124 Participants Needed

Dupilumab for Eczema

(DISCOVER Trial)

Recruiting at 41 trial locations
CT
Overseen ByClinical Trials Administrator
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Regeneron Pharmaceuticals
Must be taking: Topical emollients
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing a medication for treating eczema in people with skin of color. Eczema causes itchy, dry, and cracked skin. The medication aims to reduce these symptoms by calming the immune system. The study will also look at side effects, how much of the drug is in the blood at different times, and improvements in quality of life and mental health.

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 data supports the effectiveness of the drug Dupilumab for eczema?

Dupilumab has been shown to improve symptoms of moderate-to-severe eczema, such as reducing itchiness and improving sleep and quality of life, in adults who did not respond well to other treatments. It is generally well tolerated and provides long-term benefits when used alone or with topical corticosteroids.12345

What is the safety profile of Dupilumab for eczema?

Dupilumab, used for treating eczema, is generally safe with common side effects like injection site reactions, conjunctivitis (eye inflammation), headache, and nasopharyngitis (cold-like symptoms). Some rare side effects include hair loss and eyelid issues, but overall, its safety is comparable to a placebo.16789

What makes the drug Dupilumab unique for treating eczema?

Dupilumab is unique because it is the first FDA-approved biological therapy for moderate-to-severe eczema that works by blocking the IL-4 receptor, which helps reduce inflammation caused by the immune system. Unlike traditional topical treatments, it is administered as an injection and is specifically designed for patients whose eczema is not well-controlled with topical therapies.1581011

Research Team

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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.
See 6 more

Timeline

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

Treatment Details

Interventions

  • Dupilumab
  • Topical emollient (moisturizer)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: dupilumabExperimental Treatment2 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

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

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 profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

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

Findings from Research

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.
Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis.Rowane, M., Valencia, R., Schend, J., et al.[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.
Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis.Frampton, JE., Blair, HA.[2019]
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.
Dupilumab for the treatment of adolescents with atopic dermatitis.Senner, S., Seegräber, M., Frey, S., et al.[2021]

References

Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis. [2022]
Dupilumab: A Review in Moderate-to-Severe Atopic Dermatitis. [2019]
Dupilumab for the treatment of adolescents with atopic dermatitis. [2021]
Dupixent, a New Entrant In the Asthma Lists. [2019]
Dupilumab: First Global Approval. [2022]
Dupilumab side effect in a patient with atopic dermatitis: a case report study. [2020]
Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review and Meta-Analysis. [2022]
Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]
Safety update: dupilumab and ocular adverse reactions. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]
Dupilumab in pediatric dermatology. [2022]