Clinical Trials/NCT00659659

NCT00659659

Completed

Phase 1

A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma

MedImmune LLC1 site in 1 country27 target enrollmentJanuary 2008

ConditionsAsthma

InterventionsMEDI-563 Placebo Comp.Placebo

DrugsMEDI-563

Overview

Phase: Phase 1
Intervention: MEDI-563
Conditions: Asthma
Sponsor: MedImmune LLC
Enrollment: 27
Locations: 1
Primary Endpoint: Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies

Detailed Description

Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

March 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adults, 18 through 65 years of age at time of randomization;
•Written informed consent obtained from the subject prior to beginning study procedures or receipt of any study medication;
•Previously documented diagnosis of asthma of ≥ 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction ≥ 12% (in USA only - if subject does not achieve this during screening, proof of ≥12% reversibility within 1 year of randomization is acceptable) or proof of a positive response to a methacholine challenge during screening with prior approval from MedImmune (in USA only - within 1 year of randomization is acceptable) as represented by a provoking concentration of methacholine to cause a 20% fall in FEV1 (PC20) \< 8 mg/ml \[American Thoracic Society (ATS), 2000)\]; and exclusion of alternative pulmonary diagnoses (eg, cystic fibrosis, COPD);
•Asthma symptoms are adequately controlled on a therapeutic regimen that has not changed in the last 4 weeks prior to Study Day 0, and the subject is willing to maintain the same therapeutic regimen and doses from the time of screening to the time of the first follow-up bronchoscopy with airway mucosal biopsies (Study Day 28 for Cohort 1; Study Day 84 for Cohort 2);
•Pre-bronchodilator FEV1/forced vital capacity (FVC) ratio that is below the age-adjusted normal limit as defined by the 2007 National Heart Lung and Blood Institute Asthma guidelines (Appendix D) and post-bronchodilator FEV1 ≥ 65% at screening;
•Must have ≥ 2.5% eosinophils in sputum;
•Have had no hospitalizations due to asthma in the last year prior to screening;
•Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use 2 effective methods of avoiding pregnancy
•Able to complete the follow-up period as required by the protocol;
•Willing to forego other forms of experimental treatment and study procedures during the study and during an 84-day period after the last dose of study drug;

Exclusion Criteria

•Participation in any previous MEDI-563 clinical study;
•Known history of allergy or adverse reactions to any component of the study drug formulation;
•Lung disease other than asthma (eg, COPD, cystic fibrosis, eosinophilic pneumonia);
•Current use of any systemic or inhaled immunosuppressive drugs \[oral (up to a maximum dose of 10 mg/day or 20 mg every other day) and inhaled corticosteroids are allowed if dose has been stable for at least 4 weeks prior to study drug administration on Study Day 0\].
•Current use of any β-blocker (eg, propranolol);
•Acute illnesses or evidence of clinically significant active infection, such as fever ≥ 38.0ºC (100.5ºF) at screening and through the time of the study drug administration on Study Day 0;
•Receipt of any investigational drug therapy, intravenous immunoglobulin (IVIG), or monoclonal therapy (eg, Xolair) within 30 days or within 5-half lives prior to study drug administration on Study Day 0 through End of Study/Study Termination (Study Day 84 for Cohort 1 or Study Day 140 for Cohort 2);
•Pregnancy (women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
•Breastfeeding or lactating;
•History of alcohol or drug abuse \< 1 year prior to Study Day 0;

Arms & Interventions

1

MEDI-563

Intervention: MEDI-563

2

MEDI-563

Intervention: MEDI-563

4

Placebo

Intervention: Placebo Comp.

5

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.

Time Frame: Study Day 84 or Day 140 - (dose-driven)

Secondary Outcomes

Evaluate the pharmacokinetics (PK) of MEDI-563 in adults with atopic asthma, and evaluate the immunogenicity (IM) of MEDI-563 in adults with atopic asthma.(Day 84 or 140)