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Evaluation of MEpolizumab-based regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis
EU CTIS ID: 2024-513653-75-00
What this study is testing
To determine the glucocorticoid-sparing effect of mepolizumab-based regimen, defined as a prednisone dose of 4.0 mg or less per day at day 168, in patients with newly-diagnosed or relapsing EGPA
- Therapeutic confirmatory (Phase III)
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
- Patients with a diagnosis of EGPA independently of ANCA status
- Patient aged of 18 years or older
- Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥3
- Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy are authorized)
- Written informed consent prior to participation in the study
- Affiliation to social security or CMU (beneficiary or assignee)
You likely can't join if
- Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference
- Patients with contraindication to use mepolizumab, cyclophosphamide, mesna, azathioprine or maintenance therapy used for vasculitis
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol
- Patients included in other investigational therapeutic study within the previous 3 months
- Patients suspected not to be observant to the proposed treatments
- Patients who have white blood cell count ≤4,000/mm3
See the full eligibility criteria
Who can join
- Patients with a diagnosis of EGPA independently of ANCA status
- Patient aged of 18 years or older
- Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥3
- Patients within the first 21 days following initiation/increase of corticosteroids at a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy are authorized)
- Written informed consent prior to participation in the study
- Affiliation to social security or CMU (beneficiary or assignee)
What rules you out
- Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference
- Patients with contraindication to use mepolizumab, cyclophosphamide, mesna, azathioprine or maintenance therapy used for vasculitis
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol
- Patients included in other investigational therapeutic study within the previous 3 months
- Patients suspected not to be observant to the proposed treatments
- Patients who have white blood cell count ≤4,000/mm3
- Patients who have platelet count ≤100,000/mm3
- Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease
- Patients unable to give written informed consent prior to participation in the study
- Patients under tutorship or curatorship and protected adults
- Patients with vasculitis in remission of the disease defined as a BVAS <3
- Patients with severe cardiac failure defined as class IV in New York Heart Association
- Patients with acute infections or chronic active infections (including HIV, HBV or HCV and checked in the last 12 months)
- Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment
- Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative serum pregnancy test 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 for WOCPB with FFS≥1 at least 12 months after stopping cyclophosphamide: 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 with FFS≥1 who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 6 months after stopping cyclophosphamide (unless permanently sterile by bilateral orchidectomy)
- Patients with EGPA who have already been treated with mepolizumab or benraluzimab within the previous 6 months
- Patients with hypersensitivity to a monoclonal antibody or biologic agent
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, 18-64 years, 65+ 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.