Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06192563
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-12-20
Brief Title:
A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Eczema Area and Severity Index Score 16 Respond to Dupilumab Treatment
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Prospective Observational Study of Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Eczema Area and Severity Index Score 16 Receiving Dupilumab
Status:
RECRUITING
Status Verified Date:
2024-04
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:
AD-BEASCUITS
Brief Summary:
In adolescents treated with dupilumab clinical trials showed significant improvement of atopic dermatitis AD signs and symptoms with a good safety profile In these clinical trials only patients with Eczema Area and Severity Index EASI score greater than or equal to 16 were enrolled and effectiveness on sensitivevisible areas was not specifically evaluated Further data about the effectiveness of dupilumab in adolescent participants with moderate to mild EASI score and severe itching andor localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations
This is an Italian multicenter 52-week observational non-interventional study which will collect data on the characteristics of adolescent aged 12 to 17 years participants who suffer from severe AD with EASI score less than 16 eligible for systemic dupilumab treatment according to Italian reimbursement criteria It will study the real-world effectiveness and safety of dupilumab in this population the effect of dupilumab on itching pruritus sleep quality of life and related outcomes localized AD in sensitivevisible areas and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants
This is an Italian multicenter 52-week observational non-interventional study which will collect data on the characteristics of adolescent aged 12 to 17 years participants who suffer from severe AD with EASI score less than 16 eligible for systemic dupilumab treatment according to Italian reimbursement criteria It will study the real-world effectiveness and safety of dupilumab in this population the effect of dupilumab on itching pruritus sleep quality of life and related outcomes localized AD in sensitivevisible areas and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants
Detailed Description:
The individual observational period is planned to be up to 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1290-5921 | REGISTRY | ICTRP | None |