Last updated: 09/23/2025 17:20:09

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

GSK study ID
223977
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants with Bronchiectasis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Annualized rate of Exacerbations for GSK3862995B Dose Level 1 Following Repeat Doses Compared with Placebo

Timeframe: Up to Week 48

Secondary outcomes:

Annualized rate of Exacerbations for GSK3862995B Dose Level 2 Following Repeat Doses Compared with Placebo

Timeframe: Up to Week 48

Time to first Exacerbation for GSK3862995B Dose Level 2 and Dose Level 1 Compared to Placebo

Timeframe: Up to Week 48

Annualized Rate of Severe Exacerbations for GSK3862995B Dose Level 1 and Dose Level 2 Compared to Placebo

Timeframe: Up to Week 48

Change from Baseline in Quality-of-life bronchiectasis respiratory symptom scale score (QOL-B RSS)

Timeframe: Baseline up to Week 48

Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ)

Timeframe: Baseline up to Week 48

Change from Baseline in Post-bronchodilator Forced expiratory volume in one second (FEV1) value

Timeframe: Baseline up to Week 48

Number of Participants with Serious Adverse Events (SAE)

Timeframe: From screening (Day -1) up to Week 72

Number of Participants with of Adverse Events (AE)

Timeframe: From randomization (Day 1) to Week 72

Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

Timeframe: Up to Week 72

Number of Participants with Clinically Significant Changes from Baseline in Vital Signs

Timeframe: Up to Week 72

Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECG)

Timeframe: Up to Week 72

Serum Concentration of GSK3862995B

Timeframe: Week 1 up to Week 48

Number of Participants with Anti-drug Antibodies (ADAs) Against GSK3862995B

Timeframe: Up to Week 72

Interventions:
  • Drug: GSK3862995B
  • Drug: Placebo
  • Enrollment:
    400
    Primary completion date:
    2027-15-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Bronchiectasis
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2025 to November 2027
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 85 Years
    Accepts healthy volunteers
    No
    • 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)
    • 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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