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

NCT00527566 | Completed Phase 1 Results

• 1 other identifier: 2007-P-000012/1;BWH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Churg Strauss Syndrome

Keywords

Churg Strauss Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Indicated Side Effects

  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

  Number of participants who experienced specific symptoms during the trial.

  44 weeks

Secondary Outcomes (3)

• Steroid Dosing During Trial

  20 weeks

• Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims

  20 weeks

• Efficacy- Exacerbation Rate

  Treatment period (12 weeks)

Study Arms (1)

Mepolizumab

EXPERIMENTAL

Subjects will receive open-label mepolizumab

Biological: Mepolizumab

Interventions

Mepolizumab BIOLOGICAL

IV mepolizumab, 750 mg

Also known as: Anti IL-5

Mepolizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

• 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. doi: 10.1002/(SICI)1099-1557(199905/06)8:33.0.CO;2-K.

  PMID: 15073927 BACKGROUND

• 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.

  PMID: 15940771 BACKGROUND

• Hellmich B, Csernok E, Gross WL. Proinflammatory cytokines and autoimmunity in Churg-Strauss syndrome. Ann N Y Acad Sci. 2005 Jun;1051:121-31. doi: 10.1196/annals.1361.053.

  PMID: 16126951 BACKGROUND

• 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. doi: 10.1016/j.jaci.2003.10.049. Epub 2003 Dec 12.

  PMID: 14699394 BACKGROUND

• 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. doi: 10.1016/j.jaci.2006.09.007. Epub 2006 Nov 7.

  PMID: 17157662 BACKGROUND

• 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. doi: 10.1056/NEJMoa031261. No abstract available.

  PMID: 14668459 BACKGROUND

• 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. doi: 10.1067/mai.2003.1382.

  PMID: 12704348 BACKGROUND

MeSH Terms

Conditions

Churg-Strauss Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Michael Wechsler
• Organization: National Jewish Health

wechslerm@NJHealth.org

617-285-4987

Study Officials

• Michael Wechsler, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 22, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-02

Locations

US (1)