Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600362
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2020-10-19
Brief Title:
Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
An Investigator-initiated Multi-center Randomized Double-blind Placebo Controlled Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUPINUM
Brief Summary:
Nummular eczema NE is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods Diagnosis is made primarily clinically in correlation with histological findings Treatment of NE is difficult Standard treatment consists of the use of emollients topical as well as systemic corticosteroids and phototherapy Nevertheless remission is hard to achieve and relapse occurs often Patients usually suffer from severe pruritus and reduced quality of life Therefore new therapeutic strategies are urgently needed
Dupilumab Dupixent a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor has been approved for the treatment of moderate-to-severe atopic dermatitis AD Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier broad immune-mediated inflammation and microbial skin colonization using Dupilumab in NE seems to be promising
Dupilumab Dupixent a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor has been approved for the treatment of moderate-to-severe atopic dermatitis AD Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier broad immune-mediated inflammation and microbial skin colonization using Dupilumab in NE seems to be promising
Detailed Description:
This study aims on investigating the efficacy of Dupilumab in NE patients The primary endpoint is the percent change in Eczema Area and Severity Index EASI score from baseline to week 16
Secondary endpoints include the number of patients achieving an improvement decrease in Physician Global Assessment PGA by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16 the EASI 50 score at week 16 the change from baseline in transepidermal waterloss TEWL at week 16 significant histological improvement at week 16 change from baseline in the reduction of the use of topical steroids at week 16 change form baseline in the Dermatology Life Quality Index DLQI at week 16 change from baseline in Pruritus Visual Analog Scale VAS change from baseline in the global satisfaction subscale of the treatment satisfaction questionnaire for medication TSQM score at week 16 and the safety of Dupilumab
Secondary endpoints include the number of patients achieving an improvement decrease in Physician Global Assessment PGA by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16 the EASI 50 score at week 16 the change from baseline in transepidermal waterloss TEWL at week 16 significant histological improvement at week 16 change from baseline in the reduction of the use of topical steroids at week 16 change form baseline in the Dermatology Life Quality Index DLQI at week 16 change from baseline in Pruritus Visual Analog Scale VAS change from baseline in the global satisfaction subscale of the treatment satisfaction questionnaire for medication TSQM score at week 16 and the safety of Dupilumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None