Clinical trial Recruiting at 134 sites Phase 2 Interventional Ages 18 to 85

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment363 (estimated)
SponsorGlaxoSmithKline
Industry-sponsored
Locations134 sites (Mobile, Alabama and 133 other locations)
StatusRecruiting
StartedOctober 30, 2025
Main results expectedMay 4, 2027
Study endsDecember 10, 2027
Registry record updatedAugust 12, 2026
Trial IDNCT07201051 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.