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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

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Rate of Moderate or Severe COPD Exacerbation

    Time frame: Baseline up to Week 24

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 24

  4. Time to First COPD Exacerbation

    Time frame: Baseline up to Week 24

  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

  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

  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

  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

  9. Percentage of Participants with Adverse Events And Serious Adverse Events

    Time frame: Baseline up to Week 36

  10. Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab

    Time frame: Baseline up to Week 36

  11. Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin)

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

  12. Plasma Decay Half-Life (t1/2)

    Time frame: Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 8, 12, 16, 20; at Weeks 24, 28, and 36

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 6, 2017

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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