Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05107115
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2021-10-27
Brief Title:
Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Dose-ranging Phase 2 Study of Rilzabrutinib Followed by an Open-label Extension Phase in Patients With Moderate-to-severe Chronic Spontaneous Urticaria CSU Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment
Status:
COMPLETED
Status Verified Date:
2024-07
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:
RILECSU
Brief Summary:
The first phase of this study will be a parallel 12-week treatment Phase 2 double-blind 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 rilzabrutinib ie dose A B and C compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU
After completion of the double-blind phase of the study participants will be given the option of enrolling in the 40-week open label extension OLE phase of the study Participants will receive open-label rilzabrutinib at dose C the dose may be modified based on the 12-week safety and efficacy data Due to the fact that some participants may be receiving rilzabrutinib for the first time all participants will be monitored at Week 14 Week 16 Week 20 and Week 24 Afterwards participants will be monitored at Week 36 and Week 52
After completion of the double-blind phase of the study participants will be given the option of enrolling in the 40-week open label extension OLE phase of the study Participants will receive open-label rilzabrutinib at dose C the dose may be modified based on the 12-week safety and efficacy data Due to the fact that some participants may be receiving rilzabrutinib for the first time all participants will be monitored at Week 14 Week 16 Week 20 and Week 24 Afterwards participants will be monitored at Week 36 and Week 52
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-002609-93 | EUDRACT_NUMBER | Sanofi Identifier | None |
| U1111-1263-4226 | REGISTRY | None | None |
| DRI17224 | OTHER | None | None |