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Tests treatment safety and results for Bronchiectasis
Official title A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis
ClinicalTrials.gov ID: NCT07201051
What this study is testing
What is GSK3862995B?
GSK3862995B is an investigational medicine, being studied as a potential treatment for bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 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...
- Active non-tuberculosis mycobacterial (NTM) lung infection on treatment or meeting ATS/Infectious Diseases Society of America (IDSA) criteria for...
- 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...
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- La Palma, California, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Plantation, Florida, United States
- St. Petersburg, Florida, United States
- Rockville, Maryland, United States
- DuBois, Pennsylvania, United States
- Anderson, South Carolina, United States
- Rock Hill, South Carolina, United States
- Spartanburg, South Carolina, United States
- Conroe, Texas, United States
- Sugar Land, Texas, United States
- Beijing, China
- Chongqing, China
- Dongguan, China
- Guangzhou, China
- Guilin, China
- Hangzhou, China
- Huizhou, China
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; La Palma, California, United States; Miami, Florida, United States; Naples, Florida, United States; Plantation, Florida, United States; St. Petersburg, Florida, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.