About the study

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

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. ACR) Systemic Lupus Erythematosus (
2. SLE) classification criteria - Have a positive anti-nuclear antibody (
3. 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: - 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

Participants meeting any of the following criteria are not eligible for inclusion in this study:

1. 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
2. Sclerosis in > 50% of glomeruli on renal biopsy
3. 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
4. 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
5. Prior treatment with any of the following within 12 weeks prior to randomization
6. Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
7. Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
8. Thalidomide treatment and/or one of the following DMARDs: methotrexate or an imidazole derivative (e.g., mizoribine)
9. Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization
10. History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
11. Any one of the following laboratory values at screening:
12. 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
13. Platelet count < 25 x 1000/µL
14. Absolute neutrophil count (ANC) < 0.8 x 1000/µL
15. Active viral, bacterial or other infections requiring systemic treatment at the time of screening, or history of recurrent clinically significant infection
16. History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
17. Receipt of live/attenuated vaccine within a 4-week period prior to randomization
18. History of primary or secondary immunodeficiency, including a positive HIV test result
19. 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
20. 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
21. Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant
22. Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines)
23. Pregnant or nursing (lactating) women
24. 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
25. 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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.