Phase 2
N=10
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Churg Strauss Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00527566 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants With Indicated Side Effects — 3; 1; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mepolizumab (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Indicated Side Effects |
3; 1; 0; 1 | — |
| PRIMARY Number of Participants Who Experienced Specific Symptoms |
4; 4; 3; 6; 1 | — |
| SECONDARY Steroid Dosing During Trial |
14.3; 5.6; 4.9 | — |
| SECONDARY Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims |
1.40; 1.76; 1.30 | — |
| SECONDARY Efficacy- Exacerbation Rate |
0.14; 0.69 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00527566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.