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OBI-WAN : Obinutuzumab for remission induction in patients with relapsing PR3-ANCA granulomatosis with polyangiitis (Wegener’s). Phase 2 prospective, open-label study
EU CTIS ID: 2022-501557-36-00
What this study is testing
To determine the efficacy of obinutuzumab in patients with relapsing PR3-ANCA positive patients at week 24 (month 6), defined by: 1) the percentage of patients who achieved a BVAS of 0, 2) a negativation of PR3-ANCA, and 3) successful discontinuation of corticoids treatment after completion of the prednisone taper.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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, 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
- Patient able to give written informed consent prior to participation in the study
- Affiliation with a mode of social security (profit or being entitled)
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 unable to give written informed consent prior to participation in the study.
- 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,
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
- 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 unable to give written informed consent prior to participation in the study.
- 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 severe liver insufficiency (prothrombin time <50% and total bilirubin >50 micrmol/L) or pulmonary insufficiency requiring nasal oxygen
- Patients with hypersensitivity to obinutuzumab or to its excipients,
- 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
- Contra-indications to auxiliary medicinal products (methylprednisolone, paracetamol, prednisone, dexchlorpheniramine),
- Patients with other uncontrolled 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,
- 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,
- Patient participating in another investigational therapeutic study,
- Protected adults (including individual under legal guardianship by court order or curatorship) or adults deprived of liberty,
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.