* Study of safety, efficacy and tolerability of ianalumab versus placebo, in combination with SoC ther
Research type
Research Study
Full 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 patients with active lupus nephritis (SIRIUS-LN)
IRAS ID
1004225
Contact name
Claus-Peter Danzer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-005830-14
Clinicaltrials.gov Identifier
Research summary
This clinical trial aims to find out if ianalumab is safe and effective in treating lupus nephritis LN). Ianalumab belongs to a class of drugs called monoclonal antibodies. Ianalumab attaches to a protein on B cells called B cell Activating Factor (BAFF) receptor. B cells are a group of white blood cells which play a role in the development of LN. When ianalumab attaches to the BAFF receptor on a B cell, the B cell is destroyed, resulting in reduced numbers of these cells in the blood and other tissues. However, ianalumab does not attach to a different type of B cell called a plasma cell that carries information to fight certain infections, and so these remain functional. By removing B cells that have the BAFF receptor, ianalumab may be able to improve kidney function in people with LN.
The study has three treatment groups: ianalumab 300 mg every 4 weeks with Standard of Care (SoC), ianalumab 300 mg every 12 weeks with SoC, or placebo with SoC. SoC is the usual treatment given for LN: corticosteroids and mycophenolic acid (MPA). The study treatment is given by a needle under the skin.
Approximately 420 participants in about 38 countries will be in the study.
Patient will remain on study for up to 5 years and during that time, will need to visit the Study Doctor about 49 times: 20 times during the first treatment period; 19 times during the second treatment period; and then up to 12 times during the Post-Treatment Follow Up period.
At the study visits, the following procedures should happen: physical examination, blood draws and testing, and answering questionnaires about how you are feeling.
Key eligibility criteria are: Adults over 18; confirmed and active LN, willing and able to received SoC, no severe renal impairment or sclerosis, no prior use of B-cell depleting therapy.REC name
London - City & East Research Ethics Committee
REC reference
21/FT/0149
Date of REC Opinion
11 Mar 2022
REC opinion
Further Information Favourable Opinion