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 69 weeks.
The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis. The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need): * TAK-279 * Apremilast * Placebo This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. 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 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,108
Specified drug on specified days.
Specified drug on specified days.
Specified drug on specified days.
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: Baseline, Week 16
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Baseline, Week 16
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Baseline, Week 16
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Dermatology
Birmingham, Alabama, United States
Cahaba Dermatology Skin Health Center
Hoover, Alabama, United States
Medical Dermatology Specialists
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Johnson Dermatology Clinic
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Zenith Research, Inc.
Beverly Hills, California, United States
UNISON Clinical Trials (Shahram Jacobs md inc.)
Encino, California, United States
First OC Dermatology Research Inc.
Fountain Valley, California, United States
Long Beach Research Institute, LLC
Long Beach, California, United States
...and 207 more locations
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.
Time frame: Week 16
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 16
Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Placebo
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Time frame: Baseline, Week 16
Percentage of Participants Achieving PASI-75 at Week 4 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 4
Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Week 16
Percentage of Participants With a Baseline Psoriasis Symptoms and Signs Diary (PSSD) ≥1 who Achieve Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Time frame: Week 16
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants With Nail Involvement at Baseline Comparing TAK-279 Against Placebo
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis.
Time frame: Baseline, Week 16
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.
Time frame: Week 16
Percentage Change from Baseline in BSA Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.
Time frame: Week 16
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo
PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1.
Time frame: Baseline, Week 16
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life). It will be evaluated for participants with a baseline DLQI score ≥2.
Time frame: Baseline, Week 16
Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo
The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the physical component summary (PCS) and mental component summary (MCS), will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.
Time frame: Baseline, Week 16
Change from Baseline in the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo
EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.
Time frame: Baseline, Week 16
Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Time frame: Week 16
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. Higher scores indicate worsening. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: Baseline to Week 16
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 16
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 16
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: Baseline to Week 24
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 24
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 24
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Time frame: Baseline to Week 16
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Time frame: Baseline to Week 16
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 16
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.
Time frame: Week 16
Percentage of Participants with a Baseline DLQI Score ≥2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Week 16
Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Time frame: Week 16
Change from Baseline in NAPSI Among Participants With Nail Involvement at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis.
Time frame: Baseline, Weeks 16 and 24
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Time frame: Baseline to Week 24
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Baseline, Weeks 16 and 24
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.
Time frame: Baseline, Weeks 16 and 24
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.
Time frame: Baseline, Weeks 16 and 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' will include all participants who score a 0.
Time frame: Week 24
Percentage of Participants With a Baseline DLQI Score ≥2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Time frame: Week 24
Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Time frame: Week 24
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Time frame: Baseline, Weeks 16 and 24
Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease From Baseline at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and/or feet (palmoplantar), where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1.
Time frame: Baseline, Weeks 16 and 24
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the PCS and MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.
Time frame: Baseline, Weeks 16 and 24
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.
Time frame: Baseline, Weeks 16 and 24
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Time frame: Baseline, Weeks 16 and 24
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: Baseline, Weeks 24 and 40
Percentage of Participants Achieving PASI-75 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Weeks 24 and 40
Percentage of Participants Achieving PASI-90 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 90% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Weeks 24 and 40
Time to Relapse for PASI-75 Responders at Week 40 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Up to Week 60
Percentage of Participants With Maintenance of PASI-75 Response at Week 60 Comparing TAK-279 Against Placebo
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
Time frame: Week 60
Percentage of Participants with Maintenance of sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 60 Comparing TAK-279 Against Placebo
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Time frame: Baseline to Week 60
Percentage of Participants With a Disease Relapse Comparing TAK-279 Against Placebo
Relapse is defined as a percent change from baseline in PASI score that is at least 50% worse than that observed at Week 40. 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. Higher scores indicate worsening.
Time frame: Week 40
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI (serious or nonserious) is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Time frame: Up to week 69
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Up to week 69
Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to week 69
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Up to week 69