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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513653-75-00
Acronym
D20180135
Enrollment
100
Registered
2024-10-04
Start date
2022-05-30
Completion date
2025-09-05
Last updated
2025-08-12

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

Conditions

Eosinophilic granulomatosis with polyangiitis (EGPA), formerly called Churg-Strauss syndrome

Brief summary

The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse

Detailed description

Prednisone dosage at days 168 and 364, The area under the curve for corticosteroids at days 168 and 364 in the two treatment groups, 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), Proportion of participants with a prednisone dose of 4.0 mg or less per day at both days 168 and 364, Proportion of participants experiencing a relapse, Number of relapse during the study period, Number of asthma and sinonasal exacerbations during the study period, Time from inclusion to first relapse, The ACQ and SNOT-22 during the study period, 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, The Vasculitis Damage Index at days 168 and 364 in the two treatment groups, The HAQ and SF-36 at days 168 and 364 in the two treatment groups, Evolution of ANCA titers and eosinophils in the two treatment groups, and correlation with clinical events during follow-up

Interventions

DRUGcomprimé pelliculé
DRUGCYCLOPHOSPHAMIDE
DRUGSODIUM CHLORIDE
DRUGPLACEBO D AZATHIOPRINE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The percentage of patients who achieved a prednisone dose of 4.0 mg or less per day at day 168, without experiencing a relapse

Secondary

MeasureTime frame
Prednisone dosage at days 168 and 364, The area under the curve for corticosteroids at days 168 and 364 in the two treatment groups, 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), Proportion of participants with a prednisone dose of 4.0 mg or less per day at both days 168 and 364, Proportion of participants experiencing a relapse, Number of relapse during the study period, Number of asthma and sinonasal exacerbations during the study period, Time from inclusion to first relapse, The ACQ and SNOT-22 during the study period, 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 infection

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026