CVAY736F12301E1 SIRIUS-SLE extension
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension).
IRAS ID
1012090
Contact name
Denis Burkhalter
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of this trial is to learn if continued treatment with VAY736 (ianalumab) is safe and effective in adolescent and adult patients with systemic lupus erythematosus (SLE). This is an extension study offered to patients who have completed the 1-year treatment period in the SIRIUS-SLE core trial (CVAY736F12302) and will provide additional 3 years of treatment, followed by a post-treatment safety follow up of between 20 weeks and two years. At the Week 60 visit of the SIRIUS-SLE core study, patients who agree to participate in the extension study, and are deemed eligible, will be assigned to one of 5 treatment arms. Patients who were receiving the study drug (either 300mg monthly, or quarterly) will continue at the same dose. Patients who were receiving placebo (no study drug) will have a 1 in 3 chance of receiving either ianalumab monthly, ianalumab every three months with placebo in between, or placebo.
Study treatment or placebo will be given as 2 mL monthly subcutaneous injections using a prefilled syringe or a device called auto-injector (prefilled pen). Patients who are willing / able to self administer the study drug will be able to do so at home for some of the visits after being trained at the study site. Study assessments will include the collection of blood and urine samples, physical examinations and vital signs, recordings of electrocardiograms (heart electrical activity), and completion of questionnaires. Patients will be expected to visit the hospital between 26 and 50 times depending on if they can self administer the study drug at home.REC name
London - South East Research Ethics Committee
REC reference
26/LO/0062
Date of REC Opinion
3 Feb 2026
REC opinion
Further Information Favourable Opinion