Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome - Full Text View

Sponsor:	University of Schleswig-Holstein
Collaborator:	GlaxoSmithKline
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00716651

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 II

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

Drug Information available for: Mepolizumab

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 ]

Estimated Enrollment:	10
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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:	Prof. W L Gross, University Hospital 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:	January 11, 2010
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 February 09, 2012