Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03363854
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2017-12-01
Brief Title:
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2021-02
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 demonstrate that tralokinumab in combination with topical corticosteroids TCS is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis AD
Secondary objectives
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD itch and health-related quality of life compared with placebo in combination with TCS
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks
To demonstrate that tralokinumab in combination with topical corticosteroids TCS is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis AD
Secondary objectives
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD itch and health-related quality of life compared with placebo in combination with TCS
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002065-21 | EUDRACT_NUMBER | None | None |