RecruitingPHASE2INTERVENTIONAL

Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

This research study is looking into a new medication called Tarperprumig. It's for adults aged 18 to 80 who have a condition called ANCA-associated vasculitis, either recently diagnosed or returning. ANCA-associated vasculitis is a rare disease where the body's immune system mistakenly attacks its own small blood vessels, causing swelling and damage. Researchers want to compare Tarperprumig against a placebo (a dummy medicine) to understand if it's safe to use and how well it works to treat the condition. This type of study, called a Phase 2 trial, helps scientists learn more about new treatments before they can be widely used, ultimately aiming to improve care for people living with this illness.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

Start

26 Nov 2025

Estimated completion

14 Feb 2028

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What is this study about?

ANCA-associated vasculitis is a rare, sometimes serious, illness where your body's immune system accidentally attacks your small blood vessels. This can lead to swelling and damage in different parts of the body, including the kidneys or lungs. Doctors already have treatments for this condition, but they are always looking for new and potentially better ways to help people.

This study is testing a new medicine called Tarperprumig. The main goal is to find out if Tarperprumig is safe for people with ANCA-associated vasculitis and if their bodies tolerate it well. Researchers will also be looking to see if the medicine helps improve the condition. They will compare Tarperprumig to a placebo, which is a dummy medicine containing no active drug. This helps them understand if any changes are due to Tarperprumig or other factors.

By taking part, you would be helping doctors and scientists learn more about ANCA-associated vasculitis and contribute to finding new treatments that could benefit many people in the future. This is a Phase 2 study, meaning it's an important step in researching new medicines after initial safety tests but before larger studies designed to confirm effectiveness.

Key takeaways

The study is for adults with ANCA-associated vasculitis (newly diagnosed or returning).
It's testing a new medicine called Tarperprumig against a placebo.
The main goals are to check the medicine's safety and how well it's tolerated.
Participation could help improve future treatments for this condition.
You would receive close medical monitoring throughout the study.

Who may be eligible?

To join this study, you must be an adult between 18 and 80 years old and have ANCA-associated vasculitis that has been recently diagnosed or has come back after treatment. Your doctor would have considered treatments like rituximab or cyclophosphamide for you. You also need to have specific antibodies (PR3-ANCA or MPO-ANCA) in your blood, which are signs of the condition, and have certain symptoms that show your vasculitis is active.

There are also some reasons why you might not be able to join. For example, if you have other serious health conditions that are not ANCA-associated vasculitis – such as lupus, rheumatoid vasculitis, or certain kidney conditions – these would prevent you from taking part. You also couldn't join if the research team believes it might be unsafe for you due to other illnesses or conditions, or if you have severe bleeding in your lungs requiring breathing support.

The research team will carefully check all these points to make sure the study is right and safe for you. It's important to be upfront about your full medical history so they can make the best decision.

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 80 years old?
Do you have ANCA-associated vasculitis that's newly diagnosed or has come back?
Has your doctor considered treatments like rituximab or cyclophosphamide for you?
Do you have other serious health conditions like lupus or severe lung bleeding?
Are you able to commit to regular hospital visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the specific number of visits, assessments, medication schedule, or total duration of the study. Typically, clinical trials involve regular visits to the study clinic for check-ups, blood tests, and other assessments related to your condition and the study medication. You would receive either Tarperprumig or a placebo as part of the study, and there would be a follow-up period to monitor your health after the main treatment phase. The full commitment, including how long you would be in the study, will be discussed in detail by the research team if you are suitable to join.

Potential risks and benefits

Participating in a study like this offers the potential benefit of accessing a new treatment, Tarperprumig, before it becomes widely available. You would also receive close medical attention and monitoring. However, there are potential risks, including side effects from the study medication, which may or may not be known yet, or that the treatment might not work for you. The placebo group receives no active drug, meaning their condition might not improve. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (78)

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

Research Site
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Ciudad de Buenos Aires, Argentina· Recruiting
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Ciudad de Buenos Aires, Argentina· Recruiting
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La Plata, Argentina· Recruiting
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Rosario, Argentina· Recruiting
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San Juan Bautista, Argentina· Recruiting
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Santa Fe, Argentina· Withdrawn
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Clayton, Australia· Recruiting
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Heidelberg, Australia· Recruiting
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Nedlands, Australia· Recruiting
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Wollongong, Australia· Recruiting
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Barretos, Brazil· Recruiting
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Belo Horizonte, Brazil· Recruiting

Common questions

What is ANCA-associated vasculitis?

It's a rare condition where your body's immune system attacks its own small blood vessels, causing inflammation and damage.

What is Tarperprumig?

It's a new medicine being tested in this study to see if it's safe and effective for treating ANCA-associated vasculitis.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real treatment but contains no active drug. It helps researchers compare the effects of the new medicine.

Who can join this study?

Adults between 18 and 80 with newly diagnosed or returning ANCA-associated vasculitis, who meet specific medical criteria.

What does a 'Phase 2' study mean?

Phase 2 studies focus on understanding if a new medicine is safe and if it shows promise in treating the condition, after initial safety tests.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com 1-855-752-2356 Official trial record

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