Not yet recruitingPhase IIIInterventional

A Phase III trial evaluating the response to belimumab after rituximab in lupus patients who have high levels of IgA2 anti-DNA antibodies

Systemic lupus erythematosus (lupus) is an autoimmune condition where the body's defence system mistakenly attacks healthy tissues. When standard medicines do not work well enough, doctors often prescribe a treatment called rituximab. This trial tests whether adding another medicine, belimumab, after rituximab helps keep lupus symptoms under control. Earlier research suggests that a specific immune protein in the blood (an antibody called IgA2 anti-dsDNA) can show which patients will respond best to this combination. In this 52-week study, people aged 16 to 75 who have this antibody and are starting rituximab will be randomly chosen to receive either belimumab or dummy (placebo) drips. The goal is to find out if belimumab stops lupus flares and to help doctors personalise future treatments for people with severe lupus.

At a glance

Status

Not yet recruiting

Phase

Phase III

Sponsor

University College London

Enrolment target

Start

01 Nov 2026

Estimated completion

31 Oct 2028

Systemic lupus erythematosus

What is this study about?

Lupus is a long-term condition where the immune system attacks healthy parts of the body, such as the joints, skin, and kidneys. This can cause joint pain, extreme tiredness, and skin rashes. Many people manage their condition with standard medicines like steroids, but sometimes these treatments are not enough to keep the disease under control.

When usual treatments fail, doctors often turn to a medicine called rituximab. An earlier study found that giving a second medicine, called belimumab, after rituximab helped prevent severe flare-ups of lupus symptoms. Scientists also discovered a specific immune protein in the blood—an antibody called IgA2 anti-dsDNA—that seems to show which patients will benefit most from having both medicines.

This trial, called STRATIFY lupus, aims to confirm whether testing for this antibody can help doctors tailor treatment to the right patients. If successful, the study could help people with hard-to-treat lupus get faster access to targeted, more effective care on the NHS.

Key takeaways

Tests whether adding belimumab after rituximab reduces severe lupus flares.
Aims to see if a specific blood antibody can predict who will benefit most.
Open to people aged 16 to 75 with active lupus who are starting rituximab.
Lasts 52 weeks and involves regular hospital visits for drips and health checks.
Half of the participants receive belimumab, and half receive a dummy treatment (placebo).

Who may be eligible?

You may be able to take part if you are aged between 16 and 75 and have active lupus that is not responding well to standard treatments. You must be due to start rituximab treatment and test positive for the specific IgA2 antibody, which the trial team can check with a blood test.

You will not be able to join if you are pregnant, breastfeeding, or planning to become pregnant during the trial or within four months of finishing treatment. Anyone who could become pregnant must be willing to use reliable contraception or practise abstinence throughout the study.

You will also not be eligible if you have serious kidney problems, an active or long-term infection (such as hepatitis, tuberculosis, or HIV), or if you have recently taken part in another clinical trial or taken certain other advanced immune therapies.

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 aged between 16 and 75.
I have been diagnosed with systemic lupus erythematosus (lupus).
My current lupus medicines are not working well enough.
My specialist is planning for me to start rituximab treatment.
I am not pregnant or breastfeeding, and I agree to use reliable contraception if needed.
I do not have a serious ongoing infection, such as hepatitis or tuberculosis.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for 52 weeks (one year). First, you will receive your planned rituximab treatment. Between 4 and 8 weeks later, you will be randomly placed into one of two groups: one receives belimumab and the other receives a placebo (a dummy drip containing no active medicine). Neither you nor your doctors will know which group you are in.

You will receive the medicine through a drip into a vein at hospital. Visits happen every two weeks for your first three treatments, and then every four weeks until week 48. During these visits, the research team will check your health, take blood and urine samples, and ask you to fill in questionnaires. There is a final check-up at week 52, which does not involve a drip.

Potential risks and benefits

Taking part may help doctors find better, more targeted ways to manage lupus flares in the future, and you will receive regular, close health checks from a specialist team. However, belimumab carries risks, including a higher chance of infections and allergic reactions during or after the drip. To keep you safe, the team will monitor you closely for at least three hours after your first two treatments and give you a 24-hour emergency contact card. Attending hospital visits may also feel tiring, especially if you feel unwell. You are free to leave the trial at any time, and doing so will not affect your normal NHS care.

Locations (19)

University College London Hospital
City only
London, England
The Royal Glamorgan Hospital
City only
Pontyclun, Wales
Manchester Royal Infirmary
Approximate
Manchester, England
King's College Hospital
Approximate
London, England
Guy's and St Thomas' Hospitals
City only
London, England
Royal Free Hospital
Unverified
London, England
Royal Hallamshire Hospital
Unverified
Sheffield, England
Doncaster Royal Infirmary
Unverified
Doncaster, England
Sandwell General Hospital
Unverified
West Bromwich, England
Mile End Hospital
Unverified
London, England
Royal United Hospital
Unverified
Bath, England
Chapel Allerton Hospital
Unverified
Leeds, England

Common questions

Will I definitely receive the active study medicine?

No. You will have an equal chance of receiving either belimumab or a placebo (dummy drip). This comparison helps researchers clearly see whether the medicine works.

Can I take part if I am under 18?

Yes, people aged 16 and 17 can take part. The clinic team will provide a private, confidential space to discuss personal topics, such as contraception and pregnancy tests, away from parents or guardians if you prefer.

Why do I need to use contraception during the trial?

We do not yet know enough about how belimumab might affect an unborn baby. Because of this, anyone who can become pregnant must use effective contraception during the study and for four months after the final dose.

What happens if I get an infection during the study?

You should contact the trial team right away using your 24-hour contact card. The doctors will check your symptoms and may pause or stop your trial treatment if needed to keep you safe.

Can I leave the trial if it becomes too much for me?

Yes. Taking part is completely voluntary. You can choose to stop at any time without giving a reason, and your regular NHS medical care will continue as normal.

How to find out more

STRATIFY lupus Trial Team

cctu.stratifylupus@ucl.ac.uk - Official trial record

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