September 7, 2007 |
April 16, 2009 |
September 2007 |
Safety and tolerability of mepolizumab [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ] |
Same as current |
Complete list of historical versions of study NCT00527566 on ClinicalTrials.gov Archive Site |
- Demonstrate the steroid sparing effect of mepolizumab [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
- Evaluate overall improvement in CSS via the measures outlined in Study Aims [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
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Same as current |
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Mepolizumab As a Steroid-Sparing Treatment Option in the Churg Strauss Syndrome |
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). |
Specific Aims:
- Document the safety of mepolizumab therapy in patients with CSS.
- Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.
Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:
- Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.
- Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
- Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.
- Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.
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Phase I, Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Churg Strauss Syndrome |
Biological: Mepolizumab |
Experimental: Subjects will receive open-label mepolizumab |
- Martin RM, Wilton LV, Mann RD. Prevalence of Churg-Strauss syndrome, vasculitis, eosinophilia and associated conditions: retrospective analysis of 58 prescription-event monitoring cohort studies. Pharmacoepidemiol Drug Saf. 1999 May;8(3):179-89.
- Harrold LR, Andrade SE, Go AS, Buist AS, Eisner M, Vollmer WM, Chan KA, Frazier EA, Weller PF, Wechsler ME, Yood RA, Davis KJ, Platt R. Incidence of Churg-Strauss syndrome in asthma drug users: a population-based perspective. J Rheumatol. 2005 Jun;32(6):1076-80.
- Hellmich B, Csernok E, Gross WL. Proinflammatory cytokines and autoimmunity in Churg-Strauss syndrome. Ann N Y Acad Sci. 2005 Jun;1051:121-31. Review.
- Garrett JK, Jameson SC, Thomson B, Collins MH, Wagoner LE, Freese DK, Beck LA, Boyce JA, Filipovich AH, Villanueva JM, Sutton SA, Assa'ad AH, Rothenberg ME. Anti-interleukin-5 (mepolizumab) therapy for hypereosinophilic syndromes. J Allergy Clin Immunol. 2004 Jan;113(1):115-9. Epub 2003 Dec 12.
- Stein ML, Collins MH, Villanueva JM, Kushner JP, Putnam PE, Buckmeier BK, Filipovich AH, Assa'ad AH, Rothenberg ME. Anti-IL-5 (mepolizumab) therapy for eosinophilic esophagitis. J Allergy Clin Immunol. 2006 Dec;118(6):1312-9. Epub 2006 Nov 7.
- Plotz SG, Simon HU, Darsow U, Simon D, Vassina E, Yousefi S, Hein R, Smith T, Behrendt H, Ring J. Use of an anti-interleukin-5 antibody in the hypereosinophilic syndrome with eosinophilic dermatitis. N Engl J Med. 2003 Dec 11;349(24):2334-9. No abstract available.
- Menzies-Gow A, Flood-Page P, Sehmi R, Burman J, Hamid Q, Robinson DS, Kay AB, Denburg J. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asthmatics. J Allergy Clin Immunol. 2003 Apr;111(4):714-9.
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Active, not recruiting |
10 |
August 2009 |
August 2009 (final data collection date for primary outcome measure) |
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
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Both |
19 Years and older |
No |
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United States |
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NCT00527566 |
Michael E. Wechsler, MD, Brigham and Women's Hospital |
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Brigham and Women's Hospital |
GlaxoSmithKline |
Principal Investigator: |
Michael Wechsler, MD |
Brigham and Women's Hospital |
|
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Brigham and Women's Hospital |
April 2009 |