Active not recruitingPHASE3INTERVENTIONAL

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

This study is looking into a new medication called ianalumab for adults who have active lupus nephritis, a kidney problem caused by lupus. We want to see how safe and effective ianalumab is when given by injection, either every 4 weeks or every 12 weeks. Participants will also receive their usual standard treatments for lupus nephritis. We'll be comparing ianalumab to a placebo, which is a dummy injection that contains no medicine. This helps researchers understand the true effects of the new medicine. The study aims to find out if ianalumab can help improve kidney function and reduce symptoms for people living with this condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

452

Start

14 Jul 2022

Estimated completion

11 Feb 2031

Lupus Nephritis

What is this study about?

This study is about a kidney condition called lupus nephritis, which can happen when someone has lupus. Lupus is an autoimmune disease, meaning the body's immune system mistakenly attacks its own healthy tissues. In lupus nephritis, this attack harms the kidneys, which are vital for filtering waste from the blood. This can lead to serious health problems.

Researchers are testing a new medicine called ianalumab. They want to see if this medicine can help adults who have active lupus nephritis. 'Active' means the condition is currently causing problems. This study is in 'Phase 3', which means it's one of the final steps before a medicine might be approved for wider use. It's carefully designed to check both how well the medicine works (its 'efficacy') and if it causes any unwanted side effects (its 'safety' and 'tolerability').

Participants in the study will be given either ianalumab, an active medicine, or a placebo, which looks exactly like ianalumab but contains no medicine. This is done to make sure that any improvements seen are truly due to ianalumab and not just other factors. Everyone in the study will also continue to receive the standard treatments that doctors usually prescribe for lupus nephritis. By doing this, researchers hope to find out if ianalumab, when added to usual care, offers a better way to manage this challenging condition.

Key takeaways

This study is testing a new medicine called ianalab for active lupus nephritis.
It's a Phase 3 study, one of the final steps before potential wider use.
Participants will receive ianalab or a placebo, plus their usual standard treatments.
The study aims to check if ianalab is safe and effective for adults.
Regular health checks and monitoring are part of taking part.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older, and weigh at least 35 kilograms (about 5 stone 7 pounds). You must have a confirmed diagnosis of lupus, according to specific medical guidelines, and a positive blood test for 'anti-nuclear antibody' (ANA) which is often found in people with lupus.

A key part of joining is having 'active lupus nephritis'. This means your kidneys are currently affected by lupus. Doctors would need to confirm this through a kidney biopsy (a small tissue sample) taken recently, showing certain types of kidney damage. Your urine and blood tests would also need to show specific signs of kidney problems, like a certain level of protein in your urine and good enough kidney function.

You might be able to join if you've recently been diagnosed with lupus nephritis, or if you've been treated for it before, even if it's been difficult to manage. You must be currently taking, or willing to start, a standard treatment called MPA (mycophenolate mofetil). You might also have received recent treatment with high-dose steroids.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of lupus?
Do you have 'active' lupus nephritis (kidney inflammation from lupus)?
Have you recently had a kidney biopsy showing specific kidney damage?
Are you currently taking, or willing to start, MPA medication for your lupus nephritis?
Do your urine and blood tests show specific levels for kidney function?

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

What does participation involve?

If you join this study, you would receive the study medication (ianalab, or a placebo) as an injection under your skin, either once every 4 weeks or once every 12 weeks, depending on which group you are assigned to. You would also continue to take your usual standard medications for lupus nephritis.

Taking part would involve regular visits to the clinic for medical check-ups, blood tests, urine tests, and possibly other assessments. These appointments are important for monitoring your health, how the medicine is working, and checking for any side effects. The study also includes follow-up appointments after you stop taking the study medication to ensure your well-being. The total length of your participation, including the treatment and follow-up periods, would be discussed with you by the study team.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. You might benefit from receiving a new treatment that could improve your lupus nephritis symptoms and kidney function, potentially better than standard care alone. However, there's also a chance you could receive a placebo, meaning you wouldn't get the active study drug. Possible risks include side effects from the study medication, though these would be carefully monitored. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (156)

University Of Alabama
Birmingham, United States
Advanced Medical Research
La Palma, United States
University of California Irvine
Orange, United States
School Of Medicine
Sacramento, United States
University of California San Diego
San Diego, United States
Kaiser Permanente
San Diego, United States
Mayo Clinic Jacksonville
Jacksonville, United States
University Of Miami
Miami, United States
Emory University School of Medicine
Atlanta, United States
Fides Clinical Research
Atlanta, United States
Parris and Associates Rheumatology
Lawrenceville, United States
Accurate Clinical Research
Lake Charles, United States

+144 more sites — see the official record for the full list.

Common questions

What is lupus nephritis?

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

What is 'ianalab'?

Ianalab is the name of the new investigational medicine being tested in this study for lupus nephritis.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers understand if the new medicine really works.

Why is this study important?

This study aims to find out if ianalab, when added to standard care, can be a more effective and safe treatment option for adults with active lupus nephritis.

Will I still take my regular lupus nephritis medications?

Yes, all participants in this study will continue to receive their usual standard treatments for lupus nephritis alongside the study medication or placebo.