What this study is
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.
What's being tested
- GSK3862995B
Intervention · DRUG
Participants will be administered with dose level 1 of GSK3862995B.
- Placebo
Intervention · DRUG
Participants will be administered with matching placebo.
Study details
- Official title
- A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Investigate Efficacy, Safety, Immunogenicity, and Pharmacokinetics, of GSK3862995B in Participants With Bronchiectasis
- Sponsor
- GlaxoSmithKline
- Conditions
- Bronchiectasis
- Enrolling
- 363 people
- Starts
- 2025-10-30
- Est. completion
- 2027-12-10
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify 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 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
You 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 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (134)
134 openContact for every open site
- US GSK Clinical Trials Call Center · Contact877-379-3718GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Centre · Contact+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Mobile, Alabama, United States
- Lawrence Sindel · Principal investigator
RecruitingGSK Investigational Site
Phoenix, Arizona, United States
- Da-Wei Liao · Principal investigator
RecruitingGSK Investigational Site
La Palma, California, United States
- Andrew Morado · Principal investigator
RecruitingGSK Investigational Site
Valencia, California, United States
- Rami El Yousef · Principal investigator
RecruitingGSK Investigational Site
Aurora, Colorado, United States
- Nathaniel Moore · Principal investigator
RecruitingGSK Investigational Site
Miami, Florida, United States
- Maria Campos-Yatzkan · Principal investigator
RecruitingGSK Investigational Site
Miami, Florida, United States
- Juvenal Martinez · Principal investigator
RecruitingGSK Investigational Site
Naples, Florida, United States
- Lisette Delgado Sanchez · Principal investigator
RecruitingGSK Investigational Site
Pembroke Pines, Florida, United States
- Jorge Konopka · Principal investigator
RecruitingGSK Investigational Site
Plantation, Florida, United States
- Frank Hull · Principal investigator
RecruitingGSK Investigational Site
St. Petersburg, Florida, United States
- Mohamed Ali Eltoum · Principal investigator
RecruitingGSK Investigational Site
Tamarac, Florida, United States
- Mazyar Rouhani · Principal investigator
RecruitingGSK Investigational Site
Winter Park, Florida, United States
- Shirish Kirtane · Principal investigator
RecruitingGSK Investigational Site
Hammond, Indiana, United States
- Mohan Kesani · Principal investigator
RecruitingGSK Investigational Site
New Orleans, Louisiana, United States
- Shelby MacRae · Principal investigator
RecruitingGSK Investigational Site
Rockville, Maryland, United States
- Asefa Mekonnen · Principal investigator
RecruitingGSK Investigational Site
St Louis, Missouri, United States
- Shail Mehta · Principal investigator
RecruitingGSK Investigational Site
Henderson, Nevada, United States
- Vikas Sayal · Principal investigator
RecruitingGSK Investigational Site
New Hyde Park, New York, United States
- Effie Singas · Principal investigator
RecruitingGSK Investigational Site
Winston-Salem, North Carolina, United States
- Benjamin Bregman · Principal investigator
RecruitingGSK Investigational Site
DuBois, Pennsylvania, United States
- Sandeep Bansal · Principal investigator
RecruitingGSK Investigational Site
Anderson, South Carolina, United States
- Charles Thompson · Principal investigator
RecruitingGSK Investigational Site
Rock Hill, South Carolina, United States
- Michael Denenberg · Principal investigator
RecruitingGSK Investigational Site
Spartanburg, South Carolina, United States
- Farhan Siddiqui · Principal investigator
RecruitingGSK Investigational Site
Union, South Carolina, United States
- Joseph Boscia · Principal investigator
RecruitingGSK Investigational Site
Franklin, Tennessee, United States
- Aaron Milstone · Principal investigator
RecruitingGSK Investigational Site
Knoxville, Tennessee, United States
- Bashar Bargoty · Principal investigator
RecruitingGSK Investigational Site
Conroe, Texas, United States
- Ather Siddiqi · Principal investigator
RecruitingGSK Investigational Site
Cypress, Texas, United States
- Dileep Puppala · Principal investigator
RecruitingGSK Investigational Site
Sugar Land, Texas, United States
- Subodh Bhuchar · Principal investigator
RecruitingGSK Investigational Site
Williamsburg, Virginia, United States
- Richard Parisi · Principal investigator
Recruiting
103 sites outside the US
GSK Investigational Site
Buenos Aires, Argentina
- Jose Maria Malet Ruiz · Principal investigator
RecruitingGSK Investigational Site
CABA, Argentina
- Abel Bordon · Principal investigator
RecruitingGSK Investigational Site
CABA, Argentina
- María Cristina De Salvo · Principal investigator
RecruitingGSK Investigational Site
Rosario Provincia de Santa FE, Argentina
- Tomas Alvarez · Principal investigator
RecruitingGSK Investigational Site
San Miguel de Tucumán, Argentina
- Ana Stok · Principal investigator
RecruitingGSK Investigational Site
San Miguel de Tucumán, Argentina
- Roxana Willigs Rolon · Principal investigator
RecruitingGSK Investigational Site
San Miguel de Tucumán, Argentina
- Maria Espeche · Principal investigator
RecruitingGSK Investigational Site
Santa Fe, Argentina
- Martin Maillo · Principal investigator
RecruitingGSK Investigational Site
Beijing, China
- Zhaohui Tong · Principal investigator
RecruitingGSK Investigational Site
Chongqing, China
- Qianli Ma · Principal investigator
RecruitingGSK Investigational Site
Dongguan, China
- Lei Wu · Principal investigator
RecruitingGSK Investigational Site
Guangzhou, China
- Zhuxiang Zhao · Principal investigator
RecruitingGSK Investigational Site
Guangzhou, China
- Guan Weijie · Principal investigator
RecruitingGSK Investigational Site
Guilin, China
- Bin Huang · Principal investigator
RecruitingGSK Investigational Site
Hangzhou, China
- Limin Wang · Principal investigator
RecruitingGSK Investigational Site
Huizhou, China
- Feng Wu · Principal investigator
RecruitingGSK Investigational Site
Jiangmen, China
- yanming huang · Principal investigator
RecruitingGSK Investigational Site
Jiangsu, China
- Bi Chen · Principal investigator
RecruitingGSK Investigational Site
Nanjing, China
- Surong Fang · Principal investigator
RecruitingGSK Investigational Site
Qingyuan, China
- Dongbo Tian · Principal investigator
RecruitingGSK Investigational Site
Shanghai, China
- Jinfu Xu · Principal investigator
RecruitingGSK Investigational Site
Taizhou, China
- Jiaxi Feng · Principal investigator
RecruitingGSK Investigational Site
Weifang, China
- Guoru Yang · Principal investigator
RecruitingGSK Investigational Site
Yangzhou, China
- Feng Wu · Principal investigator
RecruitingGSK Investigational Site
Zhanjiang, China
- Bin Wu · Principal investigator
RecruitingGSK Investigational Site
Bendorf, Germany
- Olaf Schmidt · Principal investigator
RecruitingGSK Investigational Site
Berlin, Germany
- Thomas Schultz · Principal investigator
RecruitingGSK Investigational Site
Frankfurt, Germany
- Claus Keller · Principal investigator
RecruitingGSK Investigational Site
Frankfurt, Germany
- Marc Oliver Kornmann · Principal investigator
RecruitingGSK Investigational Site
Geesthacht, Germany
- Wolfgang Zachgo · Principal investigator
RecruitingGSK Investigational Site
Hamburg, Germany
- Sven Aries · Principal investigator
RecruitingGSK Investigational Site
München, Germany
- Rainald Fischer · Principal investigator
RecruitingGSK Investigational Site
Ashdod, Israel
- Daniel Starobin · Principal investigator
RecruitingGSK Investigational Site
Ashkelon, Israel
- Ori Wand · Principal investigator
RecruitingGSK Investigational Site
Beersheba, Israel
- Yael Raviv · Principal investigator
RecruitingGSK Investigational Site
Haifa, Israel
- Michal Shteinberg · Principal investigator
RecruitingGSK Investigational Site
Jerusalem, Israel
- Gabriel Izbicki · Principal investigator
RecruitingGSK Investigational Site
Jerusalem, Israel
- Neville Berkman · Principal investigator
RecruitingGSK Investigational Site
Kfar Saba, Israel
- David Shitrit · Principal investigator
RecruitingGSK Investigational Site
Koranit, Israel
- Yaniv Dotan · Principal investigator
RecruitingGSK Investigational Site
Petah Tikva, Israel
- Moshe Heching · Principal investigator
RecruitingGSK Investigational Site
Tel Aviv, Israel
- Amir Bar Shai · Principal investigator
RecruitingGSK Investigational Site
Milan, Italy
- Francesco Blasi · Principal investigator
RecruitingGSK Investigational Site
Naples, Italy
- Rosa Di Matteo · Principal investigator
RecruitingGSK Investigational Site
Roma, Italy
- Franco Pasqua · Principal investigator
RecruitingGSK Investigational Site
Toyonaka-Shi, Osaka, Japan
- Hiroshi Kida · Principal investigator
RecruitingGSK Investigational Site
Aichi, Japan
- Taku Nakagawa · Principal investigator
RecruitingGSK Investigational Site
Aichi, Japan
- Makoto Ishii · Principal investigator
RecruitingGSK Investigational Site
Fukuoka, Japan
- Shohei Takata · Principal investigator
RecruitingGSK Investigational Site
Fukuoka, Japan
- Isamu Okamoto · Principal investigator
RecruitingGSK Investigational Site
Fukuoka, Japan
- Masaki Fujita · Principal investigator
RecruitingGSK Investigational Site
Fukuoka, Japan
- Kazunori Tobino · Principal investigator
RecruitingGSK Investigational Site
Hyōgo, Japan
- Ryo Tachikawa · Principal investigator
RecruitingGSK Investigational Site
Ibaraki, Japan
- Takeo Endo · Principal investigator
RecruitingGSK Investigational Site
Ibaraki, Japan
- Takefumi Saito · Principal investigator
RecruitingGSK Investigational Site
Ishikawa, Japan
- Toshiyuki Kita · Principal investigator
RecruitingGSK Investigational Site
Kanagawa, Japan
- Naoki Miyazawa · Principal investigator
RecruitingGSK Investigational Site
Kanagawa, Japan
- Tomoya Fukui · Principal investigator
RecruitingGSK Investigational Site
Mie, Japan
- Osamu Hataji · Principal investigator
RecruitingGSK Investigational Site
Miyagi, Japan
- Yukihiro Toi · Principal investigator
RecruitingGSK Investigational Site
Osaka, Japan
- Satoshi Marumo · Principal investigator
RecruitingGSK Investigational Site
Tokyo, Japan
- Jin Takasaki · Principal investigator
RecruitingGSK Investigational Site
Tokyo, Japan
- Kozo Morimoto · Principal investigator
RecruitingGSK Investigational Site
Tokyo, Japan
- Osamu Narumoto · Principal investigator
RecruitingGSK Investigational Site
Auckland, New Zealand
- Sandra Hotu · Principal investigator
RecruitingGSK Investigational Site
Kapiti, New Zealand
- Andrew Edwards · Principal investigator
RecruitingGSK Investigational Site
Bialystok, Poland
- Robert Mroz · Principal investigator
RecruitingGSK Investigational Site
Ksawerów, Poland
- Adam Śmiałowski · Principal investigator
RecruitingGSK Investigational Site
Piaseczno, Poland
- Adam Nowinski · Principal investigator
RecruitingGSK Investigational Site
Rzeszów, Poland
- Małgorzata Pawlukiewicz · Principal investigator
RecruitingGSK Investigational Site
Sosnowiec, Poland
- Grzegorz Gasior · Principal investigator
RecruitingGSK Investigational Site
Busan, South Korea
- Jae Ha Lee · Principal investigator
RecruitingGSK Investigational Site
Incheon, South Korea
- Sung Hwan Jeong · Principal investigator
RecruitingGSK Investigational Site
Incheon, South Korea
- Hyesoo Kim · Principal investigator
RecruitingGSK Investigational Site
Jeonju, South Korea
- So Ri Kim · Principal investigator
RecruitingGSK Investigational Site
Seoul, South Korea
- Sang Haak Lee · Principal investigator
RecruitingGSK Investigational Site
Seoul, South Korea
- Hyun Lee · Principal investigator
RecruitingGSK Investigational Site
Seoul, South Korea
- Min Kwang Byun · Principal investigator
RecruitingGSK Investigational Site
Seoul, South Korea
- Kyung Hoon Min · Principal investigator
RecruitingGSK Investigational Site
Seoul, South Korea
- Jung-Kyu Lee · Principal investigator
RecruitingGSK Investigational Site
Barcelona, Spain
- Esther Barreiro Portela · Principal investigator
RecruitingGSK Investigational Site
Barcelona, Spain
- Eva Polverino · Principal investigator
RecruitingGSK Investigational Site
Barcelona, Spain
- Oriol Sibila · Principal investigator
RecruitingGSK Investigational Site
Lleida, Spain
- Jessica Gonzalez Gutierrez · Principal investigator
RecruitingGSK Investigational Site
Madrid, Spain
- Jesus Fernandez Frances · Principal investigator
RecruitingGSK Investigational Site
Madrid, Spain
- Carolina María Gotera Rivera · Principal investigator
RecruitingGSK Investigational Site
Madrid, Spain
- Layla Diab Caceres · Principal investigator
RecruitingGSK Investigational Site
Madrid, Spain
- Jose Maria Echave-Sustaeta · Principal investigator
RecruitingGSK Investigational Site
MErida Badajoz, Spain
- Antonio Manuel Pérez Fernández · Principal investigator
RecruitingGSK Investigational Site
Oviedo, Spain
- Marta García Clemente · Principal investigator
RecruitingGSK Investigational Site
Valencia, Spain
- Asier Bengoechea · Principal investigator
RecruitingGSK Investigational Site
North Finchley, London, United Kingdom
- Kamran Hussain · Principal investigator
RecruitingGSK Investigational Site
Bedford, United Kingdom
- Peter Adura · Principal investigator
RecruitingGSK Investigational Site
Bristol Avon, United Kingdom
- Rahul Bhatnagar · Principal investigator
RecruitingGSK Investigational Site
Coventry, United Kingdom
- Beatriz Lara Gallego · Principal investigator
RecruitingGSK Investigational Site
Dagenham, United Kingdom
- Suman Paul · Principal investigator
RecruitingGSK Investigational Site
Dundee, United Kingdom
- James Chalmers · Principal investigator
RecruitingGSK Investigational Site
High Wycombe, United Kingdom
- Ronnie Beboso · Principal investigator
RecruitingGSK Investigational Site
Little Baldon, United Kingdom
- Abdulsalam Shahin · Principal investigator
RecruitingGSK Investigational Site
Liverpool, United Kingdom
- Frederick Frost · Principal investigator
RecruitingGSK Investigational Site
London, United Kingdom
- Suman Paul · Principal investigator
RecruitingGSK Investigational Site
Sheffield, United Kingdom
- Hani Abo-Leyah · Principal investigator
RecruitingGSK Investigational Site
Tyne and Wear, United Kingdom
- John Steer · Principal investigator
Recruiting
Study team
Sponsor
GlaxoSmithKline
Study ID 223977
Study director
GSK Clinical Trials
GlaxoSmithKline
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.