Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT03912259
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2023-12
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:
None
Brief Summary:
Primary Objective:
To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).
Secondary Objectives:
* To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
* To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
* To evaluate dupilumab immunogenicity.
To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).
Secondary Objectives:
* To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
* To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
* To evaluate dupilumab immunogenicity.
Detailed Description:
The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1190-7728 | OTHER | UTN | View |