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OpenTrials
Completed

NCT Number: NCT02546700

A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Médico Dra de Salvo, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented history of COPD greater than or equal to (>/=) 12 months prior to Visit 1
  • Post-bronchodilator FEV1/FVC less than (<) 0.70 at Visit 1 or 2
  • Post bronchodilator FEV1 <80% predicted at Visit 1 or 2
  • Documented history of one or more acute COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1
  • Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking >/=10 pack-years (20 cigarettes/day for 10 years)
  • On inhaled corticosteroids (ICS) therapy for >/=6 months prior to Visit 1
  • On an eligible bronchodilator medication for >/=6 months prior to Visit 1
  • Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray prior to Visit 2 that confirms absence of clinically significant lung disease besides COPD
  • Demonstrated adherence with background COPD inhaler medication during screening period
  • For female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study

Exclusion criteria

  • History of severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection
  • History of clinically significant pulmonary disease other than COPD
  • Diagnosis of alpha-1-antitrypsin deficiency
  • Lung volume reduction surgery or procedure within 12 months prior to Visit 1
  • Supplemental oxygen requirement >2 liters/minute (L/min) at rest or with exertion
  • Current diagnosis of asthma
  • Participants participating in, or scheduled for, an intensive COPD rehabilitation program
  • Maintenance oral corticosteroid therapy
  • Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during screen period
  • Unstable ischemic heart disease or other relevant cardiovascular disorders
  • Use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (IL) or anti-IL-4/IL-13 therapy)
  • Body weight <40 kg
  • Any infection that resulted in hospital admission for >/= 24 hours and/or treatment with oral, intravenous (IV), or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
  • Active parasitic or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
  • Received a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening
  • Active tuberculosis requiring treatment within 12 months prior to Visit 1
  • Human immunodeficiency virus (HIV) or other known immunodeficiency
  • Hepatitis or known liver cirrhosis
  • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ATL), or total bilirubin elevation >/=2.0 x upper limit of normal (ULN) during screening
  • Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests
  • History of alcohol or drug abuse
  • Pregnant or lactating

Treatment and study plan

Lebrikizumab

Drug

Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.

Placebo

Drug

Matching placebo will be administered subcutaneously once in every 4 weeks.

Primary outcomes

  1. Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 12

    Time frame: Baseline, Week 12

    Adjusted mean change from baseline in pre-bronchodilator FEV1 (assessed using spirometry) at Week 12 was calculated.

Secondary outcomes

  1. Rate of Moderate or Severe COPD Exacerbation

    Time frame: Baseline up to Week 24

    A moderate COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that lead to hospitalization. Adjusted exacerbation rate per year was calculated.

    Results are reported as a 'Number' representing the unadjusted annualized rate of COPD exacerbations per person-year. The total number of exacerbations observed during the period was defined as starting at the date of randomization and ending at most 172 days after randomization (including data collected during safety follow-up in the case of early drug discontinuation) regardless of adherence to study drug divided by the total patient-weeks at risk divided by 52 weeks per year.

  2. Change From Baseline in Post-bronchodilator FEV1 at Week 24

    Time frame: Baseline, Week 24

    Adjusted mean change from baseline in post-bronchodilator FEV1 at Week 24 was calculated.

  3. Change From Baseline in Pre-bronchodilator FEV1 at Week 24

    Time frame: Baseline, Week 24

    Adjusted mean change from baseline in pre-bronchodilator FEV1 at Week 24 was calculated.

  4. Time to First COPD Exacerbation

    Time frame: Baseline up to Week 24

    COPD exacerbation was defined as new or increased COPD symptoms (for example, dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days. Time to first COPD exacerbation was estimated using Kaplan-Meier analysis.

  5. Change From Baseline in Health-Related Quality of Life as Assessed by the Overall Score of the Saint George's Respiratory Questionnaire for COPD (SGRQ-C) at Week 24

    Time frame: Baseline, Week 24

    SGRQ-C was assessed by asking participants to recall their COPD-related experiences and to respond to 40 questions included within three domains: symptoms (7 items), activity (13 items), and impacts (20 items). Overall SGRQ-C score ranged from 0 to 100, where lower score indicated better health-related quality of life. Change from baseline in overall SGRQ-C score at Week 24 was reported.

  6. Change From Baseline in COPD Symptoms as Measured by the Overall Score of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) at Week 24

    Time frame: Baseline, Week 24

    EXACT comprised of 14-item questionnaire containing four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (3 items). Overall EXACT score was the average of domain scores. It ranged from 0 to 100, where higher score indicated a more severe condition. Change from baseline in overall EXACT score at Week 24 was reported.

  7. Change From Baseline in Cough and Sputum as Measured by the Cough and Sputum Domain Score of the EXACT at Week 24

    Time frame: Baseline, Week 24

    EXACT comprised of 14-item questionnaire containing four domains: breathlessness (5 items), cough and sputum (3 items), chest symptoms (3 items), and additional attributes (3 items). Cough and Sputum domain score ranged from 0 to 100, where higher score indicated a more severe condition. Change from baseline in cough and sputum domain EXACT score at Week 24 was reported.

  8. Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24

    Time frame: Baseline, Week 24

    The BDI scores ranged from 0 (very severe impairment) to 4 (no impairment) for each of 3 domains (functional impairment, magnitude of task, and magnitude of effort) and were summed to determine the BDI total score (0 to 12). The TDI scores ranged from -3 (major deterioration) to +3 (major improvement) for each of the 3 domains (functional impairment, magnitude of task, and magnitude of effort). The sum of all domains yielded the TDI total score (-9 to +9). Change from baseline in BDI/TDI at Week 24 was reported.

  9. Percentage of Participants With Anti-Therapeutic Antibody (ATA) to Lebrikizumab

    Time frame: Baseline up to Week 36

    This outcome measure was planned to be analyzed only in overall lebrikizumab arm.

  10. Minimum Observed Serum Trough Concentration (Cmin) of Lebrikizumab

    Time frame: Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24

    This outcome measure was planned to be analyzed only in overall lebrikizumab arm.

  11. Elimination Half-Life (t1/2) of Lebrikizumab

    Time frame: Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 12, 24, 28, and 36

    Elimination half-life was defined as the time measured for the serum concentration to decrease by one half. This outcome measure was planned to be analyzed only in overall lebrikizumab arm.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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