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A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01782664
Enrollment
68
Registered
2013-02-04
Start date
2013-03-01
Completion date
2014-03-24
Last updated
2017-08-03

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

Conditions

Psoriasis

Keywords

PASI, DLQI, GSK2586184, plaque-type psoriasis, PGA, inflammatory gene transcription, JAK-1 inhibitor, serum neopterin, skin biopsy, ACR response criteria, VAS itch score

Brief summary

A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis. There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184. In both Cohorts A and B, study medication will be administered orally (as tablets), twice daily, for up to 12 weeks. Each subject will have 7 out-patient visits: Screening; Baseline & Start of treatment; Week 2; Week 4; Week 8; Week 12; and Follow-up (Week 16)

Interventions

DRUG100 mg GSK2586184

100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.

DRUG200 mg GSK2586184

200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.

DRUG400 mg GSK2586184

400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.

DRUGPlacebo

Placebo tablets to be taken twice daily with food for up to 84 days.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Otherwise healthy subjects with a diagnosis of moderate to severe plaque psoriasis defined by the following criteria: * Diagnosed for at least 12 months before the first dose of study medication * Psoriasis plaques cover \>=10% of body surface area. * PASI score of \>=12, and PGA score of\>=3, and suitable for systemic or light therapy. * Male or female, between 18 and 75 years of age inclusive. * Female subjects of childbearing potential must agree to avoid pregnancy and male subjects must agree to avoid female partners becoming pregnant. * Subjects must agree to use ultra violet (UV) light protection. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

* Unable to refrain from the use of the following prescription and non-prescription drugs from the following periods before the first dose of study medication until completion of the follow-up visit: * 12 weeks: alefacept, ustekinumab, adalimumab, etanercept, infliximab, or certolizumab pegol * 4 weeks or 5 half-lives, whichever is longer: * systemic medications for other medical conditions that are known to affect psoriasis, including but not limited to oral corticosteroids, cyclosporine, methotrexate, lithium, and beta-adrenergic blockers * 7 days or 5 half-lives, whichever is longer: * statins and other OATP and BCRP sensitive substrates (e.g. rapaglinide) * any agent known to be a substrate of MATE1 and MATE2-K, which undergoes significant renal secretion (e.g. cimetidine) * 3 weeks or 5 half-lives, whichever is longer: * any agent known to be a strong CYP3A4 inhibitor or inducer * 2 weeks: topical therapies that are known to affect psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, tar and anthralin * Other medications (including vitamins, herbal and dietary supplements) will be considered on a case-by-case basis, and will be allowed if in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety. * Phototherapy within 4 weeks before the first dose of study medication. * A live vaccination within 4 weeks before the first dose of study medication, or a live vaccination planned during the course of the study (until completion of the follow-up visit). * A major organ transplant (e.g. heart, lung, kidney, liver) or haematopoietic stem cell/marrow transplant. * Significant unstable or uncontrolled acute or chronic disease unrelated to psoriasis (i.e. cardiovascular including uncontrolled hypertension, hypercholesterolemia, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. * A planned surgical procedure that, in the opinion of the investigator, makes the subject unsuitable for the study. * A history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. * Acute or chronic infections, as follows: * Known previous or active infection with Mycobacterium Tuberculosis * Currently on any suppressive therapy for a chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria). * Hospitalisation for treatment of infection within 60 days before first dose. * Use of parenteral (IV or intramuscular) antibiotics (antibacterials, antivirals, antifungals, or antiparasitic agents) within 60 days before first dose. * Unable to refrain from the consumption of grapefruit or grapefruit juice from 3 weeks before the first dose of study medication until 2 weeks after the last dose of study medication. * History of sensitivity to any components of the study medications, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation. * Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc antibody as follows: subjects positive for HBsAg are excluded; and subjects positive for anti-HBc antibody (regardless of anti-HBs antibody status) are excluded. * Positive test for Hepatitis C antibody confirmed sample with a Hepatitis C RIBA immunoblot assay or equivalent. Subjects who are positive for Hepatitis C antibody, but negative when the Hepatitis C RIBA immunoblot assay or equivalent test is performed will be eligible to participate. Subjects who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RIBA immunoblot assay or equivalent test is performed will not be eligible to participate. * A positive test for HIV antibody. * Pregnant females as determined by a positive serum hCG test at screening, or a positive urine hCG test pre-dose on Day 1. * Lactating females. * Haemoglobin \<11 g/dL, haematocrit \<30%, WBC count (absolute) \<3 × 10\^9/L, neutrophils \<1.5 × 10\^9/L, platelets \<100 × 10\^9/L, lymphocytes \<1 x 10\^9/L. * Current or history of renal disease, or estimated creatinine clearance \<60 mL/min/1.73m\^2 or serum creatinine \>1.5 ULN. * Single QTc \> 450 msec; or QTc \> 480 msec in subjects with Bundle Branch Block. * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * ALT \> 2xULN; alkaline phosphatase and bilirubin ≥ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\ 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits. * The subject has participated in a clinical trial and has received an investigational product within 3 months before the first dose of study medication, or plans to take part in another clinical trial at the same time as participating in this clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)Baseline and Week 12PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.

Secondary

MeasureTime frameDescription
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyFrom BL (Day 1) until the Follow-up visit (Day 112)Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyFrom Baseline (Day 1) until the Follow-up visit (Day 112)Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (\> high or \< low) at any time post-BL, including unscheduled or scheduled assessments, are presented.
Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyFrom Baseline (Day 1) until the follow-up visit (Day 112)Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP low was measured as less than 85 millimeters of mercury (mmHg)and high was measured as greater than 160 mmHg. DBP low was measured as less than 45 mmHg and high was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the StudyFrom Baseline (Day 1) until the Follow-up visit (Day 112)Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR low was any HR less than 40 beats per minute (bpm) and high was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.
Change From Baseline in Body TemperatureFrom Baseline (Day 1) until Week 16Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.
Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsFrom Baseline (Day 1) until the Follow-up visit (Day 112)ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds \[msec\]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.
Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12From Baseline (Day 1) until Week 12Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
PASI Score at Week 2, 4, 8 and 12Week 2, 4, 8 and 12Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.
Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12From Baseline (Day 1) until Week 12Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.
Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Weeks 2, 4, 8 and 12The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)From Baseline (Day 1) until the Follow-up visit (Day 112)An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A 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 or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.
Time to PASI 75From Baseline (Day 1) until Week 12PASI 75 was \>= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.
Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)From Baseline (Day 1) until Week 12The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.
Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12From Baseline (Day 1) until Week 12The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Itch VAS Scores at Week 2, 4, 8 and 12Week 2, 4, 8 and 12The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.
Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12Baseline and Week 12The DLQI was used to assess a participant's health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0-3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant's quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Clearance of GSK2586184Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Steady State Volume of Distribution (Vss) of GSK2586184Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.
Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Baseline (pre-dose) and Weeks 2, 4, 8 and 12Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.
Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Weeks 2, 4, 8 and 12The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.

Countries

Germany, United Kingdom

Participant flow

Recruitment details

A total of 68 participants with chronic plaque psoriasis were enrolled. The study was conducted at 13 centers in 2 countries: 10 in Germany and 3 in United Kingdom from 12 March 2013 to 24 March 2014.

Pre-assignment details

A total of 68 participants were enrolled for this study. Of these, 1 participant was not dosed any study medication because the participant was taking prohibited concomitant medications.

Participants by arm

ArmCount
Placebo
Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks.
14
GSK2586184 100 mg
Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
15
GSK2586184 200 mg
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
16
GSK2586184 400 mg
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
14
GSK2586184 400 mg OL
Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
6
GSK2586184 200 mg OL
Participants incorrectly received Open-Label 200 mg (rather than 400 mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
2
Total67

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event222200
Overall StudyLack of Efficacy202200
Overall StudyProtocol Violation010100
Overall StudyWithdrawal by Subject220000

Baseline characteristics

CharacteristicPlaceboGSK2586184 100 mgGSK2586184 200 mgGSK2586184 400 mgGSK2586184 400 mg OLGSK2586184 200 mg OLTotal
Age, Continuous49.0 Years
STANDARD_DEVIATION 13.79
43.9 Years
STANDARD_DEVIATION 14.1
49.0 Years
STANDARD_DEVIATION 13.24
41.5 Years
STANDARD_DEVIATION 12.08
50.7 Years
STANDARD_DEVIATION 11.96
53.5 Years
STANDARD_DEVIATION 2.12
46.6 Years
STANDARD_DEVIATION 13.11
Race/Ethnicity, Customized
African American/African Heritage
0 Participants0 Participants2 Participants0 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Asian - South East Asian Heritage
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
14 Participants14 Participants14 Participants14 Participants6 Participants2 Participants64 Participants
Sex: Female, Male
Female
5 Participants6 Participants6 Participants8 Participants3 Participants2 Participants30 Participants
Sex: Female, Male
Male
9 Participants9 Participants10 Participants6 Participants3 Participants0 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 150 / 160 / 140 / 60 / 2
other
Total, other adverse events
13 / 1410 / 1514 / 1610 / 146 / 61 / 2
serious
Total, serious adverse events
0 / 142 / 150 / 161 / 141 / 60 / 2

Outcome results

Primary

Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)

PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with LOCF analysis.

Time frame: Baseline and Week 12

Population: Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)0 Percentage of participants
GSK2586184 100 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)14 Percentage of participants
GSK2586184 200 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)36 Percentage of participants
GSK2586184 400 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)62 Percentage of participants
GSK2586184 400 mg OLPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)75 Percentage of participants
Primary

Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)

PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.

Time frame: Baseline and Week 12

Population: Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)0 Percentage of participants
GSK2586184 100 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)13 Percentage of participants
GSK2586184 200 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)25 Percentage of participants
GSK2586184 400 mgPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)57 Percentage of participants
GSK2586184 400 mg OLPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)50 Percentage of participants
GSK2586184 200 mg OLPercentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)50 Percentage of participants
Secondary

Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12

Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.

Time frame: From Baseline (Day 1) until Week 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-0.05 Scores on a ScaleStandard Deviation 1.716
PlaceboChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-0.73 Scores on a ScaleStandard Deviation 3.335
PlaceboChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-1.41 Scores on a ScaleStandard Deviation 2.122
PlaceboChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-3.13 Scores on a ScaleStandard Deviation 2.694
GSK2586184 100 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-6.54 Scores on a ScaleStandard Deviation 6.915
GSK2586184 100 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-4.50 Scores on a ScaleStandard Deviation 4.344
GSK2586184 100 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-2.39 Scores on a ScaleStandard Deviation 3.12
GSK2586184 100 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-9.76 Scores on a ScaleStandard Deviation 6.341
GSK2586184 200 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-9.21 Scores on a ScaleStandard Deviation 12.446
GSK2586184 200 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-8.45 Scores on a ScaleStandard Deviation 11.396
GSK2586184 200 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-7.03 Scores on a ScaleStandard Deviation 7.594
GSK2586184 200 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-0.51 Scores on a ScaleStandard Deviation 7.693
GSK2586184 400 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-3.94 Scores on a ScaleStandard Deviation 4.766
GSK2586184 400 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-13.55 Scores on a ScaleStandard Deviation 6.393
GSK2586184 400 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-8.04 Scores on a ScaleStandard Deviation 7.739
GSK2586184 400 mgChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-10.32 Scores on a ScaleStandard Deviation 8.293
GSK2586184 400 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-7.85 Scores on a ScaleStandard Deviation 5.39
GSK2586184 400 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-9.37 Scores on a ScaleStandard Deviation 7.181
GSK2586184 400 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-9.10 Scores on a ScaleStandard Deviation 3.854
GSK2586184 400 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-5.25 Scores on a ScaleStandard Deviation 4.192
GSK2586184 200 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 4-8.20 Scores on a ScaleStandard Deviation 0.99
GSK2586184 200 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 8-11.50 Scores on a ScaleStandard Deviation 0.424
GSK2586184 200 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 12-12.45 Scores on a ScaleStandard Deviation 1.061
GSK2586184 200 mg OLChange From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12Week 2-3.75 Scores on a ScaleStandard Deviation 2.192
Secondary

Change From Baseline in Body Temperature

Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.

Time frame: From Baseline (Day 1) until Week 16

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Body TemperatureWeek 160.3 CelsiusStandard Deviation 0.45
PlaceboChange From Baseline in Body TemperatureWeek 2-0.2 CelsiusStandard Deviation 0.54
PlaceboChange From Baseline in Body TemperatureWeek 80.1 CelsiusStandard Deviation 0.44
PlaceboChange From Baseline in Body TemperatureWeek 4-0.1 CelsiusStandard Deviation 0.52
PlaceboChange From Baseline in Body TemperatureWeek 12-0.1 CelsiusStandard Deviation 0.38
GSK2586184 100 mgChange From Baseline in Body TemperatureWeek 12-0.2 CelsiusStandard Deviation 0.64
GSK2586184 100 mgChange From Baseline in Body TemperatureWeek 80.1 CelsiusStandard Deviation 0.51
GSK2586184 100 mgChange From Baseline in Body TemperatureWeek 16-0.1 CelsiusStandard Deviation 0.66
GSK2586184 100 mgChange From Baseline in Body TemperatureWeek 2-0.0 CelsiusStandard Deviation 0.38
GSK2586184 100 mgChange From Baseline in Body TemperatureWeek 40.1 CelsiusStandard Deviation 0.44
GSK2586184 200 mgChange From Baseline in Body TemperatureWeek 8-0.2 CelsiusStandard Deviation 0.55
GSK2586184 200 mgChange From Baseline in Body TemperatureWeek 2-0.1 CelsiusStandard Deviation 0.73
GSK2586184 200 mgChange From Baseline in Body TemperatureWeek 160.1 CelsiusStandard Deviation 0.39
GSK2586184 200 mgChange From Baseline in Body TemperatureWeek 4-0.1 CelsiusStandard Deviation 0.53
GSK2586184 200 mgChange From Baseline in Body TemperatureWeek 12-0.1 CelsiusStandard Deviation 0.38
GSK2586184 400 mgChange From Baseline in Body TemperatureWeek 12-0.0 CelsiusStandard Deviation 0.23
GSK2586184 400 mgChange From Baseline in Body TemperatureWeek 2-0.0 CelsiusStandard Deviation 0.36
GSK2586184 400 mgChange From Baseline in Body TemperatureWeek 16-0.1 CelsiusStandard Deviation 0.21
GSK2586184 400 mgChange From Baseline in Body TemperatureWeek 8-0.1 CelsiusStandard Deviation 0.28
GSK2586184 400 mgChange From Baseline in Body TemperatureWeek 40.0 CelsiusStandard Deviation 0.28
GSK2586184 400 mg OLChange From Baseline in Body TemperatureWeek 120.0 CelsiusStandard Deviation 0.29
GSK2586184 400 mg OLChange From Baseline in Body TemperatureWeek 160.4 CelsiusStandard Deviation 0.29
GSK2586184 400 mg OLChange From Baseline in Body TemperatureWeek 80.2 CelsiusStandard Deviation 0.51
GSK2586184 400 mg OLChange From Baseline in Body TemperatureWeek 20.0 CelsiusStandard Deviation 0.21
GSK2586184 400 mg OLChange From Baseline in Body TemperatureWeek 40.3 CelsiusStandard Deviation 0.37
GSK2586184 200 mg OLChange From Baseline in Body TemperatureWeek 80.1 CelsiusStandard Deviation 0.21
GSK2586184 200 mg OLChange From Baseline in Body TemperatureWeek 40.0 CelsiusStandard Deviation 0
GSK2586184 200 mg OLChange From Baseline in Body TemperatureWeek 20.6 CelsiusStandard Deviation 0.49
GSK2586184 200 mg OLChange From Baseline in Body TemperatureWeek 16-0.0 CelsiusStandard Deviation 0.35
GSK2586184 200 mg OLChange From Baseline in Body TemperatureWeek 120.2 CelsiusStandard Deviation 0
Secondary

Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12

Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.

Time frame: Baseline (pre-dose) and Weeks 2, 4, 8 and 12

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 20.19 Nanomol per Liter (nmol/L)Standard Deviation 1.219
PlaceboChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 40.18 Nanomol per Liter (nmol/L)Standard Deviation 0.844
PlaceboChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 8-0.14 Nanomol per Liter (nmol/L)Standard Deviation 0.597
PlaceboChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 12-0.01 Nanomol per Liter (nmol/L)Standard Deviation 1.038
GSK2586184 100 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 8-1.13 Nanomol per Liter (nmol/L)Standard Deviation 2.312
GSK2586184 100 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 4-1.69 Nanomol per Liter (nmol/L)Standard Deviation 2.933
GSK2586184 100 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 20.43 Nanomol per Liter (nmol/L)Standard Deviation 5.394
GSK2586184 100 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 12-1.32 Nanomol per Liter (nmol/L)Standard Deviation 2.355
GSK2586184 200 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 12-0.79 Nanomol per Liter (nmol/L)Standard Deviation 1.738
GSK2586184 200 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 8-0.81 Nanomol per Liter (nmol/L)Standard Deviation 2.294
GSK2586184 200 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 4-1.15 Nanomol per Liter (nmol/L)Standard Deviation 1.768
GSK2586184 200 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 22.35 Nanomol per Liter (nmol/L)Standard Deviation 6.475
GSK2586184 400 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 2-0.42 Nanomol per Liter (nmol/L)Standard Deviation 1.858
GSK2586184 400 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 124.37 Nanomol per Liter (nmol/L)Standard Deviation 13.387
GSK2586184 400 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 4-0.69 Nanomol per Liter (nmol/L)Standard Deviation 1.195
GSK2586184 400 mgChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 80.31 Nanomol per Liter (nmol/L)Standard Deviation 2.998
GSK2586184 400 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 8-0.40 Nanomol per Liter (nmol/L)Standard Deviation 1.52
GSK2586184 400 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 12-0.42 Nanomol per Liter (nmol/L)Standard Deviation 1.182
GSK2586184 400 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 4-0.67 Nanomol per Liter (nmol/L)Standard Deviation 0.378
GSK2586184 400 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 2-0.47 Nanomol per Liter (nmol/L)Standard Deviation 0.918
GSK2586184 200 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 41.80 Nanomol per Liter (nmol/L)Standard Deviation 2.828
GSK2586184 200 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 80.15 Nanomol per Liter (nmol/L)Standard Deviation 2.192
GSK2586184 200 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 120.35 Nanomol per Liter (nmol/L)Standard Deviation 0.212
GSK2586184 200 mg OLChange From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12Week 29.95 Nanomol per Liter (nmol/L)Standard Deviation 13.93
Secondary

Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12

The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.

Time frame: From Baseline (Day 1) until Week 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-5.67 Scores on a ScaleStandard Deviation 32.129
PlaceboChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-7.00 Scores on a ScaleStandard Deviation 37.944
PlaceboChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 80.22 Scores on a ScaleStandard Deviation 26.138
PlaceboChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-1.56 Scores on a ScaleStandard Deviation 34.348
GSK2586184 100 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-21.40 Scores on a ScaleStandard Deviation 40.533
GSK2586184 100 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 8-26.27 Scores on a ScaleStandard Deviation 35.707
GSK2586184 100 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-14.79 Scores on a ScaleStandard Deviation 31.396
GSK2586184 100 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-26.50 Scores on a ScaleStandard Deviation 28.659
GSK2586184 200 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-23.92 Scores on a ScaleStandard Deviation 40.586
GSK2586184 200 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-22.36 Scores on a ScaleStandard Deviation 27.244
GSK2586184 200 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 8-24.86 Scores on a ScaleStandard Deviation 37.134
GSK2586184 200 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-14.87 Scores on a ScaleStandard Deviation 23.67
GSK2586184 400 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-24.92 Scores on a ScaleStandard Deviation 24.737
GSK2586184 400 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-41.13 Scores on a ScaleStandard Deviation 31.791
GSK2586184 400 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-28.08 Scores on a ScaleStandard Deviation 25.678
GSK2586184 400 mgChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 8-36.30 Scores on a ScaleStandard Deviation 29.788
GSK2586184 400 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-56.33 Scores on a ScaleStandard Deviation 30.329
GSK2586184 400 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-60.80 Scores on a ScaleStandard Deviation 38.16
GSK2586184 400 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-47.50 Scores on a ScaleStandard Deviation 39.48
GSK2586184 400 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 8-61.50 Scores on a ScaleStandard Deviation 31.729
GSK2586184 200 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 2-22.00 Scores on a ScaleStandard Deviation 43.841
GSK2586184 200 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 8-32.50 Scores on a ScaleStandard Deviation 65.761
GSK2586184 200 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 12-25.00 Scores on a ScaleStandard Deviation 76.368
GSK2586184 200 mg OLChange From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12Week 4-30.00 Scores on a ScaleStandard Deviation 62.225
Secondary

Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12

The DLQI was used to assess a participant's health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0-3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant's quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.

Time frame: Baseline and Week 12

Population: ITT Population. Only those participants who had a Week 12 evaluation were analyzed.

ArmMeasureValue (MEAN)Dispersion
PlaceboChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 121.70 Scores on a ScaleStandard Deviation 5.638
GSK2586184 100 mgChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12-2.80 Scores on a ScaleStandard Deviation 7.743
GSK2586184 200 mgChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12-4.29 Scores on a ScaleStandard Deviation 8.389
GSK2586184 400 mgChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12-8.00 Scores on a ScaleStandard Deviation 3.83
GSK2586184 400 mg OLChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12-6.75 Scores on a ScaleStandard Deviation 5.123
GSK2586184 200 mg OLChange From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12-8.00 Scores on a ScaleStandard Deviation 11.314
Secondary

Clearance of GSK2586184

Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.

Time frame: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)

Population: PK Population.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
GSK2586184 100 mgClearance of GSK258618468.30232 Litre (L)/hrGeometric Coefficient of Variation 43.9
GSK2586184 200 mgClearance of GSK258618456.86726 Litre (L)/hrGeometric Coefficient of Variation 38.7
GSK2586184 400 mgClearance of GSK258618451.49060 Litre (L)/hrGeometric Coefficient of Variation 62.4
GSK2586184 400 mg OLClearance of GSK258618452.89690 Litre (L)/hrGeometric Coefficient of Variation 79.1
GSK2586184 200 mg OLClearance of GSK258618462.34017 Litre (L)/hrGeometric Coefficient of Variation 53.5
Secondary

Itch VAS Scores at Week 2, 4, 8 and 12

The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.

Time frame: Week 2, 4, 8 and 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,246.42 Scores on a ScaleStandard Deviation 28.909
PlaceboItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,244.40 Scores on a ScaleStandard Deviation 35.485
PlaceboItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,257.33 Scores on a ScaleStandard Deviation 29.368
PlaceboItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,250.67 Scores on a ScaleStandard Deviation 37.683
GSK2586184 100 mgItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,231.55 Scores on a ScaleStandard Deviation 29.156
GSK2586184 100 mgItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,233.42 Scores on a ScaleStandard Deviation 25.939
GSK2586184 100 mgItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,241.64 Scores on a ScaleStandard Deviation 21.995
GSK2586184 100 mgItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,239.50 Scores on a ScaleStandard Deviation 33.58
GSK2586184 200 mgItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,230.08 Scores on a ScaleStandard Deviation 34.697
GSK2586184 200 mgItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,229.93 Scores on a ScaleStandard Deviation 29.437
GSK2586184 200 mgItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,232.57 Scores on a ScaleStandard Deviation 30.729
GSK2586184 200 mgItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,242.07 Scores on a ScaleStandard Deviation 31.176
GSK2586184 400 mgItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,222.92 Scores on a ScaleStandard Deviation 21.707
GSK2586184 400 mgItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,214.00 Scores on a ScaleStandard Deviation 23.701
GSK2586184 400 mgItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,223.85 Scores on a ScaleStandard Deviation 23.14
GSK2586184 400 mgItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,214.45 Scores on a ScaleStandard Deviation 21.92
GSK2586184 400 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,26.67 Scores on a ScaleStandard Deviation 7.763
GSK2586184 400 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,25.40 Scores on a ScaleStandard Deviation 6.693
GSK2586184 400 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,220.67 Scores on a ScaleStandard Deviation 30.051
GSK2586184 400 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,211.83 Scores on a ScaleStandard Deviation 14.73
GSK2586184 200 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 4,n=10,12,14,13,6,234.00 Scores on a ScaleStandard Deviation 41.012
GSK2586184 200 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 8,n=9,11,14,11,6,231.50 Scores on a ScaleStandard Deviation 44.548
GSK2586184 200 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 12,n=9,10,13,9,5,239.00 Scores on a ScaleStandard Deviation 55.154
GSK2586184 200 mg OLItch VAS Scores at Week 2, 4, 8 and 12Week 2,n=12,14,15,12,6,242.00 Scores on a ScaleStandard Deviation 22.627
Secondary

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A 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 or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.

Time frame: From Baseline (Day 1) until the Follow-up visit (Day 112)

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE13 Participants
PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE0 Participants
GSK2586184 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE10 Participants
GSK2586184 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE2 Participants
GSK2586184 200 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE14 Participants
GSK2586184 200 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE0 Participants
GSK2586184 400 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE10 Participants
GSK2586184 400 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE1 Participants
GSK2586184 400 mg OLNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE6 Participants
GSK2586184 400 mg OLNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE1 Participants
GSK2586184 200 mg OLNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any AE1 Participants
GSK2586184 200 mg OLNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)Any SAE0 Participants
Secondary

Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study

Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR low was any HR less than 40 beats per minute (bpm) and high was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.

Time frame: From Baseline (Day 1) until the Follow-up visit (Day 112)

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureValue (NUMBER)
PlaceboNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study0 Participants
GSK2586184 100 mgNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study0 Participants
GSK2586184 200 mgNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study0 Participants
GSK2586184 400 mgNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study0 Participants
GSK2586184 400 mg OLNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study0 Participants
GSK2586184 200 mg OLNumber of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study1 Participants
Secondary

Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study

Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (\> high or \< low) at any time post-BL, including unscheduled or scheduled assessments, are presented.

Time frame: From Baseline (Day 1) until the Follow-up visit (Day 112)

Population: ITT population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,25 Participants
PlaceboNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,21 Participants
PlaceboNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,20 Participants
PlaceboNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,20 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,20 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,20 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,22 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,20 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,23 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,20 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,20 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,24 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,20 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,20 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,21 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,22 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,20 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,20 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,20 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,21 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, high, n=13,15,16,14,6,20 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, low, n=13,15,16,14,6,21 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCystatin C, high, n=13,15,16,14,6,20 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the StudyCreatinine, low, n=13,15,16,14,6,20 Participants
Secondary

Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study

Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.

Time frame: From BL (Day 1) until the Follow-up visit (Day 112)

Population: ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low3 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high2 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low6 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low2 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low3 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high5 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high3 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high1 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low0 Participants
PlaceboNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low2 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low5 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high2 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high2 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high4 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low5 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high2 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low2 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low7 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high2 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high3 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high3 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyESR, high1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low2 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high4 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low2 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low3 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high4 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low4 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high2 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low2 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high3 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high1 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low5 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high3 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low3 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low3 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low4 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low5 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high1 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyESR, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high0 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high1 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyESR, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high3 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high1 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low3 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high3 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low2 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low2 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high2 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high2 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high3 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high2 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, low1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, low1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, high1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, low1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHb, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyErythrocytes, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLymphocytes, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHemoglobin, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyReticulocytes, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyESR, high1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyHematocrit, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, low1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCV, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEMCHbC, low2 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyLeukocytes, low1 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyNeutrophils, Segmented, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyMonocytes, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyEosinophils, low0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During StudyPlatelets, high0 Participants
Secondary

Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings

ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds \[msec\]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.

Time frame: From Baseline (Day 1) until the Follow-up visit (Day 112)

Population: ITT Population.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec13 Participants
PlaceboNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec0 Participants
PlaceboNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec13 Participants
PlaceboNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec0 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec15 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec1 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec14 Participants
GSK2586184 100 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec16 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec0 Participants
GSK2586184 200 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec16 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec12 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec2 Participants
GSK2586184 400 mgNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec12 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec6 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec0 Participants
GSK2586184 400 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec6 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, >=30 to <60 msec0 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, <30 msec2 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcB, <30 msec2 Participants
GSK2586184 200 mg OLNumber of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) FindingsQTcF, >=30 to <60 msec0 Participants
Secondary

Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study

Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP low was measured as less than 85 millimeters of mercury (mmHg)and high was measured as greater than 160 mmHg. DBP low was measured as less than 45 mmHg and high was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.

Time frame: From Baseline (Day 1) until the follow-up visit (Day 112)

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (NUMBER)
PlaceboNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
PlaceboNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high1 Participants
PlaceboNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high3 Participants
GSK2586184 100 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
GSK2586184 100 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high0 Participants
GSK2586184 100 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high0 Participants
GSK2586184 200 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
GSK2586184 200 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high0 Participants
GSK2586184 200 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high0 Participants
GSK2586184 400 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
GSK2586184 400 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high1 Participants
GSK2586184 400 mgNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high2 Participants
GSK2586184 400 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
GSK2586184 400 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high1 Participants
GSK2586184 400 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high1 Participants
GSK2586184 200 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudySBP, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, high0 Participants
GSK2586184 200 mg OLNumber of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the StudyDBP, low0 Participants
Secondary

PASI Score at Week 2, 4, 8 and 12

Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.

Time frame: Week 2, 4, 8 and 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboPASI Score at Week 2, 4, 8 and 12Week 216.33 Scores on a ScaleStandard Deviation 4.896
PlaceboPASI Score at Week 2, 4, 8 and 12Week 415.12 Scores on a ScaleStandard Deviation 4.683
PlaceboPASI Score at Week 2, 4, 8 and 12Week 814.64 Scores on a ScaleStandard Deviation 4.289
PlaceboPASI Score at Week 2, 4, 8 and 12Week 1212.92 Scores on a ScaleStandard Deviation 3.384
GSK2586184 100 mgPASI Score at Week 2, 4, 8 and 12Week 812.56 Scores on a ScaleStandard Deviation 5.442
GSK2586184 100 mgPASI Score at Week 2, 4, 8 and 12Week 413.94 Scores on a ScaleStandard Deviation 6.616
GSK2586184 100 mgPASI Score at Week 2, 4, 8 and 12Week 216.56 Scores on a ScaleStandard Deviation 5.708
GSK2586184 100 mgPASI Score at Week 2, 4, 8 and 12Week 1210.52 Scores on a ScaleStandard Deviation 4.932
GSK2586184 200 mgPASI Score at Week 2, 4, 8 and 12Week 129.67 Scores on a ScaleStandard Deviation 7.799
GSK2586184 200 mgPASI Score at Week 2, 4, 8 and 12Week 811.03 Scores on a ScaleStandard Deviation 8.322
GSK2586184 200 mgPASI Score at Week 2, 4, 8 and 12Week 412.59 Scores on a ScaleStandard Deviation 5.524
GSK2586184 200 mgPASI Score at Week 2, 4, 8 and 12Week 218.92 Scores on a ScaleStandard Deviation 9.969
GSK2586184 400 mgPASI Score at Week 2, 4, 8 and 12Week 213.39 Scores on a ScaleStandard Deviation 5.594
GSK2586184 400 mgPASI Score at Week 2, 4, 8 and 12Week 124.03 Scores on a ScaleStandard Deviation 4.666
GSK2586184 400 mgPASI Score at Week 2, 4, 8 and 12Week 49.58 Scores on a ScaleStandard Deviation 7.91
GSK2586184 400 mgPASI Score at Week 2, 4, 8 and 12Week 87.30 Scores on a ScaleStandard Deviation 9.11
GSK2586184 400 mg OLPASI Score at Week 2, 4, 8 and 12Week 811.15 Scores on a ScaleStandard Deviation 9.573
GSK2586184 400 mg OLPASI Score at Week 2, 4, 8 and 12Week 129.63 Scores on a ScaleStandard Deviation 10.688
GSK2586184 400 mg OLPASI Score at Week 2, 4, 8 and 12Week 49.90 Scores on a ScaleStandard Deviation 6.271
GSK2586184 400 mg OLPASI Score at Week 2, 4, 8 and 12Week 213.75 Scores on a ScaleStandard Deviation 4.807
GSK2586184 200 mg OLPASI Score at Week 2, 4, 8 and 12Week 46.75 Scores on a ScaleStandard Deviation 1.485
GSK2586184 200 mg OLPASI Score at Week 2, 4, 8 and 12Week 83.45 Scores on a ScaleStandard Deviation 2.899
GSK2586184 200 mg OLPASI Score at Week 2, 4, 8 and 12Week 122.50 Scores on a ScaleStandard Deviation 3.536
GSK2586184 200 mg OLPASI Score at Week 2, 4, 8 and 12Week 211.20 Scores on a ScaleStandard Deviation 0.283
Secondary

Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12

The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.

Time frame: Weeks 2, 4, 8 and 12

Population: ITT Population. Only those participants available at the specified time points were analyzed.

ArmMeasureGroupValue (NUMBER)
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe10 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,44 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate23 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate50 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate50 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate22 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate46 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate25 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate30 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe31 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild10 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe33 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe0 Percentage of Participants
PlaceboPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe25 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe14 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate29 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate36 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild14 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear10 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe9 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe10 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe9 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate30 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,36 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate27 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate14 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate50 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild9 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate64 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear9 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe14 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild0 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe7 Percentage of Participants
GSK2586184 100 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,33 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe21 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear6 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate19 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate44 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe13 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe19 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate29 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate43 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe14 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild20 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate20 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe13 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear7 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear21 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild0 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate29 Percentage of Participants
GSK2586184 200 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate21 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear30 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear20 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate36 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild23 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear31 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe10 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate54 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe7 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate8 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild23 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild20 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate43 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate23 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,8 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe14 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe8 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe15 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear0 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate20 Percentage of Participants
GSK2586184 400 mgPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe8 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate33 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate33 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate50 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild50 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe33 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild33 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate17 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate33 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe0 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate17 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate to severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate100 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, moderate0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, moderate to severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate to severe50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, moderate50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, Clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, almost clear50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild to moderate0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, mild0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, mild to moderate50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate,0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, almost clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, moderate to severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, Clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 8, severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Clear50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, Severe0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, mild to moderate50 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, almost clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 12, almost clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, Clear0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 4, mild to moderate0 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12Week 2, severe0 Percentage of Participants
Secondary

Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12

Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.

Time frame: From Baseline (Day 1) until Week 12

Population: ITT Population.

ArmMeasureGroupValue (NUMBER)
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 120 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 120 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 80 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 120 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 80 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 40 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 40 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 80 Percentage of Participants
PlaceboPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 20 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 47 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 87 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 1213 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 87 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 413 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 27 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 820 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 120 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 1227 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 26 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 425 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 46 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 1231 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 1225 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 1225 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 86 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 825 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 831 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 1264 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 1236 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 1257 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 457 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 871 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 814 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 27 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 421 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 850 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 817 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 217 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 40 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 1250 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 1250 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 850 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 450 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 1217 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 80 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 1250 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 20 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 4100 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 8100 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 50, Week 12100 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 40 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 850 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 75, Week 1250 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12PASI 90, Week 80 Percentage of Participants
Secondary

Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12

The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.

Time frame: Weeks 2, 4, 8 and 12

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
PlaceboPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 20 Percentage of Participants
PlaceboPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 40 Percentage of Participants
PlaceboPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 80 Percentage of Participants
PlaceboPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 120 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 87 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 40 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 20 Percentage of Participants
GSK2586184 100 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 127 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 1225 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 86 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 46 Percentage of Participants
GSK2586184 200 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 26 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 20 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 1243 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 40 Percentage of Participants
GSK2586184 400 mgPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 829 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 80 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 1217 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 40 Percentage of Participants
GSK2586184 400 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 20 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 40 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 850 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 1250 Percentage of Participants
GSK2586184 200 mg OLPercentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12Week 20 Percentage of Participants
Secondary

Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184

Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.

Time frame: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)

Population: PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
GSK2586184 100 mgPopulation Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK25861841464.07903 Nanogram/milliLitre*hour (ng/mL*hr)Geometric Coefficient of Variation 43.9
GSK2586184 200 mgPopulation Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK25861843516.96224 Nanogram/milliLitre*hour (ng/mL*hr)Geometric Coefficient of Variation 38.7
GSK2586184 400 mgPopulation Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK25861847768.40786 Nanogram/milliLitre*hour (ng/mL*hr)Geometric Coefficient of Variation 62.4
GSK2586184 400 mg OLPopulation Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK25861847561.87974 Nanogram/milliLitre*hour (ng/mL*hr)Geometric Coefficient of Variation 79.1
GSK2586184 200 mg OLPopulation Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK25861843208.20452 Nanogram/milliLitre*hour (ng/mL*hr)Geometric Coefficient of Variation 53.5
Secondary

Steady State Volume of Distribution (Vss) of GSK2586184

Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.

Time frame: Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)

Population: PK Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
GSK2586184 100 mgSteady State Volume of Distribution (Vss) of GSK2586184244.10260 LGeometric Coefficient of Variation 62.3
GSK2586184 200 mgSteady State Volume of Distribution (Vss) of GSK2586184193.75344 LGeometric Coefficient of Variation 47.1
GSK2586184 400 mgSteady State Volume of Distribution (Vss) of GSK2586184186.78323 LGeometric Coefficient of Variation 64.4
GSK2586184 400 mg OLSteady State Volume of Distribution (Vss) of GSK2586184199.73746 LGeometric Coefficient of Variation 85.4
GSK2586184 200 mg OLSteady State Volume of Distribution (Vss) of GSK2586184216.00359 LGeometric Coefficient of Variation 66.5
Secondary

Time to PASI 75

PASI 75 was \>= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.

Time frame: From Baseline (Day 1) until Week 12

Population: ITT Population. Only participants achieving PASI 75 were analyzed.

ArmMeasureValue (MEDIAN)
GSK2586184 100 mgTime to PASI 7559 Days
GSK2586184 200 mgTime to PASI 7555.5 Days
GSK2586184 400 mgTime to PASI 7557 Days
GSK2586184 400 mg OLTime to PASI 7584 Days
GSK2586184 200 mg OLTime to PASI 7557 Days
Secondary

Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)

The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.

Time frame: From Baseline (Day 1) until Week 12

Population: ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed.

ArmMeasureValue (MEDIAN)
GSK2586184 100 mgTime to PGA Score of 'Clear' (0) or 'Almost Clear' (1)55 Days
GSK2586184 200 mgTime to PGA Score of 'Clear' (0) or 'Almost Clear' (1)84.5 Days
GSK2586184 400 mgTime to PGA Score of 'Clear' (0) or 'Almost Clear' (1)57 Days
GSK2586184 400 mg OLTime to PGA Score of 'Clear' (0) or 'Almost Clear' (1)84 Days
GSK2586184 200 mg OLTime to PGA Score of 'Clear' (0) or 'Almost Clear' (1)57 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026