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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~baseline and 8-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8-12 weeks for reporting.

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 • NCT04033367
12%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/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
2,593 Previous Clinical Trials
14,887,935 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

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05858619 — Phase 4
Atopic Dermatitis Research Study Groups: dupilumab treatment
Atopic Dermatitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05858619 — Phase 4
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05858619 — Phase 4
~5 spots leftby Feb 2026
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