New drug may tame rare vasculitis and cut steroid dependence
NCT ID NCT05030155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called mepolizumab can help people with a rare disease called eosinophilic granulomatosis with polyangiitis (EGPA) reach remission better than standard treatments. About 100 adults with active EGPA will receive either mepolizumab or usual care, and doctors will track how much steroid medication they need. The goal is to see if mepolizumab allows patients to use lower steroid doses without their disease flaring up.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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100 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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Nov 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with a diagnosis of EGPA independently of ANCA status, * Patients 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) * Patients having given their written informed consent prior to participation in the study. * Patients affiliated with social security or CMU (profit or being entitled) Exclusion Criteria: * Patients with GPA, MPA, 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 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. Patients with childbearing potential should have reliable contraception for the 12 months duration of the study, * Patients with EGPA who have already been treated with mepolizumab within the previous 12 months, * Patients with hypersensitivity to a monoclonal antibody or biologic agent, * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service de Médecine Interne, Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques "Hôpital Cochin
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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