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A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

11 augustus 2016 bijgewerkt door: MedImmune LLC

A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia

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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

421

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • Denemarken
      • Hellerup, Denemarken
        • Research Site
      • København NV, Denemarken
        • Research Site
      • Odense C, Denemarken
        • Research Site
      • Århus C, Denemarken
        • Research Site
  • Duitsland
      • Frankfurt, Duitsland
        • Research Site
      • Mainz, Duitsland
        • Research Site
  • Polen
      • Gdańsk, Polen
        • Research Site
      • Kraków, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Łódź, Polen
        • Research Site
  • Spanje
      • Barcelona, Spanje
        • Research Site
      • Lérida, Spanje
        • Research Site
      • Málaga, Spanje
        • Research Site
      • Oviedo, Spanje
        • Research Site
  • Verenigd Koninkrijk
      • Cambridge, Verenigd Koninkrijk
        • Research Site
      • Edinburgh, Verenigd Koninkrijk
        • Research Site
      • Leicester, Verenigd Koninkrijk
        • Research Site
      • Manchester, Verenigd Koninkrijk
        • Research Site
  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten
        • Research Site
    • Georgia
      • Marietta, Georgia, Verenigde Staten
        • Research Site
    • Illinois
      • Normal, Illinois, Verenigde Staten
        • Research Site
    • New York
      • Brooklyn, New York, Verenigde Staten
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Verenigde Staten
        • Research Site
    • Texas
      • Boerne, Texas, Verenigde Staten
        • Research Site
      • Tyler, Texas, Verenigde Staten
        • Research Site
    • Virginia
      • Richmond, Virginia, Verenigde Staten
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
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).
Ander: Placebo
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).
Experimenteel: Benralizumab 100 mg
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).
Biologisch: Benralizumab 100 mg
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).
Andere namen:
  • MEDI-563

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tijdsspanne: Day 1 up to 393
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tijdsspanne: Day 1 up to 561
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Day 1 up to 561
Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tijdsspanne: Day 1 up to 393
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.
Day 1 up to 393
Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tijdsspanne: Day 1 up to 393
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.
Day 1 up to 393
Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tijdsspanne: Day 1 up to 393
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 hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.
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
Tijdsspanne: Baseline, Day 393
The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Baseline, Day 393
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Tijdsspanne: Day 393
SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.
Day 393
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Tijdsspanne: Baseline, Day 393
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
Baseline, Day 393
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Tijdsspanne: Day 393
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.
Day 393
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Tijdsspanne: Baseline, Day 393
The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Baseline, Day 393

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

MedImmune LLC

Medewerkers

AstraZeneca

Onderzoekers

  • Studie directeur: Rene van der Merwe, MBChB, MedImmune Ltd

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2010

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

1 juli 2013

Studieregistratiedata

Eerst ingediend

21 oktober 2010

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2010

Eerst geplaatst (Schatting)

25 oktober 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

5 oktober 2016

Laatste update ingediend die voldeed aan QC-criteria

11 augustus 2016

Laatst geverifieerd

1 maart 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MI-CP196
  • 2010-020127-52 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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