Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636656
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IIa Single-arm Open-label Multi-center Clinical Trial to Evaluate the Efficacy Safety and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis
Status:
NOT_YET_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:
None
Brief Summary:
Adults between 18 and 80 years of age with ulcerative colitis can participate in this study This is a study for people for whom previous treatment was not successful or who stopped previous treatment The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis
This study has 2 parts In Part A participants get BI 3032950 as an infusion into a vein every 4 weeks After 12 weeks doctors check whether the signs and symptoms of ulcerative colitis have improved Before the results of this assessment are available participants move on to Part B and get BI 3032950 as an injection under the skin Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950 They get BI 3032950 injections under the skin every 4 weeks for up to 2 years
Participants visit their doctors every 4 weeks During these visits the doctors check the signs and symptoms of ulcerative colitis This includes taking blood and stool samples Doctors also do endoscopies This is a procedure that uses a tube with a camera to look inside the body
The doctors also regularly check participants health and take note of any unwanted effects
This study has 2 parts In Part A participants get BI 3032950 as an infusion into a vein every 4 weeks After 12 weeks doctors check whether the signs and symptoms of ulcerative colitis have improved Before the results of this assessment are available participants move on to Part B and get BI 3032950 as an injection under the skin Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950 They get BI 3032950 injections under the skin every 4 weeks for up to 2 years
Participants visit their doctors every 4 weeks During these visits the doctors check the signs and symptoms of ulcerative colitis This includes taking blood and stool samples Doctors also do endoscopies This is a procedure that uses a tube with a camera to look inside the body
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?:
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