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

NCT01448850 | Completed Phase 2 Results DMC

• 1 other identifier: CD-RI-MEDI8968-1103
• Study Type: interventional
• Target: 464
• Locations: 10 countries
• Sites: 60

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD); MEDI8968

Outcome Measures

Primary Outcomes (1)

• Mean 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. 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

Secondary Outcomes (9)

• Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

  Day 1 up to 393

• Time to First Moderate or Severe 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 Subscales Scores at Week 53

  Baseline and Week 53

• Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score

  Week 53

• Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53

  Baseline and Week 53

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.

Other: Placebo

MEDI8968 600 mg IV, 300 mg SC

EXPERIMENTAL

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.

Biological: MEDI8968 600 mg IV, 300 mg SC

Interventions

MEDI8968 600 mg IV, 300 mg SC BIOLOGICAL

MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.

MEDI8968 600 mg IV, 300 mg SC

Placebo OTHER

Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (60)

Research Site

Peoria, Arizona, United States

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Clearwater, Florida, United States

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Duluth, Georgia, United States

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Auburn, Maine, United States

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Buffalo, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Boerne, Texas, United States

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Richmond, Virginia, United States

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Veliko Tarnovo, Bulgaria

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Brno, Czechia

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Jindřichův Hradec, Czechia

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Karlovy Vary, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Strakonice, Czechia

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Balassagyarmat, Hungary

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Budapest, Hungary

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Farkasgyepü, Hungary

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Komárom, Hungary

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Mátészalka, Hungary

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Mátraháza, Hungary

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Mosonmagyaróvár, Hungary

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Nagykanizsa, Hungary

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Szikszó, Hungary

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Tatabánya, Hungary

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Törökbálint, Hungary

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Daugavpils, Latvia

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Riga, Latvia

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Iloilo City, Philippines

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Lipa City, Philippines

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Quezon City, Philippines

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Bialystok, Poland

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Oświęcim, Poland

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Poznan, Poland

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Wroclaw, Poland

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Zgierz, Poland

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Odesa, Ukraine

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Poltava, Ukraine

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Simferopol, Ukraine

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Vinnytsia, Ukraine

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Cambridge, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Wolverhampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28793896 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological 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, MFPM

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 30, 2017
• Results First Posted: January 30, 2017

Record last verified: 2016-11

Locations

BU (5); HU (11); LI (3); PL (8); UA (7); CZ (6); GB (3); US (12); PH (3); LA (2)