What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis include immunosuppressive agents such as corticosteroids, cyclophosphamide, mycophenolate mofetil, and biologics like rituximab. Side effects of these treatments can vary but often include increased risk of infections, gastrointestinal disturbances, bone marrow suppression, and potential organ toxicity. Specifically, treatments targeting the BAFF receptor, like Ianalumab, may also lead to similar immunosuppressive-related side effects, including increased susceptibility to infections and potential infusion reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including immunosuppressive therapies and biologics. One notable approval is belimumab, a monoclonal antibody that inhibits the B-cell activating factor (BAFF), similar to the mechanism of Ianalumab. Belimumab was the first biologic approved for systemic lupus erythematosus (SLE) and has shown efficacy in treating Lupus Nephritis. Other treatments include corticosteroids and immunosuppressive agents like mycophenolate mofetil and cyclophosphamide, which are commonly used in combination with newer biologics to manage the disease.

What other types of research exist?

Promising novel alternatives to Ianalumab for Lupus Nephritis patients include Belimumab (a monoclonal antibody targeting BLyS), Voclosporin (a calcineurin inhibitor), and Anifrolumab (an anti-interferon receptor antibody). These therapies have shown positive results in clinical trials for efficacy and safety in treating Lupus Nephritis.

← Back to Search

Monoclonal Antibodies

Ianalumab + Standard Therapy for Lupus Nephritis (SIRIUS-LN 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

Adult male and female participants aged 18 years or older at the time of screening

Weigh at least 35 kg at screening

Must not have

Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment

History of malignancy of any organ system within the past 5 years, regardless of whether there is evidence of local recurrence or metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 72

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Ianalumab aren't listed here, similar medications can cause injection site reactions, increased risk of infections due to immune system suppression, possible allergic reactions if there's a sensitivity to ingredients in the medication as well as general symptoms like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I weigh at least 35 kg.

Select...

I am willing to switch from azathioprine to MPA before the study starts.

Select...

I have been diagnosed with SLE according to EULAR/ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I agree to use barrier protection during sex while on the study treatment.

Select...

I have had cancer in any part of my body in the last 5 years.

Select...

I have an active TB infection.

Select...

I have severe kidney problems.

Select...

I have not received more than 3000 mg of IV pulse steroids in the last 3 months.

Select...

I have had or am scheduled for a major organ or bone marrow transplant.

Select...

I do not have any current infections needing treatment or a history of serious infections.

Select...

I have a chronic hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 72 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency and percentage of participants achieving stable Complete Renal Response (CRR)

Secondary study objectives

Change in British Isles Lupus Activity Group (BILAG) score

Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score

Ianalumab concentration in serum

+6 more

Awards & Highlights

Pivotal Trial

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

Trial Design

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

0 / 12Eligibility criteria met

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

Lupus Nephritis treatments often target the immune system to reduce inflammation and prevent kidney damage. BAFF receptor inhibitors, like Ianalumab, work by reducing the survival and activity of B-cells, which are implicated in the autoimmune response in Lupus Nephritis. This is crucial as overactive B-cells produce autoantibodies that attack the kidneys. Other common treatments include corticosteroids and immunosuppressive drugs like cyclophosphamide and mycophenolate mofetil, which broadly suppress the immune system to reduce inflammation and prevent further kidney damage. These treatments are vital for managing the disease, preventing progression, and preserving kidney function in patients with Lupus Nephritis.