Safety, efficacy and tolerability of ianalumab versus placebo, combination with SoC therapy, in participants with active lupus nephritis (SIRIUS-LN)
Safety, efficacy and tolerability of ianalumab versus placebo, combination with SoC therapy, in participants with active lupus nephritis (SIRIUS-LN)
ClinicalTrials.gov ID: NCT05126277
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis (Novartis Pharmaceuticals) (Responsible Party)
Last Update Posted: 2024-07-09
Brief Summary:
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
Detailed Description:
This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).
Official Title:
A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).
Intervention / Treatment:
- Drug: ianalumab s.c. q4w
- Drug: ianalumab s.c. q12w
- Drug: placebo s.c.
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-07-14
|
| Primary Completion (Estimated) |
2027-03-01
|
| Study Completion (Estimated) |
2030-07-15
|
| Enrollment (Estimated) | 420 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CVAY736K12301
2020-005830-14 (EudraCT Number) |