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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06088043
Registration number
NCT06088043
Ethics application status
Date submitted
12/10/2023
Date registered
18/10/2023
Titles & IDs
Public title
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
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Scientific title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis
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Secondary ID [1]
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2023-505841-22
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Secondary ID [2]
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TAK-279-3001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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0
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-279
Treatment: Drugs - Placebo
Treatment: Drugs - Apremilast
Experimental: TAK-279 -
Placebo comparator: Placebo -
Active comparator: Apremilast -
Treatment: Drugs: TAK-279
Specified drug on specified days.
Treatment: Drugs: Placebo
Specified drug on specified days.
Treatment: Drugs: Apremilast
Specified drug on specified days.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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0
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.
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Timepoint [1]
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Baseline, Week 16
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Primary outcome [2]
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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
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
Baseline, Week 16
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Secondary outcome [1]
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Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [1]
0
0
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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Timepoint [1]
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0
Baseline, Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [2]
0
0
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.
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Timepoint [2]
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0
Week 16
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Secondary outcome [3]
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Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [3]
0
0
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.
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Timepoint [3]
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0
Week 16
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 16
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Secondary outcome [5]
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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
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Assessment method [5]
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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).
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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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
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Assessment method [6]
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0
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.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants with Nail Involvement at Baseline Comparing TAK-279 Against Placebo
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and Week 16
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Secondary outcome [8]
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Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Week 16
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Secondary outcome [9]
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Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline and Week 16
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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0
Baseline and Week 16
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Secondary outcome [11]
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Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [11]
0
0
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.
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Timepoint [11]
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Baseline and Week 16
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Secondary outcome [12]
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Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [12]
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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.
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Timepoint [12]
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0
Baseline and Week 16
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Secondary outcome [13]
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Change from Baseline in the EuroQoL 5-Dimension 5-level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [13]
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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.
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Timepoint [13]
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0
Baseline and Week 16
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Secondary outcome [14]
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Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo
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Assessment method [14]
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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.
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Timepoint [14]
0
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Week 16
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Secondary outcome [15]
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0
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
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Assessment method [15]
0
0
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.
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Timepoint [15]
0
0
Baseline and Week 16
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Secondary outcome [16]
0
0
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [16]
0
0
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.
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Timepoint [16]
0
0
Week 16
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Secondary outcome [17]
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0
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [17]
0
0
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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Timepoint [17]
0
0
Week 16
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Secondary outcome [18]
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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
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Assessment method [18]
0
0
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.
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Timepoint [18]
0
0
Baseline and Week 24
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Secondary outcome [19]
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0
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast
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Assessment method [19]
0
0
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.
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Timepoint [19]
0
0
Week 24
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Secondary outcome [20]
0
0
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast
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Assessment method [20]
0
0
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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Timepoint [20]
0
0
Week 24
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Secondary outcome [21]
0
0
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [21]
0
0
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.
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Timepoint [21]
0
0
Baseline and Week 16
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Secondary outcome [22]
0
0
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
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Assessment method [22]
0
0
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.
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Timepoint [22]
0
0
Week 16
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Secondary outcome [23]
0
0
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [23]
0
0
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.
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Timepoint [23]
0
0
Week 16
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Secondary outcome [24]
0
0
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast
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Assessment method [24]
0
0
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.
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Timepoint [24]
0
0
Week 24
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Secondary outcome [25]
0
0
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [25]
0
0
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.
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Timepoint [25]
0
0
Week 16
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Secondary outcome [26]
0
0
Percentage of Participants with a Baseline DLQI Score >=2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast
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Assessment method [26]
0
0
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).
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Timepoint [26]
0
0
Week 16
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Secondary outcome [27]
0
0
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
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Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
Week 16
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Secondary outcome [28]
0
0
Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
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Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [29]
0
0
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
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Baseline and Week 24
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Secondary outcome [30]
0
0
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [30]
0
0
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).
Query!
Timepoint [30]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [31]
0
0
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [31]
0
0
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.
Query!
Timepoint [31]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [32]
0
0
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [32]
0
0
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.
Query!
Timepoint [32]
0
0
Baseline, Weeks 16 and 24
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Secondary outcome [33]
0
0
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [33]
0
0
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.
Query!
Timepoint [33]
0
0
Week 24
Query!
Secondary outcome [34]
0
0
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
Query!
Assessment method [34]
0
0
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).
Query!
Timepoint [34]
0
0
Week 24
Query!
Secondary outcome [35]
0
0
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
Query!
Assessment method [35]
0
0
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.
Query!
Timepoint [35]
0
0
Week 24
Query!
Secondary outcome [36]
0
0
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Baseline, Weeks 16 and 24
Query!
Secondary outcome [37]
0
0
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
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Baseline, Weeks 16 and 24
Query!
Secondary outcome [38]
0
0
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Baseline, Weeks 16 and 24
Query!
Secondary outcome [39]
0
0
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [39]
0
0
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.
Query!
Timepoint [39]
0
0
Baseline, Weeks 16 and 24
Query!
Secondary outcome [40]
0
0
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Query!
Assessment method [40]
0
0
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.
Query!
Timepoint [40]
0
0
Baseline, Weeks 16 and 24
Query!
Secondary outcome [41]
0
0
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
Query!
Assessment method [41]
0
0
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.
Query!
Timepoint [41]
0
0
Baseline, Weeks 24, 40 and 52
Query!
Secondary outcome [42]
0
0
Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast
Query!
Assessment method [42]
0
0
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.
Query!
Timepoint [42]
0
0
Weeks 24, 40 and 52
Query!
Secondary outcome [43]
0
0
Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast
Query!
Assessment method [43]
0
0
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.
Query!
Timepoint [43]
0
0
Weeks 24, 40 and 52
Query!
Secondary outcome [44]
0
0
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
Query!
Assessment method [44]
0
0
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.
Query!
Timepoint [44]
0
0
Up to Week 56
Query!
Secondary outcome [45]
0
0
Number of Participants with Clinically Significant Vital Signs
Query!
Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
Up to Week 56
Query!
Secondary outcome [46]
0
0
Number of Participants with Clinically Significant Laboratory Values
Query!
Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Up to Week 56
Query!
Secondary outcome [47]
0
0
Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings
Query!
Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Up to Week 56
Query!
Eligibility
Key inclusion criteria
1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
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Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.
Other protocol defined inclusion/exclusion criteria apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
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Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
6/11/2023
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
15/04/2026
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Actual
Query!
Sample size
Target
600
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Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
St George Dermatology and Skin Cancer Center - Probity - PPDS - Kogarah
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Recruitment hospital [2]
0
0
The Skin Center - Probity - PPDS - Benowa
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Recruitment hospital [3]
0
0
Skin Health Institute Inc - Probity - PPDS - Carlton
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Recruitment hospital [4]
0
0
Sinclair Dermatology-East Melbourne - East Melbourne
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Recruitment hospital [5]
0
0
Alfred Health - Parkville
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Recruitment hospital [6]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
0
0
2217 - Kogarah
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Recruitment postcode(s) [2]
0
0
4217 - Benowa
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Recruitment postcode(s) [3]
0
0
3053 - Carlton
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Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
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Recruitment postcode(s) [5]
0
0
3004 - Parkville
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Recruitment postcode(s) [6]
0
0
3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Idaho
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Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Nevada
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New Hampshire
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
North Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Ohio
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Tennessee
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Texas
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Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
British Columbia
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Country [20]
0
0
Canada
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State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Beijing
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Country [22]
0
0
China
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State/province [22]
0
0
Chongqing
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Country [23]
0
0
China
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State/province [23]
0
0
Fujian
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Country [24]
0
0
China
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State/province [24]
0
0
Guangdong
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Hebei
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Hubei
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Liaoning
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Ningxia
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Shaanxi
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Country [30]
0
0
China
Query!
State/province [30]
0
0
Shandong
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Zhejiang
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Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Brandenburg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Niedersachsen
Query!
Country [35]
0
0
Germany
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State/province [35]
0
0
Nordrhein-Westfalen
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Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Schleswig-Holstein
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Abruzzo
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Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Campania
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Liguria
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Lombardia
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Sicilia
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Toscana
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Hokkaidô
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Hukuoka
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Kagosima
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Kanagawa
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Tokyo
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Totigi
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Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Kumamoto
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Country [50]
0
0
Japan
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State/province [50]
0
0
Ôsaka
Query!
Country [51]
0
0
Korea, Republic of
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State/province [51]
0
0
Busan Gwangyeogsi
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Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Daejeon Gwang'yeogsi
Query!
Country [53]
0
0
Korea, Republic of
Query!
State/province [53]
0
0
Georgia
Query!
Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Gwangju Gwang'yeogsi
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Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Gyeonggido
Query!
Country [56]
0
0
Korea, Republic of
Query!
State/province [56]
0
0
Seoul Teugbyeolsi
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Country [57]
0
0
Korea, Republic of
Query!
State/province [57]
0
0
Seoul
Query!
Country [58]
0
0
Korea, Republic of
Query!
State/province [58]
0
0
Wonju
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Dolnoslaskie
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lubelskie
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Lódzkie
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Mazowieckie
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Podlaskie
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Pomorskie
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Slaskie
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Wielkopolskie
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Zachodniopomorskie
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bydgoszcz
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Krakow
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Lodz
Query!
Country [71]
0
0
Taiwan
Query!
State/province [71]
0
0
Hsinchu
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Kaohsiung City
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
New Taipei City
Query!
Country [74]
0
0
Taiwan
Query!
State/province [74]
0
0
Tainan
Query!
Country [75]
0
0
Taiwan
Query!
State/province [75]
0
0
Taipei City
Query!
Country [76]
0
0
Taiwan
Query!
State/province [76]
0
0
Zhong Zheng Qu
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
Query!
Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06088043
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
Takeda
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Takeda Contact
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1-877-825-3327
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06088043