Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome

Churg Strauss Syndrome Clinical Trial

— MEPOCHUSS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716651
• Other study ID #: RBB1
• Secondary ID: EudraCT 2006-001
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2008
• Last updated: June 14, 2012
• Start date: July 2008

Study information

• Verified date: June 2012
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutGermany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• informed consent

• documented history of Churg Strauss Syndrome

• active disease

• subjects must complete screening and baseline assessment

• stable corticosteroid dose of > 12.5 mg prednisolone for at least one week

• treatment with cyclophosphamide (pulse or daily oral) or methotrexate or azathioprin or leflunomide in a stable dose for at least 4 weeks

• not pregnant or nursing

• negative pregnancy test and agree to practice birth control

Exclusion Criteria:

• life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator

• treatment with other immunosuppressive agents within 4 weeks prior to randomisation

• corticosteroid pulse of > 60 mg within the last three weeks prior to randomisation

• known secondary cause of eosinophilia

• no history or clinical features of vasculitis

• diagnosis of other primary systemic vasculitis

• currently active malignant disease

• abnormal laboratory values

• impaired cardiac function

• history of allergic reaction due to monoclonal antibodies

• prior treatment with anti-hIL-5 monoclonal antibody

• exposure to investigational drug within 30 days prior to randomisation

• positive pregnancy test

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg Strauss Syndrome
• Churg-Strauss Syndrome
• Syndrome

Intervention

Drug:
• mepolizumab
750 mg mepolizumab iv q4wk until week 32

Locations

Country	Name	City	State
Germany	University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd	Bad Bramstedt	SH

Sponsors (2)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission		52 weeks	No
Secondary	Change in BVAS score		52 weeks	No
Secondary	Change in Disease Extent Index score		52 weeks	No
Secondary	Permanent End organ damage assessed by the Vasculitis Damage Index		52 weeks	No
Secondary	Time to remission		52 weeks	No
Secondary	Response, defined as a 50 % reduction of the BVAS score		52 weeks	No
Secondary	Time to response		52 weeks	No
Secondary	The frequency of relapses		52 weeks	No
Secondary	Blood eosinophil count		52 weeks	No
Secondary	Frequency of all AEs and SAEs		52 weeks	Yes