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

A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03893565

Enrollment

104

Registered

2019-03-28

Start date

2019-05-06

Completion date

2021-05-17

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Keywords

GSK2831781, Ulcerative colitis, Anti-LAG3 cell Depleting monoclonal antibody, Dose-response

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

DRUGGSK2831781 - Double Blind Phase

GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).

DRUGPlacebo

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).

DRUGGSK2831781 - Open Label phase

GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

This will be a double-blind study. Induction doses will be matched with placebo. For Maintenance dosing, participant and investigator will be masked. Participants will be allocated to the next treatment phase according to their Responder status. Non-responders to the double-blind Induction Phase will receive treatment in Open-Label Induction phase where there will be no masking.

Intervention model description

This is a parallel group, placebo controlled study where participants will be randomized to receive either GSK2831781 or placebo.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants must be 18 years of age or older and \> 40 kilograms (kg) at the time of signing the informed consent. * Participants who have a diagnosis of ulcerative colitis, established at least 3 months prior to screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and biopsy. * Complete 4-domain Mayo Score of 6 to 12, with disease extending \>= 15 centimeters (cm) from the anal verge, with a centrally read endoscopic sub score of \>=2 at screening endoscopy, and a rectal bleeding sub score \>=1. * A history of at least one of the following: inadequate response to, loss of response to, or intolerance to azathioprine or mercaptopurine (including thiopurine methyltransferase \[TPMT\] and nudix hydrolase 15 \[NUDT15\] genetic mutations precluding use), ciclosporin, tacrolimus or methotrexate; inadequate response to, loss of response to, intolerance to, or demonstrated dependence on oral corticosteroids; inadequate response to, loss of response to, or intolerance to at least one approved advanced therapy for UC including anti- tumor necrosis factor (TNF) therapies (example given \[e.g.\] infliximab, adalimumab, golimumab, or biosimilar), anti-integrin therapies, anti-interleukin (IL)-12/23 monoclonal antibodies or Janus Kinase (JAK) inhibitors. * Surveillance colonoscopy (performed according to local standards) within 12 months of screening (or during screening, if required) for participants with: Pancolitis of \>8 years duration; or participants with left-sided colitis of \>12 years duration. For participants for whom this criterion does not apply, colorectal cancer surveillance should be undertaken according to local or national guidelines for participants with age \>=50, or with other known risk factors for colorectal cancer. * Both male and female participants are eligible to participate. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP); A WOCBP who agrees to use a highly effective contraceptive method for at least 4 weeks prior to dosing, until the Follow-Up visit. * Capable of giving signed informed consent.

Exclusion criteria

* Participants with a current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischemic colitis. * Participants with fulminant ulcerative colitis (as defined by 6 bloody stools daily and 1 or more of body temperature \>=100.4 degrees Fahrenheit (or 38 degree Celsius) or heart rate \>90 beats per minute), or toxic megacolon. * Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for ulcerative colitis. * Participants with any uncontrolled medical conditions, other than active ulcerative colitis, that in the opinion of the investigator put the participant at unacceptable risk or interfere with study assessments or integrity of the data. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study. * Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to the extent that in the opinion of the investigator they would interfere with the ability of a participant to complete the study. * An active infection or a history of serious infections as follows: a) Use of antimicrobials (antibacterials, antivirals, antifungals or antiparasitic agents) for an infection within 30 days before first dose (topical treatments may be allowed at the Medical Monitor's discretion). b) A history of opportunistic infections within 1 year of screening (e.g. Pneumocystis jirovecii, aspergillosis or Cytomegalovirus colitis). This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature. c) Recurrent or chronic infection or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the participant. d) Symptomatic herpes zoster within 3 months prior to screening. e) History of tuberculosis (active or latent), irrespective of treatment status. f) A positive diagnostic tuberculosis test at screening (defined as a positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once and if their second test is negative they will be eligible. In the event a second test is also indeterminate, the investigator has the option to undertake Purified Protein Derivative (PPD) testing. If the PPD reaction is less than (\<) 5 millimeter (mm), then the participant is eligible. If the reaction is \>= 5mm, or PPD testing is not undertaken, the participant is not eligible. g) Positive Clostridium difficile toxin test during screening. However, rescreening can be undertaken following successful treatment. * Current or history of chronic liver or biliary disease (with the exception of Gilbert's syndrome, asymptomatic gallstones or uncomplicated fatty liver disease). * Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency (unless the participant has a documented history of selective immunoglobulin A deficiency). * A major organ transplant (e.g. heart, lung, kidney, liver, pancreas) or hematopoietic stem cell/marrow transplant. * Any planned major surgical procedure during the study. * A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma in situ of the uterine cervix (within 3 years) that has been fully treated and shows no evidence of recurrence. * A change in dose of oral sulfasalazine or aminosalicylate within 2 weeks prior to Baseline endoscopy. * Greater than 20 mg per day oral prednisolone (or equivalent), or a change in dose of corticosteroid within 2 weeks prior to Baseline endoscopy, or anticipated inability to maintain a stable dose of corticosteroids (\<=20 mg oral prednisolone or equivalent) until Week 12. * Topical (rectal) corticosteroids or topical (rectal) aminosalicylate within 2 weeks prior to Baseline endoscopy. * Initiation or a change in dose of mercaptopurine or azathioprine (including initiation or discontinuation of allopurinol) or methotrexate within 8 weeks prior to Baseline endoscopy. * Treatment with ciclosporin, tacrolimus or thalidomide within 4 weeks prior to Baseline endoscopy. * Treatment with an anti-TNF biologic within 8 weeks prior to Baseline endoscopy, anti-integrin or anti-IL-12/23 biologics within 12 weeks prior to Baseline endoscopy, or a JAK inhibitor within 4 weeks prior to Baseline endoscopy. * A history of inadequate response, loss of response, or intolerance to more than three classes of approved advanced therapies for UC (including anti-TNF therapies, anti-integrin therapies, anti-IL-12/23 monoclonal antibodies, or JAK inhibitors; but excluding exposure within a clinical trial setting), of which participants must not have had inadequate response (primary non-response) to more than two classes. * Received fecal microbiota transplantation within 4 weeks prior to Baseline endoscopy. * Received live vaccination within 4 weeks of Day 1 or plan to receive during the study until Follow-Up. * The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the screening endoscopy day in the current study: 1. Biologics: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer); 2. New Chemical Entities (NCEs): 30 days, 5 half-lives, or twice the duration of the biological effect (whichever is longer). * Absolute neutrophil count \<1.5 times 10\^9 cells per liter (L) or a hemoglobin \<80 grams per liter (g/L) or lymphocyte count \<0.8 times 10\^9 cells /L. * Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation \<60 milliliter (mL) per minute per 1.73 m\^2 at screening. * ALT \>2 times upper limit of normal (ULN) and bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent) at screening. * Other clinically significant abnormalities of laboratory assessments, as judged by the investigator and/or GlaxoSmithKline Medical Monitor that could affect the safety of the participant, or the interpretation of the data from the study. * Presence of hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), or positive hepatitis C antibody result at screening (Nota bene \[NB\]-Participants with Hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative Hepatitis C ribonucleic acid \[RNA\] test is obtained). * Positive serology for human immunodeficiency virus (HIV) at screening. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months. * QTc \>450 milliseconds (msec) or QTc \>480 msec for participants with bundle branch block at screening and Day 1. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another method, machine or over read. * Participants with hypersensitivity to GSK2831781 or any excipients in the clinical formulation of GSK2831781.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	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 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).
Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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 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 (%).
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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 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%.
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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) (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.
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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 to High), or whose value became within range, were recorded in the To within (w/in) Range or No Change category.
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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 per high power field \[hpf\]); specific gravity (sp gra) (low: \<1.001 and high: \>1.035) and urobilinogen (uro) (high: \>1 mg/deciliter).
Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	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.
Change From Baseline in Complete 4-domain Mayo Score at Week 10	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 phase. Change from Baseline was calculated as value at specified time point minus Baseline value.

Secondary

Measure	Time frame	Description
Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	Week 10	The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical remission is defined as adapted Mayo Clinical Score of \<=2 with no individual sub-score \>1 and a rectal bleeding sub score of 0 with stool frequency sub score not greater than Baseline.
Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	Week 10	The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical response is defined as reduction in adapted Mayo clinical score \>=3 points from Baseline and \>=30% from Baseline and decrease in the rectal bleeding sub-score of \>=1 point from Baseline (or a score of 0 or 1).
Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	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, PGA and endoscopic appearance (with mild friability associated with an endoscopic score of 1). Symptomatic remission is defined as a rectal bleeding subscore of 0, and a stool frequency subscore of \<=1, with no worsening from Baseline.
Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Baseline and Weeks 2, 4, 6, and 10	The partial Mayo clinical score is based on the complete 4-domain Mayo clinical score but without the endoscopy sub-score. It consists of three components: stool frequency, rectal bleeding, and PGA. The score for each component ranges from 0 (normal/none) to 3 (severe). The total partial Mayo score is calculated as the sum of all three components and ranges from 0 to 9. 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.
Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	Baseline and Week 10	The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The total adapted Mayo endoscopy score ranges from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). 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.
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	Baseline and Week 10	UCEIS was used as an additional tool to assess disease activity based on 3 sub-scales: endoscopic vascular pattern, bleeding, erosions and ulcerations. Individual sub-scale scores were vascular pattern (0=Normal, 1=Patchy loss, 2=Obliterated); bleeding (0=None, 1=Mucosal, 2=Luminal mild, 3=Luminal severe); erosions and ulcerations (0=None, 1=Erosions, 2=Superficial ulcer, 3=Deep ulcer). UCEIS total score was calculated as the sum of all 3 sub-scale scores and ranges from 0 to 8, with higher scores indicating more severe disease. 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.
Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	Week 10	RHI was assessed by central reading of gut pinch biopsies. The RHI Score is a continuous score, ranging from 0-33 with higher scores indicating more severe disease. RHI Remission is defined as an RHI score \<=6. Responders were defined as number of participants with RHI score \<=6.
Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase	Week 14 to 30	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.
Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	Week 10	The Geboes Index is divided in 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\]. The subscores for grade 0 to 4 ranges from 0 (none/no abnormality) to 3 (marked increase/severe abnormality) and for grade 5 ranges from 0 (No erosion, ulceration, or granulation tissue) to 4 (Ulcer or granulation tissue). The overall Geboes score is derived by summing the subscores of the grades and ranges from 0 to 22, with higher scores indicating greater disease severity. Geboes Histological Remission was defined as a Geboes score \<2. Responders were defined as number of participants with Geboes score \<2.
Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Baseline and Weeks 2, 4, 6, and 10	Serum samples were collected at indicated time points to measure CRP levels. 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.
Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Baseline and Weeks 2, 4, 6, and 10	Fecal samples were collected at indicated time points to measure fecal calprotectin. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Ratio to Baseline is the value at specified time point divided by Baseline value
Area Under the Concentration-time Curve Over the 1st Dosing Interval (AUC[0-tau]) for GSK2831781 Following SC Dosing in Double-Blind Extended Treatment Phase	Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Maximum Concentration (Cmax) of GSK2831781 Observed Following 1st SC Dosing in Double-Blind Extended Treatment Phase	Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)	Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Time at Which the Maximum Concentration is Observed (Tmax) for GSK2831781 Following 1st SC Dosing in Double-Blind Extended Treatment Phase	Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)	Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.
Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline, Weeks 2, 4, 6, and 10	Serum samples were assessed for the presence of anti-drug antibodies using a tiered approach. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'confirmed positive'.
Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	Week 10	Nancy Histological Index was assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate, neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Nancy Histological Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity). Nancy Index Remission was defined as a grade of 0 or 1. Responders were defined as number of participants with Nancy Index score of 0 or 1.
Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	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 recorded in the To 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%.
Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	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), 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 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%.
Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	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 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 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%.
Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Week 14 to 30	Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: ALT (high: \>=2 times ULN); AST (high: \>=2 times ULN); ALP (high: \>=2 times ULN) and Bil (high: \>=1.5 times ULN). 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 w/in Range or No Change category.
Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Week 14 to 30	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+); ket (high: \>2+); leuko (high: \>1+); LE; nit (high: positive); OB (high: \>1+); pH (low: \<4.6 and high: \>8); prot (high:\>1+); erythro (high: \>3 cells per hpf); sp gra (low: \<1.001 and high: \>1.035) and uro (high: \>1 mg/deciliter).
Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Week 14 to 30	Twelve lead ECGs were obtained using an ECG machine that automatically calculated the QTcB and QTcF intervals. The clinical concern range for the QTcB and QTcF intervals was upper: \>450 milliseconds.
Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	Week 10	The adapted Mayo clinical score consists of three components: stool frequency, rectal bleeding, and endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The adapted Mayo endoscopic score of 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern).

Countries

Bulgaria, Czechia, Estonia, France, India, Japan, Netherlands, Poland, Russia, Serbia, Slovakia, South Africa, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

This was a randomized, placebo-controlled study to evaluate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with ulcerative colitis. The study was conducted across 13 countries.

Pre-assignment details

A total of 104 participants were enrolled in the study. This study was terminated based on the assessment of clinical data.

Participants by arm

Arm	Count
Placebo IV Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.Participants were administered placebo via the intravenous (IV) route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.	27
GSK2831781 450 mg IV Participants were administered GSK2831781 450 milligrams (mg) via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.	48
GSK2831781 300 mg IV Participants were administered GSK2831781 300 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.	11
GSK2831781 150 mg IV Participants were administered GSK2831781 150 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.	10
GSK2831781 45 mg IV Participants were administered GSK2831781 45 mg via the IV route on Day 1, Weeks 2, 6 and 10. At Week 10, participants underwent Induction assessment including endoscopy.	8
Total	104

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008
Double-blind Extended Treatment(20weeks)	Other	0	0	0	0	0	1	1	0	0
Double-blind Extended Treatment(20weeks)	Study terminated by sponsor	0	0	0	0	0	2	2	0	0
Double-blind Extended Treatment(20weeks)	Withdrawal by Subject	0	0	0	0	0	0	1	0	0
Double-blind Induction Phase (10 Weeks)	Adverse Event	0	2	1	1	0	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Lack of Efficacy	0	0	0	1	0	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Lost to Follow-up	0	1	0	6	0	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Other	1	3	0	0	1	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Physician Decision	0	1	0	0	0	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Protocol-specified withdrawal criterion met	0	2	0	0	0	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Study terminated by sponsor	5	5	9	0	6	0	0	0	0
Double-blind Induction Phase (10 Weeks)	Withdrawal by Subject	0	2	0	1	0	0	0	0	0
Open-label Extended Treatment (20 Weeks)	Study terminated by sponsor	0	0	0	0	0	0	0	0	4
Open-label Induction Phase (10 Weeks)	Lack of Efficacy	0	0	0	0	0	0	0	7	0
Open-label Induction Phase (10 Weeks)	Other	0	0	0	0	0	0	0	3	0
Open-label Induction Phase (10 Weeks)	Study terminated by sponsor	0	0	0	0	0	0	0	15	0
Open-label Induction Phase (10 Weeks)	Withdrawal by Subject	0	0	0	0	0	0	0	5	0

Baseline characteristics

Characteristic	Placebo IV	GSK2831781 450 mg IV	GSK2831781 300 mg IV	GSK2831781 150 mg IV	GSK2831781 45 mg IV	Total
Age, Continuous	43.9 Years STANDARD_DEVIATION 12.82	40.7 Years STANDARD_DEVIATION 12.7	37.6 Years STANDARD_DEVIATION 13.06	42.5 Years STANDARD_DEVIATION 15.06	40.6 Years STANDARD_DEVIATION 10.6	41.4 Years STANDARD_DEVIATION 12.75
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Mixed White race	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	25 Participants	44 Participants	9 Participants	10 Participants	7 Participants	95 Participants
Sex: Female, Male Female	12 Participants	22 Participants	4 Participants	4 Participants	1 Participants	43 Participants
Sex: Female, Male Male	15 Participants	26 Participants	7 Participants	6 Participants	7 Participants	61 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 48	0 / 11	0 / 10	0 / 8	0 / 5	0 / 8	0 / 42	0 / 7
other Total, other adverse events	10 / 27	26 / 48	6 / 11	2 / 10	2 / 8	1 / 5	3 / 8	18 / 42	2 / 7
serious Total, serious adverse events	0 / 27	6 / 48	1 / 11	0 / 10	0 / 8	0 / 5	1 / 8	3 / 42	0 / 7

Outcome results

Primary

Change From Baseline in Complete 4-domain Mayo Score at 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 phase. Change from Baseline was calculated as value at specified time point minus Baseline value.

Time frame: Baseline and Week 10

Population: Intent-To-Treat-Exposed (ITTE) Population comprised of all enrolled participants who received at least one dose of study treatment, and who had at least one valid post dose assessment. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Placebo IV	Change From Baseline in Complete 4-domain Mayo Score at Week 10	-1.5 Scores on a scale	Standard Error 0.45
GSK2831781 450 mg IV	Change From Baseline in Complete 4-domain Mayo Score at Week 10	-1.4 Scores on a scale	Standard Error 0.36
GSK2831781 300 mg IV	Change From Baseline in Complete 4-domain Mayo Score at Week 10	-0.3 Scores on a scale	Standard Error 0.48
GSK2831781 150 mg IV	Change From Baseline in Complete 4-domain Mayo Score at Week 10	-1.0 Scores on a scale	Standard Error 2
GSK2831781 45 mg IV	Change From Baseline in Complete 4-domain Mayo Score at Week 10	-2.3 Scores on a scale	Standard Error 0.33

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase

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).

Time frame: Up to a maximum of Week 14

Population: Safety Population comprised of all participants who received at least one dose of study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	AEs	10 Participants
Placebo IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	SAEs	0 Participants
GSK2831781 450 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	AEs	27 Participants
GSK2831781 450 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	SAEs	6 Participants
GSK2831781 300 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	AEs	6 Participants
GSK2831781 300 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	SAEs	1 Participants
GSK2831781 150 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	SAEs	0 Participants
GSK2831781 150 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	AEs	2 Participants
GSK2831781 45 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	AEs	2 Participants
GSK2831781 45 mg IV	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase	SAEs	0 Participants

Primary

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

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.

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; No change or decrease to <450; n=26,46,7,9,7	26 Participants
Placebo IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; No change or decrease to <450; n=26,44,8,9,7	22 Participants
Placebo IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; Any increase to >=450; n=26,44,8,9,7	4 Participants
Placebo IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; Any increase to >=450; n=26,46,7,9,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; Any increase to >=450; n=26,44,8,9,7	3 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; No change or decrease to <450; n=26,44,8,9,7	41 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; Any increase to >=450; n=26,46,7,9,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; No change or decrease to <450; n=26,46,7,9,7	45 Participants
GSK2831781 300 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; No change or decrease to <450; n=26,44,8,9,7	6 Participants
GSK2831781 300 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; Any increase to >=450; n=26,46,7,9,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; Any increase to >=450; n=26,44,8,9,7	2 Participants
GSK2831781 300 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; No change or decrease to <450; n=26,46,7,9,7	7 Participants
GSK2831781 150 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; No change or decrease to <450; n=26,44,8,9,7	7 Participants
GSK2831781 150 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; Any increase to >=450; n=26,46,7,9,7	1 Participants
GSK2831781 150 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; No change or decrease to <450; n=26,46,7,9,7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; Any increase to >=450; n=26,44,8,9,7	2 Participants
GSK2831781 45 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; Any increase to >=450; n=26,46,7,9,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; No change or decrease to <450; n=26,44,8,9,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcB; Any increase to >=450; n=26,44,8,9,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Maximum Corrected QT (QTc) Values Post-Baseline Relative to Baseline-Double-Blind Induction Phase	QTcF; No change or decrease to <450; n=26,46,7,9,7	7 Participants

Primary

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

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.

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To w/in range or no change; n=26,42,7,6,6	26 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To low; n=26,45,5,8,7	1 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To w/in range or no change; n=24,46,6,9,7	23 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To low; n=24,46,6,9,7	1 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To w/in range or no change; n=26,45,7,4,7	25 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To high; n=27,44,9,6,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To high; n=26,45,7,4,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To w/in range or no change; n=26,45,5,6,7	26 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To high; n=25,45,10,8,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To w/in range or no change; n=25,45,10,8,8	25 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To high; n=26,42,7,6,6	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To w/in range or no change; n=27,44,9,6,7	27 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To low; n=25,45,10,8,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To high; n=26,43,7,5,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro To w/in range or no change; n=26,43,7,5,7	26 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To w/in range or no change; n=26, 46,9,10,8	25 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To low; n=26,42,7,6,6	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To low; n=26,43,7,5,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To high; n=27,44,10,7,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To w/in range or no change; n=27,44,10,7,8	27 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To high; n=26, 46,9,10,8	1 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To high; n=26,45,5,6,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To low; n=27,44,10,7,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=26,45,5,8,7	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=26,45,5,8,7	25 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To low; n=26,45,7,4,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To w/in range or no change; n=26, 46,9,10,8	36 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To low; n=26,42,7,6,6	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To w/in range or no change; n=26,42,7,6,6	40 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To high; n=26,42,7,6,6	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To high; n=26, 46,9,10,8	10 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To low; n=26,45,7,4,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To w/in range or no change; n=26,45,7,4,7	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To high; n=26,45,7,4,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To low; n=24,46,6,9,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To w/in range or no change; n=24,46,6,9,7	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To low; n=26,45,5,8,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=26,45,5,8,7	43 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=26,45,5,8,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To low; n=27,44,10,7,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To w/in range or no change; n=27,44,10,7,8	43 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To high; n=27,44,10,7,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To low; n=26,43,7,5,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro To w/in range or no change; n=26,43,7,5,7	41 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To high; n=26,43,7,5,7	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To low; n=25,45,10,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To w/in range or no change; n=25,45,10,8,8	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To high; n=25,45,10,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To w/in range or no change; n=26,45,5,6,7	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To high; n=26,45,5,6,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To w/in range or no change; n=27,44,9,6,7	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To high; n=27,44,9,6,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To low; n=26,45,5,8,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=26,45,5,8,7	5 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To high; n=27,44,9,6,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=26,45,5,8,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To high; n=26, 46,9,10,8	2 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To high; n=26,45,5,6,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To low; n=27,44,10,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To w/in range or no change; n=27,44,10,7,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To high; n=27,44,10,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To w/in range or no change; n=26, 46,9,10,8	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To low; n=26,43,7,5,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro To w/in range or no change; n=26,43,7,5,7	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To w/in range or no change; n=27,44,9,6,7	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To high; n=26,43,7,5,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To high; n=26,42,7,6,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To low; n=25,45,10,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To w/in range or no change; n=25,45,10,8,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To low; n=26,42,7,6,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To high; n=25,45,10,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To w/in range or no change; n=26,42,7,6,6	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To w/in range or no change; n=26,45,7,4,7	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To high; n=26,45,7,4,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To w/in range or no change; n=26,45,5,6,7	5 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To low; n=24,46,6,9,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To w/in range or no change; n=24,46,6,9,7	6 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To low; n=26,45,7,4,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To high; n=25,45,10,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To w/in range or no change; n=26,45,5,6,7	6 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To low; n=26,42,7,6,6	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To low; n=26,43,7,5,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To high; n=27,44,9,6,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro To w/in range or no change; n=26,43,7,5,7	5 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To high; n=26,42,7,6,6	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To high; n=26,45,7,4,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To high; n=26,43,7,5,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To w/in range or no change; n=27,44,9,6,7	6 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To w/in range or no change; n=24,46,6,9,7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To low; n=25,45,10,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To w/in range or no change; n=25,45,10,8,8	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To low; n=26,45,5,8,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To w/in range or no change; n=26,42,7,6,6	5 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=26,45,5,8,7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To high; n=26, 46,9,10,8	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To low; n=24,46,6,9,7	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=26,45,5,8,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To high; n=27,44,10,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To low; n=26,45,7,4,7	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To low; n=27,44,10,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To high; n=26,45,5,6,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To w/in range or no change; n=26,45,7,4,7	3 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To w/in range or no change; n=27,44,10,7,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To w/in range or no change; n=26, 46,9,10,8	9 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To w/in range or no change; n=25,45,10,8,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To high; n=27,44,10,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To w/in range or no change; n=27,44,10,7,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To low; n=26,45,5,8,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To high; n=27,44,9,6,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To high; n=26, 46,9,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To low; n=26,43,7,5,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To high; n=26,42,7,6,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To low; n=26,42,7,6,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To w/in range or no change; n=26,45,5,6,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To high; n=25,45,10,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro To w/in range or no change; n=26,43,7,5,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To w/in range or no change; n=26,45,7,4,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=26,45,5,8,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To high; n=26,45,7,4,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Urea; To high; n=26,45,5,6,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pro; To high; n=26,43,7,5,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Cal; To low; n=26,45,7,4,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Pot; To low; n=27,44,10,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To low; n=24,46,6,9,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	CRP; To w/in range or no change; n=26, 46,9,10,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sod; To low; n=25,45,10,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Alb; To w/in range or no change; n=26,42,7,6,6	6 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Creat; To w/in range or no change; n=27,44,9,6,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	eGFR; To w/in range or no change; n=24,46,6,9,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=26,45,5,8,7	0 Participants

Primary

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

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%.

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To w/in range or no change; n=24,45,5,7,7	24 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos;w/in range or no change; n=25,45,9,8,7	24 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To w/in range or no change; n=26,43,9,8,6	25 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To high; n=24,43,7,6,7	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To w/in range or no change; n=26,45,8,8,8	25 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos; To high; n=25,45,9,8,7	1 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To low; n=24,45,5,7,7	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To low; n=26,43,9,8,6	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To low; n=24,43,7,6,7	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=27,43,8,9,6	27 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To w/in range or no change; n=26,42,7,9,8	26 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To low; n=26,42,7,9,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=27,43,8,9,6	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To low; n=27,43,8,9,6	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To high; n=24,45,5,7,7	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To high; n=26,43,9,8,6	1 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To w/in range or no change; n=24,43,7,6,7	24 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To low; n=26,45,8,8,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=27,43,8,9,6	41 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To low; n=24,43,7,6,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To w/in range or no change; n=26,42,7,9,8	40 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To w/in range or no change; n=26,45,8,8,8	39 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To low; n=26,42,7,9,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To w/in range or no change; n=24,43,7,6,7	43 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To high; n=24,43,7,6,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To w/in range or no change; n=26,43,9,8,6	41 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To low; n=24,45,5,7,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To w/in range or no change; n=24,45,5,7,7	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos; To high; n=25,45,9,8,7	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To low; n=26,45,8,8,8	6 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To high; n=24,45,5,7,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To low; n=27,43,8,9,6	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos;w/in range or no change; n=25,45,9,8,7	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To low; n=26,43,9,8,6	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To high; n=26,43,9,8,6	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=27,43,8,9,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos;w/in range or no change; n=25,45,9,8,7	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=27,43,8,9,6	8 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To high; n=24,45,5,7,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos; To high; n=25,45,9,8,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To low; n=26,43,9,8,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To low; n=26,42,7,9,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=27,43,8,9,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To low; n=27,43,8,9,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To high; n=26,43,9,8,6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To low; n=26,45,8,8,8	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To low; n=24,45,5,7,7	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To high; n=24,43,7,6,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To w/in range or no change; n=26,43,9,8,6	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To w/in range or no change; n=24,43,7,6,7	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To w/in range or no change; n=26,42,7,9,8	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To w/in range or no change; n=24,45,5,7,7	4 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To low; n=24,43,7,6,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To w/in range or no change; n=26,45,8,8,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To low; n=26,43,9,8,6	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos;w/in range or no change; n=25,45,9,8,7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos; To high; n=25,45,9,8,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To low; n=24,43,7,6,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To w/in range or no change; n=24,43,7,6,7	6 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To high; n=24,43,7,6,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To low; n=24,45,5,7,7	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To w/in range or no change; n=24,45,5,7,7	6 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To high; n=24,45,5,7,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To low; n=27,43,8,9,6	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=27,43,8,9,6	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=27,43,8,9,6	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To low; n=26,45,8,8,8	3 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To w/in range or no change; n=26,45,8,8,8	5 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To low; n=26,42,7,9,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To w/in range or no change; n=26,42,7,9,8	9 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To w/in range or no change; n=26,43,9,8,6	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To high; n=26,43,9,8,6	1 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=27,43,8,9,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos;w/in range or no change; n=25,45,9,8,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To w/in range or no change; n=26,42,7,9,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=27,43,8,9,6	6 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To low; n=27,43,8,9,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To high; n=24,45,5,7,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To w/in range or no change; n=24,45,5,7,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To low; n=26,43,9,8,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hgb; To low; n=24,45,5,7,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To high; n=24,43,7,6,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To w/in range or no change; n=24,43,7,6,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To high; n=26,43,9,8,6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Plat; To w/in range or no change; n=26,43,9,8,6	6 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Hct; To low; n=24,43,7,6,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Eos; To high; n=25,45,9,8,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Neut; To low; n=26,42,7,9,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To w/in range or no change; n=26,45,8,8,8	6 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Lymph; To low; n=26,45,8,8,8	2 Participants

Primary

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

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.

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To w/in range or no change; n=27,44,9,9,8	27 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To low; n=25,45,9,8,8	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To high; n=27,44,9,9,8	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT;To w/in range or no change; n=26,44,7,7,8	25 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=25,45,9,8,8	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To high; n=26,44,7,7,8	1 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To low; n=26,44,7,7,8	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To low; n=26,45,7,8,7	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To w/in range or no change; n=26,45,7,8,7	26 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=25,45,9,8,8	25 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To high;n=26,45,7,8,7	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To low; n=27,44,9,9,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To low; n=26,45,7,8,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To w/in range or no change; n=27,44,9,9,8	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To high; n=26,44,7,7,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=25,45,9,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To low; n=26,44,7,7,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To low; n=27,44,9,9,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To high; n=27,44,9,9,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=25,45,9,8,8	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To low; n=25,45,9,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT;To w/in range or no change; n=26,44,7,7,8	42 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To w/in range or no change; n=26,45,7,8,7	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To high;n=26,45,7,8,7	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=25,45,9,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To high;n=26,45,7,8,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To high; n=26,44,7,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To low; n=26,44,7,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=25,45,9,8,8	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To low; n=25,45,9,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To low; n=26,45,7,8,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To w/in range or no change; n=26,45,7,8,7	7 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To w/in range or no change; n=27,44,9,9,8	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To high; n=27,44,9,9,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To low; n=27,44,9,9,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT;To w/in range or no change; n=26,44,7,7,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To low; n=26,45,7,8,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To low; n=26,44,7,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT;To w/in range or no change; n=26,44,7,7,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To high; n=26,44,7,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To w/in range or no change; n=26,45,7,8,7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To high;n=26,45,7,8,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To low; n=27,44,9,9,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To w/in range or no change; n=27,44,9,9,8	9 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To high; n=27,44,9,9,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To low; n=25,45,9,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=25,45,9,8,8	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=25,45,9,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To high;n=26,45,7,8,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To low; n=25,45,9,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To w/in range or no change; n=26,45,7,8,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	AST; To low; n=26,45,7,8,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To high; n=26,44,7,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=25,45,9,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=25,45,9,8,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT;To w/in range or no change; n=26,44,7,7,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALT; To low; n=26,44,7,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To high; n=27,44,9,9,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To w/in range or no change; n=27,44,9,9,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	ALP; To low; n=27,44,9,9,8	0 Participants

Primary

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

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).

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=27,47,10,9,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To w/in range or no change; n=26,46,9,10,8	24 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To high; n=27,47,10,10,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To w/in range or no change; n=27,47,10,10,8	27 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To w/in range or no change; n=26,45,9,8,8	25 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To high; n=25,47,5,7,8	4 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To high; n=26,45,9,8,8	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To high; n=9,18,2,3,1	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To w/in range or no change; n=9,18,2,3,1	9 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=9,18,2,3,1	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=27,47,10,10,8	27 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To w/in range or no change; n=25,47,5,7,8	21 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=9,18,2,3,1	8 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To high; n=27,47,10,8,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To w/in range or no change; n=27,47,10,8,8	27 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=27,47,10,10,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=27,47,10,9,8	27 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To high; n=25,47,10,9,8	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To w/in range or no change; n=25,47,10,9,8	24 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To high; n=27,46,9,10,7	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To w/in range or no change; n=27,47,10,8,8	25 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To low; n=25,47,5,7,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To w/in range or no change; n=27,46,9,10,7	26 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To low; n=27,46,9,10,7	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To high; n=26,46,9,10,8	2 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To high; n=27,47,10,8,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=27,47,10,10,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=27,47,10,9,8	46 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=27,47,10,9,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=27,47,10,10,8	47 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To w/in range or no change; n=27,47,10,8,8	47 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To high; n=27,47,10,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To w/in range or no change; n=26,45,9,8,8	37 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To high; n=26,45,9,8,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To w/in range or no change; n=27,47,10,10,8	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To high; n=27,47,10,10,8	3 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To w/in range or no change; n=26,46,9,10,8	42 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To high; n=26,46,9,10,8	4 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To low; n=27,46,9,10,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To w/in range or no change; n=27,46,9,10,7	46 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To high; n=27,46,9,10,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To w/in range or no change; n=25,47,10,9,8	43 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To high; n=25,47,10,9,8	4 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To w/in range or no change; n=27,47,10,8,8	47 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To high; n=27,47,10,8,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=9,18,2,3,1	15 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=9,18,2,3,1	3 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To w/in range or no change; n=9,18,2,3,1	16 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To high; n=9,18,2,3,1	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To low; n=25,47,5,7,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To w/in range or no change; n=25,47,5,7,8	44 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To high; n=25,47,5,7,8	3 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To w/in range or no change; n=26,46,9,10,8	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To high; n=26,46,9,10,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To high; n=25,47,5,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To low; n=27,46,9,10,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To w/in range or no change; n=27,47,10,8,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To low; n=25,47,5,7,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To w/in range or no change; n=27,46,9,10,7	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To high; n=27,46,9,10,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To w/in range or no change; n=25,47,10,9,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=27,47,10,10,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To high; n=25,47,10,9,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To w/in range or no change; n=27,47,10,8,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To w/in range or no change; n=25,47,5,7,8	5 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To high; n=27,47,10,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=27,47,10,10,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=9,18,2,3,1	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=9,18,2,3,1	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=27,47,10,9,8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To w/in range or no change; n=9,18,2,3,1	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=27,47,10,9,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To w/in range or no change; n=26,45,9,8,8	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To high; n=26,45,9,8,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To high; n=9,18,2,3,1	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To w/in range or no change; n=27,47,10,10,8	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To high; n=27,47,10,10,8	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To high; n=27,47,10,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To w/in range or no change; n=9,18,2,3,1	3 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To high; n=9,18,2,3,1	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=27,47,10,9,8	9 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To high; n=25,47,10,9,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To high; n=25,47,5,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To w/in range or no change; n=27,47,10,8,8	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=27,47,10,10,8	10 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To high; n=26,45,9,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To high; n=27,47,10,8,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To w/in range or no change; n=25,47,5,7,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To high; n=27,47,10,10,8	2 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=9,18,2,3,1	3 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=9,18,2,3,1	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To w/in range or no change; n=26,46,9,10,8	10 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=27,47,10,9,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To high; n=26,46,9,10,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To w/in range or no change; n=27,47,10,8,8	7 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To w/in range or no change; n=27,47,10,10,8	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To low; n=27,46,9,10,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To w/in range or no change; n=25,47,10,9,8	9 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To high; n=27,47,10,8,8	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To w/in range or no change; n=27,46,9,10,7	10 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To low; n=25,47,5,7,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To w/in range or no change; n=26,45,9,8,8	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To high; n=27,46,9,10,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=27,47,10,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To high; n=9,18,2,3,1	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To w/in range or no change; n=25,47,10,9,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To high; n=27,46,9,10,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To w/in range or no change; n=26,46,9,10,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To high; n=25,47,5,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To w/in range or no change; n=27,47,10,8,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Prot; To high; n=25,47,10,9,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To w/in range or no change; n=27,47,10,10,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To w/in range or no change; n=27,47,10,9,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To high; n=9,18,2,3,1	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Erythro; To w/in range or no change; n=9,18,2,3,1	1 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To w/in range or no change; n=27,47,10,8,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To w/in range or no change; n=26,45,9,8,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	OB; To high; n=26,46,9,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	LE; To high; n=26,45,9,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To low; n=25,47,5,7,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Uro; To high; n=27,47,10,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Ket; To high; n=27,47,10,8,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To w/in range or no change; n=27,46,9,10,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To w/in range or no change; n=27,47,10,10,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Glu; To high; n=27,47,10,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Leuko; To w/in range or no change; n=9,18,2,3,1	1 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Bil; To high; n=27,47,10,9,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Sp gra; To w/in range or no change; n=25,47,5,7,8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Nit; To high; n=27,47,10,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	pH; To low; n=27,46,9,10,7	0 Participants

Primary

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

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 (%).

Time frame: Up to Week 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To w/in range or no change; n=27, 47, 11, 9, 8	27 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To w/in range or no change; n=27, 47, 9, 8, 7	27 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To low; n=26, 46, 11, 10, 7	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To high; n=27, 47, 11, 9, 8	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To w/in range or no change; n=27, 47, 10, 9,6	26 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To high; n=27, 47, 9, 8, 7	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To low; n=27, 47, 9, 8, 7	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To high; n=27, 47, 10, 9, 6	1 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To high; n=26, 46, 11, 10, 7	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To low; n=27, 47, 11, 9, 8	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To low; n=27, 47, 10, 9, 6	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To w/in range or no change; n=26,46,11,10,7	26 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To w/in range or no change; n=26,46,11,10,7	46 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To low; n=27, 47, 11, 9, 8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To low; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To high; n=27, 47, 10, 9, 6	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To low; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To high; n=27, 47, 11, 9, 8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To w/in range or no change; n=27, 47, 9, 8, 7	47 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To high; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To high; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To w/in range or no change; n=27, 47, 10, 9,6	45 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To low; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To w/in range or no change; n=27, 47, 11, 9, 8	45 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To high; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To low; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To w/in range or no change; n=27, 47, 10, 9,6	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To high; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To low; n=27, 47, 11, 9, 8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To w/in range or no change; n=27, 47, 11, 9, 8	10 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To high; n=27, 47, 11, 9, 8	1 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To low; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To w/in range or no change; n=26,46,11,10,7	11 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To w/in range or no change; n=27, 47, 9, 8, 7	9 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To high; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To low; n=27, 47, 10, 9, 6	1 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To low; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To low; n=27, 47, 11, 9, 8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To w/in range or no change; n=26,46,11,10,7	10 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To high; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To high; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To low; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To w/in range or no change; n=27, 47, 9, 8, 7	8 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To w/in range or no change; n=27, 47, 10, 9,6	9 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To low; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To high; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To high; n=27, 47, 11, 9, 8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To w/in range or no change; n=27, 47, 11, 9, 8	9 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To high; n=27, 47, 11, 9, 8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To low; n=26, 46, 11, 10, 7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To low; n=27, 47, 11, 9, 8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	PR; To w/in range or no change; n=27, 47, 11, 9, 8	8 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To low; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To w/in range or no change; n=27, 47, 9, 8, 7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To w/in range or no change; n=26,46,11,10,7	7 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To high; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	DBP; To high; n=27, 47, 9, 8, 7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To w/in range or no change; n=27, 47, 10, 9,6	6 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	SBP; To low; n=27, 47, 10, 9, 6	0 Participants
GSK2831781 45 mg IV	Number of Participants With Worst-case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline-Double-Blind Induction Phase	Temp; To high; n=26, 46, 11, 10, 7	0 Participants

Secondary

Area Under the Concentration-time Curve Over the 1st Dosing Interval (AUC[0-tau]) for GSK2831781 Following SC Dosing in Double-Blind Extended Treatment Phase

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.

Time frame: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)

Population: Pharmacokinetic Double-Blind Extended Population comprised of all participants in the Safety Extended Treatment Phase population who had at least 1 non-missing PK assessment in the Extended Treatment phase. Only those participants with data at more than two of the specified time points were analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo IV	Area Under the Concentration-time Curve Over the 1st Dosing Interval (AUC[0-tau]) for GSK2831781 Following SC Dosing in Double-Blind Extended Treatment Phase	24336.92 Hours*micrograms per milliliter	Geometric Coefficient of Variation 23.797

Secondary

Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase

The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The total adapted Mayo endoscopy score ranges from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). 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.

Time frame: Baseline and Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed

Arm	Measure	Value (MEAN)	Dispersion
Placebo IV	Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	-0.2 Scores on a scale	Standard Error 0.14
GSK2831781 450 mg IV	Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	-0.1 Scores on a scale	Standard Error 0.12
GSK2831781 300 mg IV	Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	0.0 Scores on a scale	Standard Error 0
GSK2831781 150 mg IV	Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	0.5 Scores on a scale	Standard Error 0.5
GSK2831781 45 mg IV	Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase	-0.3 Scores on a scale	Standard Error 0.33

Secondary

Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase

The partial Mayo clinical score is based on the complete 4-domain Mayo clinical score but without the endoscopy sub-score. It consists of three components: stool frequency, rectal bleeding, and PGA. The score for each component ranges from 0 (normal/none) to 3 (severe). The total partial Mayo score is calculated as the sum of all three components and ranges from 0 to 9. 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.

Time frame: Baseline and Weeks 2, 4, 6, and 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-0.8 Scores on a scale	Standard Error 0.33
Placebo IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 4; n=26, 46, 8, 8, 7	-1.0 Scores on a scale	Standard Error 0.31
Placebo IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 6; n=24, 44, 8, 6, 8	-1.3 Scores on a scale	Standard Error 0.4
Placebo IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 10; n=22, 39, 4, 4, 4	-1.1 Scores on a scale	Standard Error 0.44
GSK2831781 450 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-0.6 Scores on a scale	Standard Error 0.22
GSK2831781 450 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 10; n=22, 39, 4, 4, 4	-1.0 Scores on a scale	Standard Error 0.32
GSK2831781 450 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 4; n=26, 46, 8, 8, 7	-0.7 Scores on a scale	Standard Error 0.28
GSK2831781 450 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 6; n=24, 44, 8, 6, 8	-0.8 Scores on a scale	Standard Error 0.31
GSK2831781 300 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 10; n=22, 39, 4, 4, 4	0.3 Scores on a scale	Standard Error 0.48
GSK2831781 300 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 4; n=26, 46, 8, 8, 7	-1.4 Scores on a scale	Standard Error 0.6
GSK2831781 300 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 6; n=24, 44, 8, 6, 8	-1.0 Scores on a scale	Standard Error 0.53
GSK2831781 300 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-1.0 Scores on a scale	Standard Error 0.5
GSK2831781 150 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	0.5 Scores on a scale	Standard Error 0.54
GSK2831781 150 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 4; n=26, 46, 8, 8, 7	-0.4 Scores on a scale	Standard Error 0.18
GSK2831781 150 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 10; n=22, 39, 4, 4, 4	-1.0 Scores on a scale	Standard Error 0.41
GSK2831781 150 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 6; n=24, 44, 8, 6, 8	-0.8 Scores on a scale	Standard Error 0.31
GSK2831781 45 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 10; n=22, 39, 4, 4, 4	-2.0 Scores on a scale	Standard Error 0.41
GSK2831781 45 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 6; n=24, 44, 8, 6, 8	-2.6 Scores on a scale	Standard Error 0.53
GSK2831781 45 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 4; n=26, 46, 8, 8, 7	-1.7 Scores on a scale	Standard Error 0.52
GSK2831781 45 mg IV	Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-1.3 Scores on a scale	Standard Error 0.65

Secondary

Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase

Serum samples were collected at indicated time points to measure CRP levels. 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.

Time frame: Baseline and Weeks 2, 4, 6, and 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-1.52 Milligrams per liter	Standard Deviation 8.508
Placebo IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 4; n=26,45,7,7,7	-3.38 Milligrams per liter	Standard Deviation 8.188
Placebo IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 6; n=24,45,8,6,8	-3.09 Milligrams per liter	Standard Deviation 6.748
Placebo IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	2.89 Milligrams per liter	Standard Deviation 9.46
GSK2831781 450 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	1.01 Milligrams per liter	Standard Deviation 8.004
GSK2831781 450 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	8.99 Milligrams per liter	Standard Deviation 21.549
GSK2831781 450 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 4; n=26,45,7,7,7	6.73 Milligrams per liter	Standard Deviation 21.625
GSK2831781 450 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 6; n=24,45,8,6,8	4.45 Milligrams per liter	Standard Deviation 13.491
GSK2831781 300 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	8.40 Milligrams per liter	Standard Deviation 8.102
GSK2831781 300 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 4; n=26,45,7,7,7	0.74 Milligrams per liter	Standard Deviation 3.376
GSK2831781 300 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 6; n=24,45,8,6,8	2.34 Milligrams per liter	Standard Deviation 7.016
GSK2831781 300 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	8.23 Milligrams per liter	Standard Deviation 16.881
GSK2831781 150 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	25.14 Milligrams per liter	Standard Deviation 62.574
GSK2831781 150 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 4; n=26,45,7,7,7	26.23 Milligrams per liter	Standard Deviation 62.003
GSK2831781 150 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	6.75 Milligrams per liter	Standard Deviation 13.749
GSK2831781 150 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 6; n=24,45,8,6,8	12.20 Milligrams per liter	Standard Deviation 15.566
GSK2831781 45 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	-8.48 Milligrams per liter	Standard Deviation 20.407
GSK2831781 45 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 6; n=24,45,8,6,8	-8.16 Milligrams per liter	Standard Deviation 18.602
GSK2831781 45 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 4; n=26,45,7,7,7	-9.41 Milligrams per liter	Standard Deviation 18.059
GSK2831781 45 mg IV	Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase	Week 2; n=27, 47, 11, 10, 8	-7.71 Milligrams per liter	Standard Deviation 14.627

Secondary

Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase

UCEIS was used as an additional tool to assess disease activity based on 3 sub-scales: endoscopic vascular pattern, bleeding, erosions and ulcerations. Individual sub-scale scores were vascular pattern (0=Normal, 1=Patchy loss, 2=Obliterated); bleeding (0=None, 1=Mucosal, 2=Luminal mild, 3=Luminal severe); erosions and ulcerations (0=None, 1=Erosions, 2=Superficial ulcer, 3=Deep ulcer). UCEIS total score was calculated as the sum of all 3 sub-scale scores and ranges from 0 to 8, with higher scores indicating more severe disease. 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.

Time frame: Baseline and Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed

Arm	Measure	Value (MEAN)	Dispersion
Placebo IV	Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	-0.1 Scores on a scale	Standard Error 0.41
GSK2831781 450 mg IV	Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	-0.0 Scores on a scale	Standard Error 0.25
GSK2831781 300 mg IV	Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	0.5 Scores on a scale	Standard Error 0.65
GSK2831781 150 mg IV	Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	1.0 Scores on a scale	Standard Error 0
GSK2831781 45 mg IV	Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase	0.0 Scores on a scale	Standard Error 0.58

Secondary

Maximum Concentration (Cmax) of GSK2831781 Observed Following 1st SC Dosing in Double-Blind Extended Treatment Phase

Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.

Time frame: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)

Population: Pharmacokinetic Double-Blind Extended Population. Only those participants with data at more than two of the specified time points were analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo IV	Maximum Concentration (Cmax) of GSK2831781 Observed Following 1st SC Dosing in Double-Blind Extended Treatment Phase	55.64 Micrograms per milliliter	Geometric Coefficient of Variation 13.374

Secondary

Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase

The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical remission is defined as adapted Mayo Clinical Score of \<=2 with no individual sub-score \>1 and a rectal bleeding sub score of 0 with stool frequency sub score not greater than Baseline.

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 450 mg IV	Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	1 Participants
GSK2831781 300 mg IV	Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 45 mg IV	Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase

The adapted Mayo clinical score is based on the complete 4-domain Mayo clinical score, but without the PGA. It consists of three components: stool frequency, rectal bleeding, and mucosal endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The total adapted Mayo score is calculated as the sum of all three components and ranges from 0 to 9. Higher scores indicate greater disease severity. Clinical response is defined as reduction in adapted Mayo clinical score \>=3 points from Baseline and \>=30% from Baseline and decrease in the rectal bleeding sub-score of \>=1 point from Baseline (or a score of 0 or 1).

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	5 Participants
GSK2831781 450 mg IV	Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	6 Participants
GSK2831781 300 mg IV	Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	1 Participants
GSK2831781 45 mg IV	Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase

The adapted Mayo clinical score consists of three components: stool frequency, rectal bleeding, and endoscopic appearance. The score for each component ranges from 0 (normal/none) to 3 (severe). The adapted Mayo endoscopic score of 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern).

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	4 Participants
GSK2831781 450 mg IV	Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	3 Participants
GSK2831781 300 mg IV	Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 45 mg IV	Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population comprised of all participants who received at least one dose of study treatment in the Extended Treatment Phase

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase	AEs	1 Participants
Placebo IV	Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase	SAEs	0 Participants
GSK2831781 450 mg IV	Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase	AEs	3 Participants
GSK2831781 450 mg IV	Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase	SAEs	1 Participants

Secondary

Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the QTcB and QTcF intervals. The clinical concern range for the QTcB and QTcF intervals was upper: \>450 milliseconds.

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcB; No change or decrease to <450; n=4,6	4 Participants
Placebo IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcB; Any increase to >=450; n=4,6	0 Participants
Placebo IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcF; Any increase to >=450; n=3,6	0 Participants
Placebo IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcF; No change or decrease to <450; n=3,6	3 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcF; Any increase to >=450; n=3,6	0 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcB; No change or decrease to <450; n=4,6	6 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcB; Any increase to >=450; n=4,6	0 Participants
GSK2831781 450 mg IV	Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	QTcF; No change or decrease to <450; n=3,6	6 Participants

Secondary

Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase

Serum samples were assessed for the presence of anti-drug antibodies using a tiered approach. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'confirmed positive'.

Time frame: Baseline, Weeks 2, 4, 6, and 10

Population: Safety Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 6; n=1,3,3,0,3	0 Participants
Placebo IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline; n=27,48,11,10,8	0 Participants
Placebo IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	0 Participants
Placebo IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 2; n=27,47,11,10,8	0 Participants
Placebo IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 4; n=25,46,7,7,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 6; n=1,3,3,0,3	0 Participants
GSK2831781 450 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 4; n=25,46,7,7,7	0 Participants
GSK2831781 450 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 2; n=27,47,11,10,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	0 Participants
GSK2831781 450 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline; n=27,48,11,10,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 4; n=25,46,7,7,7	0 Participants
GSK2831781 300 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline; n=27,48,11,10,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 2; n=27,47,11,10,8	0 Participants
GSK2831781 300 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 6; n=1,3,3,0,3	0 Participants
GSK2831781 300 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	0 Participants
GSK2831781 150 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline; n=27,48,11,10,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 2; n=27,47,11,10,8	0 Participants
GSK2831781 150 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 4; n=25,46,7,7,7	0 Participants
GSK2831781 150 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	0 Participants
GSK2831781 45 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 2; n=27,47,11,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 4; n=25,46,7,7,7	0 Participants
GSK2831781 45 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 6; n=1,3,3,0,3	0 Participants
GSK2831781 45 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Baseline; n=27,48,11,10,8	0 Participants
GSK2831781 45 mg IV	Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase	Week 10; n=22,39,4,4,4	0 Participants

Secondary

Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase

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, PGA and endoscopic appearance (with mild friability associated with an endoscopic score of 1). Symptomatic remission is defined as a rectal bleeding subscore of 0, and a stool frequency subscore of \<=1, with no worsening from Baseline.

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	5 Participants
GSK2831781 450 mg IV	Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	5 Participants
GSK2831781 300 mg IV	Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	1 Participants
GSK2831781 45 mg IV	Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase	1 Participants

Secondary

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

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 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 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%.

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	CRP; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	CRP; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	eGFR; To low; n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	eGFR; To w/in range or no change; n=4,8	4 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To low;n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To w/in range or no change; n=4,8	4 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To high; n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To low; n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To w/in range or no change; n=4,8	4 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To high; n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Urea; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Urea; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Creat; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Creat; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To low; n=4,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To low; n=5,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To low;n=4,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To w/in range or no change; n=5,8	7 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Creat; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Alb; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To w/in range or no change; n=4,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	CRP; To w/in range or no change; n=5,8	6 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To w/in range or no change; n=4,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	CRP; To high; n=5,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pot; To high; n=4,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Urea; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Cal; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sod; To high; n=4,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	eGFR; To low; n=4,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	eGFR; To w/in range or no change; n=4,8	7 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Creat; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Pro; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Urea; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Clinical Chemistry Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To high; n=5,8	0 Participants

Secondary

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

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), 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 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%.

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Eos;To w/in range or no change; n=4,8	4 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Eos; To high; n=4,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Lymph; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Lymph; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Neut; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Neut; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Neut; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Eos;To w/in range or no change; n=4,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Eos; To high; n=4,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To high; n=5,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Neut; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hct; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Lymph; To low; n=5,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To w/in range or no change; n=5,8	6 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Lymph; To w/in range or no change; n=5,8	6 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Hgb; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Plat; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Hematology Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To low; n=5,8	0 Participants

Secondary

Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: ALT (high: \>=2 times ULN); AST (high: \>=2 times ULN); ALP (high: \>=2 times ULN) and Bil (high: \>=1.5 times ULN). 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 w/in Range or No Change category.

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT;To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT;To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALT; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	AST; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	ALP; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To w/in range or no change	8 Participants

Secondary

Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

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+); ket (high: \>2+); leuko (high: \>1+); LE; nit (high: positive); OB (high: \>1+); pH (low: \<4.6 and high: \>8); prot (high:\>1+); erythro (high: \>3 cells per hpf); sp gra (low: \<1.001 and high: \>1.035) and uro (high: \>1 mg/deciliter).

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population. Only those participants with data available at the specified timepoints were analyzed (indicated by n=X in category titles)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	LE; To w/in range or no change; n=5,8	3 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Ket; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Ket; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	LE; To high; n=5,8	2 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Nit; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Nit; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	OB; To w/in range or no change; n=5,8	4 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	OB; To high; n=5,8	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Prot; To w/in range or no change; n=5,8	4 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Prot; To high; n=5,8	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Uro; To w/in range or no change; n=5,8	5 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Uro; To high; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To w/in range or no change; n=1,2	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To high; n=1,2	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Erythro; To w/in range or no change; n=1,2	1 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Erythro; To high; n=1,2	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To low; n=5,8	0 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To w/in range or no change; n=5,8	4 Participants
Placebo IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To high; n=5,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To w/in range or no change; n=1,2	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Bil; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To w/in range or no change; n=5,8	6 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Glu; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Leuko; To high; n=1,2	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Ket; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Prot; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Ket; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To low; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	LE; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Prot; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	LE; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Erythro; To w/in range or no change; n=1,2	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Nit; To w/in range or no change; n=5,8	7 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Uro; To w/in range or no change; n=5,8	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Nit; To high; n=5,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Sp gra; To high; n=5,8	2 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	OB; To w/in range or no change; n=5,8	7 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Uro; To high; n=5,8	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	OB; To high; n=5,8	1 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Erythro; To high; n=1,2	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	pH; To low; n=5,8	0 Participants

Secondary

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

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 recorded in the To 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%.

Time frame: Week 14 to 30

Population: Safety Extended Treatment Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To high	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To low	0 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To w/in range or no change	5 Participants
Placebo IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	DBP; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To low	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	Temp; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To w/in range or no change	8 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	PR; To high	0 Participants
GSK2831781 450 mg IV	Number of Participants With Worst-case Vital Signs Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase	SBP; To high	0 Participants

Secondary

Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase

The Geboes Index is divided in 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\]. The subscores for grade 0 to 4 ranges from 0 (none/no abnormality) to 3 (marked increase/severe abnormality) and for grade 5 ranges from 0 (No erosion, ulceration, or granulation tissue) to 4 (Ulcer or granulation tissue). The overall Geboes score is derived by summing the subscores of the grades and ranges from 0 to 22, with higher scores indicating greater disease severity. Geboes Histological Remission was defined as a Geboes score \<2. Responders were defined as number of participants with Geboes score \<2.

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	1 Participants
GSK2831781 450 mg IV	Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	1 Participants
GSK2831781 300 mg IV	Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 45 mg IV	Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase

Nancy Histological Index was assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate, neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Nancy Histological Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity). Nancy Index Remission was defined as a grade of 0 or 1. Responders were defined as number of participants with Nancy Index score of 0 or 1.

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	4 Participants
GSK2831781 450 mg IV	Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	4 Participants
GSK2831781 300 mg IV	Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 45 mg IV	Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase

RHI was assessed by central reading of gut pinch biopsies. The RHI Score is a continuous score, ranging from 0-33 with higher scores indicating more severe disease. RHI Remission is defined as an RHI score \<=6. Responders were defined as number of participants with RHI score \<=6.

Time frame: Week 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo IV	Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	4 Participants
GSK2831781 450 mg IV	Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	5 Participants
GSK2831781 300 mg IV	Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 150 mg IV	Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	0 Participants
GSK2831781 45 mg IV	Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase	0 Participants

Secondary

Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase

Fecal samples were collected at indicated time points to measure fecal calprotectin. Baseline value was the latest pre-dose assessment with a non-missing value from Double-Blind Induction study phase. Ratio to Baseline is the value at specified time point divided by Baseline value

Time frame: Baseline and Weeks 2, 4, 6, and 10

Population: ITTE Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Placebo IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 6; n=23,37,7,6,7	0.99 Ratio	Geometric Coefficient of Variation 688.97
Placebo IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 4; n=3,2,0,2,0	0.28 Ratio	Geometric Coefficient of Variation 296.27
Placebo IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 10; n=20,31,3,3,4	1.68 Ratio	Geometric Coefficient of Variation 217.05
Placebo IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 2; n=25,40,9,9,6	1.28 Ratio	Geometric Coefficient of Variation 311.68
GSK2831781 450 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 6; n=23,37,7,6,7	0.99 Ratio	Geometric Coefficient of Variation 576.84
GSK2831781 450 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 2; n=25,40,9,9,6	0.90 Ratio	Geometric Coefficient of Variation 504.7
GSK2831781 450 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 4; n=3,2,0,2,0	1.58 Ratio	Geometric Coefficient of Variation 794.82
GSK2831781 450 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 10; n=20,31,3,3,4	1.27 Ratio	Geometric Coefficient of Variation 961.25
GSK2831781 300 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 6; n=23,37,7,6,7	4.01 Ratio	Geometric Coefficient of Variation 8478.6
GSK2831781 300 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 10; n=20,31,3,3,4	3.82 Ratio	Geometric Coefficient of Variation 76.67
GSK2831781 300 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 2; n=25,40,9,9,6	0.57 Ratio	Geometric Coefficient of Variation 206.9
GSK2831781 150 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 4; n=3,2,0,2,0	1.60 Ratio	Geometric Coefficient of Variation 55.72
GSK2831781 150 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 2; n=25,40,9,9,6	2.05 Ratio	Geometric Coefficient of Variation 565.8
GSK2831781 150 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 6; n=23,37,7,6,7	3.42 Ratio	Geometric Coefficient of Variation 477.17
GSK2831781 150 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 10; n=20,31,3,3,4	8.50 Ratio	Geometric Coefficient of Variation 2110.12
GSK2831781 45 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 6; n=23,37,7,6,7	2.51 Ratio	Geometric Coefficient of Variation 182.31
GSK2831781 45 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 2; n=25,40,9,9,6	0.57 Ratio	Geometric Coefficient of Variation 200.43
GSK2831781 45 mg IV	Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase	Week 10; n=20,31,3,3,4	0.50 Ratio	Geometric Coefficient of Variation 251.03

Secondary

Time at Which the Maximum Concentration is Observed (Tmax) for GSK2831781 Following 1st SC Dosing in Double-Blind Extended Treatment Phase

Blood samples were collected at indicated time points for PK analysis of GSK2831781. PK parameters were calculated using standard non-compartmental analysis.

Time frame: Week 14 (pre-dose, 24, 72 and 168 hours post-dose); Week 18 (pre-dose and early withdrawal post-dose)

Population: Pharmacokinetic Double-Blind Extended Population. Only those participants with data at more than two of the specified time points were analyzed.

Arm	Measure	Value (MEDIAN)
Placebo IV	Time at Which the Maximum Concentration is Observed (Tmax) for GSK2831781 Following 1st SC Dosing in Double-Blind Extended Treatment Phase	72.03 Hours

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026

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

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Masking description

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Baseline characteristics

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Outcome results

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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Double-Blind Induction Phase

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

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

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

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

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

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

Area Under the Concentration-time Curve Over the 1st Dosing Interval (AUC[0-tau]) for GSK2831781 Following SC Dosing in Double-Blind Extended Treatment Phase

Change From Baseline in Adapted Mayo Endoscopy Score at Week 10-Double-Blind Induction Phase

Change From Baseline in Partial Mayo Score Over Time-Double-Blind Induction Phase

Change From Baseline in Serum CRP Level Over Time-Double-Blind Induction Phase

Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10-Double-Blind Induction Phase

Maximum Concentration (Cmax) of GSK2831781 Observed Following 1st SC Dosing in Double-Blind Extended Treatment Phase

Number of Participants With Adapted Mayo Clinical Remission at Week 10-Double-Blind Induction Phase

Number of Participants With Adapted Mayo Clinical Response at Week 10-Double-Blind Induction Phase

Number of Participants With Adapted Mayo Endoscopic Score of 0 or 1 at Week 10-Double-Blind Induction Phase

Number of Participants With AEs and SAEs-Double-Blind Extended Treatment Phase

Number of Participants With Maximum QTc Values Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

Number of Participants With Positive Anti-drug Antibodies at Each Visit-Double-Blind Induction Phase

Number of Participants With Symptomatic Remission at Week 10-Double-Blind Induction Phase

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

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

Number of Participants With Worst-case Liver Function Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

Number of Participants With Worst-case Urinalysis Results by PCI Criteria Post-Baseline Relative to Baseline-Double-Blind Extended Treatment Phase

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

Number of Responders for Geboes Histological Index Remission at Week 10-Double-Blind Induction Phase

Number of Responders for Nancy Histological Index Remission at Week 10-Double-Blind Induction Phase

Number of Responders for Robarts Histopathology Index (RHI) Remission at Week 10-Double-Blind Induction Phase

Ratio to Baseline in Fecal Calprotectin Over Time-Double-Blind Induction Phase

Time at Which the Maximum Concentration is Observed (Tmax) for GSK2831781 Following 1st SC Dosing in Double-Blind Extended Treatment Phase