An adaptive, randomized, double-blind, dose exploration, parallel group, placebo controlled, multicenter phase 2 trial to evaluate the efficacy, safety and tolerability of LNP023 in combination with standard-of-care with and without oral corticosteroids in adult patients with active lupus nephritis Class III-IV, +/- V
Lupus nephritis is an autoimmune condition where the body's immune system attacks the kidneys, causing swelling and possible damage. The standard treatment relies on medicines that calm the immune system and high doses of steroids, which can cause unpleasant side effects. This clinical trial is testing an experimental medicine called iptacopan (also known as LNP023). Doctors want to find out if adding iptacopan to standard treatment can help kidneys recover faster and prevent future flare-ups. They also want to see if it allows patients to reduce their steroid doses safely. Adults aged 18 and over with active lupus nephritis can take part. Over roughly one year, participants will take either iptacopan or a dummy tablet (placebo) alongside standard care. Doctors will closely track kidney health through routine blood and urine tests to see if the new medicine makes a positive difference.
At a glance
What is this study about?
Systemic lupus erythematosus (lupus) is an illness where the immune system mistakenly attacks healthy tissues. When it affects the kidneys, doctors call it lupus nephritis. This causes inflammation inside the tiny filters of the kidneys, leading to protein leaking into the urine, high blood pressure, and swollen ankles or legs. Without effective treatment, it can lead to permanent kidney damage.
Currently, treating lupus nephritis involves powerful medicines to suppress the immune system, along with oral steroids. While these drugs help protect the kidneys, long-term steroid use can cause distressing side effects such as weight gain, mood changes, fragile bones, and an increased risk of infections. Researchers are searching for targeted treatments that can calm kidney inflammation while reducing the need for high-dose steroids.
This trial is testing an investigational drug called iptacopan (LNP023). It targets a specific part of the immune system called the complement system, which is thought to drive kidney inflammation in lupus. By calming this pathway, researchers hope iptacopan can improve kidney function, lower fatigue, and reduce disease activity. The study will show whether adding this medicine to standard care is safe, well-tolerated, and more effective than standard treatments alone.
Key takeaways
- Tests a new medicine, iptacopan (LNP023), for active lupus nephritis.
- Aims to improve kidney function and safely reduce the need for oral steroids.
- Participants continue standard lupus medicines while taking iptacopan or a placebo.
- Open to adults aged 18 and older with biopsy-proven active lupus kidney disease.
- Participation lasts around 52 weeks and includes regular check-ups, urine tests, and blood tests.
Who may be eligible?
This trial is open to men and women aged 18 and older who have been diagnosed with active lupus nephritis. Doctors usually confirm this type of kidney inflammation (known medically as Class III, Class IV, or Class V) through a kidney biopsy and tests showing protein in the urine.
It may not be suitable for people whose lupus is currently inactive, those with severe kidney failure requiring dialysis, or people with active, serious infections. Women who are pregnant or planning to become pregnant may also be unable to take part, as the effects of the study drug on unborn babies are not fully known.
Because eligibility depends on specific laboratory results and medical history, a hospital specialist or the study team will carry out detailed screening tests to confirm whether joining the trial is safe and appropriate for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have been diagnosed with systemic lupus erythematosus (lupus).
- A doctor has confirmed I have active kidney inflammation (lupus nephritis).
- I am currently receiving or able to take standard medicines for lupus nephritis.
- I am willing to attend regular hospital visits and provide blood and urine samples for about a year.
What does participation involve?
Taking part in this study lasts for about 52 weeks (one year). During this time, you will take capsules of either the study medicine (iptacopan) or an identical dummy capsule (placebo) by mouth. You will continue to take your standard lupus medicines, such as mycophenolate, and your doctor will carefully manage your steroid doses.
You will need to attend regular hospital clinic visits, especially during the first few months. These visits will involve physical examinations, blood pressure checks, blood tests, and collecting your first morning urine samples to measure kidney protein levels. You will also be asked to complete short questionnaires about your energy levels, daily fatigue, and general wellbeing. The study team will monitor you closely throughout to ensure you remain safe.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedHungary
- —UnverifiedPortugal
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is a placebo and why is it used?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. Researchers use it to compare results fairly and prove whether the new medicine really works better than standard care alone.
Will I have to stop taking my regular lupus medicines?
No. All participants will continue to receive standard background care for lupus nephritis, such as mycophenolate, so your kidneys remain protected throughout the study.
Can I leave the trial if I change my mind?
Yes. You are free to withdraw from the study at any point, for any reason. Your decision will never affect the quality of your normal medical care or your relationship with your doctors.
Will taking part cost me anything?
No. The study medication and all trial-related tests are provided free of charge. Most clinical trials also help cover reasonable travel expenses to and from the hospital.
What happens if my kidneys get worse during the study?
Your health is the top priority. The medical team tracks your kidney function very closely. If you experience a lupus flare-up or your kidneys decline, the doctors will step in immediately with proven rescue treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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