Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

NCT05265234 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: OPTI-003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study is trying to answer the following question: "Can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to Dupixent (dupilumab)?"

Conditions

Eczema; Atopic Dermatitis

Keywords

dermatitis; Dupilumab; Inflammatory Skin Diseases; itch relief; biologic

Outcome Measures

Primary Outcomes (4)

• Eczema Area and Severity Index (EASI)

  The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema, ranging 0-72, 0 being least severe and 72 being most severe.

  Baseline to 16 weeks

• Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)

  Investigator will use the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) a tool used to measure the severity of atopic eczema, ranging 0-4, 0 is clear and 4 is most severe.

  Baseline to 16 weeks

• Noninvasive Imaging (clinical response) with Reflectance Confocal Microscopy (RCM)

  Reflectance Confocal Microscopy (RCM) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. RCM can visualize cells with a resolution comparable to a light microscope, allowing the investigators to identify the degree of inflammation and damage to the skin. An overall disease severity score ranging from 0-3 (0=none, 1=mild, 2= moderate, 3=severe) will use aggregates of the following \*features: * Spongiosis * Parakeratosis * Epidermal thickness * Quality of honeycomb structure of the stratum spinosum * Appearance of the dermal-epidermal junction * Appearance of the superficial dermis * Recognition of the dermal papilla * Caliber of blood vessels * Presence of inflammatory cells * Grading will be scored (0=none, 1=mild, 2= moderate, 3=severe), a greater numerical score indicates more advanced disease.

  Baseline to 16 weeks

• Noninvasive Imaging (clinical response) with Optical Coherence Tomography (OCT)

  Optical Coherence Tomography (OCT) is a noninvasive imaging device that can be used to monitor the severity of inflammatory skin disorders without the need for a biopsy. OCT can detect deep structures in the skin, identify areas of inflammation, and determine the thickness of the skin. These measures will be consolidated to a severity score ranging 0-3, (0= no disease, 3= severe disease) and will be tracked throughout the duration of the study. The following features will be aggregated to form an Optical Coherence Tomography-severity-score: * Change in the epidermal thickness * Changes in anatomy or appearance of the dermo-epidermal junction and the dermis. * Changes in vascular flow patterns, including the number and density of vessels in skin using the dynamic feature of Optical Coherence Tomography * Grading will be scored 0=none, 1=mild, 2= moderate, 3=severe

  Baseline to 16 weeks

Study Arms (1)

Dupixent

EXPERIMENTAL

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.

Drug: Dupilumab; Device: Optical Coherence Tomography; Device: Reflectance confocal microscopy

Interventions

Dupilumab DRUG

IL-4 antagonist to improve moderate-severe atopic dermatitis

Also known as: Dupixent

Dupixent

Optical Coherence Tomography DEVICE

OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.

Also known as: OCT

Dupixent

Reflectance confocal microscopy DEVICE

RCM is a noninvasive imaging device, with resolution approaching that of histology, which can monitor structural changes in the epidermis and superficial dermis, monitor inflammatory cells, and can overcome the limitations of a traditional biopsy.

Also known as: RCM

Dupixent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Atopic dermatitis (AD) affecting ≥10% body surface area (BSA) at baseline
• IGA score ≥3, on the IGA scale of 0-4 at baseline
• Eczema Area and Severity Index (EASI) score of ≥16 at baseline

You may not qualify if:

• Prior treatment with Dupilumab (REGN668/SAR231893)
• Treatment with TCS or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
• Bodyweight \<30 kg (65lb) at Baseline
• Known or suspected immunodeficiency including human immunodeficiency virus (HIV) infection
• Pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study

Sponsors & Collaborators

• OptiSkin Medical: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

OptiSkin Medical

New York, New York, 10128, United States

RECRUITING

Related Publications (5)

• Leung DY, Guttman-Yassky E. Deciphering the complexities of atopic dermatitis: shifting paradigms in treatment approaches. J Allergy Clin Immunol. 2014 Oct;134(4):769-79. doi: 10.1016/j.jaci.2014.08.008.

  PMID: 25282559 BACKGROUND

• Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30.

  PMID: 27690741 BACKGROUND

• Meinke MC, Richter H, Kleemann A, Lademann J, Tscherch K, Rohn S, Schempp CM. Characterization of atopic skin and the effect of a hyperforin-rich cream by laser scanning microscopy. J Biomed Opt. 2015 May;20(5):051013. doi: 10.1117/1.JBO.20.5.051013.

  PMID: 25467783 BACKGROUND

• Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomed Opt Express. 2018 Mar 29;9(4):2001-2017. doi: 10.1364/BOE.9.002001. eCollection 2018 Apr 1.

  PMID: 29675335 BACKGROUND

• Tang TS, Bieber T, Williams HC. Are the concepts of induction of remission and treatment of subclinical inflammation in atopic dermatitis clinically useful? J Allergy Clin Immunol. 2014 Jun;133(6):1615-25.e1. doi: 10.1016/j.jaci.2013.12.1079. Epub 2014 Mar 18.

  PMID: 24655575 BACKGROUND

Related Links

• FDA Approved Drugs: Dupixent

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic; Dermatitis

Interventions

dupilumab; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Orit Markowitz, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Bressler, DO

CONTACT

212-828-3120; moshe@optiskinmedical.com

Orit Markowitz, MD

CONTACT

212-828-3120; clinicaltrials@optiskinmedical.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: March 3, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-02

Locations

US (1)