Clinical Trial: Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: University of Schleswig-Holstein

Current Primary Outcome: Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission [ Time Frame: 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in BVAS score [ Time Frame: 52 weeks ]
  • Change in Disease Extent Index score [ Time Frame: 52 weeks ]
  • Permanent End organ damage assessed by the Vasculitis Damage Index [ Time Frame: 52 weeks ]
  • Time to remission [ Time Frame: 52 weeks ]
  • Response, defined as a 50 % reduction of the BVAS score [ Time Frame: 52 weeks ]
  • Time to response [ Time Frame: 52 weeks ]
  • The frequency of relapses [ Time Frame: 52 weeks ]
  • Blood eosinophil count [ Time Frame: 52 weeks ]
  • Frequency of all AEs and SAEs [ Time Frame: 52 weeks ]


Original Secondary Outcome: Same as current

Information By: University of Schleswig-Holstein

Dates:
Date Received: July 14, 2008
Date Started: July 2008
Date Completion:
Last Updated: June 14, 2012
Last Verified: June 2012