---
title: Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
nct_id: NCT00527566
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: "Brigham and Women's Hospital"
study_type: INTERVENTIONAL
primary_condition: Churg Strauss Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00527566.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00527566"
ct_last_update_post_date: 2017-03-22
last_seen_at: "2026-05-12T06:22:41.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

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

**NCT ID:** [NCT00527566](https://clinicaltrials.gov/study/NCT00527566)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Brigham and Women's Hospital
- **Collaborators:** GlaxoSmithKline
- **Conditions:** Churg Strauss Syndrome
- **Start Date:** 2007-09
- **Completion Date:** 2009-08
- **CT.gov Last Update:** 2017-03-22

## Brief 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.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Mepolizumab** (EXPERIMENTAL) — Subjects will receive open-label mepolizumab

## Interventions

- **Mepolizumab** (BIOLOGICAL) — IV mepolizumab, 750 mg

## Primary Outcomes

- **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.
- **Number of Participants Who Experienced Specific Symptoms** _(time frame: 44 weeks)_ — Number of participants who experienced specific symptoms during the trial.

## Secondary Outcomes

- **Steroid Dosing During Trial** _(time frame: 20 weeks)_
- **Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims** _(time frame: 20 weeks)_
- **Efficacy- Exacerbation Rate** _(time frame: Treatment period (12 weeks))_

## Locations (1)

- Brigham and Women's Hospital, Boston, Massachusetts, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.brigham and women's hospital|boston|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00527566.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00527566*  
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