Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143891
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-11-16
Brief Title:
A Study to Test an Oral Medicine Belumosudil in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Multicenter Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease cGVHD
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ROCKnrol-1
Brief Summary:
This is a parallel Phase 3 two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD
The study duration for a participant includes up to 4 weeks for screening a treatment period until clinically meaningful cGVHD progression defined as progression requiring addition of new systemic treatment for cGVHD relapserecurrence of the underlying disease participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity at the request of the participants or the investigators or until the end of study is reached whichever comes first at least 30 days follow-up of adverse events AEs after the last dose until resolution or stabilization if applicable and long-term follow-up until death or study close-out whichever comes first
The study duration for a participant includes up to 4 weeks for screening a treatment period until clinically meaningful cGVHD progression defined as progression requiring addition of new systemic treatment for cGVHD relapserecurrence of the underlying disease participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity at the request of the participants or the investigators or until the end of study is reached whichever comes first at least 30 days follow-up of adverse events AEs after the last dose until resolution or stabilization if applicable and long-term follow-up until death or study close-out whichever comes first
Detailed Description:
Up to 5 years
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 |
|---|---|---|---|
| 2023-505394-32 | REGISTRY | None | None |
| U1111-1280-4918 | REGISTRY | ICTRP | None |