Secukinumab in patients with Lupus Nephritis - SELUNE
Research type
Research Study
Full title
A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis
IRAS ID
269627
Contact name
Liz Lightstone
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-003211-57
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 3 days
Research summary
This is a phase III study evaluating the safety, efficacy and tolerability of secukinumab versus placebo in patients with active lupus nephritis.
Lupus nephritis is inflammation of the kidneys caused by systemic lupus erythematosus (SLE), also, called lupus. SLE is an autoimmune disease (body’s immune system targets its own body tissues) that can affect almost any part of the body, most often joints, skin, kidneys, heart, lungs, blood or brain. It is estimated that up to 60 percent of all people with lupus will develop kidney complications that requires medical evaluation and treatment. LN is the term used when lupus causes inflammation of nephrons, the structures within the kidneys that filter the blood, making them unable to properly remove waste from your blood or control the amount of fluids in your body.
The purpose of the study is to evaluate the ability and safety of subcutaneous secukinumab 300 mg plus standard of care, compared to placebo plus standard of care, in treating subjects with active LN specifically Class III or IV, with or without co-existing Class V features as per International Society of Nephrology/Renal Pathology Society (ISN/RPS 2003) classification.
Study duration is 2 years 5 months (6 week screening period, 104 weeks treatment period and 12 weeks of follow-up).
The study comprises two treatment arms - AIN457 150mg or placebo.
Eligible patients will be randomly assigned to the treatment arms in a 1:1 ratio.
Approximately 460 patients who have been diagnosed with lupus nephritis will be enrolled worldwide and it is anticipated that the UK will enrol 4 of these patients. We aim to recruit the UK patients from 2 out of the 3 sites listed. We will update the Ethics Committee of the site that we will not be proceeding with later.Summary of results
No patients were recruited in the UK (study start date listed above is global FPFV date). The English lay summary is available to PIs to share with patients and posted in the public domain on Novartis public website.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0117
Date of REC Opinion
23 Mar 2020
REC opinion
Favourable Opinion