Back to resultsDupixent and Narrowband UVB for Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dupixent
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Male or female adult ≥ 18 years of age;
Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
- EASI score of 16 or greater,
- IGA score of 3 or greater
- BSA of 10% or greater,
Exclusion Criteria:
- Subjects with previous exposure to dupilumab.
- Known or suspected hypersensitivity to dupilumab or any of its excipients.
- History of photosensitivity.
Sites / Locations
- Eczema Treatment Center of New Jersey
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dupixent and Narrowband UVB
Arm Description
Dupixent and Narrowband UVB
Outcomes
Primary Outcome Measures
Investigators Global Assessment Score of score of 0 or 1
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12
Secondary Outcome Measures
Full Information
NCT ID
NCT05285839
First Posted
March 8, 2022
Last Updated
March 8, 2022
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05285839
Brief Title
Dupixent and Narrowband UVB for Atopic Dermatitis
Official Title
Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
Detailed Description
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dupixent and Narrowband UVB
Arm Type
Experimental
Arm Description
Dupixent and Narrowband UVB
Intervention Type
Drug
Intervention Name(s)
Dupixent
Intervention Description
dupilumab 300mg
Primary Outcome Measure Information:
Title
Investigators Global Assessment Score of score of 0 or 1
Description
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adult ≥ 18 years of age;
Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
EASI score of 16 or greater,
IGA score of 3 or greater
BSA of 10% or greater,
Exclusion Criteria:
Subjects with previous exposure to dupilumab.
Known or suspected hypersensitivity to dupilumab or any of its excipients.
History of photosensitivity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Nelson
Phone
6094434500
Email
enelson@windsordermatology.com
Facility Information:
Facility Name
Eczema Treatment Center of New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Nelson
Phone
609-443-4500
Ext
1402
Email
enelson@windsordermatology.com
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dupixent and Narrowband UVB for Atopic Dermatitis
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