Trial Outcomes & Findings for GSK2982772 Study in Subjects With Ulcerative Colitis (NCT NCT02903966)

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; is associated with liver injury and impaired liver function.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Up to Day 43

Results posted on

2020-06-11

Participant Flow

This study evaluated the safety and tolerability of repeat oral doses of GSK2982772 60 milligram (mg) or placebo three times daily (TID) in Part A (double blind \[DB\]) followed by GSK2982772 60 mg TID in Part B open label extension (OL) in active ulcerative colitis (UC) participants.

A total of 77 participants were screened, of which 36 eligible participants were enrolled (41 were screening failure). All 36 participants were randomized to receive GSK2982772 60 mg or Placebo in Part A of the study.

Participant milestones

Participant milestones
Measure	Placebo TID DB /GSK2982772 60 mg TID OL Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.	GSK2982772 60 mg TID DB/ GSK2982772 60 mg TID OL Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the pharmacokinetic (PK) profile is comparable for BID \& TID regimen.
Part A (Day 1 to 43) STARTED	12	24
Part A (Day 1 to 43) COMPLETED	11	24
Part A (Day 1 to 43) NOT COMPLETED	1	0
Part B (Day 44 to 112) STARTED	11	24
Part B (Day 44 to 112) COMPLETED	11	22
Part B (Day 44 to 112) NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo TID DB /GSK2982772 60 mg TID OL Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.	GSK2982772 60 mg TID DB/ GSK2982772 60 mg TID OL Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the pharmacokinetic (PK) profile is comparable for BID \& TID regimen.
Part A (Day 1 to 43) Adverse Event	1	0
Part B (Day 44 to 112) Lack of Efficacy	0	1
Part B (Day 44 to 112) Withdrawal by Subject	0	1

Baseline Characteristics

GSK2982772 Study in Subjects With Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo TID DB /GSK2982772 60 mg TID OL n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112.	GSK2982772 60 mg TID DB/ GSK2982772 60 mg TID OL n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 1 to 43) in Part A (double blind phase), followed by GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days (from Day 44 to 85) in Part B (open label phase). There was no wash out period in between Part A and B. All participants were followed up until Day 112. 1 participant was randomized to receive BID regimen instead of TID regimen prior to protocol amendment; however, BID and TID are presented in the same arm because the pharmacokinetic (PK) profile is comparable for BID \& TID regimen.	Total n=36 Participants Total of all reporting groups
Age, Continuous	50.4 Years STANDARD_DEVIATION 11.17 • n=5 Participants	39.0 Years STANDARD_DEVIATION 13.69 • n=7 Participants	42.8 Years STANDARD_DEVIATION 13.87 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Count of Participants n=5 Participants	1 Count of Participants n=7 Participants	1 Count of Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	12 Count of Participants n=5 Participants	23 Count of Participants n=7 Participants	35 Count of Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 43

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

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; is associated with liver injury and impaired liver function.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Common (>=5%) Non-serious Adverse Events (Non-SAEs) and Any Serious Adverse Events (SAEs) Common non-SAEs	7 Participants	13 Participants
Part A: Number of Participants With Common (>=5%) Non-serious Adverse Events (Non-SAEs) and Any Serious Adverse Events (SAEs) Any SAEs	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; is associated with liver injury and impaired liver function.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Common (>=5%) Non Serious AEs and SAEs Common non-SAEs	7 Participants	—
Part B: Number of Participants With Common (>=5%) Non Serious AEs and SAEs Any SAEs	2 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population

Clinical chemistry parameters with PCI ranges: aspartate amino transferase (AST), alanine amino transferase (ALT), and alkaline phosphatase (ALP) (high: \>=2 times upper limit of normal \[ULN\] units per liter \[U/L\]); calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L); glucose (low: \<3 and high: \>9 mmol/L); potassium (low: \<3 and high: \>5.5 mmol/L); sodium (low: \<130 and high: \>150 mmol/L); total bilirubin (high: \>=1.5 times ULN micromoles per liter \[µmol/L\]); high density lipoproteins (HDL) 0.9 to 99.99 mmol/L; low density lipoprotein (LDL) 0 to 3.35 mmol/L; triglycerides 0 to 2.24 mmol/L, creatinine (high: change from Baseline \[BL\]\>44.2 µmol/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 within Range or No Change'

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To Low	0 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To within range or no change	11 Participants	23 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To High	1 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL, To within range or no change	10 Participants	22 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL To High	2 Participants	2 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To within range or no change	12 Participants	23 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To High	0 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To High	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

Clinical chemistry parameters with their PCI ranges were: AST, ALT, and ALP (high: \>=2 ULN \[U/L\]); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); glucose (low: \<3 and high: \>9 mmol/L); potassium (low: \<3 and high: \>5.5 mmol/L); sodium (low: \<130 and high: \>150 mmol/L); total bilirubin (high: \>=1.5 times ULN \[µmol/L\]); HDL 0.9 to 99.99 mmol/L; LDL 0.to 3.35 mmol/L; triglycerides 0 to 2.24 mmol/L, creatinine (high: change from BL \>44.2 µmol/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 within Range or No Change' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria AST, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALT, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria ALP, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Calcium, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To Low	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Glucose, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To within range or no change	33 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Potassium, To High	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Sodium, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Total Bilirubin, To High	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To Low	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To within range or no change	33 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria HDL, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL, To within range or no change	33 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria LDL, To High	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Triglycerides, To High	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria Creatinine, To High	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population

Hematology parameters with their PCI ranges were: hematocrit (high: \>0.54 proportion of red blood cells in blood and low: change from BL\<0.075); hemoglobin (high: \>180 grams per liter \[g/L\] and low: change from BL\<25 g/L); lymphocytes (low: \<0.8 Giga cells/L); platelet count (low: \<100 Giga cells/L and high: \>550 Giga cells/L); neutrophil count (low: \<1.5 Giga cells/L); white blood cell (WBC) count (low: \<3 Giga cells/L and high: \>20 Giga 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 within Range or No Change' category. Participants were counted twice if the participant had both values that changed 'To Low' and 'To High'.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To Low	1 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To within range or no change	11 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To within range or no change	12 Participants	22 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To High	0 Participants	2 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To Low	0 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To within range or no change	12 Participants	23 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC, To Low	0 Participants	2 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC, To High	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

Hematology parameters with their PCI ranges were: hematocrit (high: \>0.54 proportion of red blood cells in blood and low: change from BL\<0.075); hemoglobin (high: \>180 g/L and low: change from BL\<25 g/L); lymphocytes (low: \<0.8 Giga cells/L); platelet count (low: \<100 Giga cells/L and high: \>550 Giga cells/L); neutrophil count (low: \<1.5 Giga cells/L); WBC count (low: \<3 Giga cells/L and high: \>20 Giga 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 within Range or No Change' category. Participants were counted twice if the participant had both values that changed 'To Low' and 'To High'.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hematocrit, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Hemoglobin, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To Low	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Lymphocytes, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Platelet count, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria Neutrophil count, To High	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC, To Low	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria WBC, To High	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

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

Urine samples were collected for the assessment of following urine parameters by dipstick method: glucose, protein, blood and ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, protein, blood and ketones can be read as negative (-), trace, 1+, 2+, 3+, 4+, 5+ indicating proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'increase to trace' or 'increase to 1+, 2+, 3+, 4+, 5+' relative to BL (Day 1) value. Participants whose value was unchanged (e.g., Trace to Trace), or whose value was decreased, were recorded in the 'No change or Decreased' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, No change or decreased	11 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to Trace	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 1+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 2+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 3+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 4+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 5+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, No change or decreased	10 Participants	16 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to Trace	0 Participants	3 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 1+	0 Participants	3 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 2+	1 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 3+	0 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 4+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 5+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, No change or decreased	7 Participants	21 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to Trace,	2 Participants	2 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 1+	0 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 2+	2 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 3+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 4+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 5+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, No change or Decreased	8 Participants	19 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to Trace	2 Participants	4 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 1+	1 Participants	1 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 2+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 3+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 4+	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 5+	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

Urine samples were collected for the assessment of following urine parameters by dipstick method: glucose, protein, blood and ketones. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, protein, blood and ketones can be read as negative (-), trace, 1+, 2+, 3+, 4+, 5+ indicating proportional concentrations in the urine sample. Number of participants with abnormal results were reported as 'increase to trace' or 'increase to 1+, 2+, 3+, 4+, 5+' relative to BL (Day 1) value. Participants whose value was unchanged (e.g., Trace to Trace), or whose value was decreased, were recorded in the 'No change or Decreased' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=34 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, No change or Decreased	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to Trace	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 1+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 2+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 3+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 4+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Glucose, Increase to 5+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, No change or Decrease	21 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to Trace	9 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 1+	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 2+	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 3+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 4+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Ketones, Increase to 5+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, No change or Decreased	30 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to Trace	2 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 1+	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 2+	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 3+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 4+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Occult Blood, Increase to 5+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, No change or Decreased	30 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to Trace	3 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 1+	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 2+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 3+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 4+	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method Protein, Increase to 5+	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population

Vital signs were measured in a semi-supine position after 5 minutes rest and included body temperature, systolic and diastolic blood pressure. The clinical concern range for vital signs were: systolic blood pressure (SBP) (low: \<85 and high: \>160 millimeters of mercury \[mmHg\]); diastolic blood pressure (DBP) (low: \<45 and high: \>100 mmHg). 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 Range or No Change' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To High	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To within range or no change	12 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To High	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

Vital signs were measured in a semi-supine position after 5 minutes rest and included body temperature, systolic and diastolic blood pressure. The clinical concern range for vital signs were: SBP (low: \<85 and high: \>160 mmHg); DBP (low: \<45 and high: \>100 mmHg). 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 Range or No Change' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To within range or no change	34 Participants	—
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria DBP, To High	1 Participants	—
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To within range or no change	33 Participants	—
Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria SBP, To High	2 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population

Vital signs were measured in a semi-supine position after 5 minutes rest which included HR. The clinical concern range for HR (low \<40 beats per min \[bpm\] and high \>100 bpm). 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 Range or No Change' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst Case Abnormal Heart Rate (HR) Results by PCI Criteria HR, To Low	0 Participants	0 Participants
Part A: Number of Participants With Worst Case Abnormal Heart Rate (HR) Results by PCI Criteria HR, To within range or no change	11 Participants	24 Participants
Part A: Number of Participants With Worst Case Abnormal Heart Rate (HR) Results by PCI Criteria HR, To High	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

Vital signs were measured in a semi-supine position after 5 minutes rest which included HR. The clinical concern range for HR (low \<40 bpm and high \>100 bpm). 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 Range or No Change' category.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst Case Abnormal HR Results by PCI Criteria HR, To Low	0 Participants	—
Part B: Number of Participants With Worst Case Abnormal HR Results by PCI Criteria HR, To within range or no change	35 Participants	—
Part B: Number of Participants With Worst Case Abnormal HR Results by PCI Criteria HR, To High	0 Participants	—

PRIMARY outcome

Timeframe: Up to Day 43

Population: Safety population

12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=12 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants With Worst-case Abnormal Electrocardiogram (ECG) Findings Abnormal-not clinically significant	5 Participants	11 Participants
Part A: Number of Participants With Worst-case Abnormal Electrocardiogram (ECG) Findings Abnormal-clinically significant	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 44 to Day 112

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B were presented in a single arm as they all received GSK2982772 60 mg in Part B (OL Phase).

12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=35 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants With Worst-case Abnormal ECG Findings Abnormal-not clinically significant	18 Participants	—
Part B: Number of Participants With Worst-case Abnormal ECG Findings Abnormal-clinically significant	1 Participants	—

SECONDARY outcome

Timeframe: Day 43

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

The Mayo scoring system was used to assess UC disease activity, scoring ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools;1=1 to 2 stools/day more than normal;2=3 to 4 stools/day more than normal;3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time;2= visible blood with stool half the time or more;3=passing blood alone); findings at endoscopy (0=normal or inactive disease;1=mild disease \[erythema,decreased vascular pattern,mild friability\];2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\];3=severe disease \[spontaneous bleeding, ulceration\]); and physician's global assessment (PGA) (0=normal;1=mild;2=moderate;3=severe). Number of participants with Mayo endoscopic sub-score of 0 or 1 are presented. (range=0 to 3, higher scores indicating more severe disease).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 43 Mayo endoscopy sub-score =0	0 Percentage of participants	4 Percentage of participants
Part A: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 43 Mayo endoscopy sub-score=1	0 Percentage of participants	8 Percentage of participants

SECONDARY outcome

Timeframe: Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

The Mayo scoring system was used to assess UC disease activity, scoring ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more; 3=passing blood alone); findings at endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and PGA (0=normal; 1=mild; 2=moderate; 3=severe). Number of participants with Mayo endoscopic sub-score of 0 or 1 are presented. (range=0 to 3, higher scores indicating more severe disease).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=22 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 85 Mayo endoscopy sub-score =0	0 Percentage of participants	5 Percentage of participants
Part B: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 85 Mayo endoscopy sub-score=1	11 Percentage of participants	9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (screening - within 30 days prior to Day 1) and Day 43

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

UCEIS was used as an additional tool to assess disease activity based on 3 sub-scales: 'endoscopic vascular pattern, bleeding, erosions and ulcerations'. UCEIS total score was calculated by sum of all 3 sub-scale scores. Total score ranges from 0 to 8, with higher scores indicating more severe disease. Individual sub-scales 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). BL is defined as the latest pre-dose assessment at Screening (within 30 days prior to Day 1). Change from BL was calculated as post-BL visit value minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Total Score	-0.24 Scores on scale Standard Error 0.428	-0.42 Scores on scale Standard Error 0.289

SECONDARY outcome

Timeframe: Baseline (screening - within 30 days prior to Day 1) and Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

UCEIS was used as an additional tool to assess disease activity based on 3 sub-scales: 'endoscopic vascular pattern, bleeding, erosions and ulcerations'. UCEIS total score was calculated by sum of all 3 sub-scale scores. Total score ranges from 0 to 8, with higher scores indicating more severe disease. Individual sub-scales 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). Baseline is defined as the latest pre-dose assessment at Screening (within 30 days prior to Day 1). Change from BL was calculated as post-BL visit value minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=22 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Total Score	-0.84 Scores on scale Standard Error 0.495	-0.82 Scores on scale Standard Error 0.318

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Days 15, 29, 43

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

Blood samples were collected to measure CRP. BL is defined as the latest pre-dose assessment on Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Mean C Reactive Protein (CRP) Day 15, n=11,24	0.25 Milligrams per liter Standard Error 1.648	0.20 Milligrams per liter Standard Error 1.112
Part A: Change From Baseline in Mean C Reactive Protein (CRP) Day 29, n=11, 23	1.34 Milligrams per liter Standard Error 1.119	-1.84 Milligrams per liter Standard Error 0.782
Part A: Change From Baseline in Mean C Reactive Protein (CRP) Day 43, n=11, 24	1.06 Milligrams per liter Standard Error 1.854	-0.64 Milligrams per liter Standard Error 1.251

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Days 57, 71, 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

Blood samples were collected to measure CRP. BL is defined as the latest pre-dose assessment on Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=23 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B:Change From Baseline in Mean CRP Day 71, n=11, 22	-2.82 Milligrams per liter Standard Error 1.510	-2.71 Milligrams per liter Standard Error 1.040
Part B:Change From Baseline in Mean CRP Day 57, n=11,23	-2.61 Milligrams per liter Standard Error 1.740	-2.32 Milligrams per liter Standard Error 1.186
Part B:Change From Baseline in Mean CRP Day 85, n=10, 22	-2.77 Milligrams per liter Standard Error 1.616	-1.66 Milligrams per liter Standard Error 1.092

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Days 15, 29, 43

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

Fecal sample were collected to measure FCP. BL is defined as the latest pre-dose assessment on Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=23 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Fecal Calprotectin (FCP) Day 15, n=10, 23	0.78 Microgram per gram Geometric Coefficient of Variation 39.2	0.55 Microgram per gram Geometric Coefficient of Variation 25.1
Part A: Change From Baseline in Fecal Calprotectin (FCP) Day 29, n=11, 23	1.23 Microgram per gram Geometric Coefficient of Variation 33.5	0.54 Microgram per gram Geometric Coefficient of Variation 22.3
Part A: Change From Baseline in Fecal Calprotectin (FCP) Day 43, n=11, 22	1.90 Microgram per gram Geometric Coefficient of Variation 40.7	0.44 Microgram per gram Geometric Coefficient of Variation 27.1

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Days 57, 71, 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

Fecal sample were collected to measure FCP. BL is defined as the latest pre-dose assessment on Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=23 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B:Change From Baseline in FCP Day 57, n=11, 23	1.13 Microgram per gram Geometric Coefficient of Variation 27.7	0.56 Microgram per gram Geometric Coefficient of Variation 18.7
Part B:Change From Baseline in FCP Day 71, n=11, 22	0.69 Microgram per gram Geometric Coefficient of Variation 42.1	0.39 Microgram per gram Geometric Coefficient of Variation 28.9
Part B:Change From Baseline in FCP Day 85, n=11, 22	0.48 Microgram per gram Geometric Coefficient of Variation 39.9	0.40 Microgram per gram Geometric Coefficient of Variation 27.2

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Day 43

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

The MRS is a 4-point scale (none, mild, moderate and severe) which scores histologic activity based on localization and quantification of neutrophils in the mucosa. MRS Score ranges from 0 to 7, with higher scores indicates more severity. 0= Normal biopsy, 1= Lamina propria neutrophils only (Scattered individual neutrophils), 2= Lamina propria neutrophils only (Patchy collections of neutrophils), 3= Lamina propria neutrophils only (Diffuse neutrophils infiltrate), 4= Cryptitis/crypt abscesses (\<25% crypts involved), 5= Cryptitis/crypt abscesses (25% to 74% crypts involved), 6= Cryptitis/crypt abscesses (\>=75% crypts involved), 7= Erosion or ulceration present. Score 0 indicates normal condition; 1 to 3 indicates mild condition; 4 to 6 indicates moderate condition and score 7 indicates severe condition. BL is defined as the latest pre-dose assessment. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=10 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=23 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Modified Riley Scale Score (MRS)	0.04 Scores on scale Standard Error 0.842	0.04 Scores on scale Standard Error 0.558

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose) and Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes

The MRS is a 4-point scale (none, mild, moderate and severe) which scores histologic activity based on localization and quantification of neutrophils in the mucosa. MRS Score ranges from 0 to 7, with higher scores indicates more severity. 0= Normal biopsy, 1= Lamina propria neutrophils only (Scattered individual neutrophils), 2= Lamina propria neutrophils only (Patchy collections of neutrophils), 3= Lamina propria neutrophils only (Diffuse neutrophils infiltrate), 4= Cryptitis/crypt abscesses (\<25% crypts involved), 5= Cryptitis/crypt abscesses (25% to 74% crypts involved), 6= Cryptitis/crypt abscesses (\>=75% crypts involved), 7= Erosion or ulceration present. Score 0 indicates normal condition; 1 to 3 indicates mild condition; 4 to 6 indicates moderate condition and score 7 indicates severe condition. BL is defined as the latest pre-dose assessment. Change from BL is the value at indicated time point minus BL value

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=21 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Change From Baseline in MRS Score	-0.72 Scores on scale Standard Error 0.894	-0.65 Scores on scale Standard Error 0.576

SECONDARY outcome

Timeframe: Baseline and Day 43

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

Geboes score is a 7-items instrument which classifies histologic changes and generates a score from 0 to 5.4. The 7 items are: grade 0=structural-architectural changes (scored from 0.0 to 0.3); grade 1=chronic inflammatory infiltrate (scored from 1.0 to 1.3); grade 2A=lamina propria neutrophils (scored from 2.0 to 2.3), grade 2B= lamina propria eosinophils (scored from 2.0 to 2.3); 3=neutrophils in the epithelium (scored from 3.0 to 3.3); 4=crypt destruction (scored from 4.0 to 4.3); 5=erosions or ulceration (scored from 5.0 to 5.4). The most severe observation that the histopathologist sees on the slide is considered as the Geboes index total score, ranges from 0 to 5.4, with higher scores indicates severe disease. BL is defined as the latest pre-dose assessment before Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=10 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=23 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Geboes Index Total Score	1.04 Scores on scale Standard Error 1.847	0.28 Scores on scale Standard Error 1.223

SECONDARY outcome

Timeframe: Baseline and Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes

Geboes score is a 7-items instrument which classifies histologic changes and generates a score from 0 to 5.4. The 7 items are: grade 0=structural-architectural changes (scored from 0.0 to 0.3); grade 1=chronic inflammatory infiltrate (scored from 1.0 to 1.3); grade 2A=lamina propria neutrophils (scored from 2.0 to 2.3), grade 2B= lamina propria eosinophils (scored from 2.0 to 2.3); 3=neutrophils in the epithelium (scored from 3.0 to 3.3); 4=crypt destruction (scored from 4.0 to 4.3); 5=erosions or ulceration (scored from 5.0 to 5.4). The most severe observation that the histopathologist sees on the slide is considered as the Geboes index total score, ranges from 0 to 5.4, with higher scores indicates severe disease. BL is defined as the latest pre-dose assessment before Day 1. Change from BL is the value at indicated time point minus BL value.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=21 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Change From Baseline in Geboes Index Total Score	-0.67 Scores on scale Standard Error 1.981	-1.47 Scores on scale Standard Error 1.286

SECONDARY outcome

Timeframe: Day 43

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

Mayo Clinical Response is defined as a \>=3 points or \>=30% improvement from BL in Total Mayo Score, along with a decrease in the rectal bleeding sub-score of \>= 1 point. The Mayo scoring system ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more; 3=passing blood alone); findings at endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and PGA (0=normal; 1=mild; 2=moderate; 3=severe).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants Who Achieved Mayo Clinical Response	4 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

Mayo Clinical Response is defined as a \>=3 points or \>=30% improvement from BL in Total Mayo Score, along with a decrease in the rectal bleeding sub-score of \>= 1 point. The Mayo scoring system ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more; 3=passing blood alone); findings at endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and PGA (0=normal; 1=mild; 2=moderate; 3=severe).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=22 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants Who Achieved Mayo Clinical Response	5 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 43

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

Mayo clinical remission is defined as total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. The Mayo scoring system ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more; 3=passing blood alone); findings at endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and PGA (0=normal; 1=mild; 2=moderate; 3=severe).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Number of Participants Who Achieved Mayo Clinical Remission	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes.

Mayo clinical remission is defined as total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. The Mayo scoring system ranges from 0 to 12, calculated as sum of 4 sub-scores, higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more; 3=passing blood alone); findings at endoscopy (0=normal or inactive disease; 1=mild disease \[erythema, decreased vascular pattern, mild friability\]; 2=moderate disease \[marked erythema, lack of vascular pattern, friability, erosions\]; 3=severe disease \[spontaneous bleeding, ulceration\]); and PGA (0=normal; 1=mild; 2=moderate; 3=severe).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=9 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=22 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Number of Participants Who Achieved Mayo Clinical Remission	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Screening - within 30 days prior to Day 1) and at Days 15, 29, 43

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

Partial Mayo Score is defined as the total score of 3 domain subscores-stool frequency, rectal bleeding and PGA. Scoring ranges from 0 to 9, higher scores indicating more severe disease. The Mayo scoring system has 4 sub-scores: Stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more;3=passing blood alone); findings at endoscopy (0=normal or inactive disease;1=mild disease\[erythema,decreased vascular pattern,mild friability\];2=moderate disease\[marked erythema,lack of vascular pattern,friability,erosions\];3=severe disease \[spontaneous bleeding,ulceration\]);and PGA (0=normal; 1=mild; 2=moderate; 3=severe). Change from BL=post-BL value minus BL value (screening-within 30 days prior to Day 1).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Change From Baseline in Partial Mayo Score Day 15	-0.68 Scores on scale Standard Error 0.493	-1.04 Scores on scale Standard Error 0.333
Part A: Change From Baseline in Partial Mayo Score Day 29	-1.05 Scores on scale Standard Error 0.480	-1.16 Scores on scale Standard Error 0.324
Part A: Change From Baseline in Partial Mayo Score Day 43	-1.30 Scores on scale Standard Error 0.557	-1.64 Scores on scale Standard Error 0.376

SECONDARY outcome

Timeframe: Baseline and Day 85

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to allow statistical comparison of efficacy outcomes

Partial Mayo Score defined as total score of 3 domain subscores-stool frequency, rectal bleeding and PGA, ranges from 0 to 9, higher score indicate more severe disease. It has 4 sub-scores: Stool frequency (0=normal number of stools; 1=1 to 2 stools/day more than normal; 2=3 to 4 stools/day more than normal; 3= \>4 stools/day more than normal); rectal bleeding (0=no blood seen; 1=visible blood with stools less than half the time; 2= visible blood with stool half the time or more;3=passing blood alone); findings at endoscopy (0=normal or inactive disease;1=mild disease\[erythema,decreased vascular pattern,mild friability\];2=moderate disease\[marked erythema,lack of vascular pattern, friability, erosions\];3=severe disease \[spontaneous bleeding,ulceration\]);and PGA (0=normal, 3=severe). Change from BL=post-BL value minus BL value (screening-within 30 days prior to Day 1).

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=11 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=22 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Change From Baseline in Partial Mayo Score	-2.87 Scores on scale Standard Error 0.728	-2.93 Scores on scale Standard Error 0.502

SECONDARY outcome

Timeframe: Day 43

Population: PK Population. Participants with data available at the specified time points were analyzed.

Pre-dose blood sample was collected on Day 43 for the measurement of plasma concentration of GSK2982772. PK Population is defined as the participants in the safety population who received an active dose and for whom a GSK2982772 pharmacokinetic sample was obtained and analyzed

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=23 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Pre-dose Plasma Concentration of GSK2982772	131.749 Nanogram/milliliter Standard Deviation 214.9127	—

SECONDARY outcome

Timeframe: Days 1 and 43: 1, 2, 4 and 6 hours post dose

Population: PK Population. Participants with data available at the specified time points were analyzed.

Post-dose blood sample were collected on Days 1 and 43 at 1, 2, 4 and 6 hours for the measurement of plasma concentration of GSK2982772.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=23 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 1, 6 hours	481.304 Nanogram/milliliter Standard Deviation 679.5678	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 1, 1 hour	674.588 Nanogram/milliliter Standard Deviation 412.8928	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 1, 2 hours	772.043 Nanogram/milliliter Standard Deviation 378.5145	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 1, 4 hours	474.248 Nanogram/milliliter Standard Deviation 309.5524	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 43, 1 hour	918.926 Nanogram/milliliter Standard Deviation 508.8658	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 43, 2 hours	851.391 Nanogram/milliliter Standard Deviation 340.6479	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 43, 4 hours	472.132 Nanogram/milliliter Standard Deviation 246.0718	—
Part A: Post-dose Plasma Concentrations of GSK2982772 Day 43, 6 hours	278.039 Nanogram/milliliter Standard Deviation 187.2142	—

SECONDARY outcome

Timeframe: Day 85

Population: PK Population. Only those participants with data available at the specified time points were analyzed. All participants in Part B received GSK2982772 60 mg in Part B (OL Phase), however they were split into 2 arms as randomized in Part A to compare trough concentrations.

Blood samples were collected for the measurement of trough plasma concentration of GSK2982772 on Day 85.

Outcome measures

Outcome measures
Measure	Part A: Placebo TID DB n=10 Participants Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 Participants Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).
Part B: Trough Concentrations of GSK2982772 on Day 85	47.970 Nanogram/milliliter Standard Deviation 78.9909	150.642 Nanogram/milliliter Standard Deviation 305.3144

Adverse Events

Part A: Placebo TID DB

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A: GSK2982772 60 mg TID DB

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Part B: GSK2982772 60 mg TID OL

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo TID DB n=12 participants at risk Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase).	Part A: GSK2982772 60 mg TID DB n=24 participants at risk Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part A (double blind phase).	Part B: GSK2982772 60 mg TID OL n=35 participants at risk Eligible participants with UC, received GSK2982772 60 mg (given as 2 tablets of 30 mg) TID orally for 42 days in Part B (open label phase).
Gastrointestinal disorders Colitis ulcerative	8.3% 1/12 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	0.00% 0/24 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	0.00% 0/35 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/12 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	0.00% 0/24 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	2.9% 1/35 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/12 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	0.00% 0/24 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.	2.9% 1/35 • Number of events 1 • SAEs and non-serious AEs were collected from the start of study treatment (Day 1) up to Day 43 in Part A and from Day 44 till follow up visit (Day 112) in Part B. SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment. Adverse events are presented treatment wise.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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