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Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain adequate disease control. This is a multicenter, randomized, double-blind study conducted in participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy, safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772 administered as a once daily modified release (MR) formulation. Participants will be randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The duration of the study, including Screening and follow-up, will be approximately 21 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving GSK2982772 960 mg | Experimental | Participants will receive GSK2982772 960 mg oral tablets once daily for 12 weeks. |
|
| Participants receiving placebo | Placebo Comparator | Participants will receive GSK2982772 matching placebo oral tablets once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2982772 | Drug | GSK2982772 will be available as MR tablet at a unit dose strength of 480 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of Participants Who Achieved Greater Than or Equal (>=) to 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The Psoriasis area severity index (PASI) is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% credible interval (CrI) was reported as a method of dispersion. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved >=50% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. |
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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 | Edmonton | Alberta | T5K 1X3 | Canada | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 39 participants were screened, of which 29 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2982772 960 mg | Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks. |
| FG001 | Placebo | Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2982772 960 mg | Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks. |
| BG001 | Placebo | Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage (%) of Participants Who Achieved Greater Than or Equal (>=) to 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The Psoriasis area severity index (PASI) is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% credible interval (CrI) was reported as a method of dispersion. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120.
All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2982772 960 mg | Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2021 | Aug 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2021 | Aug 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000708951 | GSK2982772 |
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Participants will randomized in ratio of 2:1 to receive either 960 mg GSK2982772 or placebo
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This is a double-blind study where sponsor will be unblinded
| Placebo | Drug | GSK2982772 matching placebo tablets will be administered via the oral route. |
|
| Baseline and Week 12 |
| Percentage of Participants Who Achieved >=90% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. | Baseline and Week 12 |
| Percentage of Participants Who Achieved >=100% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. | Baseline and Week 12 |
| Change From Baseline in Psoriasis Area Severity Index (PASI) Scores at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. | Baseline and Week 12 |
| Percentage of Participants Who Have a Static Investigator's Global Assessment (sIGA) Score of 0 or 1 at Week 12 | Either investigator or his designee completed a global assessment of disease activity using the physician global assessment item. A 5-point scoring system was used to measure the severity of psoriatic lesions over the entire body at the time of evaluation. The 5-point scoring system ranging from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. Percentage of participants who have a sIGA score of 0=clear or 1=almost clear at Week 12 was summarized. Note: The 95% CrI was reported as a method of dispersion. | At Week 12 |
| Change From Baseline in Psoriatic Body Surface Area (BSA) at Week 12 | The BSA affected with psoriasis was evaluated at all study visits by the Investigator or suitably trained delegate. As a reference, the area of the whole palm was counted as 1% BSA. Change from Baseline was calculated as Post-Baseline visit values minus Baseline value. | Baseline and Week 12 |
| Number of Participants With Any Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | Up to Day 120 |
| Number of Participants With Drug Related AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The investigator was obligated to assess the relationship between study intervention and each occurrence of each AE. | Up to Day 120 |
| Number of Participants With Common (Occurring at Least 5%) Non Serious AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Non serious AEs are AEs that are not Serious Adverse Events (SAEs). All AEs occurring at least 5% in either arm were reported. Note: As both arms had small sample sizes, single occurrences of an AE met the 5% threshold for reporting. | Up to Day 120 |
| Number of Participants With AEs Leading to Permanent Discontinuation of Study Intervention | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. All AEs which led to discontinuation of the study drug were reported. | Up to Day 120 |
| Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs | An SAE is defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement. All SAEs, SAEs related to the study drug, and fatal SAEs were reported. | Up to Day 120 |
| Edmonton |
| Alberta |
| T6G 1C3 |
| Canada |
| GSK Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | London | Ontario | N6H 5L5 | Canada |
| GSK Investigational Site | Oakville | Ontario | L6J 7W5 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| GSK Investigational Site | Québec | Quebec | G1N 4V3 | Canada |
| GSK Investigational Site | Lodz | 90-265 | Poland |
| Withdrawal by Subject |
|
| SUBJECT REACHED PROTOCOL-DEFINED STOPPING CRITERIA |
|
| INVESTIGATOR DISCRETION |
|
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Percentage of Participants Who Achieved >=50% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
|
|
|
| Secondary | Percentage of Participants Who Achieved >=90% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
|
|
|
| Secondary | Percentage of Participants Who Achieved >=100% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Psoriasis Area Severity Index (PASI) Scores at Week 12 | The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and Week 12 |
|
|
|
| Secondary | Percentage of Participants Who Have a Static Investigator's Global Assessment (sIGA) Score of 0 or 1 at Week 12 | Either investigator or his designee completed a global assessment of disease activity using the physician global assessment item. A 5-point scoring system was used to measure the severity of psoriatic lesions over the entire body at the time of evaluation. The 5-point scoring system ranging from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. Percentage of participants who have a sIGA score of 0=clear or 1=almost clear at Week 12 was summarized. Note: The 95% CrI was reported as a method of dispersion. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 12 |
|
|
|
| Secondary | Change From Baseline in Psoriatic Body Surface Area (BSA) at Week 12 | The BSA affected with psoriasis was evaluated at all study visits by the Investigator or suitably trained delegate. As a reference, the area of the whole palm was counted as 1% BSA. Change from Baseline was calculated as Post-Baseline visit values minus Baseline value. | The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention. | Posted | Mean | Standard Deviation | Percentage of Body Surface Area | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Any Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With Drug Related AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The investigator was obligated to assess the relationship between study intervention and each occurrence of each AE. | The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With Common (Occurring at Least 5%) Non Serious AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Non serious AEs are AEs that are not Serious Adverse Events (SAEs). All AEs occurring at least 5% in either arm were reported. Note: As both arms had small sample sizes, single occurrences of an AE met the 5% threshold for reporting. | The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With AEs Leading to Permanent Discontinuation of Study Intervention | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. All AEs which led to discontinuation of the study drug were reported. | The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs | An SAE is defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement. All SAEs, SAEs related to the study drug, and fatal SAEs were reported. | The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 11 |
| 19 |
| EG001 | Placebo | Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks. | 0 | 10 | 0 | 10 | 6 | 10 |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatinine abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Creatinine renal clearance abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Hepatitis E antibody positive | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | 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.
| Dry eye |
|
| Diarrhea |
|
| Allergy to arthropod sting |
|
| Herpes zoster |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood creatinine abnormal |
|
| Creatinine renal clearance abnormal |
|
| Hepatitis E antibody positive |
|
| Neutrophil count decreased |
|
| White blood cell count decreased |
|
| Back pain |
|
| Headache |
|
| Suicidal ideation |
|
| Nasal congestion |
|
| Intertrigo |
|
| Pruritus |
|
| Psoriasis |
|
| Rash |
|
| Hypertension |
|
| Fatal SAE |
|