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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg GSK2586184 | Experimental | Subjects will be randomized to 100 mg GSK2586184 twice daily for up to 84 days |
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| 200 mg GSK2586184 | Experimental | Subjects will be randomized to 200 mg GSK2586184 twice daily for up to 84 days |
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| 400 mg GSK2586184 | Experimental | Subjects will be randomized to 400 mg GSK2586184 twice daily for up to 84 days |
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| Placebo | Placebo Comparator | Subjects will be randomized to receive Placebo twice daily for up to 84 days |
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| 400 mg GSK2586184 (Cohort B) | Experimental | Subjects will take 400 mg GSK2586184 twice daily for up to 84 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg GSK2586184 | Drug | 100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70178 | Germany | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116679 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks. |
| FG001 | GSK2586184 100 mg | Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 200 mg GSK2586184 | Drug | 200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
|
| 400 mg GSK2586184 | Drug | 400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
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| Placebo | Drug | Placebo tablets to be taken twice daily with food for up to 84 days. |
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| From Baseline (Day 1) until the Follow-up visit (Day 112) |
| 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. | From BL (Day 1) until the Follow-up visit (Day 112) |
| 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. | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| 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. | From Baseline (Day 1) until the follow-up visit (Day 112) |
| 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. | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| 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. | From Baseline (Day 1) until Week 16 |
| 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. | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| 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. | From Baseline (Day 1) until Week 12 |
| 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. | Week 2, 4, 8 and 12 |
| 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. | From Baseline (Day 1) until Week 12 |
| 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. | Weeks 2, 4, 8 and 12 |
| 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. | Weeks 2, 4, 8 and 12 |
| 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. | From Baseline (Day 1) until Week 12 |
| 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. | From Baseline (Day 1) until Week 12 |
| 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. | From Baseline (Day 1) until Week 12 |
| 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. | Week 2, 4, 8 and 12 |
| 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. | Baseline and Week 12 |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | Baseline (pre-dose) and Weeks 2, 4, 8 and 12 |
| Augsburg |
| Bavaria |
| 86179 |
| Germany |
| GSK Investigational Site | Osnabrück | Lower Saxony | 49074 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48159 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58453 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10827 | Germany |
| GSK Investigational Site | Berlin | 13507 | Germany |
| GSK Investigational Site | Hamburg | 20354 | Germany |
| GSK Investigational Site | Cardiff | CF14 4XN | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| GSK Investigational Site | London | SE1 7EH | United Kingdom |
| GSK Investigational Site | Salford | M6 8HD | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116679 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| FG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| FG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| FG005 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks. |
| BG001 | GSK2586184 100 mg | Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| BG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| BG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| BG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| 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. | Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | Baseline and Week 12 |
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| 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. | Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations. | Posted | Number | Percentage of participants | Baseline and Week 12 |
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| 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. | ITT Population | Posted | Number | Participants | From Baseline (Day 1) until the Follow-up visit (Day 112) |
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| 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. | 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. | Posted | Number | Participants | From BL (Day 1) until the Follow-up visit (Day 112) |
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| 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. | ITT population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | From Baseline (Day 1) until the follow-up visit (Day 112) |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Celsius | From Baseline (Day 1) until Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. | Posted | Count of Participants | Participants | From Baseline (Day 1) until the Follow-up visit (Day 112) |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a Scale | From Baseline (Day 1) until Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a Scale | Week 2, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. | Posted | Number | Percentage of Participants | From Baseline (Day 1) until Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population | Posted | Number | Percentage of Participants | Weeks 2, 4, 8 and 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Percentage of Participants | Weeks 2, 4, 8 and 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only participants achieving PASI 75 were analyzed. | Posted | Median | Full Range | Days | From Baseline (Day 1) until Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed. | Posted | Median | Full Range | Days | From Baseline (Day 1) until Week 12 |
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| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a Scale | From Baseline (Day 1) until Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| 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. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a Scale | Week 2, 4, 8 and 12 |
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| 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. | ITT Population. Only those participants who had a Week 12 evaluation were analyzed. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 12 |
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| 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. | PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliLitre*hour (ng/mL*hr) | 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) |
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| 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. | PK Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (L)/hr | 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) |
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| 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. | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 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) |
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| 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. | ITT Population | Posted | Mean | Standard Deviation | Nanomol per Liter (nmol/L) | Baseline (pre-dose) and Weeks 2, 4, 8 and 12 |
|
Non-serious Adverse Events (AEs) were collected from the start of study treatment up to and including the Follow-up visit (up to Study Week 16), Serious AEs were recorded from the time of consent to treatment up to and including the Follow-up visit.
SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received blinded matching placebo orally as tablets, with food, twice daily (BID), for up to 12 weeks. | 0 | 14 | 0 | 14 | 13 | 14 |
| EG001 | GSK2586184 100 mg | Participants received blinded 100 milligrams (mg) GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. | 0 | 15 | 2 | 15 | 10 | 15 |
| EG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. | 0 | 14 | 1 | 14 | 10 | 14 |
| EG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG005 | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Acne pustular | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Enterobiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Tooth abscess | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604226 | GSK2586184 |
Not provided
Not provided
Not provided
| Male |
|
| Asian - South East Asian Heritage |
|
| White - White/Caucasian/European Heritage |
|
| OG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 |
| GSK2586184 400 mg |
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 |
| GSK2586184 400 mg |
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG002 |
| GSK2586184 200 mg |
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG002 |
| GSK2586184 200 mg |
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| GSK2586184 200 mg |
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| GSK2586184 200 mg |
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG002 | GSK2586184 200 mg | Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 200 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG003 | GSK2586184 400 mg | Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
Participants received blinded 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks.
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
|
|
| OG004 | GSK2586184 400 mg OL | Participants received Open-Label 400 mg GSK2586184 orally as tablets, with food, BID, for up to 12 weeks. |
| OG005 | 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. |
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