| Primary | Part A: Number of Participants With Common (>=5%) Non-serious Adverse Events (Non-SAEs) and Any Serious Adverse Events (SAEs) | 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. | Safety population comprised of all participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
| | | Title | Denominators | Categories |
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| Common non-SAEs | | | | Any SAEs | | |
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| Primary | Part B: Number of Participants With Common (>=5%) Non Serious AEs and SAEs | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria | 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' | | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst Case Abnormal Clinical Chemistry Parameters by Potential Clinical Importance (PCI) Criteria | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria | 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'. | | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst Case Abnormal Hematology Parameters by PCI Criteria | 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'. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst Case Abnormal Urinalysis Results by Dipstick Method | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria | 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. | | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst Case Abnormal Blood Pressure Results by PCI Criteria | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst Case Abnormal Heart Rate (HR) Results by PCI Criteria | 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. | | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst Case Abnormal HR Results by PCI Criteria | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
|---|
| OG000 | Part B: 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 in Part B (open label phase). |
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| Primary | Part A: Number of Participants With Worst-case Abnormal Electrocardiogram (ECG) Findings | 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. | | Posted | | Count of Participants | | Participants | | Up to Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Primary | Part B: Number of Participants With Worst-case Abnormal ECG Findings | 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. | 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). | Posted | | Count of Participants | | Participants | | From Day 44 to Day 112 | | | | ID | Title | Description |
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| OG000 | Part B: 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 in Part B (open label phase). |
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| Secondary | Part A: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 43 | 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). | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Number | | Percentage of participants | | Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | Part A: GSK2982772 60 mg TID DB | |
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| Secondary | Part B: Percentage of Participants Who Achieved an Absolute Mayo Endoscopy Subscore of 0 or 1 at Day 85 | 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). | 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. | Posted | | Number | | Percentage of participants | | Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Total Score | 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. | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (screening - within 30 days prior to Day 1) and Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Secondary | Part B: Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Total Score | 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. | 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. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (screening - within 30 days prior to Day 1) and Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Change From Baseline in Mean C Reactive Protein (CRP) | 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. | Safety population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). | Posted | | Least Squares Mean | Standard Error | Milligrams per liter | | Baseline (Day 1, pre-dose) and Days 15, 29, 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo 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). | | OG001 | 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). |
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| Secondary | Part B:Change From Baseline in Mean CRP | 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. | 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. | Posted | | Least Squares Mean | Standard Error | Milligrams per liter | | Baseline (Day 1, pre-dose) and Days 57, 71, 85 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 PK profile is comparable for BID & TID regimen |
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| Secondary | Part A: Change From Baseline in Fecal Calprotectin (FCP) | 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. | Safety population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). | Posted | | Geometric Least Squares Mean | Geometric Coefficient of Variation | Microgram per gram | | Baseline (Day 1, pre-dose) and Days 15, 29, 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo 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). | | OG001 | 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). |
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| Secondary | Part B:Change From Baseline in FCP | 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. | 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. | Posted | | Geometric Least Squares Mean | Geometric Coefficient of Variation | Microgram per gram | | Baseline (Day 1, pre-dose) and Days 57, 71, 85 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 PK profile is comparable for BID & TID regimen |
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| Secondary | Part A: Change From Baseline in Modified Riley Scale Score (MRS) | 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. | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (Day 1, pre-dose) and Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Secondary | Part B: Change From Baseline in MRS Score | 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 | 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 | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (Day 1, pre-dose) and Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Change From Baseline in Geboes Index Total Score | 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. | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline and Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Secondary | Part B: Change From Baseline in Geboes Index Total Score | 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. | 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 | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline and Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Number of Participants Who Achieved Mayo Clinical Response | 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). | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Secondary | Part B: Number of Participants Who Achieved Mayo Clinical Response | 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). | 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. | Posted | | Count of Participants | | Participants | | Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Number of Participants Who Achieved Mayo Clinical Remission | 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). | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo TID DB | Eligible participants with UC, received two tablets of placebo TID orally for 42 days in Part A (double blind phase). | | OG001 | 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). |
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| Secondary | Part B: Number of Participants Who Achieved Mayo Clinical Remission | 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). | 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. | Posted | | Count of Participants | | Participants | | Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Change From Baseline in Partial Mayo Score | 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). | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline (Screening - within 30 days prior to Day 1) and at Days 15, 29, 43 | | | | ID | Title | Description |
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| OG000 | Part A: Placebo 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). | | OG001 | Part A: GSK2982772 60 mg TID DB | |
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| Secondary | Part B: Change From Baseline in Partial Mayo Score | 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). | 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 | Posted | | Least Squares Mean | Standard Error | Scores on scale | | Baseline and Day 85 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Part A: Pre-dose Plasma Concentration of GSK2982772 | 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 | PK Population. Participants with data available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Nanogram/milliliter | | Day 43 | | | | ID | Title | Description |
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| OG000 | 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). |
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| Secondary | Part A: Post-dose Plasma Concentrations of GSK2982772 | 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. | PK Population. Participants with data available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Nanogram/milliliter | | Days 1 and 43: 1, 2, 4 and 6 hours post dose | | | | ID | Title | Description |
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| OG000 | 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). |
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| Secondary | Part B: Trough Concentrations of GSK2982772 on Day 85 | Blood samples were collected for the measurement of trough plasma concentration of GSK2982772 on Day 85. | 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. | Posted | | Mean | Standard Deviation | Nanogram/milliliter | | Day 85 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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 PK profile is comparable for BID & TID regimen |
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