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RECRUITING

NCT07201051

PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

363

Start Date

2025-10-30

Completion Date

2027-12-10

Last Updated

2026-08-12

Healthy Volunteers

Conditions

Bronchiectasis

Interventions

DRUG

GSK3862995B

Participants will be administered with dose level 1 of GSK3862995B.

DRUG

Placebo

Participants will be administered with matching placebo.

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 (\<)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 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 (\<=)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 participation in a clinical trial.

Locations (134)

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

La Palma, California, United States

GSK Investigational Site

Valencia, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Naples, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Tamarac, Florida, United States

GSK Investigational Site

Winter Park, Florida, United States

GSK Investigational Site

Hammond, Indiana, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Rockville, Maryland, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

New Hyde Park, New York, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

DuBois, Pennsylvania, United States

GSK Investigational Site

Anderson, South Carolina, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

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Union, South Carolina, United States

GSK Investigational Site

Franklin, Tennessee, United States

GSK Investigational Site

Knoxville, Tennessee, United States

GSK Investigational Site

Conroe, Texas, United States

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Cypress, Texas, United States

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Sugar Land, Texas, United States

GSK Investigational Site

Williamsburg, Virginia, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

CABA, Argentina

GSK Investigational Site

CABA, Argentina

GSK Investigational Site

Rosario Provincia de Santa FE, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Beijing, China

GSK Investigational Site

Chongqing, China

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Dongguan, China

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Guangzhou, China

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Guangzhou, China

GSK Investigational Site

Guilin, China

GSK Investigational Site

Hangzhou, China

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Huizhou, China

GSK Investigational Site

Jiangmen, China

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Jiangsu, China

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Nanjing, China

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Qingyuan, China

GSK Investigational Site

Shanghai, China

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Taizhou, China

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Weifang, China

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Yangzhou, China

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Zhanjiang, China

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Bendorf, Germany

GSK Investigational Site

Berlin, Germany

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Frankfurt, Germany

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Frankfurt, Germany

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Geesthacht, Germany

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Hamburg, Germany

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München, Germany

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Ashdod, Israel

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Ashkelon, Israel

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Beersheba, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Koranit, Israel

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Petah Tikva, Israel

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Tel Aviv, Israel

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Milan, Italy

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Naples, Italy

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Roma, Italy

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Toyonaka-Shi, Osaka, Japan

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Aichi, Japan

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Aichi, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Ibaraki, Japan

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Ishikawa, Japan

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Kanagawa, Japan

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Kanagawa, Japan

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Mie, Japan

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Miyagi, Japan

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Osaka, Japan

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Tokyo, Japan

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Tokyo, Japan

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Tokyo, Japan

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Auckland, New Zealand

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Kapiti, New Zealand

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Bialystok, Poland

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Ksawerów, Poland

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Piaseczno, Poland

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Rzeszów, Poland

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Sosnowiec, Poland

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Busan, South Korea

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Incheon, South Korea

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Incheon, South Korea

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Jeonju, South Korea

GSK Investigational Site

Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

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Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Lleida, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

MErida Badajoz, Spain

GSK Investigational Site

Oviedo, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

North Finchley, London, United Kingdom

GSK Investigational Site

Bedford, United Kingdom

GSK Investigational Site

Bristol Avon, United Kingdom

GSK Investigational Site

Coventry, United Kingdom

GSK Investigational Site

Dagenham, United Kingdom

GSK Investigational Site

Dundee, United Kingdom

GSK Investigational Site

High Wycombe, United Kingdom

GSK Investigational Site

Little Baldon, United Kingdom

GSK Investigational Site

Liverpool, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Sheffield, United Kingdom

GSK Investigational Site

Tyne and Wear, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (134)