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

February 1, 2017 updated by: Michael Wechsler, MD, Brigham and Women's Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mepolizumab
Subjects will receive open-label mepolizumab
Biological: Mepolizumab
IV mepolizumab, 750 mg
Other Names:
  • Anti IL-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Indicated Side Effects
Time Frame: Participants were followed for the duration of the study, approximately 44 weeks
Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
Participants were followed for the duration of the study, approximately 44 weeks
Number of Participants Who Experienced Specific Symptoms
Time Frame: 44 weeks
Number of participants who experienced specific symptoms during the trial.
44 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steroid Dosing During Trial
Time Frame: 20 weeks
20 weeks
Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims
Time Frame: 20 weeks
The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7.
20 weeks
Efficacy- Exacerbation Rate
Time Frame: Treatment period (12 weeks)
Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis.
Treatment period (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-P-000012/1;BWH

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Publication
    Information identifier: PubMed ID: 20513524
    Information comments:

    Mepolizumab as a steroid-sparing treatment option in patients with Churg-Strauss syndrome.

    Kim S, Marigowda G, Oren E, Israel E, Wechsler ME. J Allergy Clin Immunol. 2010 Jun;125(6):1336-43. doi:10.1016/j.jaci.2010.03.028.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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