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

Churg Strauss Syndrome Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg Strauss Syndrome
• Churg-Strauss Syndrome
• Syndrome

• NCT number: NCT00527566
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2007
• Completion date: August 2009