RecruitingPHASE1INTERVENTIONAL

Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

This research is looking into new treatments, called Vonsetamig and Odronextamab, for adults who have a kidney problem known as Lupus Nephritis (LN). This condition is caused by an autoimmune disease called Lupus. The main goal is to check how safe these new medicines are and how well people tolerate them over a longer period. This is a larger 'umbrella' study that includes smaller parts, each testing different drugs for LN. Researchers also want to find out what side effects might occur, how much of the medicine stays in the blood over time, and if the body creates antibodies against the medicine, which could make it less effective or cause other reactions.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Regeneron Pharmaceuticals

Enrolment target

Start

22 Dec 2025

Estimated completion

09 Sep 2029

Lupus Nephritis (LN)

What is this study about?

This study is exploring new medicines for a type of kidney disease called Lupus Nephritis (LN). Lupus is a long-term condition where your body's immune system mistakenly attacks healthy tissues, and when it affects the kidneys, it's called Lupus Nephritis. This can cause various problems, so finding effective treatments is very important.

The main purpose of this research is to see how safe these new medicines, called Vonsetamig and Odronextamab, are for people with LN. The study also aims to understand how your body reacts to these medicines. This involves checking for any side effects, seeing how much of the medicine is in your blood at different times, and finding out if your body makes special proteins (antibodies) against the medicine, which could affect how well it works.

This is a special kind of study called an 'umbrella study'. This means it's a larger study that includes several smaller, separate studies happening at the same time. Each of these smaller studies is testing different potential treatments, all with the goal of helping people with Lupus Nephritis. The information gathered from this study will help doctors learn more about these new medicines and whether they could be a useful treatment option in the future.

Key takeaways

This study is testing new medicines (Vonsetamig, Odronextamab) for Lupus Nephritis.
The main goal is to check how safe these medicines are and how your body reacts to them.
It's open to adults aged 18-60 with a confirmed diagnosis of Lupus Nephritis.
Participants must have LN that hasn't responded well to previous treatments or has returned.
Close monitoring of your health and potential side effects will happen throughout the study.
You can withdraw from the study at any time without affecting your future medical care.

Who may be eligible?

To be able to take part in this study, you need to meet certain requirements. You must be an adult between 18 and 60 years old and have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE), which is the full name for Lupus, and also Lupus Nephritis (LN). Importantly, your Lupus Nephritis must be either 'refractory', meaning it hasn't responded well to previous treatments, or 'relapsed', meaning it has come back after getting better.

There are also some reasons why you might not be able to join. For example, if you have severe or unstable mental health issues related to Lupus that require urgent medical care, you would not be eligible. Also, if you have certain other serious conditions alongside your Lupus, such as a severe form of antiphospholipid syndrome or an 'overlap syndrome' with mixed connective tissue disease or systemic sclerosis, within the last year, you would not be able to participate.

It's important to remember that these are just the main points, and there are other specific medical rules in the study plan that your doctor would check to see if you are a good fit for this research.

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 60 years old?
Have you been diagnosed with Lupus (Systemic Lupus Erythematosus)?
Have you also been diagnosed with Lupus Nephritis (kidney problems due to Lupus)?
Has your Lupus Nephritis not gotten better with previous treatments, or has it come back?
Do you have any severe mental health problems linked to Lupus that need urgent care?
Have you had certain other serious conditions like severe antiphospholipid syndrome or an overlap syndrome in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be receiving one of the experimental medications, Vonsetamig or Odronextamab, for a limited time. The study involves regular visits to the clinic for medical check-ups, blood tests, and other assessments. These appointments are designed to monitor your health, check for any changes in your Lupus Nephritis, and see how your body is reacting to the study drug. Researchers will be looking at things like your general health, how your kidneys are functioning, and any side effects you might experience. The exact number and frequency of visits, as well as the total length of time you would be involved, would be explained in detail by your study team.

Potential risks and benefits

Taking part in a clinical study might offer the potential benefit of accessing new treatments before they are widely available, which could potentially help manage your Lupus Nephritis. However, as these are experimental drugs, there are also potential risks, including side effects that are not yet fully known. Your health will be closely monitored throughout the study, but there's no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Baylor College of Medicine
Verified postcode
Houston, United States· Recruiting
University Medical Center of the Johannes Gutenberg-University Mainz
Verified postcode
Mainz, Germany· Recruiting
Hallym University Sacred Heart Hospital
Verified postcode
Anyang-si, South Korea· Recruiting
Seoul National University Hospital
Verified postcode
Seoul, South Korea· Recruiting
Samsung Medical Center
Verified postcode
Seoul, South Korea· Recruiting
Hospital Regional Universitario de Malaga
Verified postcode
Málaga, Spain· Recruiting
Changhua Christian Hospital
Verified postcode
Changhua, Taiwan· Recruiting
Taichung General Veterans Hospital
Verified postcode
Taichung, Taiwan· Recruiting
National Taiwan University Hospital
Verified postcode
Taipei, Taiwan· Recruiting
Taipei Veterans General Hospital
Verified postcode
Taipei, Taiwan· Recruiting

Common questions

What is Lupus Nephritis?

Lupus Nephritis is a serious kidney condition caused by Lupus, an autoimmune disease where your body's immune system attacks its own tissues, including the kidneys.

What kind of medicines are being tested?

The study is testing new, experimental medicines called Vonsetamig and Odronextamab. These are a type of drug called bispecific antibodies.

Why is this study important?

This study aims to find out if these new medicines are safe and how they work in people with Lupus Nephritis, which could help develop better treatments in the future.

Will I know if I'm getting the actual study drug?

The study team will explain how the different treatments are given. In some trials, you might not know if you're getting the active drug or a placebo until the study is over, but this particular study is focused on testing new drugs.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

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