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NCT Number: NCT00716651

Safety and Efficacy Study of Mepolizumab in 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.

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Key information

Conditions

Churg Strauss Syndrome Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Churg-Strauss Syndrome Granuloma Hemic and Lymphatic Diseases Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mepolizumab

Drug

750 mg mepolizumab iv q4wk until week 32

Primary outcomes

  1. Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission

    Time frame: 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: MEPOCHUSS

Important dates

Study start
2008
Primary completion
2010
First posted
Jul 16, 2008
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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