This study is designed to find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease. The study will also test how the body processes the drug and to check for any immune reactions. Participants will be divided into groups randomly to receive either one of two different doses of the study drug or a placebo. The main goal of the study is to see how well the drug works compared to the placebo in helping those with bronchiectasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Participants will be administered with dose level 1 of GSK3862995B.
Participants will be administered with matching placebo.
Annualized rate of Exacerbations for GSK3862995B Dose Level 1 Following Repeat Doses Compared with Placebo
Annualized rate of exacerbations for GSK3862995B dose 1 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.
Time frame: Up to Week 48
Annualized rate of Exacerbations for GSK3862995B Dose Level 2 Following Repeat Doses Compared with Placebo
Annualized rate of exacerbations for GSK3862995B dose 2 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.
Time frame: Up to Week 48
Time to first Exacerbation for GSK3862995B Dose Level 2 and Dose Level 1 Compared to Placebo
Time frame: Up to Week 48
Annualized Rate of Severe Exacerbations for GSK3862995B Dose Level 1 and Dose Level 2 Compared to Placebo
Annualized rate of exacerbations for GSK3862995B dose 1 and dose 2 compared to placebo will be evaluated.
Time frame: Up to Week 48
Change from Baseline in Quality-of-life bronchiectasis respiratory symptom scale score (QOL-B RSS)
QOL-B questionnaire is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for participants with bronchiectasis. The scale contains 37- items with 8 scales (respiratory symptoms, physical, role, emotional and social functioning). Scores range from 0 to 100, with higher scores indicating a better quality of life.
Time frame: Baseline up to Week 48
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a 50-item patient reported outcome measure designed to measure health impairment by addressing the frequency of respiratory symptoms and the participant's current state. The SGRQ allows for the calculation of a total score as well as 3 subscale scores (symptoms, activity, and impact on daily life). Higher scores indicate greater impairment of health.
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Time frame: Baseline up to Week 48
Change from Baseline in Post-bronchodilator Forced expiratory volume in one second (FEV1) value
Change from baseline in post-bronchodilator FEV1 value will be reported.
Time frame: Baseline up to Week 48
Number of Participants with Serious Adverse Events (SAE)
Number of participants with SAEs will be reported.
Time frame: From screening (Day -1) up to Week 72
Number of Participants with of Adverse Events (AE)
Number of Participants with AEs will be reported.
Time frame: From randomization (Day 1) to Week 72
Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Number of participants with clinically significant changes in laboratory data (hematology, chemistry, and urinalysis) will be reported.
Time frame: Up to Week 72
Number of Participants with Clinically Significant Changes from Baseline in Vital Signs
Number of participants with clinically significant changes from baseline in vital signs will be reported.
Time frame: Up to Week 72
Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG)
Number of participants with clinically significant changes from baseline in 12-lead electrocardiogram will be reported.
Time frame: Up to Week 72
Serum Concentration of GSK3862995B
Serum concentration of GSK3862995B following repeated dose level 1 and dose level 2 will be reported.
Time frame: Week 1 up to Week 48
Number of Participants with Anti-drug Antibodies (ADAs) Against GSK3862995B
Number of participants with ADA against GSK3862995B following repeated dose level 1 and dose level 2 will be reported.
Time frame: Up to Week 72