Bronchiectasis
Conditions
Interventions
GSK3862995B 600 mg, GSK3862995B 300 mg, or placebo will be administered subcutaneously once every 12 weeks (up to 4 doses).
Sponsors
Motoda Yuichiro
Eligibility
Sex/Gender
All
Inclusion 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 (=) 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
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 (450 milliseconds (msec) at screening visit based on the average of triplicate ECGs. - Participants with a known, pre-existing parasitic infestation within 6 months prior to screening The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of exacerbations | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of exacerbations. Time-to-first exacerbation. Annualized rate of severe exacerbations. Absolute change from baseline in the quality-of-life bronchiectasis respiratory symptom scale score (QOL-B RSS) at Weeks 24, 36 and 48. Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) at Weeks 24, 36 and 48. Absolute change from baseline in postbronchodilator forced expiratory volume in one second (FEV1) value at Weeks 24, 36 and 48. Occurrence of SAEs, from screening up to, and including, the follow-up period. Occurrence of AEs, from the first dose up to, and including, the follow-up period. Occurrence of clinically significant changes from baseline in clinical laboratory parameters (hematology, clinical chemistry, urinalysis), vital signs, and cardiac parameters (12-lead ECG) from first dose up to the follow-up period. Serum concentrations of GSK3862995B at Week 1, 12 (pre-dose), 13, 24 (pre-dose), 36 (pre-dose), and 48. Incidence and titers of anti-drug antibodies (ADAs) against GSK3862995B. | — |
Countries
Argentina, Australia, Chile, Denmark, France, Germany, Israel, Italy, Japan, Korea, New Zealand, Poland, Spain, United Kingdom, United States
Contacts
Public ContactYuichiro Motoda
PPD-SNBL K.K.
Outcome results
None listed