Adults 40 to 80, any sex, with Pain or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12Primary· Baseline (Day -7 to Day -1) and at Week 12
Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to compl
Group
Value
95% CI
Placebo
-2.13
-2.55 – -1.73
GSK3858279 - 60 mg Weekly
-1.66
-2.24 – -1.10
GSK3858279 - 240 mg Every 2 Weeks
-1.88
-2.46 – -1.31
GSK3858279 - 240 mg Weekly
-1.74
-2.32 – -1.17
GSK3858279 - 360 mg Weekly
-2.03
-2.60 – -1.47
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12Secondary· Baseline (Day 1) and at Week 12
The WOMAC pain subscale have a recall period of 48 hours and includes 5 subscales of pain assessment: 1-walking on flat, 2-going up downstairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. The total WOMAC pain subscale score ranges from 0-10; where 0 is no pain and 10 is extreme pain. The WOMAC pain subscale score was calculated by taking average of the 5 pain subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from baseline indicates an improve
Group
Value
95% CI
Placebo
-2.16
-2.59 – -1.74
GSK3858279 - 60 mg Weekly
-2.13
-2.73 – -1.52
GSK3858279 - 240 mg Every 2 Weeks
-2.21
-2.82 – -1.59
GSK3858279 - 240 mg Weekly
-1.95
-2.54 – -1.36
GSK3858279 - 360 mg Weekly
-1.93
-2.52 – -1.36
Change From Baseline in WOMAC Physical Function Subscale Score at Week 12Secondary· Baseline (Day 1) and at Week 12
The WOMAC function subscale have a recall period of 48 hours and include 17 items of daily function assessments. The total WOMAC physical function subscale score ranges from 0-10 scale; where 0 is no difficulty and 10 is extremely difficult. The WOMAC physical function subscale score was calculated by taking the average of the 17 physical function subscales at each visit. Change from baseline was calculated for each visit as the mean WOMAC function subscale score minus the mean baseline WOMAC function subscale score. Baseline scores for each participant were assigned based on the score measure
Group
Value
95% CI
Placebo
-1.94
-2.36 – -1.53
GSK3858279 - 60 mg Weekly
-1.99
-2.58 – -1.40
GSK3858279 - 240 mg Every 2 Weeks
-1.56
-2.15 – -0.97
GSK3858279 - 240 mg Weekly
-1.65
-2.23 – -1.08
GSK3858279 - 360 mg Weekly
-1.65
-2.22 – -1.11
Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12Secondary· Baseline (Day 1) and at Week 12
The PtGA is an assessment for disease conditions and intensity of knee osteoarthritis (OA) pain. Participants will respond on a Likert scale ranging from 1-5 based on the question "Considering all the ways in which your knee OA affects you, how do you feel your knee OA is doing today?" and to identify a number from 1 = very good (asymptomatic and no limitation to normal activities) to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicate worse conditions. Baseline scores for each participant were assigned based on t
Group
Value
95% CI
Placebo
-0.55
-0.74 – -0.38
GSK3858279 - 60 mg Weekly
-0.57
-0.83 – -0.31
GSK3858279 - 240 mg Every 2 Weeks
-0.55
-0.82 – -0.29
GSK3858279 - 240 mg Weekly
-0.55
-0.79 – -0.31
GSK3858279 - 360 mg Weekly
-0.55
-0.79 – -0.31
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)Secondary· Up to 31 weeks
AEs, 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 SAEs. The AESIs of the study drug included serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Inj
AEs
Group
Value
95% CI
Placebo
69
GSK3858279 - 60 mg Weekly
29
GSK3858279 - 240 mg Every 2 Weeks
32
GSK3858279 - 240 mg Weekly
32
GSK3858279 - 360 mg Weekly
34
SAEs
Group
Value
95% CI
Placebo
4
GSK3858279 - 60 mg Weekly
3
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
1
GSK3858279 - 360 mg Weekly
2
AESIs
Group
Value
95% CI
Placebo
14
GSK3858279 - 60 mg Weekly
3
GSK3858279 - 240 mg Every 2 Weeks
4
GSK3858279 - 240 mg Weekly
2
GSK3858279 - 360 mg Weekly
12
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 (NCICTCAE)Secondary· Up to 31 weeks
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Worst case grade (G) increase from baseline grade was provided for all the laboratory tests that were gradable by National C
AST, Increase to Grade 3
Group
Value
95% CI
Placebo
0
GSK3858279 - 60 mg Weekly
0
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
1
GSK3858279 - 360 mg Weekly
0
Creatine Kinase, Worsening to Grade 3
Group
Value
95% CI
Placebo
2
GSK3858279 - 60 mg Weekly
0
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
1
GSK3858279 - 360 mg Weekly
0
Creatine Kinase, Worsening to Grade 4
Group
Value
95% CI
Placebo
0
GSK3858279 - 60 mg Weekly
0
GSK3858279 - 240 mg Every 2 Weeks
1
GSK3858279 - 240 mg Weekly
1
GSK3858279 - 360 mg Weekly
0
Gamma Glutamyl Transferase, Worsening to Grade 3
Group
Value
95% CI
Placebo
0
GSK3858279 - 60 mg Weekly
1
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
1
GSK3858279 - 360 mg Weekly
1
Gamma Glutamyl Transferase, Worsening to Grade 4
Group
Value
95% CI
Placebo
1
GSK3858279 - 60 mg Weekly
0
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
0
GSK3858279 - 360 mg Weekly
0
Lymphocyte count decreased, worsening to Grade 3
Group
Value
95% CI
Placebo
0
GSK3858279 - 60 mg Weekly
1
GSK3858279 - 240 mg Every 2 Weeks
0
GSK3858279 - 240 mg Weekly
0
GSK3858279 - 360 mg Weekly
0
Maximum Concentration (Cmax) of GSK3858279Secondary· Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3858279 . Pharmacokinetic analysis was conducted using a model based analysis using all available data.
Group
Value
95% CI
GSK3858279 - 60 mg Weekly
4603.1
± 48
GSK3858279 - 240 mg Every 2 Weeks
12330.0
± 47
GSK3858279 - 240 mg Weekly
15383.5
± 51
GSK3858279 - 360 mg Weekly
22169.0
± 40
Time to Maximum Plasma Concentration (Tmax) of GSK3858279Secondary· Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Tmax predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Group
Value
95% CI
GSK3858279 - 60 mg Weekly
1.454
0.78 – 2.04
GSK3858279 - 240 mg Every 2 Weeks
1.751
0.94 – 3.90
GSK3858279 - 240 mg Weekly
1.412
0.88 – 2.26
GSK3858279 - 360 mg Weekly
1.377
0.73 – 2.26
Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279Secondary· Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Ctau predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Group
Value
95% CI
GSK3858279 - 60 mg Weekly
2449.9
± 63
GSK3858279 - 240 mg Every 2 Weeks
3076.6
± 59
GSK3858279 - 240 mg Weekly
7224.0
± 60
GSK3858279 - 360 mg Weekly
11037.5
± 52
Average Concentration Over a Dosing Interval (Cavg) of GSK3858279Secondary· Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
Cavg predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Group
Value
95% CI
GSK3858279 - 60 mg Weekly
3623.3
± 51
GSK3858279 - 240 mg Every 2 Weeks
7176.4
± 48
GSK3858279 - 240 mg Weekly
11760.8
± 53
GSK3858279 - 360 mg Weekly
16997.6
± 42
Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279Secondary· Pre-dose: Day 1, Weeks 1, 2, 4, 8, 10, 11 and 12
AUC(0-tau) predicted from the population PK model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Group
Value
95% CI
GSK3858279 - 60 mg Weekly
25362.8
± 51
GSK3858279 - 240 mg Every 2 Weeks
100469.4
± 48
GSK3858279 - 240 mg Weekly
82325.8
± 53
GSK3858279 - 360 mg Weekly
118983.5
± 42
Adverse events — posted to ClinicalTrials.gov
Time frame: 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 31..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT05838755 — A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
· Phase 2
· terminated
NCT05174013 — Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Pa
· Phase 1
· completed
NCT04114656 — Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers
· Phase 1
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 10 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05838742.