Churg Strauss Syndrome Clinical Trial
Official title:
A Phase II, Single Center Open Label, Prospective Trial to Evaluate the Efficacy and Safety of Mepolizumab for Patients With Refractory or Relapsing Churg Strauss Syndrome
Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively
in patients with asthma and which is characterized by prominent blood and tissue
eosinophilia. The disease has a chronic smoldering course with a permanent need for medium
to high corticosteroid doses. Available unselective immunosuppressive agents are often
insufficient to reduce corticosteroid doses, to induce complete remission and to protect
patients from disease flares which occur in more than 50 % of cases.
Interleukin-5 is the most potent cytokine regulating the production of eosinophil
granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an
increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome.
Mepolizumab is a monoclonal IgG antibody targeting interleukin-5 and is effective in the
treatment of the HES. The hypothesis of this study is, that mepolizumab will induce
remission and allow for steroid reduction.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00527566 -
Mepolizumab As a Steroid-Sparing Treatment Option in the Churg Strauss Syndrome
|
Phase 1/Phase 2 | |
Recruiting |
NCT01066208 -
American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis
|
N/A |