NCT02683785 is a Phase 2 clinical trial of GSK3196165 in Osteoarthritis, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02683785?

NCT02683785 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02683785?

Interventions in NCT02683785: GSK3196165, Placebo.

What condition does NCT02683785 study?

NCT02683785 studies Osteoarthritis.

Is NCT02683785 still recruiting?

NCT02683785 is currently completed. Last updated 11 January 2021.

Are results published for NCT02683785?

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

NCT02683785

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

A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis

Completed Phase 2 Results posted Last updated 11 January 2021

What this trial tests

Phase 2 trial testing GSK3196165 in Osteoarthritis in 44 participants. Completed in 29 November 2017.

Timeline

17 March 2016

Primary endpoint
29 November 2017

29 November 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	17 March 2016
Primary completion	29 November 2017
Estimated completion	29 November 2017
Sites	16 locations across Netherlands, United Kingdom, Germany, Poland, United States

Drugs / interventions tested

GSK3196165 — full drug profile →
Placebo

Conditions studied

Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis. 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 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6 Primary · Baseline (Day 1 Pre-dose) and Week 6

Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visi

Group	Value	95% CI
Placebo	-1.34	± 0.325
GSK3196165 180mg	-1.70	± 0.334

Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit Secondary · Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score is calculated by sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit

Week 1, n=22, 20

Group	Value	95% CI
Placebo	-0.13	± 0.152
GSK3196165 180mg	-0.59	± 0.160

Week 2, n=21, 20

Group	Value	95% CI
Placebo	-0.48	± 0.230
GSK3196165 180mg	-0.86	± 0.239

Week 3, n=21, 20

Group	Value	95% CI
Placebo	-0.74	± 0.279
GSK3196165 180mg	-1.24	± 0.289

Week 4, n=21, 20

Group	Value	95% CI
Placebo	-0.91	± 0.291
GSK3196165 180mg	-1.65	± 0.301

Week 6, n=21, 20

Group	Value	95% CI
Placebo	-1.34	± 0.325
GSK3196165 180mg	-1.70	± 0.334

Week 8, n=20, 19

Group	Value	95% CI
Placebo	-1.27	± 0.382
GSK3196165 180mg	-2.10	± 0.393

Week 10, n=20, 19

Group	Value	95% CI
Placebo	-1.18	± 0.376
GSK3196165 180mg	-2.09	± 0.389

Week 12, n=19, 18

Group	Value	95% CI
Placebo	-1.35	± 0.402
GSK3196165 180mg	-2.24	± 0.416

Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit Secondary · Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Participants were required to complete a daily pain NRS based on their 24-hour worst hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The score is calculated as sum of daily 24 hours worst hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Basel

Week 1, n=22, 20

Group	Value	95% CI
Placebo	0.01	± 0.174
GSK3196165 180mg	-0.45	± 0.183

Week 2, n=21, 20

Group	Value	95% CI
Placebo	-0.42	± 0.235
GSK3196165 180mg	-0.69	± 0.245

Week 3, n=21, 20

Group	Value	95% CI
Placebo	-0.63	± 0.269
GSK3196165 180mg	-1.23	± 0.278

Week 4, n= 21, 20

Group	Value	95% CI
Placebo	-0.72	± 0.289
GSK3196165 180mg	-1.51	± 0.299

Week 6, n= 21, 20

Group	Value	95% CI
Placebo	-1.30	± 0.328
GSK3196165 180mg	-1.63	± 0.337

Week 8, n= 20, 19

Group	Value	95% CI
Placebo	-1.18	± 0.394
GSK3196165 180mg	-2.11	± 0.406

Week 10, n= 20, 19

Group	Value	95% CI
Placebo	-1.15	± 0.394
GSK3196165 180mg	-2.13	± 0.407

Week 12, n= 19, 18

Group	Value	95% CI
Placebo	-1.32	± 0.415
GSK3196165 180mg	-2.34	± 0.430

Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit Secondary · Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)

Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 30 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is reported.

Week 1

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	9

Week 2

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	18

Week 3

Group	Value	95% CI
Placebo	5
GSK3196165 180mg	23

Week 4

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	41

Week 6

Group	Value	95% CI
Placebo	23
GSK3196165 180mg	45

Week 8

Group	Value	95% CI
Placebo	18
GSK3196165 180mg	50

Week 10

Group	Value	95% CI
Placebo	18
GSK3196165 180mg	50

Week 12

Group	Value	95% CI
Placebo	23
GSK3196165 180mg	45

Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit Secondary · Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)

Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 50 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.

Week 1

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	0

Week 2

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	9

Week 3

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	18

Week 4

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	23

Week 6

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	27

Week 8

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	41

Week 10

Group	Value	95% CI
Placebo	9
GSK3196165 180mg	36

Week 12

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	41

Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit Secondary · Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)

Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 30 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.

Week 1

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	9

Week 2

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	18

Week 3

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	23

Week 4

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	32

Week 6

Group	Value	95% CI
Placebo	9
GSK3196165 180mg	36

Week 8

Group	Value	95% CI
Placebo	9
GSK3196165 180mg	45

Week 10

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	45

Week 12

Group	Value	95% CI
Placebo	14
GSK3196165 180mg	45

Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit Secondary · Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)

Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 50 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.

Week 1

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	0

Week 2

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	5

Week 3

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	14

Week 4

Group	Value	95% CI
Placebo	0
GSK3196165 180mg	18

Week 6

Group	Value	95% CI
Placebo	5
GSK3196165 180mg	18

Week 8

Group	Value	95% CI
Placebo	5
GSK3196165 180mg	32

Week 10

Group	Value	95% CI
Placebo	5
GSK3196165 180mg	27

Week 12

Group	Value	95% CI
Placebo	9
GSK3196165 180mg	36

Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit. Secondary · Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12

The AUSCAN Index is a self-administered questionnaire consisting of a 15-item scale which measures pain (5 items), stiffness (1 item) and degree of disability/physical function (9 items) during the preceding 48 hours. All items are rated on NRS scale with anchors "0" (none) to "10" (extreme). The scores for the pain and physical function components were calculated as simple summation of the item scores relating to that domain, so the Pain component ranges from 0 (i.e. all pain item scores are scored 0 \[none\]) to 50 (i.e. all pain item scores are scored 10 \[extreme\]), and the Physical Funct

Pain, Week 1, n=22, 20

Group	Value	95% CI
Placebo	0.8	± 0.98
GSK3196165 180mg	-1.9	± 1.03

Pain, Week 2, n=21, 21

Group	Value	95% CI
Placebo	-1.8	± 1.27
GSK3196165 180mg	-3.7	± 1.28

Pain, Week 4, n=22, 21

Group	Value	95% CI
Placebo	-3.5	± 1.61
GSK3196165 180mg	-7.2	± 1.64

Pain, Week 6, n=22, 21

Group	Value	95% CI
Placebo	-6.6	± 1.72
GSK3196165 180mg	-7.6	± 1.76

Pain, Week 8, n=20, 20

Group	Value	95% CI
Placebo	-4.9	± 1.93
GSK3196165 180mg	-8.7	± 1.97

Pain, Week 10, n=20, 20

Group	Value	95% CI
Placebo	-5.3	± 1.82
GSK3196165 180mg	-10.9	± 1.87

Pain, Week 12, n=21, 19

Group	Value	95% CI
Placebo	-4.6	± 1.84
GSK3196165 180mg	-9.3	± 1.91

Stiffness, Week 1, n= 22, 20

Group	Value	95% CI
Placebo	-0.4	± 0.29
GSK3196165 180mg	-0.6	± 0.31

Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit Secondary · Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12

Swollen Hand Joint Count was measured by the total number of soft tissue swollen hand joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joint across both hands. In case of missing observations for soft tissue swollen hand joints then the remaining observations were assessed and weighted by dividing the number presented by the number of non-missing, and by multiplying by 30 for the joint count. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose

Week 1, n = 22, 21

Group	Value	95% CI
Placebo	-0.3	± 0.64
GSK3196165 180mg	-0.3	± 0.66

Week 2, n = 21, 21

Group	Value	95% CI
Placebo	-1.6	± 0.85
GSK3196165 180mg	-1.2	± 0.86

Week 4, n = 22, 21

Group	Value	95% CI
Placebo	-1.6	± 0.76
GSK3196165 180mg	-2.1	± 0.78

Week 6, n = 22, 21

Group	Value	95% CI
Placebo	-3.7	± 0.83
GSK3196165 180mg	-2.3	± 0.85

Week 8, n = 20, 20

Group	Value	95% CI
Placebo	-3.0	± 0.92
GSK3196165 180mg	-2.8	± 0.94

Week 10, n = 20, 20

Group	Value	95% CI
Placebo	-2.6	± 1.08
GSK3196165 180mg	-2.9	± 1.10

Week 12, n = 21, 19

Group	Value	95% CI
Placebo	-2.9	± 0.91
GSK3196165 180mg	-3.1	± 0.93

Change From Baseline in Number of Tender Hand Joints at Each Visit Secondary · Baseline, Weeks 1, 2, 4, 6, 8, 10, and 12

Tender Hand Joint Count was measured by the total number of tender joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joints across both hands. A joint was considered tender if it was scored \>0 on the tender joint severity scale. Joints were rated 0=no pain/tenderness, 1=mild pain, 2=moderate pain and 3=severe pain. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.

Week 1, n= 22, 21

Group	Value	95% CI
Placebo	-0.6	± 1.10
GSK3196165 180mg	-1.8	± 1.13

Week 2, n= 21, 21

Group	Value	95% CI
Placebo	-1.7	± 1.15
GSK3196165 180mg	-2.1	± 1.17

Week 4, n= 22, 21

Group	Value	95% CI
Placebo	-1.1	± 1.33
GSK3196165 180mg	-3.0	± 1.36

Week 6, n= 22, 21

Group	Value	95% CI
Placebo	-3.7	± 1.27
GSK3196165 180mg	-4.2	± 1.30

Week 8, n= 20, 20

Group	Value	95% CI
Placebo	-2.4	± 1.36
GSK3196165 180mg	-3.9	± 1.39

Week 10, n= 20, 20

Group	Value	95% CI
Placebo	-3.7	± 1.45
GSK3196165 180mg	-4.4	± 1.48

Week 12, n= 21, 19

Group	Value	95% CI
Placebo	-3.5	± 1.46
GSK3196165 180mg	-4.0	± 1.51

Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity Secondary · Baseline (Day 1 Pre-dose), Weeks 2, 4, 8, and 12

Physicians were required to complete the global assessment of disease activity using single PhGA item with a NRS ranging from 0 (none) to 10 (extremely active). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.

Week 2, n= 19, 14

Group	Value	95% CI
Placebo	-1.8	± 0.39
GSK3196165 180mg	-1.5	± 0.45

Week 4, n= 20, 15

Group	Value	95% CI
Placebo	-2.1	± 0.44
GSK3196165 180mg	-2.6	± 0.50

Week 8, n= 17, 15

Group	Value	95% CI
Placebo	-2.2	± 0.52
GSK3196165 180mg	-3.4	± 0.57

Week 12, n= 18, 14

Group	Value	95% CI
Placebo	-2.7	± 0.56
GSK3196165 180mg	-3.0	± 0.63

Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity Secondary · Baseline, Weeks 2, 4, 8, and 12

Participants were required to complete the global assessment of disease activity using single PtGA item with an NRS ranging from 0 (very well) to 10 (very poor). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.

Week 2, n= 20, 21

Group	Value	95% CI
Placebo	-0.4	± 0.36
GSK3196165 180mg	-0.6	± 0.35

Week 4, n= 21, 21

Group	Value	95% CI
Placebo	-0.6	± 0.42
GSK3196165 180mg	-1.3	± 0.42

Week 8, n= 19, 20

Group	Value	95% CI
Placebo	-0.9	± 0.47
GSK3196165 180mg	-1.8	± 0.46

Week 12, n= 20, 19

Group	Value	95% CI
Placebo	-0.7	± 0.46
GSK3196165 180mg	-1.8	± 0.46

Adverse events — posted to ClinicalTrials.gov

Time frame: Non-serious adverse events (AEs) and serious AEs were collected up to Week 22.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/22 (5%)

Deaths: 0/22

GSK3196165 180mg

Serious: 2/22 (9%)

Deaths: 0/22

Serious adverse events (3 terms)

Reaction	System	Placebo	GSK3196165 180mg
ATRIAL FIBRILLATION	Cardiac disorders	—	—
HUMERUS FRACTURE	Injury, poisoning and procedural complications	—	—
HYPERTENSIVE CRISIS	Vascular disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Placebo	GSK3196165 180mg
PALPITATIONS	Cardiac disorders	—	—
INJECTION SITE ERYTHEMA	General disorders	—	—
INJECTION SITE RASH	General disorders	—	—
CONJUNCTIVITIS	Infections and infestations	—	—
HERPES ZOSTER	Infections and infestations	—	—
NASOPHARYNGITIS	Infections and infestations	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: ATRIAL FIBRILLATION, HUMERUS FRACTURE, HYPERTENSIVE CRISIS.

Data from ClinicalTrials.gov NCT02683785 adverse events section.

Sponsor's own description

This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA). Approximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio.

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
Recent advances in the treatment of osteoarthritis.
Grässel S, Muschter D. · · 2020 · cited 172× · PMID 32419923 · DOI 10.12688/f1000research.22115.1
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
Senescence in osteoarthritis: from mechanism to potential treatment.
Liu Y, Zhang Z, Li T, Xu H, et al · · 2022 · cited 118× · PMID 35869508 · DOI 10.1186/s13075-022-02859-x
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
What is new in pain modification in osteoarthritis?
Miller RE, Block JA, Malfait AM. · · 2018 · cited 41× · PMID 29361112 · DOI 10.1093/rheumatology/kex522
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
Anti-granulocyte-macrophage colony-stimulating factor antibody otilimab in patients with hand osteoarthritis: a phase 2a randomised trial.
Schett G, Bainbridge C, Berkowitz M, Davy K, et al · · 2020 · cited 16× · PMID 38273625 · DOI 10.1016/s2665-9913(20)30171-5

Verify or expand the search:

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Trials testing the same drug.

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Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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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 NCT02683785 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT02683785.

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

NCT02683785

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GSK3196165

Other recruiting trials for Osteoarthritis

Other GlaxoSmithKline trials

Verify against primary sources