Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome (MEPOCHUSS)
Primary Purpose
Churg Strauss Syndrome
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
mepolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Churg Strauss Syndrome
Eligibility 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
Sites / Locations
- University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
Outcomes
Primary Outcome Measures
Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission
Secondary Outcome Measures
Change in BVAS score
Change in Disease Extent Index score
Permanent End organ damage assessed by the Vasculitis Damage Index
Time to remission
Response, defined as a 50 % reduction of the BVAS score
Time to response
The frequency of relapses
Blood eosinophil count
Frequency of all AEs and SAEs
Full Information
NCT ID
NCT00716651
First Posted
July 14, 2008
Last Updated
June 14, 2012
Sponsor
University Hospital Schleswig-Holstein
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00716651
Brief Title
Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome
Acronym
MEPOCHUSS
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Churg Strauss Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mepolizumab
Intervention Description
750 mg mepolizumab iv q4wk until week 32
Primary Outcome Measure Information:
Title
Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change in BVAS score
Time Frame
52 weeks
Title
Change in Disease Extent Index score
Time Frame
52 weeks
Title
Permanent End organ damage assessed by the Vasculitis Damage Index
Time Frame
52 weeks
Title
Time to remission
Time Frame
52 weeks
Title
Response, defined as a 50 % reduction of the BVAS score
Time Frame
52 weeks
Title
Time to response
Time Frame
52 weeks
Title
The frequency of relapses
Time Frame
52 weeks
Title
Blood eosinophil count
Time Frame
52 weeks
Title
Frequency of all AEs and SAEs
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
City
Bad Bramstedt
State/Province
SH
ZIP/Postal Code
24576
Country
Germany
12. IPD Sharing Statement
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Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome
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