Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603077
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa LOTUS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTUS
Brief Summary:
The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa HS
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-group Phase 2 study Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 111 ratio
The study will comprise
1 A Screening Period which will last for 7 to 28 days
2 A Treatment Period up to 16 weeks
3 A Follow-up period of 6 weeks after the last dose of study drug
The maximum clinical trial duration for each participant is 24 weeks
The study will comprise
1 A Screening Period which will last for 7 to 28 days
2 A Treatment Period up to 16 weeks
3 A Follow-up period of 6 weeks after the last dose of study drug
The maximum clinical trial duration for each participant is 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None