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

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Churg Strauss Syndrome

Treatments: Biological: Mepolizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00527566

2007-P-000012/1 BWH;

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years old
• Diagnosis of Churg Strauss Syndrome
• Maintained on stable corticosteroid dose of at least prednisone 10mg daily (or equivalent) prior to enrollment in study
• If on cyclophosphamide, azathioprine or methotrexate, must be on a stable dose and be able to maintain that dose for the duration of the study

Exclusion criteria

• Hypereosinophilic Syndrome
• Wegener's Granulomatosis
• Malignancy
• Parasitic Disease
• Pregnant or nursing
• If female and of child-bearing potential, must have negative pregnancy test prior to each infusion of study medication and must adhere to acceptable method of contraception (with <1% failure rate)
• Any other medical illness that precludes study involvement

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Mepolizumab

Experimental group

Description:

Subjects will receive open-label mepolizumab

Treatment:

Biological: Mepolizumab