Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03761537
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2018-11-30
Brief Title:
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Parallel-group Multi-centre Phase 3 Trial Investigating the Efficacy Safety and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2023-05
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 7
Brief Summary:
Primary objective
To demonstrate that tralokinumab in combination with topical corticosteroids TCS is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A CSA
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 to placebo in combination with TCS
To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS
To demonstrate that tralokinumab in combination with topical corticosteroids TCS is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A CSA
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 to placebo in combination with TCS
To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS
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