Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome (MEPOCHUSS)

• Sponsor: University of Schleswig-Holstein
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Moosig, University of Schleswig-Holstein

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Churg Strauss Syndrome	Drug: mepolizumab	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	July 2008
Actual Primary Completion Date :	July 2010

Arms and Interventions

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Locations

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Germany
University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
Bad Bramstedt, SH, Germany, 24576

Sponsors and Collaborators

University of Schleswig-Holstein

GlaxoSmithKline

More Information

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Responsible Party:	Moosig, PD Dr. Frank Moosig, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00716651 History of Changes
Other Study ID Numbers:	RBB1; EudraCT 2006-001791-20
First Posted:	July 16, 2008
Last Update Posted:	June 15, 2012
Last Verified:	June 2012

Additional relevant MeSH terms:

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Syndrome; Churg-Strauss Syndrome; Disease; Pathologic Processes; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis	Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases