Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396026
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-29
Brief Title:
A Study of Efficacy and Safety of TLL-018 in CSU Participants
Sponsor:
Hangzhou Highlightll Pharmaceutical Co Ltd
Organization:
Hangzhou Highlightll Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria With Inadequate Controll to Second Generation H1-antihistamines
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of TLL-018 in Participants With Moderate-to-Severe Chronic Spontaneous Urticaria CSU With Inadequate Controll to Second Generation H1-antihistamines
Detailed Description:
This is a randomized double-blind single-dummy placebo-parallel-group phase 3 study to assess the safety and efficacy of TLL-018 in Moderate-to-Severe Chronic Spontaneous Urticaria CSU participants who had an Inadequate Controll to Second Generation H1-antihistamines
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