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NCT05838742: MARS-17

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

Terminated Phase 2 Results posted Last updated 10 November 2025
What this trial tests

Phase 2 trial testing GSK3858279 in Pain in 314 participants. Terminated before completion.

Timeline
13 September 2023
Primary endpoint
12 August 2024
3 December 2024

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment314
Start date13 September 2023
Primary completion12 August 2024
Estimated completion3 December 2024
Sites93 locations across France, South Africa, Japan, United Kingdom, Germany, Mexico, South Korea, Argentina

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

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 12 Primary · 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

GroupValue95% 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 12 Secondary · 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

GroupValue95% 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 12 Secondary · 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

GroupValue95% 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 12 Secondary · 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

GroupValue95% 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
GroupValue95% CI
Placebo69
GSK3858279 - 60 mg Weekly29
GSK3858279 - 240 mg Every 2 Weeks32
GSK3858279 - 240 mg Weekly32
GSK3858279 - 360 mg Weekly34
SAEs
GroupValue95% CI
Placebo4
GSK3858279 - 60 mg Weekly3
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly1
GSK3858279 - 360 mg Weekly2
AESIs
GroupValue95% CI
Placebo14
GSK3858279 - 60 mg Weekly3
GSK3858279 - 240 mg Every 2 Weeks4
GSK3858279 - 240 mg Weekly2
GSK3858279 - 360 mg Weekly12
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
GroupValue95% CI
Placebo0
GSK3858279 - 60 mg Weekly0
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly1
GSK3858279 - 360 mg Weekly0
Creatine Kinase, Worsening to Grade 3
GroupValue95% CI
Placebo2
GSK3858279 - 60 mg Weekly0
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly1
GSK3858279 - 360 mg Weekly0
Creatine Kinase, Worsening to Grade 4
GroupValue95% CI
Placebo0
GSK3858279 - 60 mg Weekly0
GSK3858279 - 240 mg Every 2 Weeks1
GSK3858279 - 240 mg Weekly1
GSK3858279 - 360 mg Weekly0
Gamma Glutamyl Transferase, Worsening to Grade 3
GroupValue95% CI
Placebo0
GSK3858279 - 60 mg Weekly1
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly1
GSK3858279 - 360 mg Weekly1
Gamma Glutamyl Transferase, Worsening to Grade 4
GroupValue95% CI
Placebo1
GSK3858279 - 60 mg Weekly0
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly0
GSK3858279 - 360 mg Weekly0
Lymphocyte count decreased, worsening to Grade 3
GroupValue95% CI
Placebo0
GSK3858279 - 60 mg Weekly1
GSK3858279 - 240 mg Every 2 Weeks0
GSK3858279 - 240 mg Weekly0
GSK3858279 - 360 mg Weekly0
Maximum Concentration (Cmax) of GSK3858279 Secondary · 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.

GroupValue95% CI
GSK3858279 - 60 mg Weekly4603.1± 48
GSK3858279 - 240 mg Every 2 Weeks12330.0± 47
GSK3858279 - 240 mg Weekly15383.5± 51
GSK3858279 - 360 mg Weekly22169.0± 40
Time to Maximum Plasma Concentration (Tmax) of GSK3858279 Secondary · 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.

GroupValue95% CI
GSK3858279 - 60 mg Weekly1.4540.78 – 2.04
GSK3858279 - 240 mg Every 2 Weeks1.7510.94 – 3.90
GSK3858279 - 240 mg Weekly1.4120.88 – 2.26
GSK3858279 - 360 mg Weekly1.3770.73 – 2.26
Pre-Dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK3858279 Secondary · 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.

GroupValue95% CI
GSK3858279 - 60 mg Weekly2449.9± 63
GSK3858279 - 240 mg Every 2 Weeks3076.6± 59
GSK3858279 - 240 mg Weekly7224.0± 60
GSK3858279 - 360 mg Weekly11037.5± 52
Average Concentration Over a Dosing Interval (Cavg) of GSK3858279 Secondary · 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.

GroupValue95% CI
GSK3858279 - 60 mg Weekly3623.3± 51
GSK3858279 - 240 mg Every 2 Weeks7176.4± 48
GSK3858279 - 240 mg Weekly11760.8± 53
GSK3858279 - 360 mg Weekly16997.6± 42
Area Under the Time-Concentration Curve (AUC) Over the Dosing Interval (0-Tau) (AUC[0-Tau]) of GSK3858279 Secondary · 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.

GroupValue95% CI
GSK3858279 - 60 mg Weekly25362.8± 51
GSK3858279 - 240 mg Every 2 Weeks100469.4± 48
GSK3858279 - 240 mg Weekly82325.8± 53
GSK3858279 - 360 mg Weekly118983.5± 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.

Placebo
Serious: 4/105 (4%)
Deaths: 0/105
GSK3858279 - 60 mg Weekly
Serious: 3/50 (6%)
Deaths: 0/50
GSK3858279 - 240 mg Every 2 Weeks
Serious: 0/51 (0%)
Deaths: 0/51
GSK3858279 - 240 mg Weekly
Serious: 1/51 (2%)
Deaths: 0/51
GSK3858279 - 360 mg Weekly
Serious: 2/53 (4%)
Deaths: 0/53

Serious adverse events (10 terms)

ReactionSystemPlaceboGSK3858279 - 60 mg WeeklyGSK3858279 - 240 mg Every …GSK3858279 - 240 mg WeeklyGSK3858279 - 360 mg Weekly
Acute coronary syndromeCardiac disorders
Angina pectorisCardiac disorders
Inguinal herniaGastrointestinal disorders
Herpes zosterInfections and infestations
Tubo-ovarian abscessInfections and infestations
Wound infectionInfections and infestations
Ankle fractureInjury, poisoning and procedural complications
Tibia fractureInjury, poisoning and procedural complications
LipoedemaMetabolism and nutrition disorders
Transient ischaemic attackNervous system disorders
Other adverse events (13 terms — click to expand)

ReactionSystemPlaceboGSK3858279 - 60 mg WeeklyGSK3858279 - 240 mg Every …GSK3858279 - 240 mg WeeklyGSK3858279 - 360 mg Weekly
HeadacheNervous system disorders
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Back painMusculoskeletal and connective tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Injection site bruisingGeneral disorders
Abdominal painGastrointestinal disorders
COVID-19Infections and infestations
Urinary tract infectionInfections and infestations
Injection site reactionGeneral disorders
FatigueGeneral disorders
DiarrhoeaGastrointestinal disorders
FallInjury, poisoning and procedural complications

Most-reported serious reactions: Acute coronary syndrome, Angina pectoris, Inguinal hernia, Herpes zoster, Tubo-ovarian abscess, Wound infection, Ankle fracture, Tibia fracture.

Data from ClinicalTrials.gov NCT05838742 adverse events section.

Sponsor's own description

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):

  1. Screening of the FDA-approved drug library identifies CCL17 inhibitors that block arthritic pain.
    Eivazitork M, Lupancu TJ, Lim K, Huang YK, et al · · 2025 · cited 1× · PMID 40702243 · DOI 10.1038/s41598-025-12191-4

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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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing