Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05639114
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-11-04
Brief Title:
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus SIRIUS-SLE 1
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Parallel Group Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus SIRIUS-SLE 1
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:
SIRIUS-SLE 1
Brief Summary:
The trial will evaluate efficacy safety and tolerability of two regimens of ianalumab compared to placebo given as monthly or quarterly subcutaneous sc injection on top of standard-of-care SoC treatment in participants with active systemic lupus erythematosus SLE
Detailed Description:
A randomized double-blind parallel group placebo-controlled multicenter phase 3 study to evaluate efficacy safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus SIRIUS-SLE 1
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 |
|---|---|---|---|
| 2023-508498-97 | OTHER | EU CT number | None |
| 2022-002691-36 | EUDRACT_NUMBER | None | None |