Ignite Creation Date:
2024-05-06 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03517566
Status:
TERMINATED
Last Update Posted:
2021-10-08
First Post:
2018-03-27
Brief Title:
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis ZEST Trial
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a randomized double-blind placebo-controlled parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks
Detailed Description:
A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period
After the end of treatment visit subjects were offered the possibility of ongoing treatment in the extension study CZPL389A2203E1 NCT03948334 or of entering the 4 week treatment-free follow-up period
After the end of treatment visit subjects were offered the possibility of ongoing treatment in the extension study CZPL389A2203E1 NCT03948334 or of entering the 4 week treatment-free follow-up period
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