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Monoclonal Antibodies
Dupilumab for Atopic Dermatitis
Phase 4
Recruiting
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
Eczema Area and Severity Index (EASI) score of ≥16 at baseline
IGA score ≥3, on the IGA scale of 0-4 at baseline
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to 16 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Study Summary
This trial is testing if Dupixent can improve eczema by using non-invasive imaging methods.
Eligible Conditions
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your skin condition is rated as moderate to severe on a scale of 0 to 4.
Select...
You have a skin condition called atopic dermatitis that covers more than 10% of your 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 • NCT0403336712%
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: 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
2017
Completed Phase 4
~12230
Optical Coherence Tomography
2016
Completed Phase 2
~1510
Reflectance confocal microscopy
2008
N/A
~990
Find a Location
Who is running the clinical trial?
OptiSkin MedicalLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
592 Previous Clinical Trials
360,646 Total Patients Enrolled
Orit Markowitz, MDPrincipal InvestigatorMedical Director
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your skin condition is rated as moderate to severe on a scale of 0 to 4.You have already been treated with Dupilumab (REGN668/SAR231893) before.You have used TCS or TCI cream in the two weeks before the start of the study.You have a skin condition called atopic dermatitis that covers more than 10% of your body.
Research Study Groups:
This trial has the following groups:- Group 1: Dupixent
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.
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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