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

June 9, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

446

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhaohui Tong
      • Chongqing, China, 408099
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qianli Ma
      • Guangzhou, China, 510180
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhuxiang Zhao
      • Guangzhou, China, 510230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guan Weijie
      • Hangzhou, China, 310000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Limin Wang
      • Huizhou, China, 516000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Feng Wu
        • Contact:
        • Contact:
      • Jiangmen, China, 529700
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • yanming huang
        • Contact:
        • Contact:
      • Jiangsu, China, 221004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bi Chen
        • Contact:
        • Contact:
      • Nanjing, China, 210012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Surong Fang
      • Qingyuan, China, 511500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dongbo Tian
      • Weifang, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guoru Yang
      • Yangzhou, China, 225001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Feng Wu
        • Contact:
        • Contact:
      • Zhanjiang, China, 524001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bin Wu
        • Contact:
        • Contact:
  • Germany
      • Frankfurt, Germany, 60596
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Oliver Kornmann
        • Contact:
        • Contact:
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Starobin
      • Ashkelon, Israel, 78278
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ori Wand
      • Beersheba, Israel, 84101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yael Raviv
      • Haifa, Israel, 3436212
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Shteinberg
      • Jerusalem, Israel, 91120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Neville Berkman
      • Jerusalem, Israel, 91031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gabriel Izbicki
        • Contact:
        • Contact:
      • Kfar Saba, Israel, 44281
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • David Shitrit
        • Contact:
        • Contact:
      • Koranit, Israel, 2018100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaniv Dotan
      • Petah Tikva, Israel, 49100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moshe Heching
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amir Bar Shai
  • Japan
      • Kanagawa, Japan, 234-8503
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naoki Miyazawa
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence Sindel
    • California
      • La Palma, California, United States, 90623
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Morado
    • Florida
      • Miami, Florida, United States, 33126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Campos-Yatzkan
      • Miami, Florida, United States, 33176
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juvenal Martinez
      • Naples, Florida, United States, 34102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisette Delgado Sanchez
      • Plantation, Florida, United States, 33324
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frank Hull
        • Contact:
        • Contact:
      • St. Petersburg, Florida, United States, 33707
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamed Ali Eltoum
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asefa Mekonnen
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandeep Bansal
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Charles Thompson
        • Contact:
        • Contact:
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Denenberg
        • Contact:
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Farhan Siddiqui
        • Contact:
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ather Siddiqi
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Subodh Bhuchar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive matching placebo.
Drug: Placebo
Participants will be administered with matching placebo.
Experimental: GSK3862995B Dose Level 1
Participants will receive GSK3862995B Dose level 1.
Drug: GSK3862995B
Participants will be administered with dose level 1 of GSK3862995B.
Experimental: GSK3862995B Dose Level 2
Participants will receive GSK3862995B Dose level 2.
Drug: GSK3862995B
Participants will be administered with dose level 1 of GSK3862995B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of Exacerbations for GSK3862995B Dose Level 1 Following Repeat Doses Compared with 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.
Up to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of Exacerbations for GSK3862995B Dose Level 2 Following Repeat Doses Compared with Placebo
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.
Up to Week 48
Time to first Exacerbation for GSK3862995B Dose Level 2 and Dose Level 1 Compared to Placebo
Time Frame: Up to Week 48
Up to Week 48
Annualized Rate of Severe Exacerbations for GSK3862995B Dose Level 1 and Dose Level 2 Compared to Placebo
Time Frame: Up to Week 48
Annualized rate of exacerbations for GSK3862995B dose 1 and dose 2 compared to placebo will be evaluated.
Up to Week 48
Change from Baseline in Quality-of-life bronchiectasis respiratory symptom scale score (QOL-B RSS)
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.
Baseline up to Week 48
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ)
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.
Baseline up to Week 48
Change from Baseline in Post-bronchodilator Forced expiratory volume in one second (FEV1) value
Time Frame: Baseline up to Week 48
Change from baseline in post-bronchodilator FEV1 value will be reported.
Baseline up to Week 48
Number of Participants with Serious Adverse Events (SAE)
Time Frame: From screening (Day -1) up to Week 72
Number of participants with SAEs will be reported.
From screening (Day -1) up to Week 72
Number of Participants with of Adverse Events (AE)
Time Frame: From randomization (Day 1) to Week 72
Number of Participants with AEs will be reported.
From randomization (Day 1) to Week 72
Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time Frame: Up to Week 72
Number of participants with clinically significant changes in laboratory data (hematology, chemistry, and urinalysis) will be reported.
Up to Week 72
Number of Participants with Clinically Significant Changes from Baseline in Vital Signs
Time Frame: Up to Week 72
Number of participants with clinically significant changes from baseline in vital signs will be reported.
Up to Week 72
Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG)
Time Frame: Up to Week 72
Number of participants with clinically significant changes from baseline in 12-lead electrocardiogram will be reported.
Up to Week 72
Serum Concentration of GSK3862995B
Time Frame: Week 1 up to Week 48
Serum concentration of GSK3862995B following repeated dose level 1 and dose level 2 will be reported.
Week 1 up to Week 48
Number of Participants with Anti-drug Antibodies (ADAs) Against GSK3862995B
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.
Up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

May 4, 2027

Study Completion (Estimated)

December 10, 2027

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Actual)

October 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223977
  • 2025-522892-27-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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