Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dupilumab

Optical Coherence Tomography

Reflectance confocal microscopy

About this trial

This is an interventional treatment trial for Eczema focused on measuring dermatitis, Dupilumab, Inflammatory Skin Diseases, itch relief, biologic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥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

Exclusion Criteria:

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

Sites / Locations

OptiSkin MedicalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupixent

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05265234

First Posted

December 16, 2021

Last Updated

February 22, 2022

Sponsor

OptiSkin Medical

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05265234

Brief Title

Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Official Title

Monitoring Response to Therapy in Atopic Dermatitis Patients Treated With Dupilumab Using Noninvasive Reflectance Confocal Microscopy and Optical Coherence Tomography

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Anticipated)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OptiSkin Medical

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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)?"

Detailed Description

Participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. Normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. This study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. This research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema, Atopic Dermatitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dupixent

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

Dupixent

Intervention Description

IL-4 antagonist to improve moderate-severe atopic dermatitis

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography

Other Intervention Name(s)

OCT

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Reflectance confocal microscopy

Other Intervention Name(s)

RCM

Intervention Description

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.

Primary Outcome Measure Information:

Title

Eczema Area and Severity Index (EASI)

Description

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.

Time Frame

Baseline to 16 weeks

Title

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

Description

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.

Time Frame

Baseline to 16 weeks

Title

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

Description

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.

Time Frame

Baseline to 16 weeks

Title

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

Description

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

Time Frame

Baseline to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: ≥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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moshe Bressler, DO

Phone

212-828-3120

Email

moshe@optiskinmedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Orit Markowitz, MD

Phone

212-828-3120

Email

clinicaltrials@optiskinmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orit Markowitz, MD

Organizational Affiliation

Medical Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

OptiSkin Medical

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Bressler, DO

Phone

212-828-3120

Email

moshe@optiskinmedical.com

First Name & Middle Initial & Last Name & Degree

Orit Markowitz, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25282559

Citation

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.

Results Reference

background

PubMed Identifier

27690741

Citation

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.

Results Reference

background

PubMed Identifier

25467783

Citation

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.

Results Reference

background

PubMed Identifier

29675335

Citation

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.

Results Reference

background

PubMed Identifier

24655575

Citation

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.

Results Reference

background

Links:

URL

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process

Description

FDA Approved Drugs: Dupixent

Eczema, Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial