Clinical trials: active, sponsored by GlaxoSmithKline
Chronic Hepatitis B Virus Infection, Hepatitis B
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy.
- Trial name
- B-UNITED (NCT06537414)
- Testing
- Daplusiran/Tomligisiran Dose Level 1, Daplusiran/Tomligisiran Dose Level 2, Bepirovirsen
- Where
- 80 sites in United States, Australia and 17 more
- Volunteers
- 283 people
- Sponsor
- GlaxoSmithKline
Asthma, Mild Asthma
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1)…
- Trial name
- NCT06433921
- Testing
- Salbutamol HFA-152a, Salbutamol HFA-134a
- Where
- United Kingdom
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary…
- Trial name
- NCT06154837
- Testing
- GSK3862995B
- Where
- 31 sites in United States, Germany and 1 more
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
- Trial name
- B-Focus (NCT06497504)
- Testing
- Bepirovirsen
- Where
- 51 sites in United States, Argentina and 8 more
- Volunteers
- 153 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study…
- Trial name
- B-Sure (NCT04954859)
- Testing
- Bepirovirsen
- Where
- 161 sites in United States, Argentina and 27 more
- Volunteers
- 366 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
- Trial name
- NCT07780669
- Testing
- GSK5784283, Standard of care
- Where
- 7 sites in United States, Japan
- Volunteers
- 624 people
- Sponsor
- GlaxoSmithKline
Diarrhoea
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study…
- Trial name
- H06_04TP (NCT07320716)
- Testing
- AltSonflex1-2-3, Menveo, Infanrix hexa
- Where
- Kenya
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Nasal Polyps
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
The aim of this study is to assess the efficacy and safety of GSK5784283 administered as add-on maintenance therapy to participants with CRSwNP.
- Trial name
- PERSISTCRSwNP1 (NCT07782970)
- Testing
- GSK5784283, Standard of Care
- Where
- 8 sites in United States, Japan and 1 more
- Volunteers
- 218 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the…
- Trial name
- NCT07220109
- Testing
- RSVPreF3 OA vaccine
- Where
- 15 sites in China
- Volunteers
- 750 people
- Sponsor
- GlaxoSmithKline
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Asthma
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
The purpose of this study is to compare how two different formulations of the study medicine (GSK5784283) move through the body over time (pharmacokinetic [PK] study) in healthy adults.
- Trial name
- NCT07712393
- Testing
- GSK5784283
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-associated Steatohepatitis
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-1 (NCT07701993)
- Testing
- Efimosfermin alfa
- Where
- 30 sites in United States, Japan
- Volunteers
- 1,740 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-associated Steatohepatitis
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-2 (NCT07704892)
- Testing
- Efimosfermin alfa
- Where
- 35 sites in United States, Japan
- Volunteers
- 380 people
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
- Trial name
- NCT07782996
- Testing
- GSK5784283, Standard of care
- Where
- 7 sites in United States
- Volunteers
- 370 people
- Sponsor
- GlaxoSmithKline
Liver Diseases, Alcoholic
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
- Trial name
- ALLSTAR (NCT07791043)
- Testing
- Efimosfermin alfa
- Where
- 13 sites in United States, Argentina and 2 more
- Volunteers
- 274 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
- Trial name
- NCT07780656
- Testing
- GSK5784283, Standard of care
- Where
- 8 sites in United States
- Volunteers
- 624 people
- Sponsor
- GlaxoSmithKline
Colitis, Ulcerative
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.
- Trial name
- NCT07747480
- Testing
- Aletekitug
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).
- Trial name
- NCT07645248
- Testing
- HFA-152a, HFA-134a
- Where
- 20 sites in United States, Argentina and 2 more
- Volunteers
- 110 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated…
- Trial name
- NCT06920043
- Testing
- Efimosfermin
- Where
- 30 sites in United States
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
This study is for adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who continue to experience exacerbations despite standard of care triple therapy treatment.
- Trial name
- ALARMONY (NCT07915791)
- Testing
- GSK3862995B, GSK5784283
- Volunteers
- 279 people
- Sponsor
- GlaxoSmithKline