SIRIUS-LN: a Phase III Clinical Trial for a New Biologic in Lupus Nephritis

Overview 

This study aims to look at how well ianalumab works in participants with renal manifestations in systemic lupus erythematosus, also called lupus nephritis (LN).

• To see if ianalumab can help to treat lupus nephritis
• To see if it is safe for participants with lupus nephritis to take ianalumab
• To compare different dosing regimens of ianalumab to see which one works best
• To see if using ianalumab with standard-of-care therapy (SoC) is better than using SoC alone with no active treatment (placebo). SoC is your current treatment for lupus nephritis you are taking at the time you enter this study.

You can find more information here: https://clinicaltrials.gov/study/NCT05126277?cond=Lupus%20Nephritis&intr=Ianalumab&rank=1

This study is sponsored by Novartis Pharmaceuticals, Inc.

What will be done?

This 3-arm study will demonstrate the clinical efficacy of ianalumab administered as a subcutaneous injection monthly (every 4 weeks) or quarterly (every 12 weeks), compared to matching subcutaneous placebo monthly in adolescent and adult participants with systemic lupus erythematosus with renal involvement, who are on standard-of-care treatment. The study will be conducted with a 60-week primary endpoint testing two active treatment arms to evaluate both monthly and quarterly ianalumab dosing regimens.

The randomized treatment (ianalumab or placebo) on top of the allowed standard-of-care therapy.

Participation in this study includes

You will get one of the following study treatments by chance, which will be given as injections under your skin (in your arm, abdomen, or thigh) as follows:

• ianalumab by injection every 4 weeks in addition to standard-of-care therapy (SoC). You have a 1 in 3 (about 33%) possibility (like the flip of a coin) of getting this treatment.
• ianalumab by injection every 12 weeks in addition to standard-of-care therapy (SoC).  You will also receive a placebo injection on the 4th and 8th week of each 12-week cycle. You have a 1 in 3 (about 33%) possibility (like the flip of a coin) of getting this treatment.
• placebo by injection every 4 weeks in addition to standard-of-care therapy (SoC). You have a 1 in 3 (about 33%) possibility (like the flip of a coin) of getting a placebo with no active ingredients.

Your study participation will last for up to 170 weeks (i.e., approx. 40 calendar months), including 4-6 weeks of the screening period, 60 weeks of the study treatment period, and up to 104 weeks of follow-up. Your participation will include outpatient clinic visits, physical examinations, disease assessments, answering questionnaires, and collection of blood and urine.

At the end of the 1-year treatment period, you will be followed up for safety for at least 2 months, until your immune system has recovered from the treatment. During this period, no treatment will be administered.

Who can participate?

YOU MAY BE ELIGIBLE IF YOU:

• Are 19 years of age or older
• Are diagnosed with ​SLE at least 6 months prior
• Have recorded protein in the urine (proteinuria)
• Are able to tolerate mycophenolate (mycophenolic acid, Myfortic, or Cellcept) and prednisolone/prednisone
• Do not require dialysis/kidney transplant
• Have no more than 50% of sclerosis (scarring) of the kidneys
• Have no active infection requiring IV or intramuscular treatment
• Have no long-term infection of Hepatitis B or C
• Have no history of major organ/stem cell/bone marrow transplantation
• Have no history of immunodeficiency
• Are not pregnant or breastfeeding
• Have no history of cancer other than localized basal cell carcinoma of the skin or in-situ cervical cancer

Want to find out more?

Talk to your rheumatologist to get involved. Ask your rheumatologist about the possibility of participating in the Lupus Nephritis trial with Dr Aviña-Zubieta.

If you have questions, you can contact the study team at clinicaltrials@arthritisresearch.ca

This study has been approved by the UBC Clinical Research Ethics Board, under application number [H23-03596].