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

University Hospital Schleswig-Holstein (UKSH)

Status and phase

Completed

Phase 2

Conditions

Churg Strauss Syndrome

Treatments

Drug: mepolizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00716651

RBB1

EudraCT 2006-001791-20

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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