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ANTI-IL5 Study - An etiological role for aeroallergens and eosinophils in experimental
esophagitis JCI -- Mishra et al. 107 (1) 83
As you are aware, there is limited therapy available to patients with eosinophilic disorders, many who have significant sequelae from their current medication. We are currently investigating the role of a humanized monoclonal antibody directed against IL-5 (Mepolizumab, SB 204563) in these patients. IL-5 is an eosinophil growth and activating factor that has been extensively studied in pre-clinical trials. In addition, anti-human IL-5 (SB 204563) has been studied in patients with asthma and no side effects have been seen.
The eligibility is as follows:
• Age between 18 and 65 years
• Adequate renal, cardiac and hepatic function Not pregnant or breastfeeding
• A diagnosis of hypereosinophilic syndrome such as:
• Idiopathic hypereosinophilic syndrome
• Eosinophilia myalgia syndrome
• Eosinophilic gastroenteritis
• Churg-Strauss syndrome
• Eosinophilic cellulitis
• Benign hypereosinophilia or Eosinophilic esophagitis
Maintained on or in need of the following:
glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine or vincristine If eligible, each patient will receive three doses of Mepolizumab four weeks apart. The study medication will be provided free of charge, and the study medication will be administered as an outpatient. During the initial phase of the study, if patients are on anti-eosinophil therapy, then we will decrease the dosage of their current anti-eosinophil medication so that we can evaluate the efficacy of Mepolizumab.
If you are a patient who may be interested in enrolling in this research study or you have further questions, please contact us at 513-636-7210.
Thank you for your time.
Marc E. Rothenberg MD, PhD
Director and Endowed Chair, Division of Allergy and Immunology, Professor of Pediatrics
Children's Hospital Medical Center, University of Cincinnati
3333 Burnet Avenue, ML7028, Cincinnati OH 45229
National Institutes of Health Clinical Allergy and Immunology Unit
Laboratory of Allergic Diseases
October 9, 2001
The Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases is beginning a study examining the effect of SCH55700 (anti-IL-5) on eosinophilic gastroenteritis (EG). SCH55700 has been shown to drop blood eosinophil counts in other patient groups; however, no studies of SCH55700 have been performed in eosinophilic gastroenteritis. We are recruiting participants to take part in this study. I would like to invite persons with EG who fit the eligibility criteria below to contact us for further information. The study takes place at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland.
There is no charge to the patient for therapy, study-related evaluation, or medical tests performed at NIH.
The eligibility criteria for this study include:
• Eosinophil blood count greater than 860
• Age 18 or older
• Failure of or side effects due to corticosteroid medication
• Evidence of malabsorption (tests to be performed at NIH)
• Food allergy as demonstrated by skin tests or RAST
If you are interested please contact the NIH Patient Recruitment Office at 1-800-411-1222.
Sincerely,
Calman Prussin, MD
Head, Clinical Allergy and Immunology Unit Laboratory of Allergic Diseases/NIAID
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