Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388941
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-17
Brief Title:
Iptacopan in Patients With ANCA Associated Vasculitis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Controlled Study to Evaluate LNP023 Iptacopan in Patients With Active ANCA-associated Vasculitis
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care SOC to induce and maintain remission in study participants with active granulomatosis with polyangiitis GPA or microscopic polyangiitis MPA when used in combination with rituximab RTX induction The trial will also assess the impact of iptacopan on disease relapses evolution of renal function and proteinuria GC side effects patients immune status and QoL
Detailed Description:
This is a randomized controlled study to evaluate the efficacy and safety of iptacopan in combination with RTX induction therapy for the treatment of newly diagnosed or relapsed patients with active GPA or MPA
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