Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526861
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2018-05-04
Brief Title:
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 ECZema TRAlokinumab Trial no 6
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Parallel-group Multi-centre Trial to Evaluate the Efficacy Safety and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis AD Who Are Candidates for Systemic Therapy
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:
None
Brief Summary:
Primary objective
To evaluate the efficacy of subcutaneous SC administration of tralokinumab compared with placebo in treating adolescent subjects age 12 to 18 years with moderate-to-severe AD
Secondary objectives
To evaluate the efficacy of tralokinumab on severity and extent of AD itch and health-related quality of life compared with placebo
To investigate the safety immunogenicity and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects age 12 to 18 years with moderate-to-severe AD
To evaluate the efficacy of subcutaneous SC administration of tralokinumab compared with placebo in treating adolescent subjects age 12 to 18 years with moderate-to-severe AD
Secondary objectives
To evaluate the efficacy of tralokinumab on severity and extent of AD itch and health-related quality of life compared with placebo
To investigate the safety immunogenicity and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects age 12 to 18 years with moderate-to-severe AD
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 |
|---|---|---|---|
| 2017-005143-33 | EUDRACT_NUMBER | None | None |