Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254950
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-02
Brief Title:
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Placebo-Controlled Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
Status:
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:
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems
The participants will take capsules of either TAK-279 or placebo for up to 3 months 12 weeks Then all the participants will receive TAK-279 for the rest of the treatment part of the study 1 year or 52 weeks
During the study participants will visit their study clinic several times
The participants will take capsules of either TAK-279 or placebo for up to 3 months 12 weeks Then all the participants will receive TAK-279 for the rest of the treatment part of the study 1 year or 52 weeks
During the study participants will visit their study clinic several times
Detailed Description:
Study TAK-279-UC-2001 is a multicenter randomized placebo-controlled study with a 12-week double-blinded induction treatment period a 40-week open-label treatment period 52 total weeks of treatment and a 4-week safety follow-up period
An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -
1 TAK-279 Dose 1
2 TAK-279 Dose 2
3 Placebo
The maximum study duration per participant is approximately 60 weeks including up to 30 days for the screening period a 12-week randomized and double-blinded induction treatment period a 40-week open-label treatment period and a 4-week safety follow-up period
An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -
1 TAK-279 Dose 1
2 TAK-279 Dose 2
3 Placebo
The maximum study duration per participant is approximately 60 weeks including up to 30 days for the screening period a 12-week randomized and double-blinded induction treatment period a 40-week open-label treatment period and a 4-week safety follow-up period
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 |
|---|---|---|---|
| 2023-506769-67 | REGISTRY | Abbreviated EU CT Number | None |