RecruitingPhase IIIInterventional

A study of nipocalimab in adults with moderate to severe systemic lupus erythematosus

This study is looking into a new treatment called nipocalimab for adults aged 18 to 75 who have moderate to severe systemic lupus erythematosus (lupus or SLE). Lupus is a long-term condition where the body's immune system mistakenly attacks healthy tissues, causing inflammation. Current treatments aim to manage symptoms or suppress the immune system, but new options are needed. Nipocalimab is a special protein designed to reduce harmful inflammatory substances in the body. The study will compare nipocalimab to a dummy drug (placebo) to see how well it works. Participants will be monitored closely for their health and any side effects throughout the study, which could last several years.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International NV

Enrolment target

600

Start

06 Mar 2026

Estimated completion

27 Oct 2027

Systemic lupus erythematosus

What is this study about?

This research is looking at a new medicine called nipocalimab for people who have systemic lupus erythematosus, often simply called lupus or SLE. Lupus is a long-term illness where your body's defence system, known as the immune system, starts to attack its own healthy parts by mistake. This can cause swelling and pain in many different areas of the body. For example, it can often lead to kidney inflammation, and in some cases, serious kidney problems. While there are treatments for lupus already, they mostly focus on easing symptoms or lowering your immune system's activity overall. This means there's a real need for newer, more effective ways to help people with lupus.

Nipocalimab is a type of protein, sometimes called a monoclonal antibody, that has been specifically designed. It works by blocking a certain part of the immune system that leads to inflammation. By doing this, it aims to reduce the amount of harmful substances in your body that are causing the problems associated with lupus. In this study, scientists want to find out if nipocalimab can help people with moderate to severe lupus feel better and if it works better than a 'placebo' – which is a dummy drug that looks like the real medicine but contains no active ingredient.

Taking part in this study could potentially help others with lupus in the future by providing new information about this treatment. Participants will also continue to receive their usual care for lupus alongside the study treatment. The study is carefully planned to gather as much information as possible about nipocalimab's effects, and researchers will be keeping a close eye on everyone's health throughout.

Key takeaways

Tests a new drug (nipocalimab) for moderate to severe lupus.
Compares nipocalimab to a dummy drug (placebo) in a fair way.
Participation involves regular visits and health checks over several years.
Potential benefits might include improved symptoms or helping future lupus patients.
Known potential risks include infections and allergic reactions; not all risks are known yet.
You can continue your usual lupus treatments during the study.

Who may be eligible?

This study is looking for adults between 18 and 75 years old who have been diagnosed with moderate to severe lupus (SLE). Your doctor will make sure your lupus diagnosis meets specific criteria for the study.

To be considered, you should also be generally stable and healthy, based on a physical check-up, medical history, and some basic tests like an ECG (heart check). Your lupus symptoms should show a certain level of activity, as measured by specific medical scores that your doctor will explain.

You won't be able to join if you have other serious uncontrolled health conditions, a history of very bad allergic reactions to similar medicines, or certain unstable lupus symptoms that might need different immediate treatment. If you could become pregnant, you'll need to have negative pregnancy tests before starting.

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.

Are you between 18 and 75 years old?
Have you been diagnosed with moderate to severe lupus (SLE)?
Are you generally stable and healthy, apart from your lupus?
Do you have a specific level of lupus activity as assessed by your doctor?
Have you had any very severe allergic reactions to medicines like this before? (If yes, you might not be eligible.)
If you could become pregnant, are you prepared to have negative pregnancy tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages over about 3 years and 1 month overall. First, there's a 'screening period' that could last up to 6 weeks, where doctors will check if you're a good fit for the study.

After screening, you'll enter the main 'treatment period' which lasts for 52 weeks (about a year). You'll be randomly assigned to either receive nipocalimab or a placebo (a dummy drug). Neither you nor your study doctor will know which one you are getting – this is called a 'double-blind' approach and helps make the study fair. After this year, if you wish and are eligible, you can choose to enter an 'open-label' period, where you will definitely receive nipocalimab for a longer time, up to 156 weeks (about 3 years).

Throughout the study, you'll have regular visits for health assessments, blood tests, and to check for any side effects. There will be a final 'safety follow-up' around Week 162 to monitor your health. All your regular lupus treatments will continue throughout the study.

Potential risks and benefits

There's no guarantee that you will personally benefit from taking part in this study, as nipocalimab is still being tested. However, based on how the drug is designed to work, it might help improve your lupus symptoms. Even if the drug doesn't directly help you, some people find they benefit from the extra health monitoring and regular check-ups that come with being in a study. Crucially, your participation could provide valuable information that helps develop better treatments for other people with lupus in the future. All participants will continue to receive their regular lupus medications. Potential risks include side effects from the drug or study procedures. These could be mild, severe, or very rarely, life-threatening. Common potential risks include increased risk of infections, reduced effectiveness of some vaccines, allergic reactions, injection site reactions, and changes in blood levels of proteins or cholesterol. There might also be other less common risks that are not fully known yet. You will be given a detailed information sheet and asked to sign a consent form, which explains all the known risks. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (9)

Peterborough City Hospital
Approximate
Peterborough, England
Great Western Hospitals NHS Foundation Trust
City only
Swindon, England
Guy's Hospital
Approximate
London, England
Southampton General Hospital
Approximate
Southampton, England
Haywood Hospital
Approximate
Stoke-on-trent, England
Freeman Hospital
Unverified
Newcastle upon Tyne, England
Royal United Hospital
Unverified
Bath, England
Addenbrooke's Hospital
Unverified
Cambridge, England
Royal Berkshire Hospital
Unverified
Reading, England

Common questions

What is systemic lupus erythematosus (lupus or SLE)?

Lupus is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues, causing inflammation and damage to different organs.

What is nipocalimab?

Nipocalimab is a new experimental drug, a special type of protein, designed to reduce harmful inflammatory substances in the body that contribute to lupus symptoms.

Will I definitely get the new drug?

For the first year of the study, you have a 50% chance of receiving nipocalimab and a 50% chance of receiving a placebo (dummy drug) because it's a 'double-blind' study. After this, you might be able to receive nipocalimab for a longer period if you're eligible.

What kinds of checks will I have?

You'll have regular physical exams, blood tests, and other assessments to monitor your health, lupus symptoms, and any potential side effects throughout the study.

Who is paying for this study?

The study is funded by Janssen-Cilag International NV, a pharmaceutical company based in the Netherlands.

How to find out more

- Medical Information and Product Information Enquiry

JanssenUKRegistryQueries@its.jnj.com +44 (0)800 731 8450 Official trial record

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