Dupilumab Dosing for Eczema

Overseen By Sumrah Jilani, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must be taking: Dupilumab

Must not be taking: Methotrexate, Cyclosporine, others

Disqualifiers: Poor AD control, 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: 8

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether children aged 1-17 with eczema (atopic dermatitis) who have responded well to dupilumab can reduce their dosage or stop taking it altogether. The goal is to determine if less medication can still manage their eczema effectively. Participants are divided into three groups: one continues the usual dose, the second reduces the dose, and the third stops the medication. Children with well-controlled eczema on dupilumab for at least a year may be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

If you are taking other systemic medications for eczema, you will need to stop them to join this trial. The trial does not specify about other medications, so it's best to discuss with the study team.

What is the safety track record for dupilumab?

A previous study found that dupilumab is generally safe for treating children and adults with eczema. Most participants tolerated the drug well, and serious side effects were rare. Some reported joint pain, but this was uncommon. The FDA has already approved dupilumab for eczema, supporting its safety. Overall, dupilumab appears to be a well-tolerated treatment for eczema with few serious risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the potential of dupilumab for eczema because it targets a specific pathway involved in inflammation, the IL-4 and IL-13 signaling pathways, which are believed to be pivotal in the development of atopic dermatitis. Unlike standard treatments such as topical corticosteroids or calcineurin inhibitors, which often require frequent application and can have side effects with long-term use, dupilumab offers a systemic option that might improve symptoms with less frequent dosing. Furthermore, this trial is exploring different dosing strategies, including dose reduction and discontinuation, which could help tailor treatment plans to individual needs and potentially reduce medication burden. These unique approaches could lead to more personalized and effective management of eczema.

What evidence suggests that this trial's treatments could be effective for eczema?

This trial will evaluate different dosing strategies for dupilumab in treating atopic dermatitis, also known as eczema. Studies have shown that dupilumab works well for this condition, with many patients experiencing lasting improvements in symptoms and quality of life with regular doses. In this trial, one group will continue with standard dosing, while another group will have their dosage reduced. Research indicates that even with reduced dosage, most patients continue to benefit. Specifically, some studies have shown that two-thirds of patients maintain these improvements. Dupilumab is already approved and widely used, providing strong evidence of its effectiveness for eczema. ^{6 7 8 9 10}

Who Is on the Research Team?

Joy Wan, MD MSCE

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for children aged 1-17 with well-controlled atopic dermatitis (eczema) who have been on dupilumab for at least a year. They must understand English and follow study procedures. A parent or guardian's consent (and child's assent if applicable) is required.

Inclusion Criteria

I have been treated with dupilumab for my skin condition for at least a year.

My skin condition has been well-managed with dupilumab in the last 6 months.

I am between 1 and 17 years old.

Exclusion Criteria

I am currently using light therapy for my skin condition.

I do not have health insurance or will lose it during the study.

I am currently on medication for atopic dermatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either discontinue, reduce, or continue standard dupilumab dosing for atopic dermatitis. This phase includes 5 study visits for skin examination and symptom questionnaires.

16 weeks

5 visits (in-person)

Observational Follow-up

Participants complete questionnaires about AD symptoms and medication use every twelve weeks to monitor long-term effects of treatment changes.

36 weeks

3 follow-up contacts (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The study tests whether it's feasible to stop giving dupilumab or reduce its dose in kids who've had their eczema under control with the standard dose of this medication. It’s a pilot trial where participants are randomly assigned to continue, stop, or reduce the drug.

How Is the Trial Designed?

Group I: Dupilumab - standard dosing Experimental Treatment 1 Intervention

Participants will continue to receive standard maintenance dupilumab dosing for atopic dermatitis according to FDA labeling, as indicated below. Infants ≥6 months and Children \<6 years: 5 to \<15 kg: 200 mg every 4 weeks. 15 to \<30 kg: 300 mg every 4 weeks Children ≥6 years and Adolescents ≤17 years: 15 to \<30 kg: 300 mg every 4 weeks 30 to \<60 kg: 200 mg every other week ≥60 kg: 300 mg every other week

Group II: Dupilumab - dose reduction Experimental Treatment 1 Intervention

Participants whose standard dupilumab dosing for atopic dermatitis is 200 mg or 300 mg every 2 weeks will decrease drug administration to every 4 weeks, and participants whose standard dupilumab dosing is 200 mg or 300 mg every 4 weeks will decrease administration to every 8 weeks.

Group III: Dupilumab - discontinuation Experimental Treatment 1 Intervention

Participants will discontinue their dupilumab treatment for atopic dermatitis.

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?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Published Research Related to This Trial

Dupilumab significantly improved symptoms of atopic dermatitis (AD) in both adults (n=3,817) and children/adolescents (n=618), showing a marked reduction in the Eczema Area Severity Index (EASI) score and pruritus, indicating its efficacy as a treatment option.

The safety profile of dupilumab was comparable to that of a placebo, with no increase in adverse events, suggesting it is a safe option for managing AD-related symptoms and improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. Koskeridis, F., Evangelou, E., Ntzani, EE., et al.[2022]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

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, an IL-4 receptor antagonist, is the first FDA-approved biological therapy for moderate-to-severe atopic dermatitis (AD) and has shown improved outcomes in patients inadequately controlled by topical treatments.

However, this case report highlights new side effects, specifically hyperhidrosis and bromhidrosis, in two patients after starting dupilumab, suggesting the need for further research on its long-term safety and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. Rowane, M., Valencia, R., Schend, J., et al.[2022]

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]

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 phase 3 clinical trial involving 422 adults with moderate to severe atopic dermatitis, dupilumab administered weekly or every 2 weeks effectively maintained treatment response, with minimal change in Eczema Area and Severity Index (EASI) scores compared to placebo.

Longer dosing intervals (every 4 or 8 weeks) led to a significant decrease in treatment efficacy, while no new safety concerns were identified, supporting the recommendation of the approved regimen of 300 mg dupilumab every 2 weeks for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial. Worm, M., Simpson, EL., Thaçi, D., 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 is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[2022]

In a study involving 379 adults with moderate-to-severe atopic dermatitis, dupilumab showed a dose-dependent increase in efficacy, particularly at higher doses of 300 mg every 2 weeks or weekly, indicating its effectiveness in reducing symptoms.

The pharmacokinetics of dupilumab were similar between Japanese and non-Japanese patients, suggesting that ethnicity does not significantly affect the drug's behavior in the body, which supports its use across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Kamal, MA., Davis, JD., Kovalenko, P., et al.[2023]

In a study of 295 adult patients with atopic dermatitis treated with dupilumab, serum levels of the drug at 16 weeks showed a wide range but did not correlate with treatment response or adverse effects over the first year.

The findings suggest that individual responses to dupilumab may vary due to differences in the availability of the interleukin-4 receptor, rather than serum drug levels, indicating a need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Serum Dupilumab Levels at 16 Weeks With Treatment Response and Adverse Effects in Patients With Atopic Dermatitis: A Prospective Clinical Cohort Study From the BioDay Registry. Spekhorst, LS., de Graaf, M., Loeff, F., et al.[2023]

Citations

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

Long-Term Effectiveness of Dupilumab in Patients with Atopic ... In summary, this study showed that long-term dupilumab treatment provides continued improvement in symptoms, treatment satisfaction, disease ...

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

Long-Term Effectiveness and Reasons for Discontinuation ... Eighty-five patients (6.6%) discontinued treatment due to ineffectiveness while being treated with dupilumab, 300 mg, every other week, and 10 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06004986

DUPIlumab Dose REDUCtion in Patients With Controlled ... The objective of this study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients with controlled atopic eczema. A ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39110432/

Long-Term Effectiveness and Reasons for Discontinuation ... In this cohort study with up to 5 years of follow-up, dupilumab maintained its clinical effectiveness, while two-thirds of patients tapered ...

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

The Safety Data of Dupilumab for the Treatment ... This study reviews the safety of the drug dupilumab, which is used to treat infants, children, adolescents, and adults who have moderate-to- ...

7. link.springer.com link.springer.com/article/10.1007/s40257-025-00952-w

The Safety Data of Dupilumab for the Treatment ... This study reviews the safety of the drug dupilumab, which is used to treat infants, children, adolescents, and adults who have moderate-to- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761055Orig1s040.pdf

761055Orig1s040 | FDA Since Dupixent (dupilumab) was approved on March 28, 2017, we have become aware of reports of arthralgia in clinical trials conducted in ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0923181119300283

Efficacy and safety of dupilumab monotherapy in adults ... The pooled data show that dupilumab has an acceptable safety profile (no new safety ... Long-term management of moderate-to-severe atopic dermatitis with ...