GSK3862995B
DrugParticipants will be administered with dose level 1 of GSK3862995B.
NCT Number: NCT07201051
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2
GSK Investigational Site, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be administered with dose level 1 of GSK3862995B.
Participants will be administered with matching placebo.
Time frame: Up to Week 48
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 2 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.
Time frame: Up to Week 48
Time frame: Up to Week 48
Annualized rate of exacerbations for GSK3862995B dose 1 and dose 2 compared to placebo will be evaluated.
Time frame: Baseline up to Week 48
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
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.
Time frame: Baseline up to Week 48
Change from baseline in post-bronchodilator FEV1 value will be reported.
Time frame: From screening (Day -1) up to Week 72
Number of participants with SAEs will be reported.
Time frame: From randomization (Day 1) to Week 72
Number of Participants with AEs will be reported.
Time frame: Up to Week 72
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 will be reported.
Time frame: Up to Week 72
Number of participants with clinically significant changes from baseline in 12-lead electrocardiogram will be reported.
Time frame: Week 1 up to Week 48
Serum concentration of GSK3862995B following repeated dose level 1 and dose level 2 will be reported.
Time frame: Up to Week 72
Number of participants with ADA against GSK3862995B following repeated dose level 1 and dose level 2 will be reported.
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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