Bronchiectasis Clinical Trials

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A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Body mass index (BMI) between 18-35 kilograms per square meters (kg/m\^2)

• Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed on chest computed tomography (CT)

• Meet one of the two criteria:

‣ In the 12 months prior to screening, have had 2 or more documented pulmonary exacerbations that required a new antibiotic prescription by a physician or 1 pulmonary exacerbation that required hospitalization; or

⁃ In the 12 months prior to screening, have had 0 or 1 pulmonary exacerbation and a QOL-B RSS of less than (\<)50 at screening

• Current sputum producers

• Post-bronchodilator FEV1 greater than or equal to (\>=) 30 percent (%) or greater of predicted normal value

• Non-smokers or former cigarette smokers

• Males and females of childbearing and non-childbearing potential

• A female participant is eligible to participate if she is not pregnant or breastfeeding

• Is a Woman of non-childbearing potential (WONCBP) or is a Woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1

• A WOCBP must have a negative highly sensitive serum pregnancy test within 28 days before the first dose of study intervention

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol

Locations
United States
Alabama
GSK Investigational Site
RECRUITING
Mobile
California
GSK Investigational Site
RECRUITING
La Palma
Florida
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Naples
GSK Investigational Site
RECRUITING
Plantation
GSK Investigational Site
RECRUITING
St. Petersburg
Maryland
GSK Investigational Site
RECRUITING
Rockville
Pennsylvania
GSK Investigational Site
RECRUITING
Dubois
South Carolina
GSK Investigational Site
RECRUITING
Anderson
GSK Investigational Site
RECRUITING
Rock Hill
GSK Investigational Site
RECRUITING
Spartanburg
Texas
GSK Investigational Site
RECRUITING
Conroe
GSK Investigational Site
RECRUITING
Sugar Land
Other Locations
China
GSK Investigational Site
RECRUITING
Beijing
GSK Investigational Site
RECRUITING
Chongqing
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Hangzhou
GSK Investigational Site
RECRUITING
Huizhou
GSK Investigational Site
RECRUITING
Jiangmen
GSK Investigational Site
RECRUITING
Jiangsu
GSK Investigational Site
RECRUITING
Nanjing
GSK Investigational Site
RECRUITING
Qingyuan
GSK Investigational Site
RECRUITING
Weifang
GSK Investigational Site
RECRUITING
Yangzhou
GSK Investigational Site
RECRUITING
Zhanjiang
Germany
GSK Investigational Site
RECRUITING
Frankfurt
Israel
GSK Investigational Site
RECRUITING
Ashdod
GSK Investigational Site
RECRUITING
Ashkelon
GSK Investigational Site
RECRUITING
Beersheba
GSK Investigational Site
RECRUITING
Haifa
GSK Investigational Site
RECRUITING
Jerusalem
GSK Investigational Site
RECRUITING
Jerusalem
GSK Investigational Site
RECRUITING
Kfar Saba
GSK Investigational Site
RECRUITING
Koranit
GSK Investigational Site
RECRUITING
Petah Tikva
GSK Investigational Site
RECRUITING
Tel Aviv
Japan
GSK Investigational Site
RECRUITING
Kanagawa
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2027-12-10
Participants
Target number of participants: 446
Treatments
Experimental: GSK3862995B Dose Level 1
Participants will receive GSK3862995B Dose level 1.
Experimental: GSK3862995B Dose Level 2
Participants will receive GSK3862995B Dose level 2.
Placebo_comparator: Placebo
Participants will receive matching placebo.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov