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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
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,860 Total Patients Enrolled
41 Trials studying Eczema
15,661 Patients Enrolled for Eczema
Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
380,611 Total Patients Enrolled
34 Trials studying Eczema
13,098 Patients Enrolled for Eczema
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,294 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How efficacious is dupilumab in promoting health and wellbeing?
"Thanks to it's Phase 4 status, dupilumab has earned a score of 3 indicating established safety."
Answered by AI
Is there still enrollment capacity for this investigation?
"Affirmative. Clinicaltrials.gov states that the trial, initially published on November 1st 2023, is currently recruiting participants. A total of 120 patients are needed from 30 separate medical facilities."
Answered by AI
How many different locations are hosting this research endeavor?
"Presently, 30 clinics are running this trial. Of these sites, Montgomery, Fremont and La Jolla have the most opportunities for participation. It is suggested that patients enroll in a clinic nearest to them so as to offset travel demands."
Answered by AI
To what extent is participant enrollment in this investigation?
"This study necessitates the recruitment of 120 patients that match the trial's requirements. Sanofi, as the main sponsor, will be running this clinical test from multiple research centres including The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham in Montgomery, California and C2 Research Center, LLC in Fremont, Florida."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Emory University
National Allergy and Asthma Research, LLC.
Center for Clinical Studies, LTD.LLP
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
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