What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, such as cyclophosphamide, mycophenolate mofetil, and glucocorticoids, have known side effects. Cyclophosphamide can cause increased risk of infections, bladder toxicity, and potential infertility. Mycophenolate mofetil is associated with gastrointestinal disturbances, increased risk of infections, and hematologic abnormalities. Glucocorticoids can lead to weight gain, hypertension, diabetes, osteoporosis, and increased susceptibility to infections. As Iptacopan is a Complement Factor B Inhibitor, its side effect profile may differ, but monitoring for similar immunosuppressive-related adverse effects is important.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, including immunosuppressive therapies like cyclophosphamide and mycophenolate mofetil, as well as biologics such as belimumab. These treatments aim to reduce inflammation and immune system activity to prevent kidney damage. While Iptacopan, a Complement Factor B Inhibitor, is still under investigation, it represents a novel approach targeting the complement system, which plays a role in the pathogenesis of Lupus Nephritis. This mechanism is different from the currently approved therapies, which primarily focus on broad immunosuppression.

What other types of research exist?

Promising novel alternatives to Iptacopan for Lupus Nephritis patients in 2024 include Danicopan (a Factor D inhibitor) and Pegcetacoplan (a C3 inhibitor). These therapies target different components of the complement pathway and have shown efficacy in other complement-mediated diseases.

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Iptacopan for Lupus Nephritis

Verified Trial

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

First presentation or flare of lupus nephritis.

You have been diagnosed with class III or IV lupus nephritis

Timeline

Screening 34 days

Treatment 52 weeks

Follow Up 30 days

Summary

This trial is testing a new medication called iptacopan to see if it can help patients when added to their usual treatments. It targets patients who are already receiving standard care and aims to make their current treatments work better.

Who is the study for?

This trial is for people who are experiencing their first or a recurring episode of lupus nephritis, specifically class III or IV. Participants must have active kidney disease and be vaccinated against certain infections. Those who've had recent kidney treatments or biopsies, or specific medications like cyclophosphamide, cannot join.

What is being tested?

The study tests the effectiveness and safety of iptacopan (LNP023) in treating lupus nephritis when added to standard care. It's divided into two parts: one where participants get iptacopan plus placebo, and another with just iptacopan.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the site of injection, increased risk of infection due to immune system suppression, liver issues, blood disorders, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My kidney problems are due to a first-time or worsening lupus.

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I have been diagnosed with severe lupus affecting my kidneys.

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I have had a kidney biopsy in the last 3 months or am willing to get one.

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I am willing to get vaccinated for the study.

Timeline

Screening ~ 34 days2 visits

Treatment ~ 52 weeks13 visits

Follow Up ~ 30 days0 visits

Screening ~ 34 days

Treatment ~ 52 weeks

Follow Up ~30 days

This trial's timeline: 34 days for screening, 52 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares

Secondary study objectives

Change from baseline FACIT-Fatigue Score

Change from baseline in BILAG-2004 score at weeks 24 and 52

Change from baseline in SLEDAI-2K score at weeks 24 and 52

+4 more

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: Placebo matching iptacopan + standard of care (part 2)Active Control1 Intervention

Placebo matching iptacopan + standard of care

Group II: Iptacopan + standard of care (part 2)Active Control1 Intervention

Iptacopan + standard of care

Group III: Iptacopan + placebo (part 2)Active Control1 Intervention

Iptacopan + placebo standard of care

Group IV: Iptacopan + standard of care (part 1)Active Control1 Intervention

Iptacopan + standard of care

Group V: Placebo matching iptacopan + standard of care (part 1)Placebo Group1 Intervention

Placebo matching iptacopan standard of care

0 / 4Eligibility 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 agents such as cyclophosphamide, mycophenolate mofetil, and glucocorticoids, which work by reducing the immune system's activity to prevent further kidney damage. Cyclophosphamide and mycophenolate mofetil inhibit the proliferation of immune cells, while glucocorticoids reduce inflammation. Complement inhibitors like Iptacopan target the complement system, a part of the immune system that contributes to inflammation and tissue damage in Lupus Nephritis. By inhibiting specific components of the complement pathway, these drugs aim to reduce kidney inflammation and preserve kidney function, offering a targeted approach that may result in fewer side effects compared to broad immunosuppression.