Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094179
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-10-08
Brief Title:
Evaluate the Safety Tolerability of BAT6026
Sponsor:
Bio-Thera Solutions
Organization:
Bio-Thera Solutions
Study Overview
Official Title:
A Study Evaluated the Safety and Efficacy of BAT6026 in Patients With Moderate to Severe Atopic Dermatitis Phase III Clinical Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This is a Phase IBIIA clinical study of BAT6026 in patients with AD The subjects were adults with moderate to severe atopic dermatitis AD whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate The first phase was the phase IB study which was double-blind controlled by placebo in the group and consisted of 3 dose groups After completing the dose escalation study the phase IIA study was entered The Phase IIA study was a randomized double-blind controlled multicentering clinical trial with different dose groups and placebo groups The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index EASI of at least 75 lower than the baseline at week 16 after 4 treatment cycles To provide the optimal dose for the phase III regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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