A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00659659
First received: April 11, 2008
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: MEDI-563
Other: Placebo Comp.
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Day 84 or 140 ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: January 2008
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-563
Drug: MEDI-563
1.0 mg/kg IV: MEDI-563
Experimental: 2
MEDI-563
Drug: MEDI-563
100 mg, 200 mg SC
Placebo Comparator: 4
Placebo
Other: Placebo Comp.
Placebo SC
Placebo Comparator: 5
Placebo
Other: Placebo
Placebo as a single IV infusion (Certain number of subjects)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  • Able to provide spirometric readings that meet ATS standards

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;
  • History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy > 1 year prior to Study Day 0;
  • History of a previous episode of active TB or a positive TB skin test without completion of an appropriate course of treatment;
  • A history of coagulation disorders that would contraindicate mucosal biopsies;
  • History of immunodeficiency or infection with HIV-1, HIV-2, or hepatitis A, B, or C virus;
  • History of use of tobacco products within 2 years of baseline (Study Day 0) or history of smoking ≥ 10 pack-years;
  • Elective surgery planned from the time of screening through first follow-up bronchoscopy with airway mucosal biopsies (Study Day 28 or Study Day 84, as applicable);
  • Evidence of any systemic disease or respiratory disease (other than asthma), history of any disease, or any finding upon physical examination, screening laboratory test, chest X-ray (CXR), or ECG that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study results;
  • Any employee of the research site who is involved with the conduct of the study;
  • History of lidocaine allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659659

Locations
United States, Colorado
Research Site
Denver, Colorado, United States, 80206
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Research Site
Galveston, Texas, United States, 77555-0561
Research Site
Houston, Texas, United States, 77030
Research Site
Houston, Texas, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53792
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N4N1
Canada, British Columbia
Research Site
Vancouver,, British Columbia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N3Z5
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2X 2P4
Canada
Research Site
Quebec, Canada, G1V4G5
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: David Gossage, M.D., MBA MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00659659     History of Changes
Other Study ID Numbers: MI-CP166
Study First Received: April 11, 2008
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014