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NCT07201051PHASE2Recruiting

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

GlaxoSmithKline

Start Date

10/30/2025

Completion Date

12/10/2027

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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.

Interventions

DRUG

GSK3862995B

DRUG

Placebo

Interested in This Trial?

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Conditions

Bronchiectasis

Locations

GSK Investigational Site

Mobile, Alabama 36608

United States

GSK Investigational Site

Phoenix, Arizona 85027

United States

GSK Investigational Site

La Palma, California 90623

United States

GSK Investigational Site

Valencia, California 91355

United States

GSK Investigational Site

Aurora, Colorado 80012

United States

GSK Investigational Site

Miami, Florida 33126

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Naples, Florida 34102

United States

GSK Investigational Site

Pembroke Pines, Florida 33029

United States

GSK Investigational Site

Plantation, Florida 33324

United States

GSK Investigational Site

St. Petersburg, Florida 33707

United States

GSK Investigational Site

Tamarac, Florida 33321

United States

GSK Investigational Site

Winter Park, Florida 32789

United States

GSK Investigational Site

Hammond, Indiana 46324

United States

GSK Investigational Site

New Orleans, Louisiana 70112

United States

GSK Investigational Site

Rockville, Maryland 20854

United States

GSK Investigational Site

St Louis, Missouri 63110

United States

GSK Investigational Site

Henderson, Nevada 89052

United States

GSK Investigational Site

New Hyde Park, New York 11040

United States

GSK Investigational Site

Winston-Salem, North Carolina 27103

United States

GSK Investigational Site

DuBois, Pennsylvania 15801

United States

GSK Investigational Site

Anderson, South Carolina 29621

United States

GSK Investigational Site

Rock Hill, South Carolina 29732

United States

GSK Investigational Site

Spartanburg, South Carolina 29303

United States

GSK Investigational Site

Union, South Carolina 29379

United States

GSK Investigational Site

Franklin, Tennessee 37067

United States

GSK Investigational Site

Knoxville, Tennessee 37919

United States

GSK Investigational Site

Conroe, Texas 77384

United States

GSK Investigational Site

Cypress, Texas 77429

United States

GSK Investigational Site

Sugar Land, Texas 77479

United States

GSK Investigational Site

Williamsburg, Virginia 23188

United States

GSK Investigational Site

Buenos Aires, C1128AAF

Argentina

GSK Investigational Site

CABA, C1023AAB

Argentina

GSK Investigational Site

CABA, C1426ABP

Argentina

GSK Investigational Site

Rosario Provincia de Santa FE, S2000DEJ

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IAI

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IFL

Argentina

GSK Investigational Site

San Miguel de Tucumán, T4000IHE

Argentina

GSK Investigational Site

Santa Fe, S3000ASF

Argentina

GSK Investigational Site

Beijing, 100020

China

GSK Investigational Site

Chongqing, 408099

China

GSK Investigational Site

Dongguan, 523326

China

GSK Investigational Site

Guangzhou, 510180

China

GSK Investigational Site

Guangzhou, 510230

China

GSK Investigational Site

Guilin, 541002

China

GSK Investigational Site

Hangzhou, 310000

China

GSK Investigational Site

Huizhou, 516000

China

GSK Investigational Site

Jiangmen, 529700

China

GSK Investigational Site

Jiangsu, 221004

China

GSK Investigational Site

Nanjing, 210012

China

GSK Investigational Site

Qingyuan, 511500

China

GSK Investigational Site

Shanghai,

China

GSK Investigational Site

Taizhou, 317000

China

GSK Investigational Site

Weifang,

China

GSK Investigational Site

Yangzhou, 225001

China

GSK Investigational Site

Zhanjiang, 524001

China

GSK Investigational Site

Bendorf, 56170

Germany

GSK Investigational Site

Berlin, 12203

Germany

GSK Investigational Site

Frankfurt, 60389

Germany

GSK Investigational Site

Frankfurt, 60596

Germany

GSK Investigational Site

Geesthacht, 21502

Germany

GSK Investigational Site

Hamburg, 22767

Germany

GSK Investigational Site

München, 81241

Germany

GSK Investigational Site

Ashdod, 7747629

Israel

GSK Investigational Site

Ashkelon, 78278

Israel

GSK Investigational Site

Beersheba, 84101

Israel

GSK Investigational Site

Haifa, 3436212

Israel

GSK Investigational Site

Jerusalem, 91031

Israel

GSK Investigational Site

Jerusalem, 91120

Israel

GSK Investigational Site

Kfar Saba, 44281

Israel

GSK Investigational Site

Koranit, 2018100

Israel

GSK Investigational Site

Petah Tikva, 49100

Israel

GSK Investigational Site

Tel Aviv, 64239

Israel

GSK Investigational Site

Milan, 20122

Italy

GSK Investigational Site

Naples, 80131

Italy

GSK Investigational Site

Roma, 11166

Italy

GSK Investigational Site

Toyonaka-Shi, Osaka 560-0045

Japan

GSK Investigational Site

Aichi, 465-8620

Japan

GSK Investigational Site

Aichi, 466-8560

Japan

GSK Investigational Site

Fukuoka, 811-3195

Japan

GSK Investigational Site

Fukuoka, 812-0054

Japan

GSK Investigational Site

Fukuoka, 814-0180

Japan

GSK Investigational Site

Fukuoka, 820-8505

Japan

GSK Investigational Site

Hyōgo, 650-0047

Japan

GSK Investigational Site

Ibaraki, 311-3193

Japan

GSK Investigational Site

Ibaraki, 319-1113

Japan

GSK Investigational Site

Ishikawa, 920-8650

Japan

GSK Investigational Site

Kanagawa, 234-8503

Japan

GSK Investigational Site

Kanagawa, 247-8533

Japan

GSK Investigational Site

Mie, 515-8544

Japan

GSK Investigational Site

Miyagi, 980-0873

Japan

GSK Investigational Site

Osaka, 530-8480

Japan

GSK Investigational Site

Tokyo, 162-8655

Japan

GSK Investigational Site

Tokyo, 204-8522

Japan

GSK Investigational Site

Tokyo, 204-8585

Japan

GSK Investigational Site

Auckland, 1051

New Zealand

GSK Investigational Site

Kapiti, 5036

New Zealand

GSK Investigational Site

Bialystok, 15-044

Poland

GSK Investigational Site

Ksawerów, 95-054

Poland

GSK Investigational Site

Piaseczno, 05-500

Poland

GSK Investigational Site

Rzeszów, 35-051

Poland

GSK Investigational Site

Sosnowiec, 41-208

Poland

GSK Investigational Site

Busan, 48108

South Korea

GSK Investigational Site

Incheon, 21565

South Korea

GSK Investigational Site

Incheon, 22332

South Korea

GSK Investigational Site

Jeonju, 54907

South Korea

GSK Investigational Site

Seoul, 03312

South Korea

GSK Investigational Site

Seoul, 04763

South Korea

GSK Investigational Site

Seoul, 06273

South Korea

GSK Investigational Site

Seoul, 08308

South Korea

GSK Investigational Site

Seoul, 7061

South Korea

GSK Investigational Site

Barcelona, 08003

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Barcelona, 08036

Spain

GSK Investigational Site

Lleida, 25198

Spain

GSK Investigational Site

Madrid, 28003

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28223

Spain

GSK Investigational Site

MErida Badajoz, 06800

Spain

GSK Investigational Site

Oviedo, 33011

Spain

GSK Investigational Site

Valencia, 46015

Spain

GSK Investigational Site

North Finchley, London N3 2JU

United Kingdom

GSK Investigational Site

Bedford, MK40 2FG

United Kingdom

GSK Investigational Site

Bristol Avon, BS10 5NB

United Kingdom

GSK Investigational Site

Coventry, CV2 2DX

United Kingdom

GSK Investigational Site

Dagenham, RM9 5NH

United Kingdom

GSK Investigational Site

Dundee, DD1 9SY

United Kingdom

GSK Investigational Site

High Wycombe, HP11 2QW

United Kingdom

GSK Investigational Site

Little Baldon, OX44 9PU

United Kingdom

GSK Investigational Site

Liverpool, L14 3PE

United Kingdom

GSK Investigational Site

London, N8 0RA

United Kingdom

GSK Investigational Site

Sheffield, S5 7AU

United Kingdom

GSK Investigational Site

Tyne and Wear, NE29 8NH

United Kingdom