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 (SIRIUS-LN)
IRB Number: 2023-2124
January 31, 2025
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
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Principal Investigator
Co-Investigators
- David R. Fernandez, MD, PhD
- Romy Kallas, MD
Summary
The SIRIUS-LN Study is a clinical research trial investigating a new therapy to help treat lupus nephritis. The purpose of this study is to see if an interventional medicine called ianalumab is safe and effective in treating lupus nephritis. The study will compare different dosing schedules of ianalumab to see which one may work best. It will also see if using ianalumab with standard of care is better than using standard of care alone.
In addition to standard of care, you will receive one of the following study treatments by chance:
• Ianalumab by injection every 4 weeks
• Ianalumab by injection every 12 weeks
• Placebo (no active ingredient) every 4 weeks
The study medication is given as an injection under your skin (in arm, abdomen, or thigh) at the clinic.
The study has 4 parts: Screening, Treatment Period 1, Treatment Period 2, and Follow-Up. Study participation may require you to come to the clinic about 49 times over 5 years.
• Screening (1 visit): Up to 6 weeks before starting treatment
• Treatment Period 1 (19 visits): 72 weeks
• Treatment Period 2 (19 visits): 72 weeks
• Follow-Up (Up to 10 visits): Up to 2 years
Inclusion/Exclusion Criteria
Inclusion criteria
• Adults 18 years or older who have:
o A confirmed clinical diagnosis of SLE
o A positive anti-nuclear antibody (ANA) test result defined as an ANA titer ≥1:80
o Presence of active LN
o eGRF ≥25 mL/min/1.73 m²
Exclusion criteria
• Pregnant or nursing (lactating) women
• Severe renal impairment
• Use of other investigational drugs
• Prior use of ianalumab (ever) or prior use of any other B cell -depleting therapy administered within 36 weeks prior to randomizations
• Prior treatment with any of the following within 12 weeks prior to randomization: belimumab, telitacicept, abatacept, anti-tumor necrosis factor-alpha mAb, immunoglobulins plasmapheresis, any other immunosuppressants, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors
• History of major organ transplant or hematopoietic stem cell/bone marrow transplant