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New treatment option for Granulomatosis With Polyangiitis
Official title Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis
ClinicalTrials.gov ID: NCT06940661
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for granulomatosis with polyangiitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Patient able to give written informed consent prior to participation in the study, - Affiliation with a mode of social security (profit or being...
You likely can't join if
- 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
See the full eligibility 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).
- 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...
- 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...
- 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...
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.