NCT02799472 is a Phase 2 clinical trial of GSK3196165 in Arthritis, Rheumatoid, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02799472?

NCT02799472 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02799472?

Interventions in NCT02799472: GSK3196165, Placebo, MTX, Folic (or folinic) acid.

What condition does NCT02799472 study?

NCT02799472 studies Arthritis, Rheumatoid.

Is NCT02799472 still recruiting?

NCT02799472 is currently completed. Last updated 11 January 2021.

Are results published for NCT02799472?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-11 · How we verify

NCT02799472

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis

Completed Phase 2 Results posted Last updated 11 January 2021

What this trial tests

Phase 2 trial testing GSK3196165 in Arthritis, Rheumatoid in 39 participants. Completed in 30 October 2017.

Timeline

15 June 2016

Primary endpoint
30 October 2017

30 October 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	15 June 2016
Primary completion	30 October 2017
Estimated completion	30 October 2017
Sites	16 locations across United States, Germany, Poland

Drugs / interventions tested

GSK3196165 — full drug profile →
Placebo
MTX — full drug profile →
Folic (or folinic) acid — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. 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 Target Engagement Biomarkers- Soluble Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Complexed to GSK3196165 Primary · Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week follow-up (FU) (Week 22)

Blood samples were collected for markers which may influence rheumatoid arthritis. Target engagement biomarkers included soluble GM-CSF complexed to GSK3196165. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for GM-CSF - Complex log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Analysis was performed on Intent-to-Treat (ITT) Population which consisted of all participants who were randomized

GM-CSF - Complex, Week 1, n=9, 27

Group	Value	95% CI
Placebo	0.972	± 35.98
GSK3196165 180 mg	13.799	± 20.65

GM-CSF - Complex, Week 2, n=8, 26

Group	Value	95% CI
Placebo	0.960	± 31.23
GSK3196165 180 mg	31.056	± 17.58

GM-CSF - Complex, Week 4, n=8, 27

Group	Value	95% CI
Placebo	0.959	± 34.51
GSK3196165 180 mg	53.496	± 18.55

GM-CSF - Complex, Week 6, n=7, 26

Group	Value	95% CI
Placebo	0.964	± 40.96
GSK3196165 180 mg	46.620	± 22.37

GM-CSF - Complex, Week 8, n=7, 24

Group	Value	95% CI
Placebo	0.964	± 41.80
GSK3196165 180 mg	33.404	± 22.47

GM-CSF - Complex, Week 12, n=7, 24

Group	Value	95% CI
Placebo	0.970	± 44.95
GSK3196165 180 mg	22.556	± 24.38

GM-CSF - Complex, 12-Week FU, n=8, 21

Group	Value	95% CI
Placebo	0.954	± 20.80
GSK3196165 180 mg	1.176	± 12.88

Change From Baseline in Predictive Biomarkers: 14-3-3 ETA Protein, S100 Calcium Binding Protein (CBP) A8 and A9 Primary · Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of 14-3-3 ETA Protein, S100 CBP A8 and A9. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for 14-3-3 ETA Protein (mg/L) and S100 CBP A8 and A9 log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with data availab

14-3-3 ETA Protein, Week 1, n=9, 27

Group	Value	95% CI
Placebo	1.046	± 3.88
GSK3196165 180 mg	0.986	± 2.16

14-3-3 ETA Protein, Week 2, n=8, 26

Group	Value	95% CI
Placebo	0.959	± 12.14
GSK3196165 180 mg	0.986	± 6.70

14-3-3 ETA Protein, Week 4, n=9, 26

Group	Value	95% CI
Placebo	1.128	± 16.59
GSK3196165 180 mg	0.838	± 9.55

14-3-3 ETA Protein, Week 6, n=7, 26

Group	Value	95% CI
Placebo	1.093	± 15.55
GSK3196165 180 mg	0.833	± 8.88

14-3-3 ETA Protein, Week 8, n=7, 23

Group	Value	95% CI
Placebo	0.950	± 15.19
GSK3196165 180 mg	0.842	± 8.48

14-3-3 ETA Protein, Week 12, n=7, 24

Group	Value	95% CI
Placebo	1.131	± 20.90
GSK3196165 180 mg	0.897	± 11.89

14-3-3 ETA Protein, 12-Week FU, n=7, 21

Group	Value	95% CI
Placebo	1.040	± 24.06
GSK3196165 180 mg	0.893	± 13.45

S100 CBP A8 and A9, Week 1, n=9, 27

Group	Value	95% CI
Placebo	0.940	± 15.20
GSK3196165 180 mg	0.939	± 8.92

Change From Baseline in Predictive Biomarkers: Amyloid A Primary · Baseline and Week 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Amyloid A. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Amyloid A log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X i

Amyloid A, Week 12, n=7, 24

Group	Value	95% CI
Placebo	0.845	± 49.31
GSK3196165 180 mg	0.653	± 25.45

Amyloid A, 12-Week FU, n=7, 21

Group	Value	95% CI
Placebo	0.529	± 35.12
GSK3196165 180 mg	0.623	± 19.68

Change From Baseline in Predictive Biomarkers: Amyloid A, Chemokine (C-C Motif) Ligand 17, Chemokine (C-X-C Motif) Ligand 13, Interleukin 6, Macrophage-Derived Chemokine Primary · Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chemokine (C-C Motif) Ligand 17 (CL17), Chemokine (C-X-C Motif) Ligand 13 (CL13), Interleukin 6, Macrophage-Derived Chemokine (MDC). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for CL17, CL13, Interleukin 6, MDC log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and trea

CL17, Week 1, n=9, 27

Group	Value	95% CI
Placebo	1.117	± 18.81
GSK3196165 180 mg	0.773	± 10.94

CL17, Week 2, n=8, 26

Group	Value	95% CI
Placebo	0.912	± 24.37
GSK3196165 180 mg	0.651	± 13.60

CL17, Week 4, n=9, 27

Group	Value	95% CI
Placebo	1.117	± 21.91
GSK3196165 180 mg	0.679	± 12.51

CL17, Week 6, n=7, 27

Group	Value	95% CI
Placebo	1.032	± 24.38
GSK3196165 180 mg	0.779	± 12.48

CL17, Week 8, n=7, 25

Group	Value	95% CI
Placebo	1.211	± 20.63
GSK3196165 180 mg	0.675	± 11.21

CL17, Week 12, n=7, 24

Group	Value	95% CI
Placebo	1.711	± 24.96
GSK3196165 180 mg	0.890	± 13.90

CL17, 12-Week FU, n=7, 20

Group	Value	95% CI
Placebo	1.434	± 23.26
GSK3196165 180 mg	1.357	± 13.59

CL13, Week 1, n=9, 27

Group	Value	95% CI
Placebo	1.198	± 15.63
GSK3196165 180 mg	0.915	± 8.87

Change From Baseline in Predictive Biomarkers: Chitinase 3 Like 1, Matrix Metalloproteinase 3 (MMP-3) Primary · Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chitinase 3 Like 1 and MMP-3. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Chitinase 3 Like 1 and MMP-3 log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data point

Chitinase 3 Like 1, Week 1, n=9, 27

Group	Value	95% CI
Placebo	1.033	± 13.97
GSK3196165 180 mg	0.917	± 8.13

Chitinase 3 Like 1, Week 2, n=8, 26

Group	Value	95% CI
Placebo	1.013	± 15.05
GSK3196165 180 mg	0.966	± 8.55

Chitinase 3 Like 1, Week 4, n=9, 27

Group	Value	95% CI
Placebo	0.961	± 17.14
GSK3196165 180 mg	1.088	± 9.96

Chitinase 3 Like 1, Week 6, n=7, 27

Group	Value	95% CI
Placebo	0.897	± 17.08
GSK3196165 180 mg	1.031	± 8.80

Chitinase 3 Like 1, Week 8, n=7, 25

Group	Value	95% CI
Placebo	0.851	± 18.24
GSK3196165 180 mg	0.947	± 9.70

Chitinase 3 Like 1, Week 12, n=7, 24

Group	Value	95% CI
Placebo	1.066	± 21.53
GSK3196165 180 mg	1.071	± 11.64

Chitinase 3 Like 1, 12-Week FU, n=7, 21

Group	Value	95% CI
Placebo	0.735	± 16.87
GSK3196165 180 mg	1.019	± 9.75

MMP 3, Week 1, n=9, 27

Group	Value	95% CI
Placebo	1.076	± 6.72
GSK3196165 180 mg	0.984	± 3.88

Change From Baseline in Cartilage Biomarkers Primary · Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers that may be predictive of rheumatoid arthritis disease activity. Cartilage biomarkers included analysis of ARGS Neo-Epitope, Citrullinated MMP-Degraded Vimentin (CMDV), MMP-Degraded C Reactive Protein (CRP), MMP-Degraded Type I Collagen (MD1C), MMP-Degraded Type II Collagen (MD2C), MMP-Degraded Type III Collagen (MD3C). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for ARGS Neo-Epitope, Citrullinated MMP-Degra

ARGS Neo-Epitope, Week 1, n=9, 27

Group	Value	95% CI
Placebo	0.979	± 16.10
GSK3196165 180 mg	1.075	± 9.67

ARGS Neo-Epitope, Week 2, n=8, 25

Group	Value	95% CI
Placebo	0.790	± 17.38
GSK3196165 180 mg	1.249	± 9.87

ARGS Neo-Epitope, Week 4, n=8, 26

Group	Value	95% CI
Placebo	0.904	± 17.02
GSK3196165 180 mg	1.104	± 10.05

ARGS Neo-Epitope, Week 6, n=6, 26

Group	Value	95% CI
Placebo	0.894	± 14.28
GSK3196165 180 mg	1.164	± 7.82

ARGS Neo-Epitope, Week 8, n=7, 24

Group	Value	95% CI
Placebo	0.854	± 26.42
GSK3196165 180 mg	1.238	± 14.20

ARGS Neo-Epitope, Week 12, n=7, 24

Group	Value	95% CI
Placebo	0.913	± 13.97
GSK3196165 180 mg	1.156	± 7.78

ARGS Neo-Epitope, 12-Week FU, n=8, 21

Group	Value	95% CI
Placebo	1.129	± 17.44
GSK3196165 180 mg	1.124	± 9.86

CMDV, Week 1,n=9,27

Group	Value	95% CI
Placebo	0.981	± 24.12
GSK3196165 180 mg	0.876	± 13.80

Change From Baseline in Flow Cytometry: Helper/Suppressor Cells Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of Helper/Suppressor. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Helper/Suppressor log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were ana

Helper/Suppressor, Week 1, n=8, 25

Group	Value	95% CI
Placebo	1.024	± 6.98
GSK3196165 180 mg	0.976	± 4.00

Helper/Suppressor, Week 4, n=8, 25

Group	Value	95% CI
Placebo	1.053	± 7.18
GSK3196165 180 mg	0.998	± 4.11

Helper/Suppressor, Week 12, n=6, 25

Group	Value	95% CI
Placebo	1.040	± 6.83
GSK3196165 180 mg	1.088	± 3.49

Helper/Suppressor, 12-Week FU, n=6, 21

Group	Value	95% CI
Placebo	1.051	± 8.99
GSK3196165 180 mg	1.065	± 4.88

Change From Baseline in Flow Cytometry: 6 Colour TB Natural Killer (NK) Panel- CD16+CD56+, CD19, CD3, CD3+CD4+ Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of cluster of differentiation (CD)16+CD56+, CD19, CD3, CD3+CD4+. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Repeated measures analysis adjusted for CD16+CD56+, CD19, CD3, CD3+CD4+, CD3+CD8+ and T Cell B Cell NKL log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participan

CD16+CD56+, Week 1, n=8, 25

Group	Value	95% CI
Placebo	0.989	± 11.39
GSK3196165 180 mg	1.025	± 6.30

CD16+CD56+, Week 4, n=8, 25

Group	Value	95% CI
Placebo	1.163	± 12.97
GSK3196165 180 mg	0.951	± 7.25

CD16+CD56+, Week 12, n=6, 25

Group	Value	95% CI
Placebo	1.193	± 15.49
GSK3196165 180 mg	0.911	± 7.81

CD16+CD56+, 12-Week FU, n=6, 21

Group	Value	95% CI
Placebo	1.298	± 15.10
GSK3196165 180 mg	0.920	± 7.98

CD19, Week 1, n=8, 25

Group	Value	95% CI
Placebo	0.880	± 11.05
GSK3196165 180 mg	0.984	± 6.23

CD19, Week 4, n=8, 25

Group	Value	95% CI
Placebo	1.090	± 15.31
GSK3196165 180 mg	0.971	± 8.60

CD19, Week 12, n=6, 25

Group	Value	95% CI
Placebo	1.054	± 12.26
GSK3196165 180 mg	1.003	± 6.51

CD19, Week 22, n=6, 21

Group	Value	95% CI
Placebo	0.980	± 17.75
GSK3196165 180 mg	0.938	± 9.75

Change From Baseline in Flow Cytometry: 6 Colour TBNK Panel- CD3+CD8+ and T Cell B Cell Natural Killer Lymphocytes (NKL) Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+CD8+ and T Cell B Cell NKL. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD3+CD8+ and T Cell B Cell NKL log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with data availabl

CD3+CD8+, Week 1, n=8, 25

Group	Value	95% CI
Placebo	-0.041	± 0.0390
GSK3196165 180 mg	-0.005	± 0.0222

CD3+CD8+, Week 4, n=8, 25

Group	Value	95% CI
Placebo	0.000	± 0.0580
GSK3196165 180 mg	-0.023	± 0.0327

CD3+CD8+, Week 12, n=6, 25

Group	Value	95% CI
Placebo	-0.056	± 0.0418
GSK3196165 180 mg	-0.037	± 0.0215

CD3+CD8+, 12-Week FU, n=6, 21

Group	Value	95% CI
Placebo	-0.060	± 0.0506
GSK3196165 180 mg	-0.027	± 0.0279

T Cell B Cell NKL, Week 1, n=8, 25

Group	Value	95% CI
Placebo	-0.123	± 0.1557
GSK3196165 180 mg	-0.020	± 0.0881

T Cell B Cell NKL, Week 4, n=8, 25

Group	Value	95% CI
Placebo	0.108	± 0.2174
GSK3196165 180 mg	-0.050	± 0.1229

T Cell B Cell NKL, Week 12, n=6, 25

Group	Value	95% CI
Placebo	-0.093	± 0.1792
GSK3196165 180 mg	-0.006	± 0.0925

T Cell B Cell NKL, 12-Week FU, n=6, 21

Group	Value	95% CI
Placebo	-0.029	± 0.2168
GSK3196165 180 mg	-0.050	± 0.1183

Change From Baseline in Flow Cytometry: T Regulatory (Reg) Cell Foxp3- CD3+ CD4+, CD3+ CD8+ and CD3+ Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+ CD4+, CD3+ CD8+ and CD3+. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for CD3+ CD4+, CD3+ CD8+ and CD3+ Number of Cells (10\^6/L) log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment group by visit interaction. Only those participants with da

CD3+ CD4+, Week 1, n=7, 23

Group	Value	95% CI
Placebo	0.905	± 10.21
GSK3196165 180 mg	1.007	± 5.65

CD3+ CD4+, Week 4, n=7, 22

Group	Value	95% CI
Placebo	1.038	± 11.31
GSK3196165 180 mg	0.976	± 6.38

CD3+ CD4+, Week 12, n=5, 21

Group	Value	95% CI
Placebo	0.981	± 10.55
GSK3196165 180 mg	1.004	± 5.31

CD3+ CD4+, 12-Week FU, n=5, 17

Group	Value	95% CI
Placebo	0.926	± 11.70
GSK3196165 180 mg	1.003	± 6.39

CD3+ CD8+, Week 1, n=7, 23

Group	Value	95% CI
Placebo	0.885	± 9.97
GSK3196165 180 mg	0.983	± 5.50

CD3+ CD8+, Week 4, n=7, 22

Group	Value	95% CI
Placebo	0.981	± 11.89
GSK3196165 180 mg	0.939	± 6.66

CD3+ CD8+, Week 12, n=5, 21

Group	Value	95% CI
Placebo	0.878	± 10.50
GSK3196165 180 mg	0.945	± 5.40

CD3+ CD8+, 12-Week FU, n=5, 17

Group	Value	95% CI
Placebo	0.936	± 10.99
GSK3196165 180 mg	0.965	± 6.05

Change From Baseline in Flow Cytometry: T Reg Cell Foxp3: CD3+CD4+CD25+CD127-, CD3+CD4+foxP3+CD25+CD127- Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+CD4+CD25+CD127- and CD3+CD4+foxP3+CD25+CD127-. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD3+CD4+CD25+CD127- and CD3+CD4+foxP3+CD25+CD127-Number of Cells (10\^6 cells/L) log(Baseline value), treatment group, disease duration (\<=2 or \>2 years), visit and treatment g

CD3+CD4+CD25+CD127-, Week 1, n=7, 23

Group	Value	95% CI
Placebo	-3.6	± 8.35
GSK3196165 180 mg	2.9	± 4.67

CD3+CD4+CD25+CD127-, Week 4, n=7, 22

Group	Value	95% CI
Placebo	1.4	± 8.34
GSK3196165 180 mg	-0.4	± 4.70

CD3+CD4+CD25+CD127-, Week 12, n=5, 21

Group	Value	95% CI
Placebo	-9.4	± 9.87
GSK3196165 180 mg	-3.1	± 4.94

CD3+CD4+CD25+CD127-, 12-Week FU, n=5, 17

Group	Value	95% CI
Placebo	-12.9	± 9.92
GSK3196165 180 mg	-2.3	± 5.43

CD3+CD4+foxP3+CD25+CD127, Week 1, n=7, 23

Group	Value	95% CI
Placebo	0.8	± 6.39
GSK3196165 180 mg	2.8	± 3.58

CD3+CD4+foxP3+CD25+CD127, Week 4, n=7, 22

Group	Value	95% CI
Placebo	4.3	± 7.05
GSK3196165 180 mg	2.0	± 3.98

CD3+CD4+foxP3+CD25+CD127, Week 12, n=5, 21

Group	Value	95% CI
Placebo	2.7	± 7.99
GSK3196165 180 mg	-4.4	± 3.91

CD3+CD4+foxP3+CD25+CD127,12-Week FU, n=5,17

Group	Value	95% CI
Placebo	-8.7	± 5.94
GSK3196165 180 mg	-4.6	± 3.15

Change From Baseline in T Helper Cell Panel Events Primary · Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)

Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. T Helper Cell Panel included analysis of CD45+3+8-4+CCR6+CXCR3+38+DR+, CD45+3+8-4+CCR6+CXCR3-38+DR+, CD45+3+8-4+CCR6-CXCR3+38+DR+, CD45+3+8-4+CCR6-CXCR3-38+DR+, CD45+CD3+CD8-CD4+, CD45+CD3+CD8-CD4+CCR6+CXCR3+, CD45+CD3+CD8-CD4+CCR6+CXCR3-, CD45+CD3+CD8-CD4+CCR6-CXCR3+ and CD45+CD3+CD8-CD4+CCR6-CXCR3-. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures ana

CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1, n=7, 23

Group	Value	95% CI
Placebo	-48.6	± 13.50
GSK3196165 180 mg	-34.0	± 7.35

CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4, n=7, 21

Group	Value	95% CI
Placebo	-14.5	± 18.36
GSK3196165 180 mg	-6.1	± 10.63

CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12, n=5, 22

Group	Value	95% CI
Placebo	42.3	± 37.80
GSK3196165 180 mg	-6.9	± 17.69

CD45+3+8-4+CCR6+CXCR3+38+DR+,12-Week FU,n=5,18

Group	Value	95% CI
Placebo	11.5	± 16.47
GSK3196165 180 mg	-18.7	± 8.66

CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1, n=7, 23

Group	Value	95% CI
Placebo	-17.0	± 6.80
GSK3196165 180 mg	-10.5	± 3.62

CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4, n=7, 21

Group	Value	95% CI
Placebo	14.2	± 15.65
GSK3196165 180 mg	12.2	± 9.10

CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12, n=5, 22

Group	Value	95% CI
Placebo	3.4	± 16.09
GSK3196165 180 mg	-3.0	± 7.55

CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU, n=5, 18

Group	Value	95% CI
Placebo	8.9	± 12.29
GSK3196165 180 mg	3.3	± 6.36

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were collected from start of study treatment up to 12-Week FU (Week 22).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/11 (0%)

Deaths: 0/11

GSK3196165 180 mg

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (20 terms — click to expand)

Reaction	System	Placebo	GSK3196165 180 mg
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Laryngitis	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Rosacea	Skin and subcutaneous tissue disorders	—	—
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Weight increased	Investigations	—	—
Headache	Nervous system disorders	—	—
Initial insomnia	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT02799472 adverse events section.

Sponsor's own description

This study is designed to explore the activity of granulocyte-macrophage colony stimulating factor (GM-CSF) signaling pathway in subjects with rheumatoid arthritis (RA), the potential impact of inhibition of this axis by GSK3196165, and to evaluate whether there are any differences in the GM-CSF axis between subjects with early RA compared with those with more established disease. This study also aims to establish the potential impact of GSK3196165 on inflammatory structural joint damage in the hand/wrist using magnetic resonance imaging (MRI). This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled parallel group study. Approximately 40 subjects with active RA despite treatment with disease-modifying antirheumatic drugs (DMARDs) (including conventional or biologic) will be randomized into the study, following a screening period of up to 6 weeks. The total treatment period is up to 10 weeks, with a 12-week follow-up period after the last dose (Week 22).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

GM-CSF in inflammation.
Hamilton JA. · · 2020 · cited 236× · PMID 31611249 · DOI 10.1084/jem.20190945
Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.
Guan F, Wang R, Yi Z, Luo P, et al · · 2025 · cited 155× · PMID 40055311 · DOI 10.1038/s41392-025-02124-y
GM-CSF: A Promising Target in Inflammation and Autoimmunity.
Lee KMC, Achuthan AA, Hamilton JA. · · 2020 · cited 112× · PMID 33150139 · DOI 10.2147/itt.s262566
Targeting GM-CSF in COVID-19 Pneumonia: Rationale and Strategies.
Bonaventura A, Vecchié A, Wang TS, Lee E, et al · · 2020 · cited 112× · PMID 32719685 · DOI 10.3389/fimmu.2020.01625
Molecular and Cellular Heterogeneity in Rheumatoid Arthritis: Mechanisms and Clinical Implications.
Zhao J, Guo S, Schrodi SJ, He D. · · 2021 · cited 105× · PMID 34899757 · DOI 10.3389/fimmu.2021.790122
Investigational therapies targeting the granulocyte macrophage colony-stimulating factor receptor-α in rheumatoid arthritis: focus on mavrilimumab.
Cook AD, Hamilton JA. · · 2018 · cited 26× · PMID 29387176 · DOI 10.1177/1759720x17752036
MRI of the joint and evaluation of the granulocyte-macrophage colony-stimulating factor-CCL17 axis in patients with rheumatoid arthritis receiving otilimab: a phase 2a randomised mechanistic study.
Genovese MC, Berkowitz M, Conaghan PG, Peterfy C, et al · · 2020 · cited 18× · PMID 38279363 · DOI 10.1016/s2665-9913(20)30224-1
P-hacking in clinical trials and how incentives shape the distribution of results across phases.
Adda J, Decker C, Ottaviani M. · · 2020 · cited 18× · PMID 32487730 · DOI 10.1073/pnas.1919906117

Verify or expand the search:

Other trials of GSK3196165

Trials testing the same drug.

NCT02683785 — A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis · Phase 2 · completed
NCT02504671 — Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheuma · Phase 2 · completed

Other recruiting trials for Arthritis, Rheumatoid

Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02799472 (US National Library of Medicine, public domain)
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: 11 January 2021

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/NCT02799472.

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