This trial is active, not recruiting.

Condition churg strauss syndrome
Treatment mepolizumab
Phase phase 1/phase 2
Sponsor Brigham and Women's Hospital
Collaborator GlaxoSmithKline
Start date September 2007
End date August 2009
Trial size 10 participants
Trial identifier NCT00527566, 2007-P-000012/1;BWH


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Subjects will receive open-label mepolizumab
mepolizumab Anti IL-5
IV mepolizumab, 750 mg

Primary Outcomes

Safety and tolerability of mepolizumab
time frame: 44 weeks

Secondary Outcomes

Demonstrate the steroid sparing effect of mepolizumab
time frame: 44 weeks
Evaluate overall improvement in CSS via the measures outlined in Study Aims
time frame: 44 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome
Principal investigator Michael Wechsler, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.