Ianalumab for Lupus (SIRIUS-SLE 2 Trial)
Palo Alto (17 mi)Age: Any Age
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 if ianalumab, an injection given regularly, is safe and effective for people with active systemic lupus erythematosus (SLE). The medication aims to calm down their overactive immune system to reduce inflammation and damage.
What safety data is available for Ianalumab in treating lupus?The provided research does not contain specific safety data for Ianalumab (also known as VAY736, NOV-5, NVP-VAY736) in the treatment of lupus. The studies mentioned focus on other treatments like belimumab, anifrolumab, tabalumab, and cenerimod for systemic lupus erythematosus (SLE). Therefore, no direct safety data for Ianalumab is available in the given research.3571112
What data supports the idea that Ianalumab for Lupus is an effective drug?The available research does not provide specific data on the effectiveness of Ianalumab for Lupus. Instead, it discusses other treatments like Belimumab, which has been shown to decrease disease activity in patients with Lupus, and Rituximab, which is effective in controlling certain types of vasculitis. Without specific data on Ianalumab, we cannot conclude its effectiveness compared to these other treatments.246910
Is the drug ianalumab a promising treatment for lupus?The information provided does not directly address ianalumab, so we cannot determine if it is a promising treatment for lupus based on this data.156813
Do I have to stop taking my current medications for the trial?The trial does not specify that you must stop taking your current medications. In fact, it mentions that participants should be on standard-of-care treatment, which includes corticosteroids, anti-malarial treatment, or other disease-modifying antirheumatic drugs. However, certain medications like high-dose corticosteroids, specific biologics, and traditional Chinese medicines must not have been used within a specified period before the trial.
Eligibility Criteria
This trial is for people aged 12+ (or 18+ in certain countries) with active systemic lupus erythematosus diagnosed at least 6 months ago. They must have specific antibodies, be on current treatments like steroids or DMARDs, and meet disease activity criteria. Exclusions include prior ianalumab use, recent other treatments, infections including hepatitis and HIV, severe organ dysfunction or life-threatening diseases.Treatment Details
The study tests the effectiveness of Ianalumab versus a placebo when given monthly as an injection alongside standard lupus care. It aims to see if Ianalumab can better manage symptoms compared to usual treatment alone.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ianalumab s.c. monthlyExperimental Treatment1 Intervention
ianalumab s.c. monthly
Group II: placebo s.c. monthlyPlacebo Group1 Intervention
placebo s.c. monthly
Find a clinic near you
Research locations nearbySelect from list below to view details:
Accurate Clinical Research ResearchLake Charles, LA
Homestead Assoc In Research IncHomestead, FL
UMC New Orleans NephrologistNew Orleans, LA
Washington Univ School Of MedicineSaint Louis, MO
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
References
Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. [2022]Type I interferons (IFNs) play an important role in the pathogenesis of systemic lupus erythematosus (SLE). This phase Ia trial was undertaken to evaluate the safety, pharmacokinetics, and immunogenicity of anti-IFNalpha monoclonal antibody (mAb) therapy in SLE. During the trial, we also examined whether overexpression of an IFNalpha/beta-inducible gene signature in whole blood could serve as a pharmacodynamic biomarker to evaluate IFNalpha neutralization and investigated downstream effects of neutralizing IFNalpha on BAFF and other key signaling pathways, i.e., granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-10 (IL-10), tumor necrosis factor alpha (TNFalpha), and IL-1beta, in SLE.
[Allergo-immunology. Clinical immunology]. [2016]The past year has been characterized by significant novelties from the point of view of the clinical immunologist. With the BLISS 52 study showing that belimumab has the ability to decrease the activity of systemic lupus erythematosus (SLE) resistant to conventional therapy an important step towards the control of this difficult disease has been carried forward. In addition, the long-term results of the ALMS study have demonstrated that mycophenolate mofetil is superior to azathioprine in maintaining the remission in patients with severe lupus nephritis. Furthermore, the results of the RAVE and RITUXVASC studies have documented that rituximab is a valid alternative to cyclophosphamide in the control of ANCA associated vasculitis.
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.
The efficacy of novel B cell biologics as the future of SLE treatment: a review. [2018]Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease with wide ranging multi-systemic effects. Current understanding centralises B cells in SLE pathogenesis with clinical features resulting from autoantibody formation, immune complex deposition, antigen presentation and cytokine activation. Existing standard of care therapies generates adverse side effects; secondary to corticosteroid use and untargeted immunosuppression. The inability to uphold remission and abolish the disease process, in addition to the increasing numbers of patients seen with refractory disease with these therapies, has provoked the development of novel B cell biologics targeting specific pathogenic pathways fundamental to the SLE disease process. Current evidence highlighting the efficacy of Rituximab, Ocrelizumab and Epratuzumab in inducing B cell depletion and achieving disease amelioration through specific B cell surface receptor antagonism is discussed. We review the efficacy of Atacicept, Briobacept and Belimumab in antagonising B lymphocyte stimulator (BLyS) and A proliferation inducing ligand (APRIL), two stimulatory cytokines crucial to B cell survival, growth and function. Two large multicentre randomised controlled trials, BLISS-52 and BLISS-76, have led to FDA approval of Belimumab. Following this breakthrough, other anti-BLyS therapies, Blisibimod and Tabalumab, are currently under Phase III evaluation. Similarly, murine models and Phase I/II trials have demonstrated significant efficacy of Rituximab, Epratuzumab, Briobacept and Atacicept as potential future therapies and we now eagerly await results from Phase III trials. Future research must compare the efficacy of different biologics amongst different patient subpopulations and SLE manifestations, in order to develop clinically and cost effective therapies.
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).
Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. [2022]We investigated the mechanistic and pharmacological properties of anifrolumab, a fully human, effector-null, anti-type I interferon (IFN) alpha receptor 1 (IFNAR1) monoclonal antibody in development for SLE.
First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. [2022]To investigate the pharmacodynamics, pharmacokinetics and safety of cenerimod-a potent, oral, selective sphingosine 1-phosphate 1 receptor modulator-in patients with SLE.
Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. [2021]To investigate long-term safety and tolerability of anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate-to-severe systemic lupus erythematosus (SLE).
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.
The relationship between serum A proliferation-inducing ligand and B-cell activating factor levels with disease activity and organ involvement in systemic lupus erythematosus. [2022]We aim to investigate the association between serum B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) levels with disease activity and clinical findings in SLE patients.
Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. [2022]Treatment of systemic lupus erythematosus (SLE) currently employs agents with relatively unselective immunosuppressive properties. However, two target-specific biological drugs have been approved: belimumab (anti-B-cell-activating factor/BAFF) and anifrolumab (anti-interferon alpha receptor-1/IFNAR1). Here, we performed a comparative risk-benefit assessment for both drugs based on the role of BAFF and IFNAR1 in host defense and the pathogenesis of SLE and by considering the available data on safety and efficacy. Due to differences in target expression sites, anti-IFNAR1, but not anti-BAFF, might elicit organ-specific effects, consistent with clinical efficacy data. The IFNAR1 is specifically involved in innate and adaptive antiviral immunity in most cells of the body. Consistent with this observation, the available safety data obtained from patients negatively selected for LN and neuropsychiatric SLE, primary immunodeficiencies, splenectomy and chronic HIV, HBV, HCV infections suggest an increased risk for some viral infections such as varicella zoster and perhaps influenza. In contrast, BAFF is mainly involved in adaptive immune responses in lymphoid tissues, thus anti-BAFF therapy modulates SLE activity and prevents SLE flares without interfering with local innate host defense mechanisms and should only marginally affect immune memory to previous pathogen exposures consistent with the available safety data from SLE patients without chronic HIV, HBV or HCV infections. When using belimumab and anifrolumab, careful patient stratification and specific precautions may minimize risks and maximize beneficial treatment effects for patients with SLE.
The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis. [2023]Evaluate the long-term safety and tolerability of anifrolumab 300 mg, alongside standard therapy, in patients from Japan with systemic lupus erythematosus (SLE) in the TULIP-LTE trial (NCT02794285).
Anifrolumab: first biologic approved in the EU not restricted to patients with a high degree of disease activity for the treatment of moderate to severe systemic lupus erythematosus. [2023]Type 1 interferons (IFNs) play a crucial role in the pathogenesis of systemic lupus erythematosus (SLE) and various type I IFNs targeting therapeutic approaches have been developed. Anifrolumab, a monoclonal antibody that binds to the subunit 1 of the type I IFN receptor, has acquired considerable interest and has entered different clinical human trials willing to evaluate its efficacy and safety.