What side effects are associated with this type of intervention?

Common treatments for lupus that involve monoclonal antibodies targeting B-cell pathways, such as belimumab and rituximab, have several known side effects. Belimumab can cause infusion reactions, infections, and hypersensitivity reactions. Rituximab is associated with infusion reactions, infections (including serious ones like pneumonia and cellulitis), and potential serum-sickness-like reactions. Both treatments require careful monitoring due to the risk of severe adverse events.

What prior FDA approvals exist?

Belimumab is a notable FDA-approved monoclonal antibody for the treatment of systemic lupus erythematosus (SLE). It targets the B-cell activating factor (BAFF), similar to Ianalumab, and was the first drug approved for lupus in over 50 years. Belimumab has shown efficacy in reducing disease activity and is used in combination with standard lupus therapies. Other treatments for lupus include immunosuppressive agents like mycophenolate mofetil and corticosteroids, but these do not specifically target the BAFF pathway.

What other types of research exist?

Promising alternatives to Ianalumab for Lupus patients include Belimumab (a monoclonal antibody targeting BLyS/BAFF), Anifrolumab (a monoclonal antibody targeting the type I interferon receptor), and Voclosporin (a calcineurin inhibitor). These therapies have shown efficacy in clinical trials and are considered effective options for managing SLE.

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Monoclonal Antibodies

Ianalumab for Lupus (SIRIUS-SLE 2 Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36 to week 60

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site, increased risk of infection due to immune system alteration by Ianalumab, and any common side effects associated with medications that modulate the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36 to week 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36 to week 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 to week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)

Secondary study objectives

Ianalumab concentration in serum during the treatment and follow-up

Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time

Proportion of participants achieving BILAG-based Composite Lupus Assessment (BICLA)

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ianalumab

2018

Completed Phase 1

~50

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus, such as monoclonal antibodies targeting the BAFF receptor (e.g., Ianalumab), work by inhibiting the activity of B-cell activating factor. This reduces the survival and proliferation of B cells, which are responsible for producing autoantibodies that attack the body's own tissues. By decreasing the number and activity of these B cells, these treatments aim to lower disease activity and alleviate symptoms, offering a targeted approach to managing the autoimmune response in Lupus patients.

The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.'That Obscure Object of Desire': in systemic lupus erythematosus B-cell activating factor/B-lymphocyte stimulator is targeted both by the immune system and by physicians.