Depemokimab compared with mepolizumab for relapsing or refractory

$Depemokimab compared with mepolizumab for relapsing or refractory EGPA on standard of care therapy$

Recruiting

18-90 years

All

Phase 3

5 participants needed

1 Location

Brief description of study

The purpose of this study is to learn more about eosinophilic granulomatosis with polyangiitis (EGPA) that returns (relapse) or has not responded to treatment, and if the investigational drug depemokimab can improve the disease. This study is being done to help determine if depemokimab is safe and how it works compared to mepolizumab. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) to treat EGPA. Depemokimab is being compared to mepolizumab, which is approved by the FDA to treat EGPA.

Detailed description of study

Participants are randomly assigned into 1 of 2 groups. One group receives depemokimab and mepolizumab placebo. The other group receives mepolizumab and depemokimab placebo. Placebo means a substance that looks like depemokimab or mepolizumab and is injected in the same way, but it does not have any active drug in it. The study drug and placebo is injected under the skin every 4 weeks for 52 weeks. This is a double-blind study, which means neither participants nor the study team know which group is assigned. The study also includes physical exams, ECGs (electrocardiogram), lung function tests, blood and urine collection, and a daily diary.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: EGPA; vasculitis; Eosinophilic Granulomatosis With Polyangiitis
Age: Between 18 Years - 90 Years
Gender: All

There are many factors that determine if you are eligible. Some requirements include:

· Adults with EGPA diagnosis and a history of relapsing or refractory disease

· Being on a stable daily dose of 7.5 mg or more of prednisone

· If on immunosuppressive therapy, the dose must be stable

Updated on 01 Aug 2024. Study ID: 851733

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