AuthorisedTherapeutic exploratory (Phase II)Interventional

Obinutuzumab for systemic lupus erythematosus pure membranous nephropathy: a phase II trial (OBLUMEN)

Lupus is a long-term condition where the body's immune system attacks healthy tissues. Sometimes it targets the kidneys, causing a problem known as membranous nephropathy. This can make the kidneys leak protein and struggle to filter waste properly. The OBLUMEN trial is testing a medicine called obinutuzumab (also known as Gazyvaro). It works by calming down specific immune cells that cause inflammation in lupus. The medicine is given through a slow drip into a vein. The main goal is to find out if obinutuzumab helps the kidneys recover over 52 weeks without causing major complications. Doctors will also check whether the drug lets people safely lower their steroid doses, prevents disease flares, and improves everyday quality of life. The trial is open to adults aged 18 and over with this specific kidney condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

15 Jul 2026

systemic lupus erythematosus pure membranous nephropathy

What is this study about?

Lupus (systemic lupus erythematosus) is an autoimmune condition. Normally, the immune system protects us from illness, but in lupus, it becomes overactive and attacks healthy body parts. When lupus damages the tiny filters inside the kidneys, it is called lupus nephropathy. One specific type is 'pure membranous nephropathy'. It causes inflammation that can lead to protein leaking into the urine, swollen legs, high blood pressure, and long-term kidney strain.

At the moment, doctors treat this condition with strong medicines, including steroids. While steroids can help control inflammation quickly, taking them for a long time can cause unpleasant side effects such as weight gain, mood changes, and bone thinning. This trial, called OBLUMEN, is exploring whether a targeted medicine named obinutuzumab can offer a better, gentler solution.

Obinutuzumab works by finding and removing specific white blood cells (B cells) that create harmful antibodies. By clearing these cells away, researchers hope to calm the immune system and give the kidneys a chance to heal. The trial lasts for one year, and doctors will carefully monitor kidney function and overall health to see how well the medicine works.

Key takeaways

Tests a targeted drip medicine called obinutuzumab for lupus kidney disease.
Aimed at adults aged 18 and over with pure membranous nephropathy.
Follows participants for 52 weeks (one year) to measure kidney healing.
Aims to help patients safely cut down on long-term steroid tablets.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is open to adults aged 18 and older who have systemic lupus erythematosus with kidney involvement called pure membranous nephropathy. Both men and women can join.

To take part, you must have an official diagnosis confirmed by your medical team, usually through blood and urine tests and a kidney biopsy. A biopsy is a standard test where a tiny sample of kidney tissue is examined under a microscope.

You might not be able to take part if you have active infections, other severe medical problems, or if you are taking certain medicines that could interfere with the study drug. The trial doctors will review your full medical history to make sure the study is completely safe 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.

You are aged 18 or older.
You have been diagnosed with systemic lupus erythematosus (lupus).
You have kidney inflammation known as pure membranous nephropathy.
You are able to travel to the clinic for hospital visits and infusions over 52 weeks.
You do not have a serious active infection.

Answer every question to see your result.

What does participation involve?

Taking part in the OBLUMEN study lasts for around 52 weeks (one year). You will receive obinutuzumab as an infusion, which means the liquid medicine is given slowly through a small tube into a vein in your arm at the hospital clinic. Before each infusion, you may be given mild medicines to help prevent allergic reactions.

Throughout the year, you will attend regular hospital appointments. During these visits, doctors will check your blood pressure, test your blood and urine to see how your kidneys are performing, and ask how you are feeling. The team will also see if you can safely lower your steroid dose. You will be asked to fill in short questionnaires about your daily wellbeing and quality of life so researchers understand how the treatment affects your everyday life.

Potential risks and benefits

Taking part may help heal your kidneys and could allow you to reduce your steroid medication, but these benefits cannot be guaranteed. Like all medicines, obinutuzumab can cause side effects. Common ones include mild reactions during the infusion (such as shivering, fever, or feeling sick), temporary drops in white blood cells, and a higher chance of picking up infections. Your care team will monitor you very closely and treat any side effects promptly. Taking part is completely your choice, and you can change your mind and leave the trial at any time without your usual NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is obinutuzumab?

Obinutuzumab (brand name Gazyvaro) is a targeted antibody medicine given by a drip. It works by temporarily clearing away specific immune cells that cause inflammation in lupus.

Will I definitely receive the trial drug?

Yes. This is a Phase II study where all enrolled participants receive obinutuzumab alongside standard care and regular monitoring.

How long will I be in the trial?

Your participation will last for about 52 weeks (one year) from your first treatment.

Does taking part cost anything?

No. The study medication, clinic visits, and all trial tests are free of charge. Many trials also offer support with travel expenses.

Can I keep taking my usual lupus medicines?

In most cases, yes. However, the trial doctor will review your prescriptions and let you know if any doses need to be adjusted during the study.