Ianalumab + Standard Therapy for Lupus Nephritis (SIRIUS-LN Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novartis Pharmaceuticals
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial will test how well ianalumab injections work and how safe they are for adults with a type of kidney inflammation caused by lupus. The medication is given under the skin at regular intervals. It aims to reduce kidney inflammation by calming the immune system.
What safety data is available for Ianalumab in lupus nephritis treatment?The provided research does not contain specific safety data for Ianalumab (also known as VAY736, NOV-5, NVP-VAY736) in the treatment of lupus nephritis. The studies focus on other treatments such as voclosporin, anifrolumab, belimumab, and tabalumab. Further research or specific studies on Ianalumab would be needed to answer this question.13789
Is the drug ianalumab a promising treatment for lupus nephritis?The information provided does not include any specific details about ianalumab or its effectiveness in treating lupus nephritis. Therefore, we cannot determine if ianalumab is a promising treatment based on the given data.45789
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you must stop all current medications. However, if you are on azathioprine, you must switch to MPA before randomization. Some medications like certain immunosuppressants, B cell depleting therapies, and others must be stopped before joining the trial. Please consult with the trial team for specific guidance on your medications.
What data supports the idea that Ianalumab + Standard Therapy for Lupus Nephritis is an effective treatment?The available research does not provide specific data on the effectiveness of Ianalumab + Standard Therapy for Lupus Nephritis. However, it does mention other treatments like voclosporin, cyclophosphamide, anifrolumab, and belimumab, which have shown varying levels of effectiveness in treating lupus nephritis. For example, belimumab, when added to standard therapy, was effective in improving kidney outcomes and reducing the risk of kidney-related events in certain patients. Without specific data on Ianalumab, it's unclear how it compares to these other treatments.26789
Eligibility Criteria
Adults with active Lupus Nephritis (LN) who have started or are willing to start standard treatment, including high-dose corticosteroids and MPA. They must weigh at least 35 kg, have a positive ANA test, and meet specific criteria for active LN. Excluded are those with severe kidney damage, recent heavy steroid use, certain infections or immunodeficiencies, cancer history within 5 years, or women who could become pregnant not using effective contraception.Inclusion Criteria
I am 18 years old or older.
I weigh at least 35 kg.
I am willing to switch from azathioprine to MPA before the study starts.
I have been diagnosed with SLE according to EULAR/ACR criteria.
Exclusion Criteria
I agree to use barrier protection during sex while on the study treatment.
I have had cancer in any part of my body in the last 5 years.
I have an active TB infection.
I have severe kidney problems.
I have not received more than 3000 mg of IV pulse steroids in the last 3 months.
I have had or am scheduled for a major organ or bone marrow transplant.
I do not have any current infections needing treatment or a history of serious infections.
I have a chronic hepatitis B or C infection.
Treatment Details
The trial is testing the effectiveness of Ianalumab administered under the skin every 4 weeks or every 12 weeks versus a placebo. All treatments will be given in combination with standard-of-care therapy for LN. The goal is to see how well Ianalumab works and how safe it is compared to just receiving the usual treatment without this additional drug.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2 - ianalumab s.c. q12wExperimental Treatment1 Intervention
ianalumab s.c. q12w in addition to SoC
Group II: Arm 1 - ianalumab s.c. q4wExperimental Treatment1 Intervention
ianalumab s.c. q4w in addition to standard of care (SoC)
Group III: Arm 3 - placebo s.c. q4wPlacebo Group1 Intervention
Placebo s.c. q4w in addition to SoC
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Texas Medical Branch .Galveston, TX
Kaiser Permanente Dpt of Research and EvaluationSan Diego, CA
Northern Assoc of Northern VAFairfax, VA
University of Kansas Medical Center CRAD001A2433Kansas City, KS
More Trial Locations
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
References
Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. [2013]To evaluate the safety profile of long-term belimumab therapy combined with standard therapy for systemic lupus erythematosus (SLE) in patients with active disease.
Induction therapy with short-term high-dose intravenous cyclophosphamide followed by mycophenolate mofetil in proliferative lupus nephritis. [2017]For decades, high-dose intravenous cyclophosphamide (ivCY) given for 24-30 months was regarded as the standard therapy for proliferative lupus nephritis, despite serious side effects. Our aim was to evaluate the effect of induction therapy with short-term high-dose ivCY followed by mycophenolate mofetil (MMF) on disease parameters, mortality and health-related quality of life (HRQoL) in patients with proliferative lupus nephritis.
Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. [2022]Evaluate efficacy and safety of tabalumab, a human IgG4 monoclonal antibody that binds and neutralises membrane and soluble B-cell activating factor (BAFF) versus placebo plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE).
Multitarget therapy versus intravenous cyclophosphamide in the induction treatment of lupus nephritis: a metaanalysis of randomized controlled trials [2019]Background/aim: Multitarget therapy for lupus nephritis (LN) remains in its exploratory phrase and the recent evidence is insufficient. This study aimed to evaluate the efficacy and safety of mycophenolate mofetil (MMF), tacrolimus (TAC), and steroids (multitarget therapy) versus intravenous cyclophosphamide (IVC) and steroids in induction treatment of LN. Materials and methods: We searched for randomized controlled trials of MMF plus TAC versus IVC in LN using PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, the China Biology Medicine Database, and the China National Knowledge Infrastructure Database. We assessed the retrieved citations and selected studies according to predefined inclusion and exclusion criteria. Results: In total, we identified 8 trials including 801 patients. The metaanalysis revealed that overall multitarget therapy is more effective at inducing complete renal remission compared with IVC (RR: 1.94, 95% CI: 1.61-2.33; P
Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. [2022]To evaluate the dose-response, efficacy and safety of dapirolizumab pegol (DZP) in patients with SLE.
A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. [2022]We performed a post hoc analysis of the Belimumab International Study in Lupus Nephritis (BLISS-LN), a Phase 3, multinational, double-blind, 104-week trial, in which 448 patients with lupus nephritis were randomized to receive intravenous belimumab 10 mg/kg or placebo with standard therapy (cyclophosphamide/azathioprine or mycophenolate mofetil). Add-on belimumab was found to be most effective in improving the primary efficacy kidney response and complete kidney response in patients with proliferative lupus nephritis and a baseline urine protein/creatinine ratio under 3 g/g. However, there was no observed improvement in the kidney response with belimumab treatment in patients with lupus nephritis and sub-epithelial deposits or with a baseline protein/creatinine ratio of 3 g/g or more. Belimumab significantly reduced the risk of kidney-related events or death and lupus nephritis flare in the overall population. Belimumab reduced the risk of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) versus standard treatment alone and attenuated the annual rate of eGFR decline in patients who remained on-study. Thus, our data suggest that the addition of belimumab to standard therapy could attenuate the risk of lupus nephritis flare and eGFR decline in a broad spectrum of patients with lupus nephritis.
Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. [2022]To assess the efficacy and safety of the type I interferon receptor antibody, anifrolumab, in patients with active, biopsy-proven, Class III/IV lupus nephritis.
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis. [2023]This integrated analysis evaluates the efficacy and safety of voclosporin, a novel calcineurin inhibitor, at 23.7 mg twice daily in combination with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) using pooled data from two large phase II and phase III clinical trials. The purpose was to expand the pool of patients for safety analyses and to increase power for efficacy analyses in patient subpopulations.
Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. [2023]To characterise the safety and efficacy of anifrolumab in active lupus nephritis (LN) through year 2 of the phase II randomised, double-blind Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-LN trial (NCT02547922) of 2 anifrolumab dosing regimens versus placebo.