Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Phase 2a & 2b: Percent change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
at Week 8 (Phase 2a); at Week 16 (Phase 2b) |
|
| Secondary |
*Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
at Week 8 |
|
| Secondary |
Phase 2a: Percent change from baseline in pruritus visual analog scale (VAS) |
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
at Week 8 |
|
| Secondary |
Phase 2a: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in pruritis visual analog scale (VAS) over time |
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in pruritis visual analog scale (VAS) over time |
At every visit, subjects rate intensity of their average pruritus over previous 3 days on 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in 5-D Pruritus total score over time |
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in 5-D Pruritus total score over time |
Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. 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) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in Sleep Loss VAS over time |
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in Sleep Loss VAS over time |
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in weekly average of difficulty falling asleep NRS over time |
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in weekly average of difficulty falling asleep NRS over time |
Subjects rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in weekly average of sleep quality NRS over time |
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in weekly average of sleep quality NRS over time |
Subjects rate daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time |
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Percent change from baseline in quality of life (QoL) measures (DLQI and Itchy QoL) over time |
QoL is assessed at designated visits and includes the Dermatology QoL Index (DLQI) whereby 0=no effect on quality of life; 30= extremely large effect on QoL; and Itchy QoL, administered as designated visits, which contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Change from baseline in Prurigo Nodularis Nodule Assessment Tool (PN-NAT) over time |
PN-NAT, assessed at designated visits, is a novel exploratory tool for the evaluation of disease severity based on estimate of the number of nodules over the whole body, estimate of hardness of nodules over the whole body, estimate of extent of excoriation over the whole body, distribution of nodules, exact number of nodules in the representative area. |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2a: Proportion of subjects with improvement in Prurigo Nodularis Investigator Global Assessment (PN-IGA) by 2 categories over time |
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease) |
to end of treatment, assessed up to 24 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
at Week 16 |
|
| Secondary |
Phase 2b: Proportion of subjects achieving 0 or 1 from baseline in PN-IGA |
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease) |
at Week 16 |
|
| Secondary |
Phase 2b: Change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Percent change from baseline in weekly average of WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS (Worst Itch [pruritis] - Numerical Rating Scale; 0=no pruritis, 10=worst imaginable pruritis) over time |
Subjects rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving 0 or 1 in PN-IGA over time |
PN-IGA is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in PN-IGA over time |
PN-IGA, assessed at designated visits, is a novel exploratory tool for the overall investigator assessment of PN disease severity based on the size of the nodules as defined by their elevation. The IGA utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe disease) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects achieving 0 or 1 in Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA-CNPG-S) over time |
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state. |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Proportion of subjects with at least 2-point improvement from baseline in IGA-CNPG-S over time |
IGA-CNPG-S, administered at designated visits, is a novel tool for the investigator assessment of PN disease severity based on the number of palpable nodules and utilizes a 5-point scale that ranges from 0 (clear) to 4 (severe). A score is assigned based on the appearance of the disease at the time of the evaluation without referring to the baseline state. |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Change from baseline in weekly average of Sleep Loss VAS over time |
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Percent change from baseline in weekly average of Sleep Loss VAS over time |
At every visit, subjects rate intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Change from baseline in ItchyQoL over time |
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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) |
to end of treatment, assessed up to 52 weeks |
|
| Secondary |
Phase 2b: Percent change from baseline in ItchyQoL over time |
Itchy QoL, administered as designated visits, contains 22 items focused on the impact of pruritus on daily activities and on the level of psychological stress. 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) |
to end of treatment, assessed up to 52 weeks |
|
