Clinical trial NCT01448850: A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Official title: A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
MEDI8968
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 464
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
Secondary outcomes:
measure: Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
measure: Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
measure: Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
timeFrame: Baseline and Week 53
measure: Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
timeFrame: Week 53
measure: Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
timeFrame: Baseline and Week 53
measure: Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
timeFrame: Baseline and Week 53
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 up to Week 69
measure: Observed Serum Concentrations of MEDI8968
timeFrame: Pre-dose (Baseline), Post-dose on Week 53
measure: Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
timeFrame: Day 1 up to Week 69
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Duluth
country: United States
facility: Research Site
state: Georgia
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Boerne
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Jindrichuv Hradec
country: Czech Republic
facility: Research Site
city: Karlovy Vary
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Farkasgyepü
country: Hungary
facility: Research Site
city: Komarom
country: Hungary
facility: Research Site
city: Mateszalka
country: Hungary
facility: Research Site
city: Matrahaza
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Szikszo
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Oswiecim
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Vinnytsya
country: Ukraine
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Rene Van Der Merwe, MBChB, MFPM
role: STUDY_DIRECTOR
References:
citation: Calverley PMA, Sethi S, Dawson M, Ward CK, Finch DK, Penney M, Newbold P, van der Merwe R. A randomised, placebo-controlled trial of anti-interleukin-1 receptor 1 monoclonal antibody MEDI8968 in chronic obstructive pulmonary disease. Respir Res. 2017 Aug 9;18(1):153. doi: 10.1186/s12931-017-0633-7.