Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
- Adult male and female participants aged 18 years or older at the time of screening
- Weigh at least 35 kg at screening
- 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
- Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
- Active LN at screening, as defined by meeting the 3 following criteria:
EXCLUSION CRITERIA
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.
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
- Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
- Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
- Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
- 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.
- Able to communicate well with the Investigator to understand and comply with the requirements of the study
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume < 400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
- Sclerosis in > 50% of glomeruli on renal biopsy
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline
- Prior use of any B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered < 36 weeks prior to randomization B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy
Prior treatment with any of the following within 12 weeks prior to randomization
- Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
- Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
- Thalidomide treatment and/or one of the following DMARDs: methotrexate or an imidazole derivative (e.g., mizoribine)
- Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization
- History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
Any one of the following laboratory values at screening:
- Hemoglobin levels < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
- Platelet count < 25 x 1000/µL
- Absolute neutrophil count (ANC) < 0.8 x 1000/µL
- Active viral, bacterial or other infections requiring systemic treatment at the time of screening, or history of recurrent clinically significant infection
- History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
- Receipt of live/attenuated vaccine within a 4-week period prior to randomization
- History of primary or secondary immunodeficiency, including a positive HIV test result
- History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study
- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant
- Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication
- Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment
Other protocol -defined Inclusion/Exclusion may apply.

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How to Apply
Study’s details
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