Dupilumab for Dermatitis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Boston Children's Hospital: Department of Immunology, Boston, MA
Dermatitis+3 More
Dupilumab - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This is a multi-center, longitudinal study which will characterize the gene expression profiles and transcriptomic endotypes that underlie mild and moderate-severe Atopic dermatitis (AD) and will determine changes in these expression patterns and endotypes in response to standard-of-care treatment. Participants will complete up to nine study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all study visits to determine the gene expression profiles and transcriptomic endotypes that underlie mild vs. moderate-severe AD disease. The investigators will also evaluate the lipidomic, metabolomic, proteomic, and microbiome profiles of AD skin endotypes associated with mild and moderate-severe AD disease. Non-AD participants will serve as a control population. The primary objective of this study is to determine if the type 2-high non-lesional skin (skin tape) endotype is associated with current mild versus moderate-severe AD disease.

Eligible Conditions

  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At Day 7 and Days 168-224

At Day 7
Non-lesional skin tape transcriptome at Day 7
Day 168
Non-lesional and lesional skin tape transcriptome at Day 7 and Days 168-224

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Non-atopic dermatitis participants
1 of 3
Experienced Dupilumab atopic dermatitis participants
1 of 3
Dupilumab-naïve atopic dermatitis participants
1 of 3
Active Control
Experimental Treatment

600 Total Participants · 3 Treatment Groups

Primary Treatment: Dupilumab · No Placebo Group · Phase 4

Experienced Dupilumab atopic dermatitis participants
Drug
Experimental Group · 1 Intervention: Vanicream · Intervention Types: Drug
Dupilumab-naïve atopic dermatitis participantsExperimental Group · 2 Interventions: Dupilumab, Triamcinolone Acetonide · Intervention Types: Biological, Drug
Non-atopic dermatitis participants
Drug
ActiveComparator Group · 1 Intervention: Vanicream · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 3
~12150
Triamcinolone Acetonide
2017
Completed Phase 4
~3470

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at day 7 and days 168-224
Closest Location: Boston Children's Hospital: Department of Immunology · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dermatitis
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,108 Previous Clinical Trials
4,671,844 Total Patients Enrolled
32 Trials studying Dermatitis
14,137 Patients Enrolled for Dermatitis
Donald Leung, M.D., Ph.D.Study ChairNational Jewish Health: Division of Pediatric Allergy and Clinical Immunology
2 Previous Clinical Trials
131 Total Patients Enrolled
1 Trials studying Dermatitis
62 Patients Enrolled for Dermatitis
Max A. Seibold, Ph.D.Study ChairNational Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of child-bearing potential and do not self-report as pregnant.
Participants must agree to apply a stable dose of a study provided topical moisturizer (Vanicream (TM)) at least twice daily between the Baseline Assessment and Day 7 Visits to a specified skin target area.
You must be using an asthma controller medication(s) for the duration of the study.
Parent or guardian must be able to understand and complete study-related questionnaires.
You have no history of anaphylaxis or food allergy as diagnosed by a physician.\n
You have a history of chronic atopic dermatitis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.