NCT00659659

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1 asthma

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

April 11, 2008

Last Update Submit

October 9, 2012

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Study Day 84 or Day 140 - (dose-driven)

Secondary Outcomes (1)

  • 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

Study Arms (4)

1

EXPERIMENTAL

MEDI-563

Drug: MEDI-563

2

EXPERIMENTAL

MEDI-563

Drug: MEDI-563

4

PLACEBO COMPARATOR

Placebo

Other: Placebo Comp.

5

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

MEDI-563DRUG

1.0 mg/kg IV: MEDI-563

1
Placebo Comp.OTHER

Placebo SC

4
PlaceboOTHER

Placebo as a single IV infusion (Certain number of subjects)

5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Denver, Colorado, 80206, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research Site

Galveston, Texas, 77555-0561, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Madison, Wisconsin, 53792, United States

Location

Research Site

Calgary, Alberta, T2N4N1, Canada

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Hamilton, Ontario, L8N3Z5, Canada

Location

Research Site

Montreal, Quebec, H2X 2P4, Canada

Location

Research Site

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (1)

  • Chachi L, Diver S, Kaul H, Rebelatto MC, Boutrin A, Nisa P, Newbold P, Brightling C. Computational modelling prediction and clinical validation of impact of benralizumab on airway smooth muscle mass in asthma. Eur Respir J. 2019 Nov 14;54(5):1900930. doi: 10.1183/13993003.00930-2019. Print 2019 Nov. No abstract available.

    PMID: 31391226DERIVED

MeSH Terms

Conditions

Asthma

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • David Gossage, M.D., MBA

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2008

First Posted

April 16, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

US(6)CA(5)