Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587453
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2020-09-29
Brief Title:
Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
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 Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Status:
COMPLETED
Status Verified Date:
2022-08
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:
ECZTRA 8
Brief Summary:
Primary objective
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids TCS compared with 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 health-related quality of life and health care resource utilisation 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 16 weeks
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids TCS compared with 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 health-related quality of life and health care resource utilisation 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 16 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?:
True
Is an FDA AA801 Violation?:
None