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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called dupilumab (Dupixent) to assess its effects on sleep, itching, and daily rhythms in children with moderate to severe atopic dermatitis (a type of eczema). Researchers aim to determine if weekly injections of this treatment can improve these symptoms over 12 weeks. Children aged 6 to 17 with eczema unresponsive to creams and who experience sleep disturbances are suitable candidates for this study. Participants must have consistently used certain medications, such as inhaled corticosteroids and antihistamines, before starting the trial. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

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 is the safety track record for dupilumab?

Research has shown that dupilumab, a treatment for atopic dermatitis, is generally safe for use. Studies with adults have found that dupilumab is well-tolerated, even when used for up to four years. The most common side effects are mild, such as injection site reactions, eye inflammation, and cold sores.

In studies with children who have moderate-to-severe atopic dermatitis, dupilumab has demonstrated similar results. Researchers have carefully studied the treatment's safety and its effects on the body. These findings support that dupilumab is safe for children and teens.

Overall, dupilumab appears to be a reliable treatment with manageable side effects, making it a good option for managing atopic dermatitis in children. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for atopic dermatitis, which often involve topical steroids or immunosuppressants, Dupilumab is a targeted biologic therapy. It works by blocking specific proteins, IL-4 and IL-13, that are key drivers of the inflammation in atopic dermatitis. This targeted approach not only addresses the underlying cause of the condition but also reduces the need for steroids, which can have significant side effects. Researchers are excited about Dupilumab because it provides a new, less invasive option with potentially fewer side effects and a more effective long-term solution for managing atopic dermatitis.

What is the effectiveness track record for Dupilumab in treating atopic dermatitis?

Research shows that dupilumab effectively treats atopic dermatitis, a common skin condition. Studies have found that people using dupilumab experience significant skin improvements and express high satisfaction with the treatment. One study demonstrated that dupilumab controlled the condition for up to five years, suggesting long-lasting benefits. Participants also reported overall well-being and symptom relief. Dupilumab is an approved treatment for atopic dermatitis, underscoring its proven effectiveness in managing the condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy Paller

Principal Investigator

Lurie Children's Hospital/Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442302/

Long-Term Effectiveness of Dupilumab in Patients with Atopic ... In this prospective, longitudinal, real-world study, patients reported maintenance of disease control and treatment satisfaction after 30–36 ...

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

Long-Term Effectiveness and Reasons for Discontinuation ... Descriptive Clinical Effectiveness Outcomes Among 1286 Patients With Atopic Dermatitis During 5 Years of Dupilumab Treatment. View Large ...

4. 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): ...

5. dupixent.com dupixent.com/atopicdermatitis/dupixent-results/adults

DUPIXENT® (dupilumab) Results in Adults with Eczema Learn about the DUPIXENT® (dupilumab) clinical trial results for uncontrolled moderate-to-severe eczema in adults. Serious side effects can occur.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35503163/

Dupilumab Provides Acceptable Safety and Sustained ... This study examined the safety and efficacy of up to 4 years of dupilumab treatment in adults with moderate-to-severe atopic dermatitis.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02407756

NCT02407756 | A Study to Determine the Safety and ... The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic ...

8. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety

Efficacy and Safety Overview The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, ...

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

Dupilumab in Adults With Moderate to Severe Atopic ... In this open-label extension study of 2677 adults with moderate to severe atopic dermatitis, dupilumab was well tolerated with no new safety incidents and ...

10. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-revolutionizing-atopic-dermatitis-rad

Dupixent® (dupilumab) Data at Revolutionizing Atopic ... Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients.