A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

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.

Key facts

Study ID: NCT07201051
Run by: GlaxoSmithKline
People needed: 446
Starts: 2025-10-30
Expected to finish: 2027-12-10
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Participants with a primary diagnosis of asthma or Chronic Obstructive Pulmonary Disorder (COPD) as judged by the investigator
Bronchiectasis due to cystic fibrosis, alpha-1-antitrypsin deficiency, common variable immunodeficiency, hypogammaglobinemia, or traction bronchiectasis due to fibrotic lung disease
Active non-tuberculosis mycobacterial (NTM) lung infection on treatment or meeting ATS/Infectious Diseases Society of America (IDSA) criteria for active lung infection
Active tuberculosis, untreated latent Tuberculosis (TB), invasive fungal lung infections or allergic bronchopulmonary aspergillosis needing treatment
Participant uses long-term oxygen therapy for more than 12 hours per day
Participants with an acute lower respiratory tract pulmonary infection needing treatment or pulmonary exacerbation within 4 weeks of the screening visit.
Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgment of the Investigator, may affect participant safety or affect study endpoints
Participants with an unstable cardiac disease, myocardial infarction, Cerebrovascular Accident (CVA), stroke or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Participants with clinically significant abnormal Electrocardiogram (ECG) at screening which in the judgment of the Investigator, may affect participant safety or affect study endpoints
Significant allergies to humanized monoclonal antibodies
Participants with a history of lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected for cure with no evidence of recurrence or metastatic disease for 1-year
A known or suspected immunodeficiency that has led to opportunistic infections, recurrent invasive infections, or prolonged infections that suggest an underlying immunocompromised state by the judgement of the investigator. Positive HIV antibody test
Alanine aminotransferase (ALT) >2x Upper limit of normal (ULN)
Total bilirubin >1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is less than or equal to (<=)1.5xULN
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Presence of hepatitis B surface antigen (Hepatitis B surface antigen [HBsAg]) and/or hepatitis B core antibody (Hepatitis B core antibody [HBcAb]) at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
Positive hepatitis C Hepatitis B core antibody (RNA) test result at screening or within 3 months prior to first dose of study intervention
Corrected QT interval (QTc) >450 milliseconds (msec) at screening visit based on the average of triplicate ECGs The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

GSK Investigational Site — Mobile, Alabama, United States (enrolling)
GSK Investigational Site — La Palma, California, United States (enrolling)
GSK Investigational Site — Miami, Florida, United States (enrolling)
GSK Investigational Site — Miami, Florida, United States (enrolling)
GSK Investigational Site — Naples, Florida, United States (enrolling)
GSK Investigational Site — Plantation, Florida, United States (enrolling)
GSK Investigational Site — St. Petersburg, Florida, United States (enrolling)
GSK Investigational Site — Rockville, Maryland, United States (enrolling)
GSK Investigational Site — DuBois, Pennsylvania, United States (enrolling)
GSK Investigational Site — Anderson, South Carolina, United States (enrolling)
GSK Investigational Site — Rock Hill, South Carolina, United States (enrolling)
GSK Investigational Site — Spartanburg, South Carolina, United States (enrolling)
GSK Investigational Site — Conroe, Texas, United States (enrolling)
GSK Investigational Site — Sugar Land, Texas, United States (enrolling)
GSK Investigational Site — Beijing, China (enrolling)
GSK Investigational Site — Chongqing, China (enrolling)
GSK Investigational Site — Dongguan, China (enrolling)
GSK Investigational Site — Guangzhou, China (enrolling)
GSK Investigational Site — Guangzhou, China (enrolling)
GSK Investigational Site — Guilin, China (enrolling)
GSK Investigational Site — Hangzhou, China (enrolling)
GSK Investigational Site — Huizhou, China (enrolling)
GSK Investigational Site — Jiangmen, China (enrolling)
GSK Investigational Site — Jiangsu, China (enrolling)
GSK Investigational Site — Nanjing, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.