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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031230583 | Registry Identifier | jRCT | |
| 2023-505841-22-00 | EU Trial (CTIS) Number |
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The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 61 weeks.
The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.
The study will enroll approximately 600 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive TAK-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
This multi-center trial will be conducted worldwide. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 52 weeks (1 year). There will be a safety follow-up visit 4 weeks after their last day of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-279 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Apremilast | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-279 | Drug | Specified drug on specified days. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. | Baseline, Week 16 |
| Percentage of Participants Achieving >=75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI-75 Response) at Week 16 Comparing TAK-279 Against Placebo | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saguaro Dermatology Associates, LLC - Probity - PPDS | Phoenix | Arizona | 85008-3884 | United States | ||
| First OC Dermatology - Fountain Valley |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Drug |
Specified drug on specified days. |
|
| Apremilast | Drug | Specified drug on specified days. |
|
| Baseline, Week 16 |
| Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. Higher scores indicate worsening. 'Clear' will include all participants who score a 0. | Week 16 |
| Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported. | Week 16 |
| Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening. | Baseline and Week 16 |
| Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score >=2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). | Week 16 |
| Percentage of Participants with a Baseline Psoriasis Symptoms and Signs Diary (PSSD) >=1 who Achieve Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo | The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease. | Week 16 |
| Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants with Nail Involvement at Baseline Comparing TAK-279 Against Placebo | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis. | Baseline and Week 16 |
| Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo | Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. | Baseline and Week 16 |
| Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo | Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. | Baseline and Week 16 |
| Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo | PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1. | Baseline and Week 16 |
| Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). It will be evaluated for participants with a baseline DLQI score >=2. | Baseline and Week 16 |
| Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo | The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the physical component summary (PCS) and mental component summary (MCS), will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. | Baseline and Week 16 |
| Change from Baseline in the EuroQoL 5-Dimension 5-level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo | EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health. | Baseline and Week 16 |
| Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo | The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. | Week 16 |
| Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. Higher scores indicate worsening. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. | Baseline and Week 16 |
| Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported. | Week 16 |
| Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported. | Week 16 |
| Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. | Baseline and Week 24 |
| Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported. | Week 24 |
| Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported. | Week 24 |
| Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast | The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease. | Baseline and Week 16 |
| Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening. | Week 16 |
| Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported. | Week 16 |
| Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported. | Week 24 |
| Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0. | Week 16 |
| Percentage of Participants with a Baseline DLQI Score >=2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). | Week 16 |
| Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast | The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease. | Week 16 |
| Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis. | Baseline, Weeks 16 and 24 |
| Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening. | Baseline and Week 24 |
| Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). | Baseline, Weeks 16 and 24 |
| Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. | Baseline, Weeks 16 and 24 |
| Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement. | Baseline, Weeks 16 and 24 |
| Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0. | Week 24 |
| Percentage of Participants with a Baseline DLQI Score >=2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast | The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). | Week 24 |
| Percentage of Participants with a Baseline PSSD >=1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast | The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease. | Week 24 |
| Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening. | Baseline, Weeks 16 and 24 |
| Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) with a >=2-Point Decrease From Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1. | Baseline, Weeks 16 and 24 |
| Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the PCS and MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL. | Baseline, Weeks 16 and 24 |
| Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health. | Baseline, Weeks 16 and 24 |
| Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast | The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. | Baseline, Weeks 16 and 24 |
| Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) with a >=2-Point Decrease from Baseline at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast | The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1. | Baseline, Weeks 24, 40 and 52 |
| Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported. | Weeks 24, 40 and 52 |
| Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast | PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported. | Weeks 24, 40 and 52 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) | TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI (serious or nonserious) is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate. | Up to Week 56 |
| Number of Participants with Clinically Significant Vital Signs | Up to Week 56 |
| Number of Participants with Clinically Significant Laboratory Values | Up to Week 56 |
| Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings | Up to Week 56 |
| Fountain Valley |
| California |
| 92708-3701 |
| United States |
| Center for Dermatology Clinical Research | Fremont | California | 94538-1614 | United States |
| UCLA University of California Los Angeles | Los Angeles | California | 90024 | United States |
| UC Davis Dermatology Clinic | Sacramento | California | 95816-3370 | United States |
| Driven Research LLC | Coral Gables | Florida | 33134-3901 | United States |
| FXM Clinical Research Ft. Lauderdale, LLC | Fort Lauderdale | Florida | 33308-5211 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012-3618 | United States |
| FXM Clinical Research Miami, LLC | Miami | Florida | 33175-3582 | United States |
| Renstar Medical Research -21 NE 1st Ave | Ocala | Florida | 34470-6657 | United States |
| Marietta Dermatology & The Skin Cancer Center - Marietta | Marietta | Georgia | 30060-7902 | United States |
| Leavitt Clinical Research - 1542 Elk Creek Dr | Idaho Falls | Idaho | 83404-8322 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008-3811 | United States |
| Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave | Indianapolis | Indiana | 46256-4697 | United States |
| Kindred Hair & Skin Center - CAR | Columbia | Maryland | 21046-1246 | United States |
| Revival Research Corporation - Michigan - ClinEdge - PPDS | Troy | Michigan | 48084-3536 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088-3671 | United States |
| Henderson Clinical Trials | Henderson | Nevada | 89052-5016 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766-1937 | United States |
| ALLCUTIS Research, LLC. | Portsmouth | New Hampshire | 03801-6822 | United States |
| Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS | New York | New York | 10003-3314 | United States |
| Accellacare of Cary | Cary | North Carolina | 27518-7414 | United States |
| Bexley Dermatology Research - Probity - PPDS | Bexley | Ohio | 43209 | United States |
| Clinical Research Center of the Carolinas, LLC | Charleston | South Carolina | 29407-5347 | United States |
| International Clinical Research-Tennessee LLC | Murfreesboro | Tennessee | 37130-2450 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401-3505 | United States |
| Progressive Clinical Research PA - San Antonio | San Antonio | Texas | 78213-2250 | United States |
| St George Dermatology and Skin Cancer Center - Probity - PPDS | Kogarah | New South Wales | 2217 | Australia |
| The Skin Center - Probity - PPDS | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research Pty Ltd | Brisbane | Queensland | 4102 | Australia |
| Skin Health Institute Inc - Probity - PPDS | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology-East Melbourne | East Melbourne | Victoria | 3002 | Australia |
| Alfred Health | Parkville | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Beacon Dermatology - Probity - PPDS | Calgary | Alberta | T3A 2N1 | Canada |
| Enverus Medical Research - Probity - PPDS | Surrey | British Columbia | V3R 6A7 | Canada |
| CCA Medical Research - Probity - PPDS | Ajax | Ontario | L1S 7K8 | Canada |
| SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS | Barrie | Ontario | L4M 7G1 | Canada |
| Kingsway Clinical Research - Probity - PPDS | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Guelph Dermatology Research - Probity - PPDS | Guelph | Ontario | N1H 1B1 | Canada |
| Mediprobe Research Inc | London | Ontario | N5X 2P1 | Canada |
| North Bay Dermatology Center - Probity - PPDS | North Bay | Ontario | P1B 3Z7 | Canada |
| North York Research Inc. - Probity - PPDS | North York | Ontario | M2M 4J5 | Canada |
| Research Toronto - Probity - PPDS | Toronto | Ontario | M4W 2N4 | Canada |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Friendship Hospital, Capital Medical University - PPDS | Beijing | Beijing Municipality | 100050 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | 510091 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | 518053 | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050031 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200020 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310000 | China |
| The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus | Wenzhou | Zhejiang | 325000 | China |
| Hautarztpraxis Mahlow | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Klinikum Oldenburg AöR | Oldenburg | Lower Saxony | 26133 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck | Schleswig-Holstein | 23562 | Germany |
| ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore | L’Aquila | Abruzzo | 67100 | Italy |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5 | Naples | Campania | 80131 | Italy |
| IRCCS Az. Osp. Universitaria San Martino- IST | Genoa | Liguria | 16132 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9 | Milan | Lombardy | 20122 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| IRCCS Policlinico San Donato | San Donato Milanese | Lombardy | 20097 | Italy |
| Presidio Ospedaliero Gaspare Rodolico | Catania | Sicily | 95123 | Italy |
| Azienda Usl Toscana Centro - Firenze | Florence | Tuscany | 50125 | Italy |
| Nagoya City University Hospital | Nagoya | Aiti | 467-0802 | Japan |
| Takagi Dermatological Clinic | Obihiro-Shi | Hokkaidô | 080-0013 | Japan |
| JR Sapporo Hospital | Sapporo | Hokkaidô | 060-0033 | Japan |
| Medical Corporation Kojinkai Sapporo Skin Clinic | Sapporo | Hokkaidô | 060-0063 | Japan |
| Fukuoka University Hospital | Fukuoka | Hukuoka | 814-0180 | Japan |
| Saruwatari Dermatology Clinic | Kagoshima | Kagoshima-ken | 892-0826 | Japan |
| Tokai University Hospital | Isehara-Shi | Kanagawa | 259-1143 | Japan |
| Jichi Medical University Hospital | Shimotsuke-Shi | Tochigi | 329-0431 | Japan |
| Teikyo University Hospital | Itabashi-Ku | Tokyo | 173-0003 | Japan |
| Tokyo Medical University Hospital | Shinjuku-Ku | Tokyo | 160-0023 | Japan |
| JCHO Tokyo Yamate Medical Center | Shinjuku-Ku | Tokyo | 169-0073 | Japan |
| Tokyo Teishin Hospital | Sumida-Ku | Tokyo | Japan |
| Ohyama Dermatology Clinic | Kumamoto | 861-4101 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakaishi | Ôsaka | 593-8324 | Japan |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan | Greater Poland Voivodeship | 60-702 | Poland |
| Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Clinical Best Solutions - Lublin | Lublin | Lublin Voivodeship | 20-078 | Poland |
| Dermoklinika-Centrum Medyczne s.c | Lódz | Lódzkie | 90-436 | Poland |
| Rheumatology Clinic NZOZ Lecznica MAK-MED | Nadarzyn | Masovian Voivodeship | 05-830 | Poland |
| Clinical Best Solutions - Warszawa | Warsaw | Masovian Voivodeship | 00-710 | Poland |
| MICS Centrum Medyczne Warszawa - MICS - PPDS | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| High-Med Przychodnia Specjalistyczna | Warsaw | Masovian Voivodeship | 01-817 | Poland |
| Klinika Reuma Park sp . zoo Sp.k. | Warsaw | Masovian Voivodeship | 02-665 | Poland |
| Klinika Ambroziak - Kosiarzy 9A | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| ClinicMed Daniluk, Nowak Spólka Komandytowa | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | Pomeranian Voivodeship | 80-382 | Poland |
| Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50 | Gdansk | Pomeranian Voivodeship | 80-462 | Poland |
| Derm-art | Gdynia | Pomeranian Voivodeship | 81-415 | Poland |
| Centrum Medyczne Katowice - PRATIA - PPDS | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Twoja Przychodnia SCM - Slowackiego | Szczecin | West Pomeranian Voivodeship | 71-500 | Poland |
| Centrum Medyczne Bydgoszcz- PRATIA - PPDS | Bydgoszcz | 85-796 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-411 | Poland |
| Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1 | Lodz | 90-647 | Poland |
| Pusan National University Hospital | Seogu | Busan Gwangyeogsi | 49241 | South Korea |
| Chungnam National University Hospital | Daejeon | Daejeon Gwang'yeogsi | 35015 | South Korea |
| Georgia Skin and Cancer Clinic | Savannah | Georgia | 31419-1768 | South Korea |
| Chosun University Hospital | Gwangju | Gwangju Gwang'yeogsi | 61453 | South Korea |
| The Catholic University of Korea, Bucheon St. Mary's Hospital | Bucheon-si | Gyeonggido | 14647 | South Korea |
| CHA Bundang Medical Center, CHA University - PPDS | Bundang-Gu Seongnam-Si | Gyeonggido | 13496 | South Korea |
| Seoul National University Bundang Hospital | Bundang-Gu | Gyeonggido | 13620 | South Korea |
| Konkuk University Medical Center | Gwangjin-Gu | Seoul Teugbyeolsi | 05030 | South Korea |
| Seoul National University Hospital | Jongno-Gu | Seoul Teugbyeolsi | 03080 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seocho-Gu | Seoul Teugbyeolsi | 06591 | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | Seoul Teugbyeolsi | 04401 | South Korea |
| Ewha Womans University Seoul Hospital | Seoul | Seoul Teugbyeolsi | 07804 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| National Taiwan University Hospital - Hsin-Chu Branch | Hsinchu | 300 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| Mackay Memorial Hospital-Taipei branch | Taipei | 104 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan City | 33305 | Taiwan |
| National Taiwan University Hospital | Zhong Zheng Qu | 100 | Taiwan |
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided