Dupilumab for Atopic Dermatitis

Recruiting at 2 trial locations

Overseen By Dermatology CTU

Age: < 18

Sex: Any

Trial Phase: Phase 4

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 2 5 9 10}

Research Team

Amy Paller

Principal Investigator

Lurie Children's Hospital/Northwestern University

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.

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

Treatment Details

Interventions

• Dupilumab

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Regeneron Pharmaceuticals

Industry 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

Findings from Research

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

In a real-life study of 241 adults with atopic dermatitis treated with dupilumab, significant improvements were observed in skin severity scores after 3 months, with 48.8% of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI).

However, the study also found a higher incidence of conjunctivitis (38.2% of patients) and increased eosinophilia (57% during follow-up) compared to baseline, indicating potential safety concerns associated with dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. Faiz, S., Giovannelli, J., Podevin, C., et al.[2019]

In a review of 22 studies involving 3303 patients, dupilumab demonstrated significant efficacy in treating atopic dermatitis, with 85.1% of patients achieving at least a 50% improvement in their Eczema Area and Severity Index (EASI) score after 16 weeks of treatment.

While dupilumab is generally well-tolerated, conjunctivitis was the most common side effect, occurring in 26.1% of patients, highlighting the need for ongoing monitoring of adverse events in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. Halling, AS., Loft, N., Silverberg, JI., et al.[2021]

In a study of 95 patients with moderate-to-severe atopic dermatitis treated with dupilumab for at least 12 weeks, significant improvements were observed in both physician-reported and patient-reported outcome measures, aligning with previous clinical trial results.

While dupilumab was generally well-tolerated, common side effects included eye symptoms in 62% of patients and orofacial herpes simplex virus reactivation in 8%, but no major safety concerns were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. de Wijs, LEM., Bosma, AL., Erler, NS., et al.[2021]

Dupilumab is the first biological medication approved for treating moderate-to-severe atopic dermatitis, demonstrating significant effectiveness and a favorable safety profile.

Despite its overall safety, there have been rare cases of local Staphylococcus aureus infections reported in patients undergoing dupilumab treatment for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Dupilumab leads to an increased chance of head and neck Staphylococcus aureus infection in atopic dermatitis patients. Chen, M., Gao, K., Ali, K., et al.[2023]

Dupilumab effectively treats moderate-to-severe atopic dermatitis by blocking IL-4/IL-13 signaling, leading to significant improvements in clinical measures like SCORAD and EASI, as well as patient-reported outcomes such as itch severity.

The safety profile of dupilumab is better than traditional immunosuppressive drugs, with fewer skin infections reported compared to placebo, although it can cause injection-site reactions and conjunctivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for treatment of atopic dermatitis. Seegräber, M., Srour, J., Walter, A., et al.[2019]

In a study of 1775 patients with atopic dermatitis using dupilumab, there was a 6-month risk of conjunctivitis of 6.5%, which is significantly higher compared to other treatments like methotrexate (3.3%) and mycophenolate (1.2%).

Dupilumab was associated with a low risk of serious infections (0.6%), similar to methotrexate (1.0%), indicating that while it is effective, the increased risk of conjunctivitis should be monitored and managed in patients.

NCBI (Pubmed)

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. Schneeweiss, MC., Kim, SC., Wyss, R., et al.[2021]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupilumab effectively improves signs, symptoms, and quality of life in adolescents with moderate to severe atopic dermatitis (AD) by targeting key inflammatory pathways, specifically blocking IL-4 and IL-13 receptors.

The safety profile of dupilumab in adolescents is similar to that in adults, with common side effects including injection-site reactions and conjunctivitis, while skin infections were less frequent compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of adolescents with atopic dermatitis. Senner, S., Seegräber, M., Frey, S., et al.[2021]

References

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

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

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

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]

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]

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]

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

Effectiveness of dupilumab treatment in 95 patients with atopic dermatitis: daily practice data. [2021]

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]

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

Dupilumab for treatment of atopic dermatitis. [2019]

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]

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]

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

Dupilumab for the treatment of adolescents with atopic dermatitis. [2021]