NCT03893565 is a Phase 2 clinical trial of GSK2831781 - Double Blind Phase in Colitis, Ulcerative, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03893565?

NCT03893565 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03893565?

Interventions in NCT03893565: GSK2831781 - Double Blind Phase, Placebo, GSK2831781 - Open Label phase.

What condition does NCT03893565 study?

NCT03893565 studies Colitis, Ulcerative.

Is NCT03893565 still recruiting?

NCT03893565 is currently terminated. Last updated 27 April 2022.

Are results published for NCT03893565?

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

Last reviewed 2022-04-27 · How we verify

NCT03893565

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

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

Terminated Phase 2 Results posted Last updated 27 April 2022

What this trial tests

Phase 2 trial testing GSK2831781 - Double Blind Phase in Colitis, Ulcerative in 104 participants. Terminated before completion.

Timeline

6 May 2019

Primary endpoint
17 May 2021

17 May 2021

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	104
Start date	6 May 2019
Primary completion	17 May 2021
Estimated completion	17 May 2021
Sites	61 locations across France, South Africa, Japan, Netherlands, Russia, Slovakia, India, Serbia

Drugs / interventions tested

GSK2831781 - Double Blind Phase — full drug profile →
Placebo
GSK2831781 - Open Label phase — full drug profile →

Conditions studied

Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Colitis, Ulcerative. 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.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase Primary · Up to a maximum of Week 14

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect or other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one

AEs

Group	Value	95% CI
Placebo IV	10
GSK2831781 450 mg IV	27
GSK2831781 300 mg IV	6
GSK2831781 150 mg IV	2
GSK2831781 45 mg IV	2

SAEs

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	6
GSK2831781 300 mg IV	1
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Vital signs were measured in a seated or semi-supine position after 5 minutes rest. The clinical concern range for vital signs were: systolic blood pressure (SBP) (lower: \<85 and upper: \> 160 millimeters of mercury \[mmHg\]); diastolic blood pressure (DBP) (lower: \<45 mmHg and upper: \>100 mmHg); pulse rate (PR) (lower: \<40 and upper: \>110 beats per minute \[bpm\]) and temperature (Temp) (lower: \<35 and upper: \>38 degree Celsius). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in thei

DBP; To low; n=27, 47, 9, 8, 7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

DBP; To w/in range or no change; n=27, 47, 9, 8, 7

Group	Value	95% CI
Placebo IV	27
GSK2831781 450 mg IV	47
GSK2831781 300 mg IV	9
GSK2831781 150 mg IV	8
GSK2831781 45 mg IV	7

DBP; To high; n=27, 47, 9, 8, 7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

SBP; To low; n=27, 47, 10, 9, 6

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	1
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

SBP; To w/in range or no change; n=27, 47, 10, 9,6

Group	Value	95% CI
Placebo IV	26
GSK2831781 450 mg IV	45
GSK2831781 300 mg IV	9
GSK2831781 150 mg IV	9
GSK2831781 45 mg IV	6

SBP; To high; n=27, 47, 10, 9, 6

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	2
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

PR; To low; n=27, 47, 11, 9, 8

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	1
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

PR; To w/in range or no change; n=27, 47, 11, 9, 8

Group	Value	95% CI
Placebo IV	27
GSK2831781 450 mg IV	45
GSK2831781 300 mg IV	10
GSK2831781 150 mg IV	9
GSK2831781 45 mg IV	8

Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (Hct) (low: 0.201 and high: \>0.599 proportion of red blood cells in blood); hemoglobin (Hgb) (low: \<80 and high: \>180 grams per liter \[g/L\]), lymphocytes (Lymph) (low: \<0.8x10\^9 cells/L); neutrophil (Neut) count (low: \<1.5x10\^9 cells/L); platelet (plat) count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); leukocytes (leuko) (low: \<3x10\^9 cells/L and high: \>20x10\^9cells/L) and eosinophils (Eos) (high: \>=1x10\^9 cells/L). Participants w

Eos;w/in range or no change; n=25,45,9,8,7

Group	Value	95% CI
Placebo IV	24
GSK2831781 450 mg IV	44
GSK2831781 300 mg IV	9
GSK2831781 150 mg IV	8
GSK2831781 45 mg IV	7

Eos; To high; n=25,45,9,8,7

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	1
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Hct; To low; n=24,43,7,6,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Hct; To w/in range or no change; n=24,43,7,6,7

Group	Value	95% CI
Placebo IV	24
GSK2831781 450 mg IV	43
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	6
GSK2831781 45 mg IV	7

Hct; To high; n=24,43,7,6,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Hgb; To low; n=24,45,5,7,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	1
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

Hgb; To w/in range or no change; n=24,45,5,7,7

Group	Value	95% CI
Placebo IV	24
GSK2831781 450 mg IV	45
GSK2831781 300 mg IV	4
GSK2831781 150 mg IV	6
GSK2831781 45 mg IV	7

Hgb; To high; n=24,45,5,7,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (Alb) (low: \<30 and high: \>55 g/L), calcium (Ca) (low: 2 and high: 2.75 millimoles per liter \[mmol/L\]), urea (high: \>10.5 mmol/L); creatinine (Creat) (high: change from Baseline \>26 micromoles per liter \[µmol/L\]), glucose (Glu) (low: \<3.5 and high: \>7.9 mmol/L); estimated glomerular filtration rate (eGFR) (low: \<60 milliliters per minute per 1.73 square meter \[mL/min/1.73m\^2)\]; potassium (Pot) (low: \<3 and high: \>5.5 mmol/L); sodium (Sod)

Alb; To low; n=26,42,7,6,6

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	2
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

Alb; To w/in range or no change; n=26,42,7,6,6

Group	Value	95% CI
Placebo IV	26
GSK2831781 450 mg IV	40
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	5
GSK2831781 45 mg IV	6

Alb; To high; n=26,42,7,6,6

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

CRP; To w/in range or no change; n=26, 46,9,10,8

Group	Value	95% CI
Placebo IV	25
GSK2831781 450 mg IV	36
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	9
GSK2831781 45 mg IV	8

CRP; To high; n=26, 46,9,10,8

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	10
GSK2831781 300 mg IV	2
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

Cal; To low; n=26,45,7,4,7

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

Cal; To w/in range or no change; n=26,45,7,4,7

Group	Value	95% CI
Placebo IV	25
GSK2831781 450 mg IV	45
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	3
GSK2831781 45 mg IV	7

Cal; To high; n=26,45,7,4,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: alanine aminotransferase (ALT) (high: \>=2 times upper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2 times ULN); alkaline phosphatase (ALP) (high: \>=2 times ULN) and bilirubin (Bil) (high: \>=1.5 times ULN). Participants were counted in the worst-case category that their value changed to (within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High t

ALT; To low; n=26,44,7,7,8

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

ALT;To w/in range or no change; n=26,44,7,7,8

Group	Value	95% CI
Placebo IV	25
GSK2831781 450 mg IV	42
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	7
GSK2831781 45 mg IV	8

ALT; To high; n=26,44,7,7,8

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	2
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

AST; To low; n=26,45,7,8,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

AST; To w/in range or no change; n=26,45,7,8,7

Group	Value	95% CI
Placebo IV	26
GSK2831781 450 mg IV	44
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	8
GSK2831781 45 mg IV	7

AST; To high;n=26,45,7,8,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	1
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

ALP; To low; n=27,44,9,9,8

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

ALP; To w/in range or no change; n=27,44,9,9,8

Group	Value	95% CI
Placebo IV	27
GSK2831781 450 mg IV	44
GSK2831781 300 mg IV	9
GSK2831781 150 mg IV	9
GSK2831781 45 mg IV	8

Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Urine samples were collected for the assessment of urine parameters by dipstick and microscopy. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample. The clinical concern range for urine parameters were: Bil (high: \>1+), glu (high: \>1+); ketone (ket) (high: \>2+); leuko (high: \>1+); leukocyte esterase (LE); nitrite (nit) (high: positive); occult blood (OB) (high: \>1+); potential of hydrogen (pH) (low: \<4.6 and high: \>8); prot (high:\>1+); erythrocytes (erythro) (high: \>3 cells p

Bil; To w/in range or no change; n=27,47,10,9,8

Group	Value	95% CI
Placebo IV	27
GSK2831781 450 mg IV	46
GSK2831781 300 mg IV	10
GSK2831781 150 mg IV	9
GSK2831781 45 mg IV	8

Bil; To high; n=27,47,10,9,8

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	1
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Glu; To w/in range or no change; n=27,47,10,10,8

Group	Value	95% CI
Placebo IV	27
GSK2831781 450 mg IV	47
GSK2831781 300 mg IV	10
GSK2831781 150 mg IV	10
GSK2831781 45 mg IV	8

Glu; To high; n=27,47,10,10,8

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Ket; To w/in range or no change; n=27,47,10,8,8

Group	Value	95% CI
Placebo IV	25
GSK2831781 450 mg IV	47
GSK2831781 300 mg IV	10
GSK2831781 150 mg IV	7
GSK2831781 45 mg IV	8

Ket; To high; n=27,47,10,8,8

Group	Value	95% CI
Placebo IV	2
GSK2831781 450 mg IV	0
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

LE; To w/in range or no change; n=26,45,9,8,8

Group	Value	95% CI
Placebo IV	25
GSK2831781 450 mg IV	37
GSK2831781 300 mg IV	9
GSK2831781 150 mg IV	8
GSK2831781 45 mg IV	8

LE; To high; n=26,45,9,8,8

Group	Value	95% CI
Placebo IV	1
GSK2831781 450 mg IV	8
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	0
GSK2831781 45 mg IV	0

Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase Primary · Up to Week 10

Twelve lead electrocardiograms (ECGs) were obtained using an ECG machine that automatically calculated the QT interval corrected for heart rate according to either Bazett's formula (QTcB) or Fridericia's formula (QTcF). The clinical concern range for the QTcB and QTcF intervals was upper: \>450 milliseconds.

QTcB; No change or decrease to <450; n=26,44,8,9,7

Group	Value	95% CI
Placebo IV	22
GSK2831781 450 mg IV	41
GSK2831781 300 mg IV	6
GSK2831781 150 mg IV	7
GSK2831781 45 mg IV	7

QTcB; Any increase to >=450; n=26,44,8,9,7

Group	Value	95% CI
Placebo IV	4
GSK2831781 450 mg IV	3
GSK2831781 300 mg IV	2
GSK2831781 150 mg IV	2
GSK2831781 45 mg IV	0

QTcF; No change or decrease to <450; n=26,46,7,9,7

Group	Value	95% CI
Placebo IV	26
GSK2831781 450 mg IV	45
GSK2831781 300 mg IV	7
GSK2831781 150 mg IV	8
GSK2831781 45 mg IV	7

QTcF; Any increase to >=450; n=26,46,7,9,7

Group	Value	95% CI
Placebo IV	0
GSK2831781 450 mg IV	1
GSK2831781 300 mg IV	0
GSK2831781 150 mg IV	1
GSK2831781 45 mg IV	0

Change From Baseline in Complete 4-domain Mayo Score at Week 10 Primary · Baseline and Week 10

The Complete 4-domain Mayo Score is a 12-point scoring system where disease is evaluated based on the four components: stool frequency, rectal bleeding, physician global assessment (PGA) and endoscopic appearance (with mild friability associated with an endoscopic score of 1). The score for each component ranges from 0 (normal/none) to 3 (severe). The complete Mayo score is calculated as the sum of four components and ranges from 0 to 12. Higher scores indicate greater disease severity. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study

Group	Value	95% CI
Placebo IV	-1.5	± 0.45
GSK2831781 450 mg IV	-1.4	± 0.36
GSK2831781 300 mg IV	-0.3	± 0.48
GSK2831781 150 mg IV	-1.0	± 2.00
GSK2831781 45 mg IV	-2.3	± 0.33

Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase Secondary · Week 14 to 30

AEs

Group	Value	95% CI
Placebo SC	1
GSK2831781 300 mg SC	3

SAEs

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	1

Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase Secondary · Week 14 to 30

Vital signs were measured in a seated or semi-supine position after 5 minutes rest. The clinical concern range for vital signs were: SBP (lower: \<85 and upper: \> 160 mmHg); DBP (lower: \<45 mmHg and upper: \>100 mmHg); PR (lower: \<40 and upper: \>110 bpm) and Temp (lower: \<35 and upper: \>38 degree Celsius). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were record

DBP; To low

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

DBP; To w/in range or no change

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

DBP; To high

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

SBP; To low

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

SBP; To w/in range or no change

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

SBP; To high

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

PR; To low

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

PR; To w/in range or no change

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase Secondary · Week 14 to 30

Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: Hct (low: 0.201 and high: \>0.599 proportion of red blood cells in blood); Hgb (low: \<80 and high: \>180 g/L), Lymph (low: \<0.8x10\^9 cells/L); Neut count (low: \<1.5x10\^9 cells/L); plat count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); leuko (low: \<3x10\^9 cells/L and high: \>20x10\^9cells/L) and Eos (high: \>=1x10\^9 cells/L). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), u

Eos;To w/in range or no change; n=4,8

Group	Value	95% CI
Placebo SC	4
GSK2831781 300 mg SC	8

Eos; To high; n=4,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Hct; To low; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Hct; To w/in range or no change; n=5,8

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

Hct; To high; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Hgb; To low; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Hgb; To w/in range or no change; n=5,8

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

Hgb; To high; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase Secondary · Week 14 to 30

Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: Alb (low: \<30 and high: \>55 g/L), C) (low: 2 and high: 2.75 mmol/L), urea (high: \>10.5 mmol/L); Creat (high: change from Baseline \>26 µmol/L), Glu (low: \<3.5 and high: \>7.9 mmol/L); eGFR (low: \<60 mL/min/1.73m\^2\]; Pot low: \<3 and high: \>5.5 mmol/L); Sod (low: \<130 and high: \>150 mmol/L); Pro (low: \<50 and high: \>85 g/L) and CRP (high: \>30 milligrams/L). Participants were counted in the worst-case category that their value changed to (low, within

Alb; To low; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	1

Alb; To w/in range or no change; n=5,8

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	7

Alb; To high; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

CRP; To w/in range or no change; n=5,8

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	6

CRP; To high; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	2

Cal; To low; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Cal; To w/in range or no change; n=5,8

Group	Value	95% CI
Placebo SC	5
GSK2831781 300 mg SC	8

Cal; To high; n=5,8

Group	Value	95% CI
Placebo SC	0
GSK2831781 300 mg SC	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Non-SAEs and SAEs were collected up to Week 12 (participants who entered OL induction phase) or Week 14 (participants who entered double-blind ETP) for Double-blind induction phase, from Week 14 to 30 for double-blind ETP, from Week 12 to 22 for OL induction phase and from Week 22 to 42 for OL ETP. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo IV

Serious: 0/27 (0%)

Deaths: 0/27

GSK2831781 450 mg IV

Serious: 6/48 (13%)

Deaths: 0/48

GSK2831781 300 mg IV

Serious: 1/11 (9%)

Deaths: 0/11

GSK2831781 150 mg IV

Serious: 0/10 (0%)

Deaths: 0/10

GSK2831781 45 mg IV

Serious: 0/8 (0%)

Deaths: 0/8

Placebo SC

Serious: 0/5 (0%)

Deaths: 0/5

GSK2831781 300 mg SC

Serious: 1/8 (13%)

Deaths: 0/8

Open-label GSK2831781 450 mg IV

Serious: 3/42 (7%)

Deaths: 0/42

Open-label GSK2831781 300 mg SC

Serious: 0/7 (0%)

Deaths: 0/7

Serious adverse events (3 terms)

Reaction	System	Placebo IV	GSK2831781 450 mg IV	GSK2831781 300 mg IV	GSK2831781 150 mg IV	GSK2831781 45 mg IV	Placebo SC	GSK2831781 300 mg SC	Open-label GSK2831781 450 …	Open-label GSK2831781 300 …
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—	—	—	—	—

Other adverse events (83 terms — click to expand)

Reaction	System	Placebo IV	GSK2831781 450 mg IV	GSK2831781 300 mg IV	GSK2831781 150 mg IV	GSK2831781 45 mg IV	Placebo SC	GSK2831781 300 mg SC	Open-label GSK2831781 450 …	Open-label GSK2831781 300 …
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Arthropathy	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Suspected COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Iron deficiency	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Thrombocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Vitamin D deficiency	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Mixed anxiety and depressive disorder	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Somatic symptom disorder	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Myocardial fibrosis	Cardiac disorders	—	—	—	—	—	—	—	—	—
Malabsorption	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Heart rate decreased	Investigations	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Aphthous ulcer	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Colitis ulcerative, Anaemia, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT03893565 adverse events section.

Sponsor's own description

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

Publications & conference data

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

Understanding LAG-3 Signaling.
Chocarro L, Blanco E, Zuazo M, Arasanz H, et al · · 2021 · cited 154× · PMID 34067904 · DOI 10.3390/ijms22105282
Clinical landscape of LAG-3-targeted therapy.
Chocarro L, Blanco E, Arasanz H, Fernández-Rubio L, et al · · 2022 · cited 69× · PMID 35755891 · DOI 10.1016/j.iotech.2022.100079
Cutting-Edge: Preclinical and Clinical Development of the First Approved Lag-3 Inhibitor.
Chocarro L, Bocanegra A, Blanco E, Fernández-Rubio L, et al · · 2022 · cited 57× · PMID 35954196 · DOI 10.3390/cells11152351
Lymphocyte Activation Gene (LAG)-3 Is Associated With Mucosal Inflammation and Disease Activity in Ulcerative Colitis.
Slevin SM, Garner LC, Lahiff C, Tan M, et al · · 2020 · cited 40× · PMID 32179884 · DOI 10.1093/ecco-jcc/jjaa054
The immune checkpoint receptor LAG3: Structure, function, and target for cancer immunotherapy.
Mariuzza RA, Shahid S, Karade SS. · · 2024 · cited 37× · PMID 38556085 · DOI 10.1016/j.jbc.2024.107241
A randomised, double-blind, placebo-controlled study of the LAG-3-depleting monoclonal antibody GSK2831781 in patients with active ulcerative colitis.
D'Haens G, Peyrin-Biroulet L, Marks DJB, Lisi E, et al · · 2023 · cited 9× · PMID 37323059 · DOI 10.1111/apt.17557
Innovations in immunotherapy for autoimmune diseases: recent breakthroughs and future directions.
Alsayb MA. · · 2025 · cited 2× · PMID 41041324 · DOI 10.3389/fimmu.2025.1647066
A machine learning approach toward automating spatial identification of LAG3+/CD3+ cells in ulcerative colitis.
Bonnevie ED, Dobrzynski E, Steiner D, Hildebrand D, et al · · 2023 · cited 1× · PMID 38066073 · DOI 10.1038/s41598-023-49163-5

Verify or expand the search:

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

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NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting

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 NCT03893565 (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: 27 April 2022

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/NCT03893565.

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