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Monoclonal Antibodies

Dupilumab for Atopic Dermatitis

Phase 4
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
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 below
Your skin condition is rated as moderate to severe on a scale of 0 to 4.
You have a skin condition called atopic dermatitis that covers more than 10% of your body.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

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 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
Accidental Overdose
Dermatitis Atopic
Multiple Fractures
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Optical Coherence Tomography
Completed Phase 2
Reflectance confocal microscopy

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

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05265234 — Phase 4
Atopic Dermatitis Research Study Groups: Dupixent
Atopic Dermatitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05265234 — Phase 4
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265234 — Phase 4

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
Recent research and studies
~6 spots leftby Nov 2024