New drug may tame rare vasculitis and cut steroid dependence

NCT ID NCT05030155

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

100 people

The number who actually took part.

Started

May 2022

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • 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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