GSK's new drug for adults with bronchiectasis
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis
Run by GlaxoSmithKline · NCT07201051 · Data updated 2026-11-12
A new drug (GSK3862995B) is being tested in adults with bronchiectasis to see if it works better than placebo and to check safety and how the body handles it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 363 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 134 sites (Mobile, Alabama and 133 other locations) |
| Status | Recruiting |
| Started | October 30, 2025 |
| Main results expected | May 4, 2027 |
| Study ends | December 10, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07201051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with bronchiectasis, current sputum production, and adequate lung function (post-bronchodilator FEV1 ≥ 30% predicted), who meet the specified exacerbation or quality-of-life criteria.
✕Probably not a fit
Patients with very advanced disease, those unable to produce sputum, or those not meeting the specific exacerbation/quality-of-life criteria may derive unlikely benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, randomized, double-blind study evaluating two dose levels of GSK3862995B versus placebo in adults with bronchiectasis. Participants will undergo safety and immunogenicity assessments, pharmacokinetic analyses, and efficacy measurements over the trial period. Key inclusion criteria include documented bronchiectasis, current sputum production, sufficient lung function, and a history of infections or a low quality-of-life score. The study is conducted across three GSK investigational sites in the United States and is sponsored by GlaxoSmithKline.
Why it matters
Potential benefit: If successful, participants may experience better control of bronchiectasis symptoms and fewer disease exacerbations compared with placebo.
How similar studies have gone: Previous studies in similar anti-inflammatory/immunomodulatory approaches have shown signals of benefit in bronchiectasis but this exact approach with GSK3862995B is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
-
GSK Investigational Site
Mobile, Alabama, United States Recruiting -
GSK Investigational Site
Phoenix, Arizona, United States Recruiting -
GSK Investigational Site
La Palma, California, United States Recruiting -
GSK Investigational Site
Valencia, California, United States Recruiting -
GSK Investigational Site
Aurora, Colorado, United States Recruiting -
GSK Investigational Site
Miami, Florida, United States Recruiting
Show 44 more locations
-
GSK Investigational Site
Miami, Florida, United States Recruiting -
GSK Investigational Site
Naples, Florida, United States Recruiting -
GSK Investigational Site
Pembroke Pines, Florida, United States Recruiting -
GSK Investigational Site
Plantation, Florida, United States Recruiting -
GSK Investigational Site
St. Petersburg, Florida, United States Recruiting -
GSK Investigational Site
Tamarac, Florida, United States Recruiting -
GSK Investigational Site
Winter Park, Florida, United States Recruiting -
GSK Investigational Site
Hammond, Indiana, United States Recruiting -
GSK Investigational Site
New Orleans, Louisiana, United States Recruiting -
GSK Investigational Site
Rockville, Maryland, United States Recruiting -
GSK Investigational Site
St Louis, Missouri, United States Recruiting -
GSK Investigational Site
Henderson, Nevada, United States Recruiting -
GSK Investigational Site
New Hyde Park, New York, United States Recruiting -
GSK Investigational Site
Winston-Salem, North Carolina, United States Recruiting -
GSK Investigational Site
DuBois, Pennsylvania, United States Recruiting -
GSK Investigational Site
Anderson, South Carolina, United States Recruiting -
GSK Investigational Site
Rock Hill, South Carolina, United States Recruiting -
GSK Investigational Site
Spartanburg, South Carolina, United States Recruiting -
GSK Investigational Site
Union, South Carolina, United States Recruiting -
GSK Investigational Site
Franklin, Tennessee, United States Recruiting -
GSK Investigational Site
Knoxville, Tennessee, United States Recruiting -
GSK Investigational Site
Conroe, Texas, United States Recruiting -
GSK Investigational Site
Cypress, Texas, United States Recruiting -
GSK Investigational Site
Sugar Land, Texas, United States Recruiting -
GSK Investigational Site
Williamsburg, Virginia, United States Recruiting -
GSK Investigational Site
Buenos Aires, Argentina Recruiting -
GSK Investigational Site
Caba, Argentina Recruiting -
GSK Investigational Site
Caba, Argentina Recruiting -
GSK Investigational Site
Rosario Provincia de Santa FE, Argentina Recruiting -
GSK Investigational Site
San Miguel de Tucumán, Argentina Recruiting -
GSK Investigational Site
San Miguel de Tucumán, Argentina Recruiting -
GSK Investigational Site
San Miguel de Tucumán, Argentina Recruiting -
GSK Investigational Site
Santa Fe, Argentina Recruiting -
GSK Investigational Site
Beijing, China Recruiting -
GSK Investigational Site
Chongqing, China Recruiting -
GSK Investigational Site
Dongguan, China Recruiting -
GSK Investigational Site
Guangzhou, China Recruiting -
GSK Investigational Site
Guangzhou, China Recruiting -
GSK Investigational Site
Guilin, China Recruiting -
GSK Investigational Site
Hangzhou, China Recruiting -
GSK Investigational Site
Huizhou, China Recruiting -
GSK Investigational Site
Jiangmen, China Recruiting -
GSK Investigational Site
Jiangsu, China Recruiting -
GSK Investigational Site
Nanjing, China Recruiting
+84 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Chronic Respiratory Disease Participant Engagement
This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.
-
Breathlessness in respiratory diseases: who feels it and why
This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.
-
Hypertonic saline inhalation for NTM lung disease
This trial tests whether starting inhaled 3% hypertonic saline early helps people with non-tuberculous mycobacterial lung disease feel better and clear bacteria better, compared with starting with normal saline first.
-
Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups
This trial tests whether taking azithromycin daily for a year reduces bronchiectasis-related flare-ups in adults with non-cystic fibrosis bronchiectasis.
-
Bronchiectasis Phenotype Identification Model for Adults
This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.
-
BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups
This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.