Clinical trials: sponsored by GlaxoSmithKline
Nasal Polyps
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS…
- Trial name
- MERIT (NCT04607005)
- Testing
- Mepolizumab, Standard of care
- Where
- Japan
- Volunteers
- 169 people
- Sponsor
- GlaxoSmithKline
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Cytomegalovirus Infections
A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults
The purpose of this study is to assess the safety, reactogenicity and immune response of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens…
- Trial name
- NCT05089630
- Testing
- Pentamer (low)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(low)/Adjuvant vaccine, Pentamer (med)/gB(med)/Adjuvant vaccine
- Where
- 18 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Study to Evaluate the Effect of Bepirovirsen on Cardiac Conduction as Assessed by 12-lead Electrocardiogram in Healthy Volunteers
This study will evaluate the effect of a single dose of bepirovirsen on the QT interval corrected by Fridericia's formula (QTcF) as compared to placebo.
- Trial name
- NCT06422767
- Testing
- Bepirovirsen
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypereosinophilic Syndrome
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
The purpose of this study is to investigate the efficacy and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.
- Trial name
- SPHERE (NCT04965636)
- Testing
- Mepolizumab
- Where
- 14 sites in United States, Argentina and 4 more
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Lung Cancer, Non-Small Cell
Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy
This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed…
- Trial name
- COSTAR Lung (NCT04655976)
- Testing
- Cobolimab, Dostarlimab, Docetaxel
- Where
- 163 sites in United States, Argentina and 22 more
- Volunteers
- 758 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function
Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb).
- Trial name
- DREAMM12 (NCT04398745)
- Testing
- Belantamab mafodotin
- Where
- 4 sites in Greece, South Korea
- Volunteers
- 36 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM.
- Trial name
- DREAMM-3 (NCT04162210)
- Testing
- Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone)
- Where
- 136 sites in United States, Australia and 17 more
- Volunteers
- 325 people
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused…
- Trial name
- NCT05082285
- Testing
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine
- Where
- 33 sites in Dominican Republic, Finland and 6 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, pomalidomide, and dexamethasone and to establish the recommended Phase 2 dose for combination treatment to…
- Trial name
- NCT07150104
- Testing
- Belantamab mafodotin, Nirogacestat, Pomalidomide
- Where
- 10 sites in Brazil, Canada and 6 more
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort…
- Trial name
- NCT07217184
- Testing
- Belantamab mafodotin, Isatuximab
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with feladilimab (GSK3359609), and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore…
- Trial name
- NCT07217119
- Testing
- Belantamab mafodotin, Feladilimab
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)
The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of…
- Trial name
- NCT06614725
- Testing
- RSVPreF3 OA investigational vaccine
- Where
- 14 sites in India
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Cancer, Non-Small Cell
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung…
- Trial name
- ZEAL-1L (NCT04475939)
- Testing
- Niraparib, Pembrolizumab
- Where
- 188 sites in United States, Argentina and 25 more
- Volunteers
- 666 people
- Sponsor
- GlaxoSmithKline
Tuberculosis
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or…
- Trial name
- NCT05382312
- Testing
- GSK3036656, Bedaquiline, Delamanid
- Where
- South Africa
- Volunteers
- 127 people
- Sponsor
- GlaxoSmithKline
Sexually Transmitted Diseases
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
The aim of this first time in human proof of concept (FTiH-PoC) study was to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized…
- Trial name
- NCT05630859
- Testing
- NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine, NgG 50 µg investigational vaccine
- Where
- 23 sites in United States, Brazil and 6 more
- Volunteers
- 1,009 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
- Trial name
- NCT05602025
- Testing
- Depemokimab
- Where
- 3 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dermatitis, Atopic
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).
- Trial name
- AtDvance (NCT06447506)
- Testing
- GSK1070806
- Where
- 51 sites in United States, Argentina and 13 more
- Volunteers
- 79 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, lenalidomide, and dexamethasone, and to establish the recommended Phase 2 dose for combination treatment to…
- Trial name
- NCT07150091
- Testing
- Belantamab mafodotin, Nirogacestat, Lenalidomide
- Where
- 12 sites in United States, Brazil and 6 more
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
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