A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT06088043
- Lead Sponsor
- Takeda
- 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.
- Detailed Description
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):
1. TAK-279
2. Placebo
3. Apremilast
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 693
- Plaque psoriasis for at least 6 months.
- Moderate to severe disease.
- Candidate for phototherapy or systemic therapy.
- Other forms of psoriasis.
- History of recent infection.
- Prior exposure to TAK-279 or active comparator.
Other protocol defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAK-279 TAK-279 - Placebo Placebo - Apremilast Apremilast -
- Primary Outcome Measures
Name Time Method 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 Baseline, Week 16 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.
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 Baseline, Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90 Response) at Week 16 Comparing TAK-279 Against Placebo Baseline, Week 16 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.
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo Week 16 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.
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo Week 16 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.
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 Baseline and Week 16 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.
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 Week 16 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).
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 Week 16 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.
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants with Nail Involvement at Baseline Comparing TAK-279 Against Placebo Baseline and Week 16 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.
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo Baseline and Week 16 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.
Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo Baseline and Week 16 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.
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 Baseline and Week 16 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.
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo Baseline and Week 16 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.
Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo Baseline and Week 16 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.
Change from Baseline in the EuroQoL 5-Dimension 5-level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo Baseline and Week 16 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.
Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo Week 16 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.
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 Baseline and Week 16 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.
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast Week 16 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.
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast Week 16 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.
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 Baseline and Week 24 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.
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast Week 24 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.
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast Week 24 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.
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast Baseline and Week 16 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.
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 Week 16 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.
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast Week 16 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.
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast Week 24 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.
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast Week 16 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.
Percentage of Participants with a Baseline DLQI Score >=2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast Week 16 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).
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 Week 16 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.
Change from Baseline in NAPSI, Among Participants with Nail Involvement at Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
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 Baseline and Week 24 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.
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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).
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast Week 24 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.
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 Week 24 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).
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 Week 24 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.
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
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 Baseline, Weeks 16 and 24 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.
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast Baseline, Weeks 16 and 24 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.
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 Baseline, Weeks 24, 40 and 52 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.
Percentage of Participants Achieving PASI-75 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Weeks 24, 40 and 52 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.
Percentage of Participants Achieving PASI-90 at Weeks 24, 40, and 52 Comparing TAK-279 Against Apremilast Weeks 24, 40 and 52 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.
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) Up to Week 56 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.
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
Trial Locations
- Locations (132)
Saguaro Dermatology Associates, LLC - Probity - PPDS
🇺🇸Phoenix, Arizona, United States
First OC Dermatology - Fountain Valley
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research
🇺🇸Fremont, California, United States
UCLA University of California Los Angeles
🇺🇸Los Angeles, California, United States
UC Davis Dermatology Clinic
🇺🇸Sacramento, California, United States
Driven Research LLC
🇺🇸Coral Gables, Florida, United States
FXM Clinical Research Ft. Lauderdale, LLC
🇺🇸Fort Lauderdale, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
FXM Clinical Research Miami, LLC
🇺🇸Miami, Florida, United States
Renstar Medical Research -21 NE 1st Ave
🇺🇸Ocala, Florida, United States
Marietta Dermatology & The Skin Cancer Center - Marietta
🇺🇸Marietta, Georgia, United States
Leavitt Clinical Research - 1542 Elk Creek Dr
🇺🇸Idaho Falls, Idaho, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
🇺🇸Indianapolis, Indiana, United States
Kindred Hair & Skin Center - CAR
🇺🇸Columbia, Maryland, United States
Revival Research Corporation - Michigan - ClinEdge - PPDS
🇺🇸Troy, Michigan, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
ALLCUTIS Research, LLC.
🇺🇸Portsmouth, New Hampshire, United States
Northwell Health Physician Partners Dermatology at Lake Success - BRANY - PPDS
🇺🇸New York, New York, United States
Accellacare of Cary
🇺🇸Cary, North Carolina, United States
Bexley Dermatology Research - Probity - PPDS
🇺🇸Bexley, Ohio, United States
Clinical Research Center of the Carolinas, LLC
🇺🇸Charleston, South Carolina, United States
International Clinical Research-Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Progressive Clinical Research PA - San Antonio
🇺🇸San Antonio, Texas, United States
St George Dermatology and Skin Cancer Center - Probity - PPDS
🇦🇺Kogarah, New South Wales, Australia
The Skin Center - Probity - PPDS
🇦🇺Benowa, Queensland, Australia
Veracity Clinical Research Pty Ltd
🇦🇺Brisbane, Queensland, Australia
Skin Health Institute Inc - Probity - PPDS
🇦🇺Carlton, Victoria, Australia
Sinclair Dermatology-East Melbourne
🇦🇺East Melbourne, Victoria, Australia
Alfred Health
🇦🇺Parkville, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Beacon Dermatology - Probity - PPDS
🇨🇦Calgary, Alberta, Canada
Enverus Medical Research - Probity - PPDS
🇨🇦Surrey, British Columbia, Canada
CCA Medical Research - Probity - PPDS
🇨🇦Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre - Probity - PPDS
🇨🇦Barrie, Ontario, Canada
Kingsway Clinical Research - Probity - PPDS
🇨🇦Etobicoke, Ontario, Canada
Guelph Dermatology Research - Probity - PPDS
🇨🇦Guelph, Ontario, Canada
Mediprobe Research Inc
🇨🇦London, Ontario, Canada
North Bay Dermatology Center - Probity - PPDS
🇨🇦North Bay, Ontario, Canada
North York Research Inc. - Probity - PPDS
🇨🇦North York, Ontario, Canada
Research Toronto - Probity - PPDS
🇨🇦Toronto, Ontario, Canada
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University - PPDS
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shaanxi, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
🇨🇳Wenzhou, Zhejiang, China
Hautarztpraxis Mahlow
🇩🇪Blankenfelde-Mahlow, Brandenburg, Germany
Klinikum Oldenburg AöR
🇩🇪Oldenburg (Oldenburg), Niedersachsen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lübeck, Schleswig-Holstein, Germany
ASL 1 L'Aquila - Presidio Ospedaliero San Salvatore
🇮🇹L'aquila, Abruzzo, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Via Pansini 5
🇮🇹Napoli, Campania, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
🇮🇹Genova, Liguria, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico -Via Pace 9
🇮🇹Milano, Lombardia, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Lombardia, Italy
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Lombardia, Italy
Presidio Ospedaliero Gaspare Rodolico
🇮🇹Catania, Sicilia, Italy
Azienda Usl Toscana Centro - Firenze
🇮🇹Firenze, Toscana, Italy
Nagoya City University Hospital
🇯🇵Nagoya-Shi, Aiti, Japan
Takagi Dermatological Clinic
🇯🇵Obihiro-Shi, Hokkaidô, Japan
JR Sapporo Hospital
🇯🇵Sapporo-Shi, Hokkaidô, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
🇯🇵Sapporo-Shi, Hokkaidô, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-Shi, Hukuoka, Japan
Saruwatari Dermatology Clinic
🇯🇵Kagoshima-Shi, Kagosima, Japan
Tokai University Hospital
🇯🇵Isehara-Shi, Kanagawa, Japan
Teikyo University Hospital
🇯🇵Itabashi-Ku, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
JCHO Tokyo Yamate Medical Center
🇯🇵Shinjuku-Ku, Tokyo, Japan
Tokyo Teishin Hospital
🇯🇵Sumida-Ku, Tokyo, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke-Shi, Totigi, Japan
Ohyama Dermatology Clinic
🇯🇵Kumamoto, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai-Shi, Ôsaka, Japan
Pusan National University Hospital
🇰🇷Seo-Gu, Busan Gwangyeogsi, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Daejeon Gwang'yeogsi, Korea, Republic of
Georgia Skin and Cancer Clinic
🇰🇷Savannah, Georgia, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon-si, Gyeonggido, Korea, Republic of
CHA Bundang Medical Center, CHA University - PPDS
🇰🇷Bundang-Gu Seongnam-Si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Bundang-Gu, Gyeonggido, Korea, Republic of
Konkuk University Medical Center
🇰🇷Gwangjin-Gu, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seocho-Gu, Seoul Teugbyeolsi, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
🇵🇱Wroclaw, Dolnoslaskie, Poland
Clinical Best Solutions - Lublin
🇵🇱Lublin, Lubelskie, Poland
Dermoklinika-Centrum Medyczne s.c
🇵🇱Lódz, Lódzkie, Poland
Rheumatology Clinic NZOZ Lecznica MAK-MED
🇵🇱Nadarzyn, Mazowieckie, Poland
Klinika Reuma Park sp . zoo Sp.k.
🇵🇱Warsaw, Mazowieckie, Poland
Klinika Ambroziak - Kosiarzy 9A
🇵🇱Warsaw, Mazowieckie, Poland
Clinical Best Solutions - Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDS
🇵🇱Warszawa, Mazowieckie, Poland
High-Med Przychodnia Specjalistyczna
🇵🇱Warszawa, Mazowieckie, Poland
ClinicMed Daniluk, Nowak Spólka Komandytowa
🇵🇱Bialystok, Podlaskie, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
🇵🇱Gdansk, Pomorskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdańsk, Pomorskie, Poland
Derm-art
🇵🇱Gdynia, Pomorskie, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
🇵🇱Katowice, Slaskie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
🇵🇱Poznań, Wielkopolskie, Poland
Twoja Przychodnia SCM - Slowackiego
🇵🇱Szczecin, Zachodniopomorskie, Poland
Centrum Medyczne Bydgoszcz- PRATIA - PPDS
🇵🇱Bydgoszcz, Poland
Centrum Medyczne PROMED
🇵🇱Krakow, Poland
Uniwersytecki Szpital Kliniczny im. WAM - Centralny Szpital Weteranow-Lodz-ul. Plac J. Hallera 1
🇵🇱Lodz, Poland
National Taiwan University Hospital - Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Mackay Memorial Hospital-Taipei branch
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan City, Taiwan
National Taiwan University Hospital
🇨🇳Zhong Zheng Qu, Taiwan