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A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)

30 november 2016 bijgewerkt door: MedImmune LLC

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

464

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

  • Bulgarije
      • Plovdiv, Bulgarije
        • Research Site
      • Ruse, Bulgarije
        • Research Site
      • Sofia, Bulgarije
        • Research Site
      • Stara Zagora, Bulgarije
        • Research Site
      • Veliko Tarnovo, Bulgarije
        • Research Site
  • Filippijnen
      • Iloilo City, Filippijnen
        • Research Site
      • Lipa City, Filippijnen
        • Research Site
      • Quezon City, Filippijnen
        • Research Site
  • Hongarije
      • Balassagyarmat, Hongarije
        • Research Site
      • Budapest, Hongarije
        • Research Site
      • Farkasgyepü, Hongarije
        • Research Site
      • Komarom, Hongarije
        • Research Site
      • Mateszalka, Hongarije
        • Research Site
      • Matrahaza, Hongarije
        • Research Site
      • Mosonmagyarovar, Hongarije
        • Research Site
      • Nagykanizsa, Hongarije
        • Research Site
      • Szikszo, Hongarije
        • Research Site
      • Tatabanya, Hongarije
        • Research Site
      • Torokbalint, Hongarije
        • Research Site
  • Letland
      • Daugavpils, Letland
        • Research Site
      • Riga, Letland
        • Research Site
  • Litouwen
      • Kaunas, Litouwen
        • Research Site
      • Klaipeda, Litouwen
        • Research Site
      • Vilnius, Litouwen
        • Research Site
  • Oekraïne
      • Ivano-Frankivsk, Oekraïne
        • Research Site
      • Kharkiv, Oekraïne
        • Research Site
      • Kyiv, Oekraïne
        • Research Site
      • Odessa, Oekraïne
        • Research Site
      • Poltava, Oekraïne
        • Research Site
      • Simferopol, Oekraïne
        • Research Site
      • Vinnytsya, Oekraïne
        • Research Site
  • Polen
      • Bialystok, Polen
        • Research Site
      • Gdansk, Polen
        • Research Site
      • Krakow, Polen
        • Research Site
      • Lodz, Polen
        • Research Site
      • Oswiecim, Polen
        • Research Site
      • Poznan, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
      • Zgierz, Polen
        • Research Site
  • Tsjechische Republiek
      • Brno, Tsjechische Republiek
        • Research Site
      • Jindrichuv Hradec, Tsjechische Republiek
        • Research Site
      • Karlovy Vary, Tsjechische Republiek
        • Research Site
      • Plzen, Tsjechische Republiek
        • Research Site
      • Praha 10, Tsjechische Republiek
        • Research Site
      • Strakonice, Tsjechische Republiek
        • Research Site
  • Verenigd Koninkrijk
      • Cambridge, Verenigd Koninkrijk
        • Research Site
      • Newcastle upon Tyne, Verenigd Koninkrijk
        • Research Site
      • Wolverhampton, Verenigd Koninkrijk
        • Research Site
  • Verenigde Staten
    • Arizona
      • Peoria, Arizona, Verenigde Staten
        • Research Site
    • Florida
      • Clearwater, Florida, Verenigde Staten
        • Research Site
    • Georgia
      • Duluth, Georgia, Verenigde Staten
        • Research Site
    • Maine
      • Auburn, Maine, Verenigde Staten
        • Research Site
    • New York
      • Buffalo, New York, Verenigde Staten
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Verenigde Staten
        • Research Site
      • Spartanburg, South Carolina, Verenigde Staten
        • Research Site
    • Texas
      • Boerne, 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

45 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 45 through 75 years
  • Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening
  • History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
  • Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
  • Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years.

Exclusion Criteria:

  • Past or present disease or disorder,
  • Significant or unstable ischemic heart disease etc
  • Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
  • Past or current malignancy within the past 5 years
  • Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
  • Use of immunosuppressive medication receipt of any biologic agent.

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: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Ander: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Experimenteel: MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53.
Biologisch: MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean 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. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Day 1 up to 393

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Rate of 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. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Day 1 up to 393
Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tijdsspanne: Day 1 up to 393
Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.
Day 1 up to 393
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Tijdsspanne: Baseline and Week 53
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 and Week 53
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Tijdsspanne: Week 53
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. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.
Week 53
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
Tijdsspanne: Baseline and Week 53
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 and Week 53
Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
Tijdsspanne: Baseline and Week 53
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). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.
Baseline and Week 53
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tijdsspanne: Day 1 up to Week 69
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 Week 69 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 Week 69
Observed Serum Concentrations of MEDI8968
Tijdsspanne: Pre-dose (Baseline), Post-dose on Week 53
Pre-dose (Baseline), Post-dose on Week 53
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
Tijdsspanne: Day 1 up to Week 69
Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.
Day 1 up to Week 69

Medewerkers en onderzoekers

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

Sponsor

MedImmune LLC

Onderzoekers

  • Studie directeur: Rene Van Der Merwe, MBChB, MFPM, 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 2011

Primaire voltooiing (Werkelijk)

1 februari 2014

Studie voltooiing (Werkelijk)

1 februari 2014

Studieregistratiedata

Eerst ingediend

6 oktober 2011

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2011

Eerst geplaatst (Schatting)

7 oktober 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

30 januari 2017

Laatste update ingediend die voldeed aan QC-criteria

30 november 2016

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CD-RI-MEDI8968-1103

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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