Evaluation of MEpolizumab-based regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis

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 study - E-merge

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003318-10-FR

Enrollment

100

Registered

2021-06-10

Start date

2021-08-05

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) with newly-diagnosed disease or with a relapsing disease at the time of screening MedDRA version: 20.0 Level: PT Classification code 10078117 Term: Eosinophilic granulomatosis with polyangiitis System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: MEPOLIZUMAB Product Name: MEPOLIZUMAB Pharmaceutical Form: Solution for injection INN or Proposed INN: MEPOLIZUMAB CAS Number: 196078-29-2 Other descriptive name: MEPOLIZUMAB Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with a diagnosis of EGPA independently of ANCA status, - Patient 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) - Written informed consent prior to participation in the study - Affiliation to social security or CMU (beneficiary or assignee) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the glucocorticoid-sparing effect of mepolizumab-based regimen, defined as a prednisone dose of 4.0 mg or less per day at day 168, in patients with newly-diagnosed or relapsing EGPA;Secondary Objective: Measure glucocorticoid dose at D168&364 of mepolizumab vs conventional therapy Measure glucocorticoid cumulative dose at D168&364 of mepolizumab vs conventional therapy Compare proportions of participants who had a prednisone dose of 4.0mg or less/day for 0 week, for more than 0 week but less than 4 weeks, for more than 4 weeks but less than 12 weeks, & for at least 12 weeks Compare proportion of participants who had a prednisone dose of 4.0mg or less/day at both D168&364 Compare proportion of participants experiencing a relapse Compare nb of relapse during study period Compare time from inclusion to 1st relapse Compare safety profile of mepolizumab & conventional treatment at D168&364 Compare sequelae (Vasculitis Damage Index) at D168&364 in 2 arms Compare functional disability & quality of life at D168&364 after randomization in 2 arms Compare evolution of ANCA titers and eosinophils in the 2 treatment groups & to assess its correlation with clinical events during follow-up;Primary end point(s): The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse;Timepoint(s) of evaluation of this end point: D168	—

Measure

Time frame

Main Objective: To determine the glucocorticoid-sparing effect of mepolizumab-based regimen, defined as a prednisone dose of 4.0 mg or less per day at day 168, in patients with newly-diagnosed or relapsing EGPA;Secondary Objective: Measure glucocorticoid dose at D168&364 of mepolizumab vs conventional therapy Measure glucocorticoid cumulative dose at D168&364 of mepolizumab vs conventional therapy Compare proportions of participants who had a prednisone dose of 4.0mg or less/day for 0 week, for more than 0 week but less than 4 weeks, for more than 4 weeks but less than 12 weeks, & for at least 12 weeks Compare proportion of participants who had a prednisone dose of 4.0mg or less/day at both D168&364 Compare proportion of participants experiencing a relapse Compare nb of relapse during study period Compare time from inclusion to 1st relapse Compare safety profile of mepolizumab & conventional treatment at D168&364 Compare sequelae (Vasculitis Damage Index) at D168&364 in 2 arms Compare functional disability & quality of life at D168&364 after randomization in 2 arms Compare evolution of ANCA titers and eosinophils in the 2 treatment groups & to assess its correlation with clinical events during follow-up;Primary end point(s): The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse;Timepoint(s) of evaluation of this end point: D168

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Secondary

Measure	Time frame
Secondary end point(s): i. Prednisone dosage at days 168 and 364 ii. The area under the curve for corticosteroids at days 168 and 364 in the two treatment groups iii. Proportion of participants with a prednisone dose of 4.0 mg or less per day for 0 weeks, for more than 0 weeks but less than 4 weeks, for more than 4 weeks but less than 12 weeks, and for at least 12 weeks (categorical quantification) iv. Proportion of participants with a prednisone dose of 4.0 mg or less per day at both days 168 and 364 v. Proportion of participants experiencing a relapse vi. Number of relapse during the study period vii. Time from inclusion to first relapse viii. The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 168 and 364 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions that result in the cessation of further infusions ix. The Vasculitis Damage Index at days 168 and 364 in the two treatment groups x. The HAQ and SF-36 at days 168 and 364 in the two treatment groups xi. Evolution of ANCA titers and eosinophils in the two treatment groups, and correlation with clinical events during follow-up;Timepoint(s) of evaluation of this end point: D168 and D364	—

Measure

Time frame

Secondary end point(s): i. Prednisone dosage at days 168 and 364 ii. The area under the curve for corticosteroids at days 168 and 364 in the two treatment groups iii. Proportion of participants with a prednisone dose of 4.0 mg or less per day for 0 weeks, for more than 0 weeks but less than 4 weeks, for more than 4 weeks but less than 12 weeks, and for at least 12 weeks (categorical quantification) iv. Proportion of participants with a prednisone dose of 4.0 mg or less per day at both days 168 and 364 v. Proportion of participants experiencing a relapse vi. Number of relapse during the study period vii. Time from inclusion to first relapse viii. The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 168 and 364 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions that result in the cessation of further infusions ix. The Vasculitis Damage Index at days 168 and 364 in the two treatment groups x. The HAQ and SF-36 at days 168 and 364 in the two treatment groups xi. Evolution of ANCA titers and eosinophils in the two treatment groups, and correlation with clinical events during follow-up;Timepoint(s) of evaluation of this end point: D168 and D364

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

ophelie.rogier@aphp.fr3301 44 84 17 89

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026