The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
402
Drug: Galvokimig Pharmaceutical form: Solution for injection
Drug: Placebo Pharmaceutical form: Solution for injection
Copd01 50003
Columbus, Ohio, United States
RECRUITINGCopd01 50002
DuBois, Pennsylvania, United States
RECRUITINGCopd01 50001
Boerne, Texas, United States
RECRUITINGCopd01 20001
Beijing, China
RECRUITINGCopd01 20004
Chengdu, China
RECRUITINGCopd01 20003
Hangzhou, China
RECRUITINGCopd01 20005
Hangzhou, China
RECRUITINGCopd01 20002
Nanchang, China
RECRUITINGCopd01 20012
Shijiazhuang, China
RECRUITINGTime from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Moderate AECOPD require use of systemic corticosteroids and/or antibiotics for at least 3 consecutive days; Severe AECOPD is an AECOPD requiring a hospitalization for \>= 24 hours or leading to a COPD-related death.
Time frame: Up to Week 60
Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks
FEV₁ (Forced Expiratory Volume in 1 second) is the amount of air a person can forcefully exhale in the first second of a maximal exhalation. It is a core spirometric measure used to evaluate airflow limitation. A low FEV₁ indicates obstructed airflow, which is a hallmark of COPD. A change of FEV₁ at Week 24 compared to baseline indicates the change in breathing impairment.
Time frame: At Week 24
Annualized rate of moderate and severe AECOPD up to End of Treatment
AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Annualized event rate is the total number of events that occurred during the treatment period divided by the total number of participant-years followed in the treatment period.
Time frame: From Baseline up to Week 52
Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C)
The St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) is based on the original longer version of the SGRQ, a patient reported outcome (PRO) which includes 50 items. The SGRQ-C comprises 40 items covering symptoms, activity limitations, and impacts on daily life, with responses on 5-point scales for symptoms and True/False weighted responses for activity and impacts. Total scores range from 0 to 100, with higher scores indicating worse health status and greater impairment, and lower scores reflecting better quality of life and fewer limitations.
Time frame: At Week 24
Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline to Week 24
The St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C) is based on the original longer version of the SGRQ, a patient reported outcome (PRO) which includes 50 items. The SGRQ-C comprises 40 items covering symptoms, activity limitations, and impacts on daily life, with responses on 5-point scales for symptoms and True/False weighted responses for activity and impacts. Total scores range from 0 to 100, with higher scores indicating worse health status and greater impairment, and lower scores reflecting better quality of life and fewer limitations.
Time frame: From Baseline up to Week 24
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention.
Time frame: Up to Week 60
Incidence of TE Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Time frame: Up to Week 60
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