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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Moosig, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00716651
First received: July 14, 2008
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Churg Strauss Syndrome
 Drug: mepolizumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in BVAS score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in Disease Extent Index score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Permanent End organ damage assessed by the Vasculitis Damage Index [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to remission [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Response, defined as a 50 % reduction of the BVAS score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The frequency of relapses [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Blood eosinophil count [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Frequency of all AEs and SAEs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: July 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mepolizumab
    750 mg mepolizumab iv q4wk until week 32
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716651

Locations
Germany
University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
Bad Bramstedt, SH, Germany, 24576
Sponsors and Collaborators
University of Schleswig-Holstein
GlaxoSmithKline
  More Information

No publications provided

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
Study First Received: July 14, 2008
Last Updated: June 14, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
 Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013