Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03677401 | Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis | PHASE3 | COMPLETED | 295 | — | — | Aug 29, 2018 | Feb 6, 2020 | May 20, 2021 | 40 | Austria, Germany +1 |
| NCT03546816 | Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis | PHASE3 | COMPLETED | 285 | — | — | May 2, 2018 | Feb 14, 2020 | May 20, 2021 | 49 | United States |
| NCT03841331 | Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin | PHASE2 | COMPLETED | 233 | — | — | Jan 22, 2019 | Jan 21, 2020 | May 20, 2021 | 41 | United States |
| NCT03343639 | Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Plaque Psoriasis | PHASE2 | COMPLETED | 204 | — | — | Nov 1, 2017 | Nov 12, 2018 | May 20, 2021 | 39 | United States |
| NCT02975206 | Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis | PHASE2 | COMPLETED | 484 | — | — | Nov 1, 2016 | Feb 23, 2018 | May 20, 2021 | 52 | United States |
During the study, WI-NRS assessments were reported by the participant via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity. A subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), higher scores indicated greater itch intensity.
The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 8.
Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.
| Arm | Type | Description |
|---|---|---|
| 5 mg Serlopitant Tablets | EXPERIMENTAL | - |
| Matching Placebo Tablets | PLACEBO_COMPARATOR | - |
| 5 mg Placebo Tablets | PLACEBO_COMPARATOR | Placebo Tablets |
| Serlopitant High Dose | EXPERIMENTAL | serlopitant tablets - high dose |
| Serlopitant Low Dose | EXPERIMENTAL | serlopitant tablets - low dose |
| Placebo Oral Tablet | PLACEBO_COMPARATOR | matching placebo tablets |
| Name | Type | Description |
|---|---|---|
| 5mg Serlopitant Tablets | DRUG | Serlopitant Tablets |
| Placebo Tablets | DRUG | Placebo Tablets |
| 5 mg Serlopitant Tablets | DRUG | Serlopitant Tablets |
| Matching Placebo Tablets | DRUG | Placebo Tablets |
| Serlopitant High Dose | DRUG | serlopitant tablets - high dose |
| Placebo Oral Tablet | DRUG | placebo tablet |
| Serlopitant Low Dose | DRUG | serlopitant tablets - low dose |
Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study: 1. Male or female, age 18 years or older at consent. 2. Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas. 3. Idiopathic PN, or an identified pruritic conditio...