Terminated
PHASE2
INTERVENTIONAL
NCT03893565
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
GSK2831781 - Double Blind Phase
Type:
DRUG
Description:
GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
Name:
Placebo
Type:
DRUG
Description:
Placebo (commercial saline solution) will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
Name:
GSK2831781 - Open Label phase
Type:
DRUG
Description:
GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP.
Primary Outcomes
Measure:
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase
TimeFrame:
Up to a maximum of Week 14
Description:
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 of the other outcomes listed before. AEs and SAEs were collected up to Week 14 (for participants who later entered the Double Blind ETP) and Week 12 (for participants who later entered OL Induction Phase).
Measure:
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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 their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To within (w/in) Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100 percent (%).
Measure:
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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 were counted in the worst-case category that their value changed to (low, w/in range or no change, or high), unless there was no change in their category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Measure:
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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) (low: \<130 and high: \>150 mmol/L); protein (Pro) (low: \<50 and high: \>85 g/L) and C-reactive protein (CRP) (high: \>30 milligrams/L). Participants were counted in the worst-case category that their value changed to (low, w/in range or no change, or high), unless there was no change in their category.
Measure:
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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 to High), or whose value became within range, were recorded in the "To within (w/in) Range or No Change category".
Measure:
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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 per high power field \[hpf\]); specific gravity (sp gra) (low: \<1.001 and high: \>1.035) and urobilinogen (uro) (high: \>1 mg/deciliter).
Measure:
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase
TimeFrame:
Up to Week 10
Description:
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.
Measure:
Change From Baseline in Complete 4-domain Mayo Score at Week 10
TimeFrame:
Baseline and Week 10
Description:
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 phase. Change from Baseline was calculated as value at specified time point minus Baseline value.
Trial Information
NCT ID
NCT03893565
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
GlaxoSmithKline
Last Updated
December 15, 2025