Clinical trials: sponsored by 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
Respiratory Syncytial Virus (RSV)
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems.
- Trial name
- STRIVE (NCT07050732)
- Testing
- Arexvy (2 doses total), Arexvy (3 doses total), Arexvy (1 dose total)
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, CAB >=400 mg/mL, CAB Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
Asthma
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
- Trial name
- NCT05757102
- Testing
- FF/UMEC/VI, ELLIPTA, FF/VI
- Where
- 67 sites in United States, Argentina and 7 more
- Volunteers
- 138 people
- Sponsor
- GlaxoSmithKline
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or…
- Trial name
- ODYSSEY (NCT06517875)
- Testing
- Momelotinib, Luspatercept
- Where
- 33 sites in United States, Canada and 4 more
- Volunteers
- 68 people
- Sponsor
- GlaxoSmithKline
Ovarian Neoplasms
Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) alone or in combination with bevacizumab works in treating ovarian cancer compared to bevacizumab alone or active observation (AO).
- Trial name
- NCT07694427
- Testing
- Mocertatug rezetecan, Bevacizumab
- Where
- 12 sites in Argentina, Australia and 3 more
- Volunteers
- 720 people
- Sponsor
- GlaxoSmithKline
Intracranial Meningioma, Recurrent Meningioma
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive).
- Conditions
- Intracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation
- Trial name
- NCT02523014
- Testing
- Vismodegib, FAK Inhibitor GSK2256098, Capivasertib
- Where
- 791 sites in United States
- Volunteers
- 124 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Neoplasms, Endometrial
A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)
This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care.
- Trial name
- NCT07286331
- Testing
- Mocertatug rezetecan, Paclitaxel, Doxorubicin
- Where
- 56 sites in United States, Argentina and 8 more
- Volunteers
- 600 people
- Sponsor
- GlaxoSmithKline
Myeloid Leukemia
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
- Trial name
- NCT06235801
- Testing
- Gilteritinib, Momelotinib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Amyloidosis
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
- Trial name
- ALANIS (NCT07224672)
- Testing
- Belantamab mafodotin, Cyclophosphamide, Bortezomib
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Neoplasms, Endometrial
A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)
The purpose of this study is to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or…
- Trial name
- NCT07684599
- Testing
- Mocertatug rezetecan, Dostarlimab, Pembrolizumab
- Where
- 12 sites in Canada, Japan and 1 more
- Volunteers
- 610 people
- Sponsor
- GlaxoSmithKline
Ovarian Neoplasms, Endometrial Neoplasms
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vulvar Cancer
- Trial name
- DOVE (NCT06023862)
- Testing
- Dostarlimab, Bevacizumab, Doxorubicin
- Where
- 27 sites in Australia, Hong Kong and 5 more
- Volunteers
- 198 people
- Sponsor
- Yonsei University
Hepatitis B
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
This multi-country, longitudinal follow-up study will enrol adults with chronic hepatitis B (CHB) who previously participated in the Phase III B-Well-1 ((202009: NCT05630807) or B-Well-2 (219288: NCT05630820) studies, received 24…
- Trial name
- B-Ensure (NCT07908459)
- Testing
- Bepirovirsen
- Volunteers
- 303 people
- Sponsor
- GlaxoSmithKline
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