Dupilumab for Eczema
(DISCOVER Trial)
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dupilumab
- Topical emollient (moisturizer)
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- 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
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
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