Condition

Patients with Bronchiectasis

Purpose of the study

To find out how effective and safe a new drug, GSK3862995B, is for adult participants with bronchiectasis, a chronic lung disease.

Official Title

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis. NCT07201051

Who is eligible to participate?

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)
• 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
• 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 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
• 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
• Significant allergies to humanized monoclonal antibodies

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane