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
- Diseases
- ANCA-associated vasculitis
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Completed |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Completed |
| Centre Hospitalier de Béziers Coordinator of this site? Confirm its status | Béziers | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny Cedex | France | Completed |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Completed |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire de Caen Normandie Coordinator of this site? Confirm its status | Caen | France | Completed |
| Centre Hospitalier de Charleville-Mézières Coordinator of this site? Confirm its status | Charleville-Mézières | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Completed |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Completed |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Completed |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Hôpital Archet 1 Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier de Niort Coordinator of this site? Confirm its status | Niort | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Completed |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Hopital Tenon Coordinator of this site? Confirm its status | Paris Cedex 20 | France | Completed |
| Centre Hospitalier De Perpignan Coordinator of this site? Confirm its status | Perpignan Cedex | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Les Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Centre Hospitalier de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
| Centre Hospitalier Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Completed |
| HOPITAL ROBERT SCHUMAN DE VANTOUX Coordinator of this site? Confirm its status | Vantoux | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.