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Monoclonal Antibodies
Dupilumab for Eczema
Phase 4
Recruiting
Led By Jeffrey Cheng, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Diagnosis of atopic dermatitis with a EASI (Eczema Area and Severity Index) score of 7 or higher
Must not have
Known parasitic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8-12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at how blocking a particular protein affects skin inflammation in those with eczema.
Who is the study for?
This trial is for adults over 18 with moderate to severe eczema, as shown by an EASI score of 7 or more. It's not open to those who are pregnant, have a known parasitic infection, or suffer from immunodeficiencies.
What is being tested?
The study is testing Dupilumab's effects on immune cells in skin lesions caused by atopic dermatitis (eczema) by blocking a specific part of the immune response thought to be involved in this condition.
What are the potential side effects?
Dupilumab may cause side effects such as injection site reactions, eye and eyelid inflammation, cold sores in your mouth or on your lips, and rarely more serious allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My eczema is severe, with a score of 7 or more.
Select...
My eczema is severe, with a score of 7 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed parasitic infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8-12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks
Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: dupilumab treatmentExperimental Treatment1 Intervention
Treatment with IL4RA inhibitor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,161 Total Patients Enrolled
Jeffrey Cheng, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Raymond Cho, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My eczema is severe, with a score of 7 or more.You have a weakened immune system.I have a diagnosed parasitic infection.My eczema is severe, with a score of 7 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: dupilumab treatment
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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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