumab is a monoclonal antibody against the IL-4/IL-13 receptor-subunit approved for the treatment of moderate-severe atopic dermatitis (AD). Some attempts to increase dose interval have been described in both trial and real-world settings.

10. England pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of adolescents with atopic dermatitis. [2021] Dupilumab is a treatment option newly licensed for adolescents with moderate to severe atopic dermatitis (AD). It reduces type 2 inflammation by blocking the shared receptor subunit for IL-4/-13. Dupilumab affects three disease mechanisms in atopic dermatitis: the skin barrier, the Th2-cell differentiation and the class switch to IgE. This report is based on a systematic literature search of the PubMed Database.