Health TrialsbyHealthPanel

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

ConditionBronchiectasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) between 18-35 kilograms per square meters (kg/m²)

Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) that is confirmed on chest computed tomography (CT)

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GSK3862995B

    Drug

    Participants will be administered with dose level 1 of GSK3862995B.

  • Placebo

    Drug

    Participants will be administered with matching placebo.

Treatment groups

363 Participants
are divided into 3 treatment groups
Group A: GSK3862995B Dose Level 1Experimental treatment 1 intervention
Group B: GSK3862995B Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Annualized rate of exacerbations for GSK3862995B dose 1 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.

Time frame
Up to Week 48

Secondary outcomes

1

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

Annualized rate of exacerbations for GSK3862995B dose 2 following repeat doses compared with placebo in participants with bronchiectasis will be evaluated.

Time frame
Up to Week 48
2

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

Time frame
Up to Week 48
3

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

Annualized rate of exacerbations for GSK3862995B dose 1 and dose 2 compared to placebo will be evaluated.

Time frame
Up to Week 48
4

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

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.

Time frame
Baseline up to Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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