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Monoclonal Antibodies

Dupixent + UVB Light Therapy for Eczema

Phase 4
Recruiting
Research Sponsored by Psoriasis Treatment Center of Central New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BSA of 10% or greater
Diagnosis of moderate to severe atopic dermatitis as defined at baseline by: EASI score of 16 or greater, IGA score of 3 or greater, BSA of 10% or greater
Must not have
Subjects with previous exposure to dupilumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new medication, dupilumab, given with a type of light therapy, UVB, to people with eczema. It lasts 24 weeks total, with 12 of those being just on the medication, and the other 12 being on the medication and light therapy.

Who is the study for?
Adults over 18 with moderate to severe atopic dermatitis can join this trial. They must have a Body Surface Area (BSA) affected by eczema of 10% or more, an Eczema Area and Severity Index (EASI) score of at least 16, and an Investigator's Global Assessment (IGA) score of 3 or higher. People who've used Dupixent before or are allergic to it, as well as those with a history of reacting badly to light therapy, cannot participate.
What is being tested?
The study is testing the effectiveness of Dupixent combined with narrowband UVB phototherapy for treating atopic dermatitis. Participants will receive both treatments for the first 12 weeks followed by only Dupixent for the next 12 weeks.
What are the potential side effects?
Dupixent may cause side effects like inflammation around the injection site, eye problems such as dryness and irritation, 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
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My body surface area is 10% or more.
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I have severe skin inflammation covering more than 10% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with dupilumab before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Investigators Global Assessment Score of score of 0 or 1

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Dupixent and Narrowband UVBExperimental Treatment1 Intervention
Dupixent and Narrowband UVB

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
386,462 Total Patients Enrolled
Psoriasis Treatment Center of Central New JerseyLead Sponsor
14 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

Dupixent (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05285839 — Phase 4
Atopic Dermatitis Research Study Groups: Dupixent and Narrowband UVB
Atopic Dermatitis Clinical Trial 2023: Dupixent Highlights & Side Effects. Trial Name: NCT05285839 — Phase 4
Dupixent (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285839 — Phase 4
~0 spots leftby Dec 2024
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