SIRIUS-SLE 2 / CVAY736F12302
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)
IRAS ID
1005646
Contact name
Pedro Rosa da Cruz
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-002690-29
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn if the trial drug VAY736 (ianalumab) is safe and effective in treating adolescents and adults with moderate to severe systemic lupus erythematosus (also called SLE) who are on standard of care (SoC) treatment. SLE is a disease in which the immune system attacks parts of the own body (also called autoimmune disease), causing inflammation and tissue damage in the affected organs. This disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels.
Ianalumab belongs to a class of drugs called monoclonal antibodies which are able to recognize and stick to specific proteins on specific cells. Ianalumab attaches to a protein on B cells, a group of white blood cells which play a role in the development of SLE. By removing such B cells, ianalumab may be able to improve SLE disease activity.
This trial is designed to find out if ianalumab improves participants’ lupus symptoms, and if it does better than the SoC treatment. This trial is also designed to learn more about the safety of ianalumab.
This is a double-blind, randomized, placebo-controlled clinical trial that has 3 periods:
1) The screening period, with a duration of up to 4 weeks.
2) The Treatment period, with a duration of 60 weeks.
3) The Follow up period, with a duration of at least 20 weeks and up to 2 years.
At the end of the treatment period, the participants may be offered to participate in a separate extension study where they continue to receive study treatment instead of moving into the follow up period without receiving study treatment.Adults who are diagnosed with SLE of moderate to severe disease activity, at least 6 months prior to screening, and who are currently receiving SoC treatment will be included in the trial.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
23/ES/0020
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion