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

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    Recruiting
Updated on 25 March 2021

Summary

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

Description

We will examine whether or not lebrikizumab improves lung function in people with COPD. We also hope to learn whether lebrikizumab reduces the number of COPD exacerbations and improves symptoms in people who do not have good control of their COPD despite being treated with a long-acting bronchodilator and an inhaled corticosteroid. We are also testing whether blood tests to measure the level of a protein called periostin and a type of cell called eosinophils can be used to identify which people are likely to benefit from lebrikizumab

Details
Clinical Study IdentifierTX142878
Last Modified on25 March 2021

Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Able and willing to provide written informed consent and to comply with the study protocol
Age 40 - 80 years old at Visit 1
Able and willing to use the electronic device for patient-reported data collection
Documented history of COPD diagnosis for ≥ 12 months prior to Visit 1
Post-bronchodilator FEV1/FVC< 0.70 at Visit 1 or Visit 2
Post-bronchodilator FEV1 < 80% predicted at Visit 1 or Visit 2
Documented history of one or more acute COPD exacerbations that required 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). A former smoker may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco)
On ICS therapy for ≥ 6 months prior to Visit 1
On an eligible bronchodilator medication (LABA, LAMA, or both) for ≥ 6 months prior to Visit 1
Chest X-ray or CT scan within 6 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 2) that confirms the absence of clinically significant lung disease besides COPD
Demonstrated adherence with background COPD inhaler medication during the screening period. Adherence is defined as patients responding affirmatively that they have taken their inhaler therapy ≥ 70% of days during the screening period (Visits 1−2), as recorded in their eDiary
For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year for the duration of the study (during the placebo-controlled period and the safety follow-up period)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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