Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
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ClinicalTrials.gov Identifier: NCT00266565 |
Recruitment Status :
Completed
First Posted : December 19, 2005
Last Update Posted : July 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Hypereosinophilic Syndromes Eosinophilic Gastroenteritis Churg-Strauss Syndrome Eosinophilic Esophagitis | Drug: Mepolizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes |
Actual Study Start Date : | December 2001 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | April 2005 |

Arm | Intervention/treatment |
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Experimental: Anti-IL5 (Mepolizumab)
The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect.
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Drug: Mepolizumab
10mg/kg (max 750 ml) once a month for 3 months
Other Name: Anti-IL5 |
- To assess the toxicity of anti-IL-5 in patients with hypereosinophilia [ Time Frame: 28 weeks ]
- To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia [ Time Frame: 28 weeks ]
- To assess whether anti-IL-5 has a steroid and/or interferon sparing effect [ Time Frame: 28 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adequate renal, cardiac, and hepatic function
- Not pregnant or breastfeeding
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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
- Blood eosinophil counts greater than 750 cells/mcl
Exclusion Criteria:
- Creatinine > 3 X upper limit for age
- AST > 5 X upper limit for age
- Platelet count < 50,000/mm3
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Cardiac function:
- NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
- Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
- Patients requiring IV heart failure medications;
- Angina or acute myocardial infarction
- History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
- History of allergic or adverse response to previous antibody type therapy
- History of allergic or adverse response to anti-IL-5 therapy
- Evidence of, or history of, a parasitic infection (within past 1 year)
- Participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation
- Receipt of anti-IL-5 therapy in the past
- Blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation
- Abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study.
- Patients who do not have eosinophil levels > 750 cells/mcl after the run-in period. Patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level > 750 cells/mcl, assuming that they meet all other eligibility requirements.
- Positive serum pregnancy test
- Breastfeeding
- Unable to use effective birth control methods for duration of study
- Unable or unwilling to give voluntary informed consent/assent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266565
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 |
Principal Investigator: | Marc E. Rothenberg, MD | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00266565 |
Other Study ID Numbers: |
01-9-18 FD-R-002396 ( Other Identifier: Cincinnati Childrens ) |
First Posted: | December 19, 2005 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Esophagitis Gastroenteritis Eosinophilic Esophagitis Churg-Strauss Syndrome Hypereosinophilic Syndrome Syndrome Disease Pathologic Processes Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Eosinophilia Leukocyte Disorders |
Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Autoimmune Diseases |