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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02546700
• Date of registration: 09/09/2015
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
• Scientific 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
• Date of first enrolment: September 30, 2015
• Target sample size: 309
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02546700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Bulgaria, Canada, Denmark, Hungary, Mexico, Poland, Russian Federation, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Placebo

Drug: Lebrikizumab

Primary Outcome(s)

Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) [Time Frame: Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24]

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]

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]

Time to First COPD Exacerbation [Time Frame: Baseline up to Week 24]

Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24 [Time Frame: Baseline, Week 24]

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]

Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab [Time Frame: Baseline up to Week 36]

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]

Percentage of Participants with Adverse Events And Serious Adverse Events [Time Frame: Baseline up to Week 36]

Rate of Moderate or Severe COPD Exacerbation [Time Frame: Baseline up to Week 24]

Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24 [Time Frame: Baseline, Week 24]

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]

Secondary ID(s)

2015-001122-42

WB29804

Source(s) of Monetary Support

Please refer to primary and secondary sponsors