Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624670
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-centre Randomised Placebo-controlled Double-blind Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab BI 655130 in Adult Patients With Ulcerative Pyoderma Gangrenosum PG Who Require Systemic Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum PG The main aim is to see whether spesolimab leads to closure of PG ulcers This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm2 to 80 cm2 in size
This study has 2 parts In Part 1 participants are put into groups randomly which means by chance 1 group gets spesolimab and the other group gets placebo Placebo injections look like spesolimab injections but do not contain any medicine Every participant has a 2 in 3 chance of getting spesolimab For the first 8 weeks participants also take corticosteroid medicine by mouth
In Part 2 participants are put into groups again Participants without open ulcers have an equal chance of getting spesolimab or placebo Participants with open skin ulcers will get spesolimab
In both parts participants receive spesolimab or placebo as an infusion into a vein every 4 weeks
Participants are in the study for about 15 years During this time they visit the study site 20 times At study visits doctors check the participants skin for signs of PG The doctors also regularly check participants health and take note of any unwanted effects The results of the groups are compared to see whether the treatment works
This study has 2 parts In Part 1 participants are put into groups randomly which means by chance 1 group gets spesolimab and the other group gets placebo Placebo injections look like spesolimab injections but do not contain any medicine Every participant has a 2 in 3 chance of getting spesolimab For the first 8 weeks participants also take corticosteroid medicine by mouth
In Part 2 participants are put into groups again Participants without open ulcers have an equal chance of getting spesolimab or placebo Participants with open skin ulcers will get spesolimab
In both parts participants receive spesolimab or placebo as an infusion into a vein every 4 weeks
Participants are in the study for about 15 years During this time they visit the study site 20 times At study visits doctors check the participants skin for signs of PG The doctors also regularly check participants health and take note of any unwanted effects The results of the groups are compared to see whether the treatment works
Detailed Description:
None
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