Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550076
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Multicenter Open-Label Study to Evaluate the Long-term Safety Tolerability and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
Status:
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:
The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis
All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules
Participants will be in the study for up to 217 weeks including up to 35 days for the screening period 52 weeks Part A up to 156 additional weeks Part B study treatment and 4 weeks follow up period During the study participants will visit their study clinic multiple times
All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules
Participants will be in the study for up to 217 weeks including up to 35 days for the screening period 52 weeks Part A up to 156 additional weeks Part B study treatment and 4 weeks follow up period During the study participants will visit their study clinic multiple times
Detailed Description:
This study consists of 2 parts Part A and Part B
Part A Participants who did not participate in either parent study TAK-279-3001 NCT06088043 or TAK-279-3002 NCT06108544 may be enrolled and will be treated for up to 52 weeks Participants who successfully complete Part A of the study are eligible to continue in Part B but investigators must confirm their eligibility to continue in Part B
Part B Participants who complete the treatment period of TAK-279-3001 NCT06088043 or TAK-279-3002 NCT06108544 parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks
Part A Participants who did not participate in either parent study TAK-279-3001 NCT06088043 or TAK-279-3002 NCT06108544 may be enrolled and will be treated for up to 52 weeks Participants who successfully complete Part A of the study are eligible to continue in Part B but investigators must confirm their eligibility to continue in Part B
Part B Participants who complete the treatment period of TAK-279-3001 NCT06088043 or TAK-279-3002 NCT06108544 parent studies or who complete Part A are eligible to enroll directly into open label extension treatment in Part B and will be treated for up to 156 weeks
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