Phase 3 Trial to Evaluate Ianalumab in Patients with Active Lupus Nephritis

Official Title

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial To Evaluate The Efficacy, Safety, And Tolerability Of Ianalumab On Top Of Standard-of-care Therapy In Participants With Active Lupus Nephritis

Details

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).

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Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Adult male and female participants aged 18 years or older at the time of screening
2. Weigh at least 35 kg at screening
3. Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
4. Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
5. Active LN at screening, as defined by meeting the 3 following criteria:
6. Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria.
7. UPCR greater than or equal to 1.0 g/g on 24h urine collection at Screening
8. eGFR greater than or equal to 25mL/min/1.73 m2. Participants with eGFR < 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
9. Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA
10. Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
11. Able to communicate well with the Investigator to understand and comply with the requirements of the study.

Other protocol-defined Inclusion/ Exclusion Criteria apply