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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My body surface area is 10% or more.
Select...
I have severe skin inflammation covering more than 10% of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigators Global Assessment Score of score of 0 or 1
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dupixent and Narrowband UVBExperimental Treatment1 Intervention
Dupixent and Narrowband UVB
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Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
621 Previous Clinical Trials
380,565 Total Patients Enrolled
Psoriasis Treatment Center of Central New JerseyLead Sponsor
14 Previous Clinical Trials
402 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your EASI score is 16 or higher.You have had reactions to sunlight in the past.My body surface area is 10% or more.Your IGA score is 3 or higher.I am 18 years old or older.I have been treated with dupilumab before.You are allergic to dupilumab or any of the ingredients in it.I have severe skin inflammation covering more than 10% of my body.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Dupixent and Narrowband UVB
Awards:
This trial has 4 awards, including:- 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.
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.
Does this experiment have any openings for participants presently?
"As indicated on clinicaltrials.gov, this research endeavour is no longer accepting patients to take part. The trial was initially published on April 1st 2022 and had its most recent update logged March 8th 2022. In spite of the fact that it has concluded recruitment, there are still 235 other studies actively looking for participants."
Answered by AI
Is Dupixent considered a secure treatment option for patients?
"The safety of Dupixent is highly regarded as this drug has already been approved and is currently being studied in a Phase 4 trial, thus receiving a rating of 3 on the scale."
Answered by AI
Who else is applying?
What state do they live in?
California
New Jersey
How old are they?
65+
18 - 65
What site did they apply to?
Eczema Treatment Center of New Jersey
What portion of applicants met pre-screening criteria?
Met criteria
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