- Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ] [ Designated as safety issue: No ]
PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.
- Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ] [ Designated as safety issue: No ]
PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.
- Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ] [ Designated as safety issue: No ]
PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
- Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
- Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ] [ Designated as safety issue: No ]
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
- Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 2 ] [ Designated as safety issue: No ]
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 4 ] [ Designated as safety issue: No ]
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
- Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 12 ] [ Designated as safety issue: No ]
DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
- Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ] [ Designated as safety issue: No ]
Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
- Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
Purpose
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