CompletedPhase IIInterventional

Obinutuzumab compared with rituximab for treating ANCA-associated vasculitis

ANCA-associated vasculitis is an autoimmune condition where the body's immune system accidentally attacks healthy blood vessels, causing swelling and damage. A type of white blood cell called a B cell drives this swelling by making harmful antibodies. The usual NHS treatment is a drug called rituximab, which clears these B cells from the bloodstream. This study tests whether another medicine, obinutuzumab, works better than rituximab. Obinutuzumab is already used safely to treat some blood cancers and may remove B cells more thoroughly from the body's tissues. Participants will receive two doses of either drug through a drip, two weeks apart, alongside standard steroid tablets. The trial lasts about 18 months and involves 11 hospital visits, four phone check-ins, routine health tests, and two small tissue samples taken from inside the nose under local anaesthetic. Doctors want to see if this treatment offers better long-term disease control.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Cambridge Clinical Trials Unit

Enrolment target

Start

09 Jan 2023

Estimated completion

17 Jan 2025

ANCA-associated vasculitis

What is this study about?

Vasculitis is a condition that causes inflammation in blood vessels throughout the body. In ANCA-associated vasculitis, your immune system—which normally fights off bugs and infections—gets confused and attacks your own tissues. White blood cells known as B cells produce proteins that trigger this swelling. Currently, doctors in the UK standardly use a medicine called rituximab to clear these B cells and calm the inflammation.

Researchers at Addenbrooke's Hospital in Cambridge are running this trial to see if a newer drug, obinutuzumab, can do an even better job. Obinutuzumab is already approved and used for certain blood cancers, and early evidence suggests it may remove B cells more completely than rituximab. If it does, it could help keep vasculitis in remission for longer and reduce the risk of symptoms returning.

During this trial, half the participants will receive obinutuzumab and the other half will receive rituximab. A computer chooses who receives which drug by chance, and neither you nor your doctor will know which one you have been given. To find out how well the drugs clear B cells directly from tissues, doctors will also take a tiny sample of lining from inside the nose at the start and after 12 weeks, using numbing spray.

By comparing these two treatments head-to-head, researchers hope to improve future NHS care and give people living with vasculitis longer periods of good health without flares.

Key takeaways

Tests whether a drug called obinutuzumab works better than the standard medicine, rituximab.
Open to adults with active, PR3-positive ANCA-associated vasculitis.
Involves two treatment drips two weeks apart, plus steroid tablets taken at home.
Includes 11 clinic visits, four phone calls, and two small nose tissue checks over 18 months.
Participation is entirely voluntary and reasonable travel expenses will be covered.

Who may be eligible?

This trial is open to adults aged 18 and older who have an active form of ANCA-associated vasculitis (specifically granulomatosis with polyangiitis or microscopic polyangiitis). To take part, your blood tests must show a specific antibody called PR3, and you must have had at least two doses of any COVID-19 vaccine.

You will not be able to take part if you are pregnant, planning to become pregnant, or breastfeeding. Women who could become pregnant must agree to use reliable contraception throughout the study and for 18 months after their final treatment dose.

People with very severe kidney disease, a history of cancer within the last five years, or active serious infections (such as tuberculosis, shingles, or hepatitis) are also unable to join. This is because the study drugs lower parts of your immune system, which could make these infections harder to fight off.

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 aged 18 or older?
Have you been diagnosed with active ANCA-associated vasculitis?
Has your doctor confirmed that your blood is PR3-positive?
Have you received at least two doses of a COVID-19 vaccine?
Are you free from recent serious infections like tuberculosis or shingles?
Are you able to use effective contraception if there is a chance of pregnancy?

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for just over 18 months. At the start, you will have two hospital visits two weeks apart to receive your trial medicine through a vein drip. Along with the drip, you will be given steroid tablets (prednisolone) to take at home, with a clear step-by-step plan explaining how to reduce your dose safely over time.

Across the 18 months, you will attend 11 hospital visits and have four phone check-ins. Visits will include routine health checks such as blood tests, urine tests, and physical examinations. On your first day and again at week 12, the doctor will take a tiny tissue sample from the lining of your nose using local anaesthetic to make the area numb. Where possible, visits will be booked alongside your usual hospital appointments, and reasonable travel costs for extra visits can be reimbursed.

Potential risks and benefits

Taking part may give you access to a newer treatment that could clear harmful immune cells better than standard therapy and help prevent your vasculitis from returning. However, there is no guarantee of direct benefit. Like all treatments that affect the immune system, both drugs carry a risk of side effects, including mild infusion reactions, headaches, chills, nausea, and a higher chance of picking up common infections. The nasal biopsy may cause minor nose discomfort or light bleeding, which is easily managed. You will be monitored very closely throughout the trial, and you are free to leave the study at any time without your regular NHS medical care being affected in any way.

Locations (1)

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

Addenbrookes Hospital
City only
Cambridge, England

Common questions

Can I choose which medicine I receive?

No. A computer will randomly decide whether you receive obinutuzumab or rituximab. Neither you nor your trial doctors will know which one you are receiving, ensuring the results are fair and unbiased.

Will the nasal biopsy hurt?

The doctor will use a local anaesthetic to completely numb the inside of your nose beforehand. You might feel a small scratch or slight pressure during the procedure, but it should not be painful.

Will taking part interfere with my everyday life?

The trial requires 11 hospital visits over 18 months. Infusion days and biopsy days will take longer than normal appointments, so you may need some time off work or help with family commitments on those days.

What happens if I forget my steroid tablet schedule?

You will be given an easy-to-follow calendar showing your exact daily dose. A trial nurse will explain it carefully, and you can contact the study team at any time if you have questions or make a mistake.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw at any point without giving a reason, and your normal NHS care and relationship with your doctors will stay exactly the same.

How to find out more

Kim Mynard

kim.mynard@nhs.net +44 (0)1223 768317 Official trial record

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