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Monoclonal Antibodies
Dupilumab for Eczema (DISCOVER Trial)
Phase 4
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 12 and 24
Awards & highlights
DISCOVER Trial Summary
This trial studies if a drug called dupilumab can help reduce symptoms of atopic dermatitis (eczema) in people aged 12 and older with moderate-to-severe symptoms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, eye issues like redness or itching, cold sores in your mouth or on your lips, and inflammation of organs similar to previous studies on participants with atopic dermatitis.
DISCOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My severe skin condition isn't controlled by creams or ointments.
Select...
I have been using a moisturizer as recommended by my doctor.
DISCOVER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4, 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 12 and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with eczema area and severity index (EASI)-75
Secondary outcome measures
Absolute change from baseline in EASI
Absolute change from baseline in weekly average of daily PP NRS
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
+24 moreDISCOVER Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2022
Completed Phase 4
~330
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for eczema primarily work through anti-inflammatory and immunomodulatory mechanisms. Topical corticosteroids reduce inflammation by suppressing the immune response in the skin.
Topical immunomodulators like tacrolimus and pimecrolimus inhibit calcineurin, which decreases the activity of T-cells and reduces inflammation. Systemic treatments such as dupilumab and lebrikizumab target specific cytokines involved in the inflammatory process; dupilumab blocks IL-4 and IL-13 signaling, while lebrikizumab inhibits IL-13.
These mechanisms are crucial for eczema patients as they directly address the underlying inflammation and immune dysregulation, leading to symptom relief and improved skin condition.
Treatment of atopic dermatitis with antihistamines: lessons from a single-patient, randomized clinical trial.Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis.Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.
Treatment of atopic dermatitis with antihistamines: lessons from a single-patient, randomized clinical trial.Systemic Immunomodulatory Treatments for Patients With Atopic Dermatitis: A Systematic Review and Network Meta-analysis.Therapeutic Potential of Lebrikizumab in the Treatment of Atopic Dermatitis.
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Who is running the clinical trial?
SanofiIndustry Sponsor
2,172 Previous Clinical Trials
3,516,705 Total Patients Enrolled
42 Trials studying Eczema
15,811 Patients Enrolled for Eczema
Regeneron PharmaceuticalsLead Sponsor
631 Previous Clinical Trials
382,149 Total Patients Enrolled
35 Trials studying Eczema
13,248 Patients Enrolled for Eczema
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
267 Previous Clinical Trials
252,416 Total Patients Enrolled
20 Trials studying Eczema
10,627 Patients Enrolled for Eczema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used dupilumab within the last 6 months.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.I have not been vaccinated for COVID-19 within a week of starting the study drug.I do not have an active worm infection.I weigh less than 30 kg.I haven't used any skin creams for my condition in the last week.I do not have skin conditions that could affect skin assessment.I have used phototherapy or tanning beds in the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: dupilumab
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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