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 (E-merge)

NCT05030155 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	100
Start date	2022-05-30
Completion	2025-11

Conditions

• Eosinophilic Granulomatosis With Polyangiitis

Interventions

• Mepolizumab
• cyclophosphamide/azathioprine
• Placebo

Primary outcomes

• Percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse — Day 168
  EGPA relapse will be defined as worsening or persistence of active disease since the last visit characterized by: a) active vasculitis (BVAS \>0); OR b) active asthma symptoms; OR c) active nasal and/or sinus disease, warranting: i) an increased dose of prednisone compared to previous dosage and at least \>4 mg/day prednisone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalisation related to EGPA worsening. A BVAS evaluation will be conducted at the time of a relapse, or as soon as possible afterwards

Countries

France