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

A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes

Toxicity of anti-IL-5

Study Overview

• Status: Completed
• Conditions: Eosinophilic Gastroenteritis; Eosinophilic Esophagitis; Churg-Strauss Syndrome; Hypereosinophilic Syndromes
• Intervention / Treatment: Drug: Mepolizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Mepolizumab; 10mg/kg (max 750 ml) once a month for 3 months; Other Names: Anti-IL5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia	28 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia	28 weeks
To assess whether anti-IL-5 has a steroid and/or interferon sparing effect	28 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Marc E. Rothenberg, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2001
• Primary Completion (Actual): April 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: December 15, 2005
• First Submitted That Met QC Criteria: December 15, 2005
• First Posted (Estimate): December 19, 2005

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Autoimmune Diseases; Hypersensitivity, Immediate; Disease; Hematologic Diseases; Gastrointestinal Diseases; Vasculitis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granuloma; Syndrome; Gastroenteritis; Eosinophilic Esophagitis; Hypereosinophilic Syndrome; Churg-Strauss Syndrome; Esophagitis
• Other Study ID Numbers: 01-9-18; FD-R-002396 (Other Identifier: Cincinnati Childrens)