NCT01227278

Brief Summary

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
421

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
7 countries

31 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

First Submitted

Initial submission to the registry

October 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

October 21, 2010

Results QC Date

August 11, 2016

Last Update Submit

August 11, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

BenralizumabMEDI-563Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

    An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.

    Day 1 up to 393

Secondary Outcomes (9)

  • Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Day 1 up to 561

  • Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

    Day 1 up to 393

  • Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

    Day 1 up to 393

  • Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

    Day 1 up to 393

  • Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393

    Baseline, Day 393

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

Other: Placebo

Benralizumab 100 mg

EXPERIMENTAL

Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

Biological: Benralizumab 100 mg

Interventions

PlaceboOTHER

Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

Placebo
Benralizumab 100 mgBIOLOGICAL

Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).

Also known as: MEDI-563
Benralizumab 100 mg

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 40-85 years at the time of Screening
  • Written informed consent obtained from the subject prior to performing any protocol related procedures
  • Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
  • Current smoker or ex-smoker with a tobacco history of greater than or equal to (\>=) 10 pack-years
  • Adequate contraception from screening through end of trial
  • Able to read and write.

You may not qualify if:

  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
  • Pregnant, breastfeeding, or lactating women
  • Known history of allergy or reaction to any component of the investigational product formulation
  • History of anaphylaxis to any other biologic therapy
  • Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
  • Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
  • Fever greater than (\>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
  • Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
  • Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
  • History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
  • Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
  • Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
  • Current diagnosis of asthma according to Global Initiative for Asthma guidelines
  • Previous treatment with MEDI-563.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Research Site

Los Angeles, California, United States

Location

Research Site

Marietta, Georgia, United States

Location

Research Site

Normal, Illinois, United States

Location

Research Site

Brooklyn, New York, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

Research Site

Greenville, South Carolina, United States

Location

Research Site

Boerne, Texas, United States

Location

Research Site

Tyler, Texas, United States

Location

Research Site

Richmond, Virginia, United States

Location

Research Site

Calgary, Alberta, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Saskatoon, Saskatchewan, Canada

Location

Research Site

Århus C, Denmark

Location

Research Site

Hellerup, Denmark

Location

Research Site

København NV, Denmark

Location

Research Site

Odense C, Denmark

Location

Research Site

Frankfurt, Germany

Location

Research Site

Mainz, Germany

Location

Research Site

Gdansk, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Barcelona, Spain

Location

Research Site

Lleida, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Oviedo, Spain

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

Edinburgh, United Kingdom

Location

Research Site

Leicester, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Related Publications (2)

  • Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019 Jan 18;20(1):14. doi: 10.1186/s12931-018-0968-8.

    PMID: 30658649DERIVED

  • Brightling CE, Bleecker ER, Panettieri RA Jr, Bafadhel M, She D, Ward CK, Xu X, Birrell C, van der Merwe R. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014 Nov;2(11):891-901. doi: 10.1016/S2213-2600(14)70187-0. Epub 2014 Sep 7.

    PMID: 25208464DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Rene van der Merwe, MBChB/Senior Director, Clinical Development
Organization
MedImmune, LLC.
vandermerwer@medimmune.com
301-398-0000

Study Officials

  • Rene van der Merwe, MBChB

    MedImmune Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 25, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

October 5, 2016

Results First Posted

October 5, 2016

Record last verified: 2015-03

Locations

DE(2)ES(4)GB(4)DK(4)CA(4)PL(4)US(9)