Dupilumab for Eczema

Overseen By Jeffrey Cheng, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Pregnancy, Immunodeficiencies, Parasitic infection

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: Unknown

Duration: 8-12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests dupilumab, a treatment designed to help people with eczema (also known as atopic dermatitis) by targeting specific immune cells in the skin. Researchers aim to see how blocking a protein called IL4RA affects skin lesions caused by eczema. This trial suits adults who have had atopic dermatitis with visible symptoms for some time. Those who often experience flare-ups or patches of eczema might find this trial suitable. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for dupilumab?

Research shows that dupilumab is generally safe for treating eczema. Studies have found that patients from infants to adults tolerate it well. The most common side effects include reactions at the injection site, such as redness or swelling, occurring in about 1% of patients. The FDA has already approved dupilumab for treating moderate-to-severe eczema in individuals as young as six months old, indicating a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for eczema focus on reducing inflammation and soothing the skin, often involving topical steroids or moisturizers. However, Dupilumab is unique because it works by specifically blocking the activity of the IL-4 and IL-13 proteins, which are key drivers of inflammation in eczema. This mechanism not only targets the root cause of the condition but also offers a systemic approach, potentially reducing the frequency and severity of flare-ups. Researchers are excited about Dupilumab because it offers a targeted therapy that could lead to longer-lasting relief compared to traditional methods.

What is the effectiveness track record for dupilumab in treating eczema?

Research shows that dupilumab, the treatment under study in this trial, effectively treats atopic dermatitis, a common type of eczema. Studies have found that people using dupilumab achieve long-term control of their symptoms and express high satisfaction with the treatment. Over up to five years, patients consistently see improvements in their skin, quality of life, and overall well-being. Real-world studies confirm that dupilumab remains effective over time, providing lasting relief from the discomfort and irritation caused by eczema. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey Cheng, MD, PhD

Principal Investigator

University of California, San Francisco

Raymond Cho, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe eczema, as shown by an EASI score of 7 or more. It's not open to those who are pregnant, have a known parasitic infection, or suffer from immunodeficiencies.

Inclusion Criteria

My eczema is severe, with a score of 7 or more.

My eczema is severe, with a score of 7 or higher.

Exclusion Criteria

You have a weakened immune system.

I have a diagnosed parasitic infection.

Known pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the IL4RA inhibitor dupilumab

8-12 weeks

Biopsy samples collected for molecular profiling

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 study is testing Dupilumab's effects on immune cells in skin lesions caused by atopic dermatitis (eczema) by blocking a specific part of the immune response thought to be involved in this condition.

How Is the Trial Designed?

Group I: dupilumab treatment Experimental Treatment 1 Intervention

Treatment with IL4RA inhibitor

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

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, a monoclonal antibody targeting the IL-4 receptor, has shown promising therapeutic outcomes for dermatologic conditions in children and adolescents, although the data is still limited.

Current evidence consists of a small number of clinical trials and case reports, highlighting the need for more extensive long-term studies to better understand the efficacy and safety of dupilumab in the pediatric population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in pediatric dermatology. Plachouri, KM., Georgiou, S.[2022]

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 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]

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 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]

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

Dupilumab, a monoclonal antibody approved by the FDA in 2017, effectively treats moderate to severe atopic dermatitis by inhibiting IL-4 and IL-13 signaling, providing an alternative for patients not responding to topical therapies.

While dupilumab is generally effective, it can cause adverse effects such as injection site reactions and conjunctivitis, with rare cases like alopecia areata reported, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab side effect in a patient with atopic dermatitis: a case report study. Albader, SS., Alharbi, AA., Alenezi, RF., et al.[2020]

Dupilumab is the first biologic therapy approved for adults with moderate-to-severe atopic dermatitis (AD), showing significant improvements in disease severity, itching, sleep quality, and overall quality of life in phase III trials involving patients inadequately controlled by other treatments.

The treatment was well tolerated with low rates of serious side effects, making dupilumab a promising long-term option for patients with AD, especially since it maintains its benefits over a year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. Frampton, JE., Blair, HA.[2019]

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]

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]

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Adult Real-World Data | DUPIXENT® (dupilumab)

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