Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-08-23
Brief Title:
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis GPP Who Need Treatment for Repeated Flares
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Effisayil REPAn Open-label Multicenter Single-arm Post-marketing Trial in Select Countries to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy Safety and Pharmacokinetics of Spesolimab iv in Treatment of Patients With Generalized Pustular Psoriasis GPP Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab iv
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 study is open to adults with a serious skin disease called generalized pustular psoriasis GPP who have repeated flares of GPP The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP
Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP They may be given a second dose 1 week later if doctors think it is helpful They are also treated for additional GPP flares
During the time of the study doctors regularly examine participants skin for signs of GPP to see how well the treatment works and take blood samples The doctors also regularly check participants health and take note of any unwanted effects
Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP They may be given a second dose 1 week later if doctors think it is helpful They are also treated for additional GPP flares
During the time of the study doctors regularly examine participants skin for signs of GPP to see how well the treatment works and take blood samples The doctors also regularly check participants health and take note of any unwanted effects
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1291-3088 | REGISTRY | WHO International Clinical Trials Registry Platform ICTRP | None |
| 2022-502128-38-00 | REGISTRY | None | None |