Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline in Weekly Average WI-NRS at Week 8 |
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Baseline, Week 8 |
|
| Primary |
Percent Change From Baseline in Weekly Average WI-NRS at Week 8 |
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Baseline, Week 8 |
|
| Secondary |
Change From Baseline in Weekly Average WI-NRS Over Time |
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Baseline, Weeks 1-18 |
|
| Secondary |
Percent Change From Baseline in Weekly Average WI-NRS Over Time |
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Baseline, Weeks 1-18 |
|
| Secondary |
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time |
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
Baseline, Weeks 1-8, 10, 12, 14, 16, 18 |
|
| Secondary |
Percent Change From Baseline in Pruritus VAS Over Time |
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. |
Baseline, Weeks 1-8, 10, 12, 14, 16, 18 |
|
| Secondary |
Change From Baseline in 5-D Pruritus Total Score Over Time |
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 |
|
| Secondary |
Percent Change From Baseline in 5-D Pruritus Total Score Over Time |
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus). |
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 |
|
| Secondary |
Percentage of Participants Achieving =4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time |
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement. |
Baseline, Weeks 1-18 |
|
| Secondary |
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only |
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort. |
Baseline, Weeks 1-18 |
|
| Secondary |
Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only |
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort |
Baseline, Weeks 1-18 |
|
| Secondary |
Change From Baseline in Sleep Loss VAS Over Time |
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. |
Baseline, Weeks 1-8, 10, 12, 14, 16, 18 |
|
| Secondary |
Percent Change From Baseline in Sleep Loss VAS Over Time |
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit. |
Baseline, Weeks 1-8, 10, 12, 14, 16, 18 |
|
| Secondary |
Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time |
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. |
Baseline, Weeks 1-18 |
|
| Secondary |
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time |
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult. |
Baseline, Weeks 1-18 |
|
| Secondary |
Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. |
Baseline, Weeks 1-18 |
|
| Secondary |
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time |
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep. |
Baseline, Weeks 1-18 |
|
| Secondary |
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time |
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. |
Baseline, Weeks 4, 8, 12, 16, 18 |
|
| Secondary |
Percent Change From Baseline in DLQI Total Score Over Time |
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect. |
Baseline, Weeks 4, 8, 12, 16, 18 |
|
| Secondary |
Change From Baseline in ItchyQoL Total Score Over Time |
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
Baseline, Weeks 4, 8, 12, 16, 18 |
|
| Secondary |
Percent Change From Baseline in ItchyQoL Total Score Over Time |
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
Baseline, Weeks 4, 8, 12, 16, 18 |
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