The purpose of this study is to investigate lung function parameters, composite endpoint for exacerbations in chronic obstructive pulmonary disease (COPDCompEx), symptoms and to provide safety information after tozorakimab or placebo administrations in participants with symptomatic chronic obstructive pulmonary disease (COPD) with history of exacerbations and high blood eosinophil counts. Study details include the following: * The maximum duration of the screening/run-in period is 5 weeks. An additional unscheduled visit may be performed prior to randomization to repeat safety assessments as deemed necessary by the investigator. * Eligible patients will enter 12-week treatment (intervention) period with site visits and investigational product (IP) administration every 2 weeks. * Participants who complete a treatment period, and have not been prematurely discontinued from IP, will enter a 10-week post-intervention follow-up period. * The study duration will be 27 weeks at maximum for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
Placebo administered subcutaneously, equivalent volume to tozorakimab throughout the study
Administered subcutaneously tozorakimab and placebo throughout the study
Research Site
Aramil, Russia
Research Site
Izhevsk, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Moscow, Russia
Research Site
Omsk, Russia
Research Site
Penza, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
...and 2 more locations
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
The difference in mean change from baseline in FEV1
Time frame: Baseline through Week 12
Annualized rate of composite endpoint for exacerbations in COPD (COPDCompEx) events
The rate ratio of COPDCopmEx events
Time frame: From baseline to Week 12
Change from baseline in post-BD FEV1
The difference in mean change from baseline in post-BD FEV1
Time frame: From baseline through Week 12
Change from baseline in pre-BD and post-BD forced vital capacity (FVC)
The difference in mean change from baseline in pre-BD and post-BD FVC
Time frame: From baseline through Week 12
FEV1 % reversibility dynamics
The difference in mean change from baseline in FEV1 % reversibility
Time frame: From baseline to Week 12
Change from baseline in peak expiratory flow (PEF) measured in clinic and at home
The difference in mean change from baseline in PEF
Time frame: From baseline through Week 12
Change from baseline in home FEV1
The difference in mean change from baseline in FEV1
Time frame: From baseline through Week 12
Time to first COPDCompEx event
The hazard ratio for COPDCompEx event occurrence
Time frame: From baseline to Week 12
Change from baseline in mean Breathless, cough and sputum scale (BCSS) score
The difference in mean change from baseline in BCSS. The BCSS, is a 3-item daily Diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough; each on a 5-point scale (from 0 to 4). Higher scores for each domain, and thus for total score, indicate more severe symptoms.
Time frame: From baseline to Week 12
Change from baseline in COPD assessment test (CAT) total score
The difference in mean change from baseline in CAT. The CAT consists of eight questions that ask the participant to rate items relating to symptoms and impact on quality of life (such as normal activity and sleep). Each question is performed on a scale from 0 to 5 with 0 being the best possible health status or least impairment and 5 being the worst health status or greatest impairment.
Time frame: From baseline to Week 12
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