RecruitingPHASE2INTERVENTIONAL

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

This study is investigating a new medication called iptacopan (also known as LNP023) for individuals with active lupus nephritis. Lupus nephritis is a condition where the immune system, which normally fights infections, mistakenly attacks the kidneys, leading to inflammation and damage. The study will be in two main parts, and its primary goal is to find out if iptacopan is effective and safe when given alongside the treatments people usually receive for lupus nephritis. Researchers will also be checking how well patients tolerate the new drug. This is a Phase 2 study, meaning it's an important step in understanding how promising the treatment might be before it can potentially be made widely available.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

240

Start

10 Aug 2022

Estimated completion

28 Sep 2028

Lupus Nephritis

What is this study about?

This research study is about a new medication called iptacopan, which is being tested for people who have active lupus nephritis. Lupus nephritis is a serious kidney condition that can affect people with lupus, an autoimmune disease. In lupus, the body's immune system, which usually defends against germs, mistakenly attacks healthy tissues and organs, including the kidneys. This can cause inflammation and damage, affecting how well your kidneys work.

The main purpose of this study is to see if adding iptacopan to the standard treatments for lupus nephritis can help manage the condition better. Researchers want to understand if the new drug is effective in improving kidney function and reducing inflammation, and importantly, if it is safe for patients to take. They will also be monitoring for any side effects and how well people tolerate the treatment. This is a crucial step in developing new therapies to improve the lives of individuals living with this challenging condition.

By carefully studying iptacopan, scientists hope to gather more information about its potential benefits and risks. Studies like this are vital for bringing new and better treatment options to patients. If successful, this research could lead to a new way to help people with lupus nephritis, potentially reducing the impact of the disease on their kidneys and overall health.

Key takeaways

A new drug, iptacopan, is being studied for lupus nephritis.
The study aims to check how well iptacopan works and if it's safe.
Participants will receive either iptacopan or a placebo, plus their usual treatment.
Close medical monitoring will be part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have specific types of active lupus nephritis, confirmed by a kidney biopsy within the last three months. You also need to show signs of active kidney disease that requires starting treatment with certain medications, including steroids.

Your kidneys should still be working reasonably well, measured by a test called eGFR. You would also need to have received vaccinations for certain infections, such as meningitis and pneumonia. If you are already taking other supportive medications for lupus, like hydroxychloroquine or blood pressure medicines (ACEi or ARB), these need to be at a stable dose.

There are also reasons why you might not be able to join, such as having recently received certain strong medications for your lupus or if your kidney damage is too severe to likely respond to treatment. If you have other serious health conditions that require high doses of steroids, or if your lupus nephritis has worsened very quickly, you might not be eligible.

Quick self-check

Do you have a diagnosis of active lupus nephritis, confirmed by a recent kidney biopsy?
Are your kidneys still working to a certain level (eGFR of 30 or more)?
Are you able to get key vaccinations for infections?
Are you not currently on very high doses of certain steroid medications for a long time?
Have you avoided certain strong immunosuppressant drugs in the last 3 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve two main phases. You would receive either the new study drug, iptacopan, or a 'dummy' drug called a placebo, always alongside your usual standard care for lupus nephritis. This helps researchers compare the effects of the new drug. You would have regular appointments for check-ups, blood tests, and other assessments to monitor your kidney function, overall health, and any potential side effects. The study team will explain the full schedule of visits and tests during the consent process. Total duration of participation in the study for a patient is not specified, but typically this type of study involves regular follow-up over several months.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks; the new drug may not work for you, or you might experience side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (103)

AKDHC Medical Research ServicesLLC
Phoenix, United States· Withdrawn
Kaiser Permanente Fontana
Fontana, United States· Withdrawn
Univ Calif Irvine
Irvine, United States· Active not recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, United States· Recruiting
Loma Linda University
San Bernardino, United States· Active not recruiting
Olive View UCLA Medical Center
Sylmar, United States· Active not recruiting
University of Colorado Denver
Aurora, United States· Recruiting
Royal Research Corp
Hollywood, United States· Recruiting
Mayo Clinic Jacksonville
Jacksonville, United States· Recruiting
Nephrology Associates Of Central FL
Orlando, United States· Active not recruiting
Florida Kidney Physicians
Riverview, United States· Recruiting
Florida Kidney Physicians
Riverview, United States· Recruiting

+91 more sites — see the official record for the full list.

Common questions

What is iptacopan?

Iptacopan is a new medication being tested in this study to see if it can help people with lupus nephritis.

What is lupus nephritis?

Lupus nephritis is a kidney problem caused by lupus, where the body's immune system attacks the kidneys.

What does 'standard of care' mean?

This refers to the usual and recommended treatments that doctors currently give for lupus nephritis.

Will I know if I'm getting the new drug or a placebo?

No, in this type of study (called 'blinded'), neither you nor your doctor will know if you're receiving the study drug or the placebo, to ensure the results are unbiased.

How long will the study last?

The study is split into two parts, and the full duration for each patient isn't specified but typically involves regular follow-up over several months.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.