Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293030|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Atopic Dermatitis Eczema Eczema Atopic Dermatitis and Related Conditions||Drug: Dupilumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2020|
Experimental: Dupilumab treatment
15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling.
Other Name: Dupixent
- CD4+ T effector cells expressing IL-4 [ Time Frame: 12 weeks ]Percentage change from pre-treatment baseline of CD4+ T effector cells expressing IL-4 at weeks 2, 4, 12 in dupilumab-treated patients.
- Number of differentially expressed genes and pathways [ Time Frame: 12 weeks ]Number of differentially expressed genes and pathways in each cell population at weeks 2, 4, 12 compared to pre-treatment baseline using RNA-seq.
- Microbiome [ Time Frame: 52 weeks ]Microbiome samples from skin and stool at weeks 0, 2, 4, 12, and 52 will be banked for future analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293030
|Contact: Quinn Thibodeaux, MDemail@example.com|
|United States, California|
|UCSF Psoriasis and Skin Treatment Center||Recruiting|
|San Francisco, California, United States, 94118|
|Contact: Quinn Thibodeaux, MD 415-944-7618 firstname.lastname@example.org|
|Principal Investigator: Wilson Liao, MD|
|Principal Investigator:||Wilson Liao, MD||University of California, San Francisco|