Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis

Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (Wegener's). Phase 2 Prospective, Open-label Study

Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (NCT06940661) is a Phase 2 interventional studying Granulomatosis With Polyangiitis, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Granulomatosis With Polyangiitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient aged of 18 years or older, - Patients with relapsing granulomatosis with polyangiitis positive for PR3-ANCA at inclusion according to the ACR/EULAR 2022 classification criteria, and/or the 2012 revised Chapel Hill Consensus Conference definition. - Patients with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥ 3, - Patients within the first 21 days following initiation/increase of glucocorticoids at a dose ≤1 mg/kg/day (pulses of methylprednisolone before oral glucocorticoid therapy are authorized) - Patient able to give written willing to sign a consent form prior to participation in the study, - Affiliation with a mode of social security (profit or being entitled). Exclusion Criteria - Patients with MPO-positive AAV, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, - Patients with vasculitis in remission of the disease defined as a BVAS \< 3, - Patients with a newly-diagnosis of GPA - Patients treated with rituximab within the last 6 months before inclusion - Patients treated with cyclophosphamide within the last 6 months before inclusion - Patients with severe cardiac failure defined as class IV in New York Heart Association - Subject known to be seropositive for human weakened immune system virus (HIV), hepatitis B (included history of previous infection) or hepatitis C - Patients with active cancer or recent cancer (\< 5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, - Patients with hypersensitivity to a monoclonal antibody or biologic agent, - Patients with hypersensitivity to obinutuzumab or to its excipients - Contra-indications to auxiliary medicinal products (methylprednisolone, paracetamol, prednisone, dexchlorpheniramine) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patient aged of 18 years or older, * Patients with relapsing granulomatosis with polyangiitis positive for PR3-ANCA at inclusion according to the ACR/EULAR 2022 classification criteria, and/or the 2012 revised Chapel Hill Consensus Conference definition. * Patients with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥ 3, * Patients within the first 21 days following initiation/increase of glucocorticoids at a dose ≤1 mg/kg/day (pulses of methylprednisolone before oral glucocorticoid therapy are authorized) * Patient able to give written informed consent prior to participation in the study, - Affiliation with a mode of social security (profit or being entitled). Exclusion Criteria * Patients with MPO-positive AAV, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, * Patients with vasculitis in remission of the disease defined as a BVAS \< 3, * Patients with a newly-diagnosis of GPA * Patients treated with rituximab within the last 6 months before inclusion * Patients treated with cyclophosphamide within the last 6 months before inclusion * Patients with severe cardiac failure defined as class IV in New York Heart Association * Subject known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C * Patients with active cancer or recent cancer (\< 5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, * Patients with hypersensitivity to a monoclonal antibody or biologic agent, * Patients with hypersensitivity to obinutuzumab or to its excipients * Contra-indications to auxiliary medicinal products (methylprednisolone, paracetamol, prednisone, dexchlorpheniramine) * Patients with other uncontrolled diseases, including drug or alcohol abuse, active infections or antecedents of chronic or recurrent infections, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol, * Patients suspected not to be observant to the proposed treatments, * Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative pregnancy test (blood or urine) before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study, and at least 18 months after stopping obinutuzumab such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner, * Men who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 18 months after stopping obinutuzumab (unless permanently sterile by bilateral orchidectomy or vasectomy), * Patient participating in another investigational therapeutic study * Protected adults (including individual under legal guardianship by court order or curatorship) or adults deprived of liberty * Patients unable to give written informed consent prior to participation in the study. * Patients with severe liver insufficiency (prothrombin time \<50% and total bilirubin \>50 micrmol/L)) or pulmonary insufficiency requiring nasal oxygen, * Patients with an active infection or a history of chronic or recurrent infections * Vaccination with live virus vaccines in the 4 weeks before study enrolment

Treatments Being Tested

DRUG

Obinutuzumab

Patient will receive 1000 milligrams intravenous (IV) infusion on week 0, week 2, week 24 and week 26. Patients will receive the same standardized glucocorticoid tapering schedule (prescribe as a standard of care management and considered as auxiliary medicinal product) Premedication for obinutuzumab infusion related reactions (considered as auxiliary medicinal products) : * 100 mg methylpredinisolone * 1000 mg paracetamol * 5 mg dexchlorpheniramine

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Service de Médecine Interne, Centre de reference "Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques"

Paris, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06940661), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06940661 clinical trial studying?

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06940661?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06940661?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06940661. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06940661. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.