Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.
NCT ID: NCT05265234
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
15 participants
INTERVENTIONAL
2022-03-01
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dupixent
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.
Dupilumab
IL-4 antagonist to improve moderate-severe atopic dermatitis
Optical Coherence Tomography
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
Reflectance confocal microscopy
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.
Interventions
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Dupilumab
IL-4 antagonist to improve moderate-severe atopic dermatitis
Optical Coherence Tomography
OCT is a noninvasive imaging device that can be used to monitor inflammatory skin disorders.
Reflectance confocal microscopy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
OptiSkin Medical
OTHER
Responsible Party
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Orit Markowitz MD
Medical Director
Principal Investigators
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Orit Markowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Director
Locations
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OptiSkin Medical
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Related Links
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FDA Approved Drugs: Dupixent
Other Identifiers
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OPTI-003
Identifier Type: -
Identifier Source: org_study_id
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