A Phase 2 interventional study of GSK3858279 and Placebo in Pain, sponsored by GlaxoSmithKline. Terminated at 81 sites in 11 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 147 is above the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks.
Drug: GSK3858279
Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks.
Drug: GSK3858279
Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks.
Drug: Placebo
GSK3858279 was administered
Placebo was administered
Change From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS)
The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day -7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as "Mean" refers to the 'posterior mean' and "95% confidence interval" to '95% credible interval'.
Time frame: Baseline (Day -7 to Day -1) and Week 12
Number of Participants With Adverse Events (AEs), Serious AE (SAEs) and AEs of Special Interest (AESI)
Adverse events, SAEs, and AESIs were collected. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB), serious hypersensitivity reactions and Injection site reactions.
Time frame: Up to 27 weeks
Number of Participants With Greater Than Or Equal To (>=) Grade 3 Hematological/Clinical Chemistry Abnormalities According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Eosinophils, Hemoglobin, White blood cell, Lymphocyte count, Neutrophil count and Platelet count, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Blood bilirubin, Hypercalcemia, Hypocalcemia, Cholesterol, Creatine Phosphokinase, Creatinine, Gamma Glutamyl Transferase (GGT), Hypoglycemia, Hyperkalemia, Hypernatremia and Hypertriglyceridemia. Worst case grade (G) increase from baseline grade was evaluated for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE). Data is presented for only those parameters for which participants had worst case \>= Grade 3 increase from Baseline.
Time frame: Up to 27 weeks
Maximum Concentration (Cmax) of GSK3858279
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which pharmacokinetic (PK) parameters were determined. Cmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Time frame: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Time to Maximum Concentration (Tmax) of GSK3858279
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Tmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Time frame: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Trough Concentration at the End of the Dosing Interval (Ctau) of GSK3858279
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Ctau was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Time frame: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Average Concentration Over a Dosing Interval (Cavg) of GSK3858279
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Cavg is the average concentration over the dosing interval (weekly). Cavg was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Time frame: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (AUC[0-Tau]) of GSK3858279
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. AUC(0-tau) was predicted from the population model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Time frame: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Change From Baseline in the Short-Form Mcgill Pain Questionnaire Total Score Over Time
The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluated multi-dimensional pain over time. The questionnaire consists of 22 different descriptors of pain, and each item is rated based on a 0-10 pain intensity scale with 0 indicating no pain and 10 as worst possible pain. The total score was calculated as the mean of all item ratings. Higher scores indicate more severe pain. Baseline is defined as the last assessment prior to the first dose with a non-missing value, including those from unscheduled visits. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented as 'Mean' refers to 'posterior mean' and '95% confidence interval' refers to '95% credible intervals'.
Time frame: Baseline (Day1), Week 2, Week 4, Week 8 and Week 12
Change From Baseline in the Weekly Average of Average Daily Pain Score Over Time, Assessed on the NRS
The change from baseline (CFB) in the weekly average of the average daily pain score at indicated time points was assessed using NRS. Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day - 7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as 'Mean' refers to the 'posterior mean' and '95% confidence interval' to the '95% credible interval'.
Time frame: Baseline (Day -7 to Day -1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12
Proportion of Participants With Greater Than or Equal To (>=) 30 Percentage (%) Reduction From Baseline in the Weekly Average of Average Daily Pain Intensity at Week 12, Assessed on the NRS
The proportion of participants who achieved \>=30 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'.
Time frame: At Week 12
Proportion of Participants With Greater Than or Equal To >= 50 % Reduction From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the NRS
The proportion of participants who achieved \>=50 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'.
Time frame: At Week 12
A total of 147 participants were enrolled in the study, Out of which 144 participants were included in the full analysis set (FAS) population.
| Milestone | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Started | 50 | 48 | 49 |
| Full analysis set | 48 | 48 | 48 |
| Completed | 20 | 17 | 17 |
| Not completed | 30 | 31 | 32 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 4 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 |
| Withdrew: Study terminated by sponsor | 26 | 27 | 26 |
| Withdrew: Randomized, not treated | 2 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day -7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as "Mean" refers to the 'posterior mean' and "95% confidence interval" to '95% credible interval'.
| Scores on a Scale | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Change From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS) | -1.85 ± -2.44 | -2.50 ± -3.09 | -2.07 ± -2.67 |
Adverse events, SAEs, and AESIs were collected. An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB), serious hypersensitivity reactions and Injection site reactions.
| Participants | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Any AE | 27 | 23 | 24 |
| Any SAE | 4 | 2 | 0 |
| Any AESI | 6 | 4 | 5 |
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Eosinophils, Hemoglobin, White blood cell, Lymphocyte count, Neutrophil count and Platelet count, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Blood bilirubin, Hypercalcemia, Hypocalcemia, Cholesterol, Creatine Phosphokinase, Creatinine, Gamma Glutamyl Transferase (GGT), Hypoglycemia, Hyperkalemia, Hypernatremia and Hypertriglyceridemia. Worst case grade (G) increase from baseline grade was evaluated for all the laboratory tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE). Data is presented for only those parameters for which participants had worst case \>= Grade 3 increase from Baseline.
| Participants | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| >= Grade 3 increase in Hematological Abnormalities | 0 | 0 | 0 |
| Grade3 increase-Clinical Chemistry Abnormality,GGT | 0 | 1 | 0 |
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which pharmacokinetic (PK) parameters were determined. Cmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
| Nanogram per milliliter (ng/mL) | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|
| Maximum Concentration (Cmax) of GSK3858279 | 2943.3 ± 58 | 17125.9 ± 34 |
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Tmax was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
| Day | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|
| Time to Maximum Concentration (Tmax) of GSK3858279 | 1.518 ± 0.64 | 1.360 ± 0.47 |
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Ctau was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
| Nanogram per milliliter (ng/mL) | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|
| Trough Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 | 1910.4 ± 52 | 9543.2 ± 43 |
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. Cavg is the average concentration over the dosing interval (weekly). Cavg was predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
| Nanogram per milliliter (ng/mL) | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|
| Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 | 2461.8 ± 54 | 13550.4 ± 35 |
Blood samples were collected for the determination of serum concentrations of GSK3858279 from which PK parameters were determined. AUC(0-tau) was predicted from the population model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
| Day*Nanogram per milliliter (Day*ng/mL) | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|
| Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (AUC[0-Tau]) of GSK3858279 | 17232.4 ± 54 | 94852.5 ± 35 |
The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluated multi-dimensional pain over time. The questionnaire consists of 22 different descriptors of pain, and each item is rated based on a 0-10 pain intensity scale with 0 indicating no pain and 10 as worst possible pain. The total score was calculated as the mean of all item ratings. Higher scores indicate more severe pain. Baseline is defined as the last assessment prior to the first dose with a non-missing value, including those from unscheduled visits. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented as 'Mean' refers to 'posterior mean' and '95% confidence interval' refers to '95% credible intervals'.
| Scores on a Scale | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Week 2 | -1.39 (-1.80 to -0.97) | -1.04 (-1.46 to -0.61) | -1.49 (-1.91 to -1.07) |
| Week 4 | -1.77 (-2.25 to -1.29) | -1.36 (-1.86 to -0.87) | -1.44 (-1.95 to -0.94) |
| Week 8 | -1.84 (-2.36 to -1.33) | -1.99 (-2.53 to -1.46) | -1.96 (-2.49 to -1.43) |
| Week 12 | -2.07 (-2.65 to -1.49) | -2.25 (-2.85 to -1.65) | -1.89 (-2.49 to -1.29) |
The change from baseline (CFB) in the weekly average of the average daily pain score at indicated time points was assessed using NRS. Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day - 7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as 'Mean' refers to the 'posterior mean' and '95% confidence interval' to the '95% credible interval'.
| Scores on a Scale | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Week 1 | -0.47 (-0.76 to -0.17) | -0.57 (-0.87 to -0.27) | -0.68 (-0.98 to -0.38) |
| Week 2 | -0.71 (-1.10 to -0.32) | -0.95 (-1.34 to -0.55) | -1.16 (-1.55 to -0.76) |
| Week 3 | -0.94 (-1.37 to -0.50) | -1.24 (-1.68 to -0.80) | -1.50 (-1.94 to -1.06) |
| Week 4 | -1.34 (-1.81 to -0.87) | -1.42 (-1.90 to -0.94) | -1.60 (-2.08 to -1.11) |
| Week 5 | -1.54 (-2.09 to -1.00) | -1.60 (-2.16 to -1.04) | -1.74 (-2.30 to -1.18) |
| Week 6 | -1.59 (-2.12 to -1.07) | -1.71 (-2.24 to -1.18) | -1.73 (-2.26 to -1.20) |
| Week 7 | -1.63 (-2.18 to -1.09) | -1.91 (-2.46 to -1.35) | -1.94 (-2.50 to -1.38) |
| Week 8 | -1.72 (-2.27 to -1.18) | -2.10 (-2.66 to -1.54) | -1.99 (-2.55 to -1.43) |
| Week 9 | -1.71 (-2.25 to -1.18) | -2.13 (-2.67 to -1.59) | -1.94 (-2.49 to -1.40) |
| Week 10 | -1.76 (-2.30 to -1.22) | -2.31 (-2.86 to -1.76) | -2.01 (-2.56 to -1.45) |
| Week 11 | -1.88 (-2.44 to -1.32) | -2.40 (-2.98 to -1.83) | -2.12 (-2.70 to -1.55) |
| Week 12 | -1.85 (-2.44 to -1.28) | -2.50 (-3.09 to -1.91) | -2.07 (-2.67 to -1.48) |
The proportion of participants who achieved \>=30 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'.
| Proportion of participants | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Proportion of Participants With Greater Than or Equal To (>=) 30 Percentage (%) Reduction From Baseline in the Weekly Average of Average Daily Pain Intensity at Week 12, Assessed on the NRS | 0.50 ± 0.38 | 0.64 ± 0.52 | 0.55 ± 0.43 |
The proportion of participants who achieved \>=50 percentage reduction from Baseline (responders) in the weekly average of the average daily pain score at Week 12 as measured by NRS is reported. Participants were instructed to assess their average daily pain daily, and to record the response in a Brief Pain Inventory item 5. It is a single item designed to capture information on the self- reported average pain score over the past 24 hours. Participants were asked to mark their pain- intensity daily, using the NRS, on an 11- point scale (0-10), with 0 = no pain, and 10 = worst pain imaginable. The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. The data is presented for proportion of responders where 'Mean' refers to 'posterior mean proportion' and '95% confidence interval' refers to '95% credible interval'.
| Proportion of participants | Placebo | GSK3858279 60 mg | GSK3858279 360 mg |
|---|---|---|---|
| Proportion of Participants With Greater Than or Equal To >= 50 % Reduction From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the NRS | 0.28 ± 0.19 | 0.40 ± 0.29 | 0.32 ± 0.22 |
Collected over All-cause mortality, Serious Adverse Events (SAEs) and non-Serious Adverse Events (non-SAEs) were collected from the start of the study intervention (Day 1) until follow up of week 27.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/48 (0%) | 4/48 (8.3%) | 11/48 (22.9%) |
| GSK3858279 60 Milligram (mg) Weekly | 0/48 (0%) | 2/48 (4.2%) | 9/48 (18.8%) |
| GSK3858279 360 mg Weekly | 0/48 (0%) | 0/48 (0%) | 10/48 (20.8%) |
| Event | Placebo | GSK3858279 60 Milligram (mg) Weekly | GSK3858279 360 mg Weekly |
|---|---|---|---|
| Angina unstableCardiac disorders | 1/48 | 0/48 | 0/48 |
| Cat scratch diseaseInfections and infestations | 1/48 | 0/48 | 0/48 |
| PneumoniaInfections and infestations | 1/48 | 0/48 | 0/48 |
| Uterine cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/48 | 1/48 | 0/48 |
| HemianopiaNervous system disorders | 0/48 | 1/48 | 0/48 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/48 | 0/48 | 0/48 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/48 | 1/48 | 0/48 |
| Event | Placebo | GSK3858279 60 Milligram (mg) Weekly | GSK3858279 360 mg Weekly |
|---|---|---|---|
| HeadacheNervous system disorders | 5/48 | 2/48 | 2/48 |
| COVID-19Infections and infestations | 0/48 | 4/48 | 1/48 |
| Injection site haemorrhageGeneral disorders | 0/48 | 0/48 | 3/48 |
| BronchitisInfections and infestations | 1/48 | 1/48 | 3/48 |
| Upper respiratory tract infectionInfections and infestations | 3/48 | 2/48 | 0/48 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/48 | 0/48 | 0/48 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/48 | 3/48 | 0/48 |
| DizzinessNervous system disorders | 0/48 | 0/48 | 3/48 |
The analysis was performed on the Full Analysis Set (FAS) set that included all randomized participants who received at least one dose of study intervention.
| Age, Continuous(YEARS) | Placebo | GSK3858279 60 mg | GSK3858279 360 mg | Total |
|---|---|---|---|---|
| Mean | 61.3 ± 8.59 | 60.1 ± 10.18 | 60.2 ± 9.26 | 60.5 ± 9.32 |
| Sex: Female, Male(Participants) | Placebo | GSK3858279 60 mg | GSK3858279 360 mg | Total |
|---|---|---|---|---|
| Female | 21 | 19 | 22 | 62 |
| Male | 27 | 29 | 26 | 82 |
| Race/Ethnicity, Customized(Participants) | Placebo | GSK3858279 60 mg | GSK3858279 360 mg | Total |
|---|---|---|---|---|
| White | 30 | 24 | 25 | 79 |
| American Indian or Alaska Native | 0 | 2 | 0 | 2 |
| Asian | 15 | 12 | 14 | 41 |
| Black or African American | 1 | 8 | 9 | 18 |
| Mixed race | 1 | 1 | 0 | 2 |
| Not reported | 0 | 1 | 0 | 1 |
| Unknown | 1 | 0 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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