Dupilumab for Eczema

(DISCOVER Trial)

No longer recruiting at 43 trial locations

Overseen By Clinical Trials Administrator

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Regeneron Pharmaceuticals

Must be taking: Topical emollients

Must not be taking: Dupilumab, Topical corticosteroids

Disqualifiers: Caucasian, Low weight, Skin diseases, 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: 24

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of Dupilumab for individuals with moderate-to-severe eczema, focusing on those with skin of color. Eczema causes itchy, dry, and cracked skin, and the study aims to gather more information on how Dupilumab affects these symptoms. The researchers will examine potential side effects, how the body processes the drug, and its impact on quality of life and mental health. Eligible participants include those with skin of color whose eczema is not well-controlled with creams and who have been using moisturizers regularly. As a Phase 4 trial, this research aims to understand how the already FDA-approved Dupilumab benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial does not clearly specify if you must stop taking your current medications. However, you cannot use certain treatments like topical corticosteroids or calcineurin inhibitors within 7 days before starting the trial. It's best to discuss your current medications with the trial team.

What is the safety track record for Dupilumab?

Research shows that dupilumab is generally safe for people with moderate-to-severe eczema, also known as atopic dermatitis. Most patients tolerate dupilumab well, though some may experience side effects, such as redness at the injection site, eye issues like pink eye, and cold sores. Serious side effects are rare.

The FDA has already approved dupilumab for treating eczema, indicating it has been tested in many people and is considered safe for humans. The current study aims to gather more safety information, particularly for individuals with skin of color. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for eczema, which typically include topical steroids and moisturizers, Dupilumab stands out because it targets a specific pathway in the immune system. Most eczema treatments focus on alleviating symptoms, but Dupilumab works by blocking the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of eczema. This targeted approach not only addresses the root cause of inflammation but also offers a new option for those who may not respond well to traditional therapies. Researchers are excited about Dupilumab because it has the potential to provide longer-lasting relief and improve the quality of life for patients with moderate to severe eczema.

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

Research has shown that dupilumab, which participants in this trial may receive, effectively treats moderate-to-severe eczema. In studies, individuals using dupilumab experienced significantly better skin improvement than those who did not. Dupilumab blocks a protein that causes inflammation, leading to eczema symptoms. The treatment has reduced itching, redness, and skin damage. Its safety and effectiveness are well-documented for people with eczema. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with darker skin (Fitzpatrick skin type ≥4) who suffer from moderate-to-severe eczema that isn't well-managed by topical treatments. Participants should be using a stable dose of moisturizer as recommended by their physician. Excluded are those who've used dupilumab recently, had certain vaccinations close to the trial start, or have other skin conditions that might affect results.

Inclusion Criteria

My severe skin condition isn't controlled by creams or ointments.

You have dark skin, defined as Fitzpatrick skin type 4 or higher.

I have been using a moisturizer as recommended by my doctor.

Exclusion Criteria

I have used dupilumab within the last 6 months.

Self-reported Caucasian or White race

I have not been vaccinated for COVID-19 within a week of starting the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab based on age and body weight to assess safety and effectiveness in skin of color participants with moderate-to-severe atopic dermatitis

24 weeks

Each visit, baseline through week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Topical emollient (moisturizer)

Trial Overview The study tests Dupilumab's safety and effectiveness in improving life quality and mental health for people with colored skin suffering from severe eczema. It also examines how much of the drug gets into the blood over time. Participants will use Dupilumab alongside regular moisturizers to manage their eczema symptoms.

How Is the Trial Designed?

Group I: dupilumab Experimental Treatment 2 Interventions

Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

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?

Regeneron Pharmaceuticals

Lead 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

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

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]

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 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]

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 (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 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]

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, 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, 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]

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 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]

Citations

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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 ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy000000185DEAQ/nct02260986

Study to Assess the Efficacy and Long-term Safety of ... The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5655850/

Exploratory Population PK Analysis of Dupilumab, a Fully ... An exploratory population pharmacokinetic model for functional dupilumab was developed. Data from healthy volunteers and patients with atopic dermatitis (AD)

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1314768

Dupilumab Treatment in Adults with Moderate-to-Severe ... Blocking IL-4Rα signaling with REGN668/SAR231893 rapidly suppresses major pathogenic pathways in severe atopic dermatitis. J Invest Dermatol ...

5. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2012-003651-11/results

EudraCT Number 2012-003651-11 - Clinical trial results To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult patients with moderate-to-severe AD. Protection of trial subjects.

6. 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 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000PharmR.pdf

761055Orig1s000 - accessdata.fda.gov A Carcinogenicity Risk Assessment for Dupilumab (REGN668/ SAR231893) ... The sponsor believes that its downregulation may prevent or reverse the ...

8. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019m2EAA/nct01639040

Study to Assess the Safety of Dupilumab (REGN668 ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7286262/

Assessing the risk of dupilumab use for atopic dermatitis ... ... (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic ... dupilumab treatment based on the safety data from phase III clinical trials.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01639040

NCT01639040 | Study to Assess the Safety of Dupilumab ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...