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Monoclonal Antibodies
Dupilumab for Eczema
Phase 4
Waitlist Available
Led By Orit Markowitz, MD
Research Sponsored by OptiSkin Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks
Awards & highlights
Study Summary
This trial is testing if Dupixent can improve eczema by using non-invasive imaging methods.
Who is the study for?
Adults over 18 with moderate to severe atopic dermatitis covering at least 10% of their body, who have not used Dupilumab before. They should not have applied certain skin treatments in the last two weeks and must weigh more than 30 kg. Individuals with immune deficiencies or those pregnant, breastfeeding, or planning pregnancy are excluded.Check my eligibility
What is being tested?
The trial is testing if non-invasive imaging techniques like Optical Coherence Tomography and Reflectance confocal microscopy can track how well Dupixent (dupilumab) works for treating eczema (atopic dermatitis).See study design
What are the potential side effects?
Dupixent may cause side effects such as eye problems, injection site reactions, cold sores in your mouth or on your lips, and inflammation of blood vessels. Rarely it could affect the immune system.
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 skin condition affects 10% or more of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Eczema Area and Severity Index (EASI)
Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)
Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)
+1 moreSide 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
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: DupixentExperimental Treatment3 Interventions
Patients will receive initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week for 16 weeks.
Patients will self-administer by subcutaneous injection at home, instructions will be provided at first visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved
Optical Coherence Tomography
2016
Completed Phase 2
~1510
Reflectance confocal microscopy
2008
N/A
~990
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Who is running the clinical trial?
OptiSkin MedicalLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,832 Total Patients Enrolled
Orit Markowitz, MDPrincipal InvestigatorMedical Director
2 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than 30 kg (65lb).You have a weakened immune system, including HIV infection.Your IGA score is 3 or higher on a scale of 0 to 4 at the beginning of the study.My skin condition affects 10% or more of my body.You have a skin condition with a score of 16 or higher on a specific test called the Eczema Area and Severity Index (EASI).I have previously been treated with Dupilumab.I am 18 years old or older.I haven't used TCS or TCI skin treatments in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Dupixent
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
What is the target enrolment size for this clinical trial?
"Affirmative. Clinicaltrials.gov details that this clinical study, which was initially posted on March 1st 2022, is actively recruiting potential participants. The goal is to secure 15 individuals from a single medical site for the trial."
Answered by AI
To what extent is Dupilumab hazardous to human health?
"After careful assessment, the safety of Dupilumab was assigned a rating of 3 - based on its status as an approved Phase 4 treatment."
Answered by AI
Is it still possible to be enrolled in this clinical investigation?
"According to the clinicaltrials.gov listing, this medical study is in need of patients and was initially published on March 1st 2022 with a subsequent update on February 22nd 2022."
Answered by AI
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