Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome

NCT00716651 | Completed Phase 2 DMC

• 2 other identifiers: RBB1EudraCT 2006-001791-20
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Churg Strauss Syndrome

Outcome Measures

Primary Outcomes (1)

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

  52 weeks

Secondary Outcomes (9)

• Change in BVAS score

  52 weeks

• Change in Disease Extent Index score

  52 weeks

• Permanent End organ damage assessed by the Vasculitis Damage Index

  52 weeks

• Time to remission

  52 weeks

• Response, defined as a 50 % reduction of the BVAS score

  52 weeks

Interventions

mepolizumab DRUG

750 mg mepolizumab iv q4wk until week 32

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

MeSH Terms

Conditions

Churg-Strauss Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Frank Moosig

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

DE (1)