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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

Must not have

Prior treatment with Dupilumab (REGN668/SAR231893)

Bodyweight <30 kg (65lb) at Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 16 weeks

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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).

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 below

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I am 18 years old or older.

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My skin condition affects 10% or more 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 previously been treated with Dupilumab.

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I weigh less than 30 kg (65lb).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 16 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Dupilumab/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

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: 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

~2610

Reflectance confocal microscopy

2008