Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266565
• Other study ID #: 01-9-18
• Secondary ID: FD-R-002396
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2001
• Est. completion date: April 2005

Study information

• Verified date: July 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Toxicity of anti-IL-5

Description:

The purpose of the study is to assess the toxicity of anti-IL-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• 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

• Cardiac function:

1. NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);

2. Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;

3. Patients requiring IV heart failure medications;

4. 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

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Eosinophilic Esophagitis
• Eosinophilic Gastroenteritis
• Esophagitis
• Gastroenteritis
• Hypereosinophilic Syndrome
• Hypereosinophilic Syndromes
• Syndrome

Intervention

Drug:
• Mepolizumab
10mg/kg (max 750 ml) once a month for 3 months

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the toxicity of anti-IL-5 in patients with hypereosinophilia		28 weeks
Secondary	To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia		28 weeks
Secondary	To assess whether anti-IL-5 has a steroid and/or interferon sparing effect		28 weeks