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NCT05030155CompletedPhase 3

Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)

Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to compare mepolizumab-based regimen to conventional therapeutic strategy for remission induction in patients with Eosinophilic Granulomatosis with Polyangiitis.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
102 (actual)
First submitted
31 Jul 2021
Start date
May 2022
Primary completion date
Feb 2025
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT05030155
EU CT number
2024-513653-75-00
EudraCT number
2020-003318-10

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 102
  • From May 2022 to the primary completion date, Feb 2025
  • 46 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with EGPA who have already been treated with mepolizumab within the previous 12 months,
  • Patients with contraindication to use mepolizumab, cyclophosphamide, mesna, azathioprine or maintenance therapy used for vasculitis,
  • Patients included in other investigational therapeutic study within the previous 3 months,
  • Patients unable to give written informed consent prior to participation in the study

Other illness

  • 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 hypersensitivity to a monoclonal antibody or biologic agent,
  • 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,

Lab values

  • 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,

Age

  • Patients with active cancer or recent cancer (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,

Other

  • Patients with GPA, MPA, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
  • Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the 12 months duration of the study,
  • Patients suspected not to be observant to the proposed treatments,
  • Patients under tutorship or curatorship and protected adults.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens - Picardie
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AmiensFranceCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Centre Hospitalier de Béziers
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BéziersFranceCompleted
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Bobigny CedexFranceCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Assistance Publique Hopitaux De Paris
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Boulogne-BillancourtFranceCompleted
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire de Caen Normandie
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CaenFranceCompleted
Centre Hospitalier de Charleville-Mézières
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Charleville-MézièresFranceCompleted
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceCompleted
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceCompleted
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Centre Hospitalier Intercommunal Créteil
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CréteilFranceCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceCompleted
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
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GrenobleFranceCompleted
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceCompleted
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceCompleted
Hospices Civils De Lyon
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Lyon Cedex 03FranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Hôpital Archet 1
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NiceFranceCompleted
Centre Hospitalier de Niort
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NiortFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 10FranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Hopital Tenon
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Paris Cedex 20FranceCompleted
Centre Hospitalier De Perpignan
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Perpignan CedexFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Annecy Genevois
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Pringy CedexFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceCompleted
Les Hopitaux Universitaires de Strasbourg
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StrasbourgFranceCompleted
Hospital Foch
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SuresnesFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre Hospitalier de Valenciennes
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ValenciennesFranceCompleted
CHRU De Nancy
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Vandoeuvre Les NancyFranceCompleted
Centre Hospitalier Bretagne Atlantique
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VannesFranceCompleted
HOPITAL ROBERT SCHUMAN DE VANTOUX
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VantouxFranceCompleted

This page is information, not medical advice. Discuss any trial with your doctor.