NCT00527566

Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).

Detailed description

Specific Aims: 1. Document the safety of mepolizumab therapy in patients with CSS. 2. Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy. 3. Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by: 1. Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels. 2. Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score 3. Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale. 4. Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.

Conditions

• Churg Strauss Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Mepolizumab	IV mepolizumab, 750 mg

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-09-11
• Last updated: 2017-03-22
• Results posted: 2017-03-22

Locations

1 site across 1 country: United States