Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336343
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-21
Brief Title:
Bimekizumab in Plaque Psoriasis
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins specifically interleukins 17a and 17F which are known to increase inflammation This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23
Detailed Description:
This study will evaluate the safety and efficacy of bimekizumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin IL-17 or 23 therapies Failure of IL-17 andor IL-23 therapy will be defined as previous treatment with either secukinumab ixekizumab brodalumab tildrakizumab guselkumab or risankizumab for at least 3 months without achieving PASI90 and a BSA 3 Sixty patients will be enrolled in this 16-week open-label study Patients will be enrolled at two different sites in the US
After enrollment study visits will occur at monthly intervals with patients receiving bimekizumab 320 mg via subcutaneous injection at weeks 0 4 8 12 and 16 At each visit patients will be evaluated for change in PGA Physicians Global Assessment PASI score BSA and any signs or symptoms of adverse events Laboratory screening will include tests for tuberculosis The primary efficacy endpoint will be the percentage of patients achieving BSA 1 by week 16
After enrollment study visits will occur at monthly intervals with patients receiving bimekizumab 320 mg via subcutaneous injection at weeks 0 4 8 12 and 16 At each visit patients will be evaluated for change in PGA Physicians Global Assessment PASI score BSA and any signs or symptoms of adverse events Laboratory screening will include tests for tuberculosis The primary efficacy endpoint will be the percentage of patients achieving BSA 1 by week 16
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?:
False
Is an FDA AA801 Violation?:
None