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Study on Obinutuzumab for Patients with Relapsing Granulomatosis with Polyangiitis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called granulomatosis with polyangiitis, which is sometimes known as Wegener's disease. This condition is a type of inflammation that affects blood vessels and can lead to damage in various organs. The study is specifically looking at cases where the disease is associated with a protein called PR3-ANCA and has relapsed, meaning it has returned after treatment.

The treatment being tested in this study is a medication called obinutuzumab, which is also known by its code name RO5072759. Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to see how effective obinutuzumab is in helping patients achieve remission, which means the disease becomes inactive or less severe. The study will also look at whether patients can stop taking steroids, a type of medication often used to reduce inflammation, after completing a gradual reduction in their dose.

Participants in the study will receive obinutuzumab infusions and will be monitored over a period of time to see how their condition responds. The study will last for about 12 months, with key assessments at 6 months and 12 months. Researchers will track the number of patients who achieve remission, any side effects experienced, and other health outcomes. The goal is to gather information on the safety and effectiveness of obinutuzumab for treating relapsing granulomatosis with polyangiitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the clinical trial.

    Eligibility criteria include being 18 years or older, having relapsing granulomatosis with polyangiitis positive for PR3-ANCA, and having an active disease with a Birmingham Vasculitis Activity Score (BVAS) of 3 or higher.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status and disease activity. This may include blood tests and other necessary examinations.

  3. Step 3

    Treatment administration

    You will receive the medication Gazyvaro, which contains the active substance obinutuzumab. This medication is administered as a solution for infusion, meaning it is given through a vein (intravenous use).

    The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess your response to the treatment and any potential side effects. This includes checking for clinical and serological remission at week 24 (month 6).

    You will be monitored for adverse events, such as infections or infusion reactions, and your healthcare provider will address any concerns that arise.

  5. Step 5

    Completion of treatment

    The primary goal is to achieve a BVAS of 0, negativation of PR3-ANCA, and successful discontinuation of corticoids treatment after completion of the prednisone taper.

    The study will continue to monitor your health and disease activity for up to 12 months, with assessments at week 24 and 52.

Who can join the trial?

6 criteria

  • Patient must be 18 years or older.
  • Patient must have a condition called granulomatosis with polyangiitis that is positive for PR3-ANCA. This can be at the initial diagnosis or during follow-up, according to specific medical classification criteria.
  • Patient must have an active disease with a score of 3 or higher on the Birmingham Vasculitis Activity Score (BVAS), which is a way to measure disease activity.
  • Patient must be within the first 21 days after starting or increasing glucocorticoids (a type of steroid medication) at a dose of 1 mg per kg of body weight per day or less.
  • Patient must be able to give written informed consent before participating in the study, meaning they understand and agree to the study procedures.
  • Patient must have an affiliation with a mode of social security, meaning they have access to health insurance or similar benefits.

Who cannot join the trial?

6 criteria

  • Patients who do not have **PR3-ANCA granulomatosis with polyangiitis** cannot participate. This is a specific medical condition required for the study.
  • Patients who are not experiencing a **relapse** of their condition cannot participate. A relapse means that the symptoms of the disease have returned after a period of improvement.
  • Patients who are unable to stop taking **corticoids** after completing a **prednisone taper** cannot participate. Corticoids are a type of medication used to reduce inflammation, and a prednisone taper is a gradual reduction in the dose of prednisone, a specific corticoid.
  • Patients who are not **PR3-ANCA positive** cannot participate. PR3-ANCA is a type of antibody found in the blood that is associated with the condition being studied.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a **vulnerable population** cannot participate. This refers to groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

Obinutuzumab is a medication used in this clinical trial to help treat patients with a condition called granulomatosis with polyangiitis, which is a type of inflammation of the blood vessels. This condition can cause various symptoms, including damage to organs. Obinutuzumab works by targeting specific cells in the immune system that are involved in causing this inflammation. The goal of using this medication in the trial is to see if it can help reduce the symptoms of the disease and help patients achieve remission, which means that the symptoms are reduced or disappear.

What is already known about the treatment

Obinutuzumab – Obinutuzumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its effectiveness in treating PR3-ANCA granulomatosis with polyangiitis, also known as Wegener's granulomatosis, which is a rare autoimmune disease. The main goal of using obinutuzumab is to help patients achieve remission, which means reducing or eliminating the symptoms of the disease. At the molecular level, obinutuzumab works by targeting and binding to a specific protein on the surface of certain immune cells, leading to their destruction. This helps to reduce the inflammation and damage caused by the disease. Obinutuzumab is classified as a monoclonal antibody, which is a type of medication designed to target specific cells in the body.

Investigated diseases

Granulomatosis with polyangiitis – Granulomatosis with polyangiitis is an autoimmune disease characterized by inflammation of small to medium-sized blood vessels, primarily affecting the respiratory tract and kidneys. The disease often begins with symptoms such as persistent nasal congestion, sinusitis, and nosebleeds. As it progresses, it can lead to more severe respiratory issues, including cough and shortness of breath. Kidney involvement may result in blood in the urine and decreased kidney function. The disease can also affect other organs, leading to joint pain, skin rashes, and eye inflammation. Over time, the inflammation can cause damage to the affected tissues and organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501557-36-00Protocol codeAPHP211000Estimated enrolment36 patientsSponsorAssistance Publique Hopitaux De Paris

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