What side effects are associated with this type of intervention?

Treatments for Lupus Nephritis, particularly monoclonal antibodies like anifrolumab, commonly cause side effects such as increased risk of infections, infusion reactions, and potential development of antibodies against the treatment. Other immunosuppressive therapies, such as cyclophosphamide and mycophenolate mofetil, can lead to bone marrow suppression, gastrointestinal disturbances, and increased susceptibility to infections. High-dose glucocorticoids, often used in combination, can result in weight gain, hypertension, diabetes, and osteoporosis.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including monoclonal antibodies like belimumab, which targets the B-lymphocyte stimulator (BLyS) to reduce immune response and inflammation. Other treatments include immunosuppressive agents such as cyclophosphamide and mycophenolate mofetil, which are used to control the overactive immune system. Anifrolumab, currently under study, targets the type I interferon receptor to reduce inflammation, representing a novel approach in the treatment landscape for Lupus Nephritis.

What other types of research exist?

Promising novel alternatives to Antifrolumab for Lupus Nephritis patients include Rituximab, which targets CD20 on B cells and has shown efficacy in primary glomerulopathies, and Mycophenolate Mofetil (MMF), which is used as an initial immunosuppressive therapy for high-risk patients who cannot tolerate glucocorticoids. Both have been evaluated for their effectiveness in reducing inflammation and proteinuria in kidney diseases.

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Monoclonal Antibodies

Anifrolumab for Lupus Nephritis (IRIS Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Be older than 18 years old

Must not have

Any history of severe COVID-19 infection

Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 52, baseline through week 104

Awards & highlights

Pivotal Trial

Summary

This trial is testing an IV medication called anifrolumab in adults with severe lupus nephritis. The goal is to see if it can reduce inflammation and prevent kidney damage. All patients will also receive standard treatments. Anifrolumab is approved by the FDA for treating moderate to severe systemic lupus erythematosus (SLE).

Who is the study for?

Adults with active proliferative lupus nephritis, a kidney condition caused by systemic lupus erythematosus. Participants must have had a kidney biopsy within the last 6 months, show no signs of tuberculosis, and meet specific criteria for kidney function and protein levels in urine. Those with pure Class V lupus nephritis or severe infections like COVID-19 are excluded.

What is being tested?

The trial is testing Anifrolumab's effectiveness compared to a placebo in treating active proliferative lupus nephritis. Patients will receive IV infusions of either Anifrolumab or placebo to see if there's an improvement in their condition.

What are the potential side effects?

Anifrolumab may cause side effects such as increased risk of infections due to immune system suppression, infusion-related reactions (like discomfort at the injection site), potential TB reactivation, and possibly other unknown risks.

Eligibility Criteria

Inclusion Criteria

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

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I have no symptoms or treatment history for active or latent TB.

Exclusion Criteria

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

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I have had a severe case of COVID-19.

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I have a condition that makes me more prone to infections or I am HIV positive.

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I have had more than two experimental treatments for lupus since my diagnosis.

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I am currently taking medication for my lupus flare-up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 52, baseline through week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 52, baseline through week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 52, baseline through week 104 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group

Secondary study objectives

Difference in change from baseline in extra-renal SLEDAI-2K total score

Difference in mean UPCR between the anifrolumab and placebo group

Difference in mean change from baseline in domains and component scores of Short Form-36 Version 2 (SF-36v2) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) total score

+10 more

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899

23%

Upper respiratory tract infection

16%

Nasopharyngitis

14%

Infusion related reaction

13%

Bronchitis

12%

Urinary tract infection

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Lip squamous cell carcinoma

Cervical dysplasia

Angioedema

Hypoaesthesia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

Study treatment Arm

Anifrolumab 300 mg

Placebo

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: AnifrolumabExperimental Treatment1 Intervention

Solution for intravenous infusion

Group II: PlaceboPlacebo Group1 Intervention

Solution for intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anifrolumab

2015

Completed Phase 3

~1990

0 / 5Eligibility 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 is commonly treated with immunosuppressive therapies such as corticosteroids, cyclophosphamide, and mycophenolate mofetil, which work by reducing the immune system's activity to prevent further kidney damage. Monoclonal antibodies like anifrolumab, which targets the type I interferon receptor, are designed to reduce inflammation by blocking specific pathways involved in the immune response. This targeted approach is crucial for Lupus Nephritis patients as it aims to minimize kidney inflammation and damage while potentially reducing the side effects associated with broader immunosuppression.