Prurigo Nodularis, Pruritus
Conditions
Brief summary
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis
Interventions
Serlopitant Tablets
DRUGPlacebo Tablets
Placebo Tablets
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 condition associated with the PN with persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition. 4. The worst pruritus is identified as within the areas of the PN lesions, with a Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study. 5. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug. 6. Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study. 7. Willing and able to comply with study visits and study related requirements including providing written informed consent.
Exclusion criteria
(Subjects who meet any of the following criteria are not eligible for participation in the study): 1. Prior treatment with serlopitant. 2. Active pruritic skin disease, other than PN, within 6 months (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks). 3. Treatment with any of the following therapies within 4 weeks. 1. Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant). 2. Systemic or topical immunosuppressive/immunomodulatory therapies. 3. Systemic therapies with recognized anti-pruritic properties. 4. Strong cytochrome-P 3A4 inhibitors. 5. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn. 4. Treatment with topical anti-pruritic therapies within 2 weeks. 5. Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer. 6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer. 7. Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal during screening. 8. Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy. 9. Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies). 10. Relevant major psychiatric diagnosis in the past 3 years, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder. 11. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks. 12. Any medical condition or disability that could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject. 13. History of hypersensitivity to serlopitant or any of its components. 14. Currently pregnant or breastfeeding or planning to become pregnant during the study. 15. Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments during participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | At Week 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With WI-NRS 4-point Responder at Week 2 | At Week 2 | During the study, 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. |
| Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | At Weeks 2, 4, 6, and 10 | During the study, 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. |
| Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | During the study, 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. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week. |
| Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. |
| Percent of Subjects With WI-NRS 4-point Responder at Week 4 | At Week 4 | During the study, 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | At Week 10 | Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. |
| Change From Baseline in DLQI Question 1 to Week 10 | At Week 10 | DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL. |
| Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | 35 days (+3 days) after Week 10 or Early Treatment Discontinuation | Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected. |
| Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | At Weeks 2, 4, and 10 | The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 49 sites in United States from 02 May 2018 to 14 February 2020. All subjects who met the study entry criteria were randomized in a 1:1 ratio to receive once-daily oral doses of serlopitant 5 mg or placebo for 10 weeks.
Pre-assignment details
During the screening period (2-4 weeks), all subjects were evaluated for eligibility and assessed for conditions associated with chronic pruritus. Subjects were to complete an electronic diary (eDiary) during screening visit.
Participants by arm
| Arm | Count |
|---|---|
| Serlopitant 5 mg Randomized subjects received serlopitant 5 mg as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. | 142 |
| Placebo Randomized subjects received placebo as an initial loading dose (3 tablets orally) on Day 1, the first day of the treatment period. Thereafter, starting on Day 2, subjects were instructed to take 1 tablet orally per day. | 143 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 |
| Overall Study | Lack of Efficacy | 2 | 4 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 10 |
Baseline characteristics
| Characteristic | Placebo | Total | Serlopitant 5 mg |
|---|---|---|---|
| Age, Continuous | 56.0 Years STANDARD_DEVIATION 12.99 | 57.4 Years STANDARD_DEVIATION 13.3 | 58.7 Years STANDARD_DEVIATION 13.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 60 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 91 Participants | 193 Participants | 102 Participants |
| Sex: Female, Male Female | 89 Participants | 181 Participants | 92 Participants |
| Sex: Female, Male Male | 52 Participants | 99 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 141 |
| other Total, other adverse events | 18 / 141 | 5 / 139 |
| serious Total, serious adverse events | 6 / 139 | 3 / 141 |
Outcome results
Primary
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10
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.
Time frame: At Week 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serlopitant 5 mg | Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | 26.45 Percentage of subjects |
| Placebo | Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10 | 20.31 Percentage of subjects |
p-value: 0.229Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
Time frame: At Week 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serlopitant 5 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | -4.1 Score on a scale | Standard Deviation 5.2 |
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | -4.3 Score on a scale | Standard Deviation 5.21 |
Comparison: At Week 10p-value: 0.814ANCOVA
Secondary
Change From Baseline in DLQI Question 1 to Week 10
DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
Time frame: At Week 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serlopitant 5 mg | Change From Baseline in DLQI Question 1 to Week 10 | -0.8 Score on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in DLQI Question 1 to Week 10 | -0.6 Score on a scale | Standard Deviation 0.81 |
Comparison: At Week 10p-value: 0.113ANCOVA
Secondary
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10
The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Time frame: At Weeks 2, 4, and 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 2 | -0.2 Score on a scale | Standard Deviation 0.52 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 4 | -0.4 Score on a scale | Standard Deviation 0.71 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 10 | -0.5 Score on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 2 | -0.1 Score on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 4 | -0.3 Score on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline to Week 10 | -0.4 Score on a scale | Standard Deviation 0.86 |
Comparison: At Week 2p-value: 0.175ANCOVA
Comparison: At Week 4p-value: 0.169ANCOVA
Comparison: At Week 10p-value: 0.516ANCOVA
Secondary
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
The IGA PN-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Time frame: At Weeks 2, 4, and 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 2 | -0.3 Score on a scale | Standard Deviation 0.71 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 4 | -0.6 Score on a scale | Standard Deviation 0.81 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 10 | -0.7 Score on a scale | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 2 | -0.3 Score on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 4 | -0.4 Score on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10 | Change from Baseline at Week 10 | -0.6 Score on a scale | Standard Deviation 0.99 |
Comparison: At Week 2p-value: 0.475ANCOVA
Comparison: At Week 4p-value: 0.02ANCOVA
Comparison: At Week 10p-value: 0.492ANCOVA
Secondary
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
During the study, 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.
Time frame: At Weeks 2, 4, 6, and 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 2 | -1.30 Score on a scale | Standard Deviation 1.725 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 4 | -1.82 Score on a scale | Standard Deviation 2.226 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 6 | -2.13 Score on a scale | Standard Deviation 2.436 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 10 | -2.47 Score on a scale | Standard Deviation 2.633 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 10 | -2.06 Score on a scale | Standard Deviation 2.612 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 2 | -0.96 Score on a scale | Standard Deviation 1.74 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 6 | -1.65 Score on a scale | Standard Deviation 2.46 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 4 | -1.32 Score on a scale | Standard Deviation 2.248 |
Comparison: At Week 2p-value: 0.083ANCOVA
Comparison: At Week 4p-value: 0.049ANCOVA
Comparison: At Week 6p-value: 0.081ANCOVA
Comparison: At Week 10p-value: 0.157ANCOVA
Secondary
Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
Time frame: 35 days (+3 days) after Week 10 or Early Treatment Discontinuation
Population: Safety population: included all treated subjects with at least one post-baseline assessment or a reported TEAE.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any TEAE | 74 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Related TEAE | 20 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Serious TEAE | 6 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Related Serious TEAE | 0 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects who Died | 0 Participants |
| Serlopitant 5 mg | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects who discontinued drug due to TEAE | 5 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects who Died | 0 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any TEAE | 64 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Related Serious TEAE | 0 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Related TEAE | 9 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects who discontinued drug due to TEAE | 3 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Subjects with any Serious TEAE | 3 Participants |
Secondary
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10
During the study, 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. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week.
Time frame: At Weeks 2, 4, and 10
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Serlopitant 5 mg | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 2 | 14.79 Percentage of subjects |
| Serlopitant 5 mg | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 4 | 23.32 Percentage of subjects |
| Serlopitant 5 mg | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 10 | 35.58 Percentage of subjects |
| Placebo | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 2 | 9.27 Percentage of subjects |
| Placebo | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 4 | 14.31 Percentage of subjects |
| Placebo | Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 10 | 27.83 Percentage of subjects |
Comparison: At Week 2p-value: 0.151Cochran-Mantel-Haenszel
Comparison: At Week 4p-value: 0.052Cochran-Mantel-Haenszel
Comparison: At Week 10p-value: 0.175Cochran-Mantel-Haenszel
Secondary
Percent of Subjects With WI-NRS 4-point Responder at Week 2
During the study, 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.
Time frame: At Week 2
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serlopitant 5 mg | Percent of Subjects With WI-NRS 4-point Responder at Week 2 | 8.45 Percentage of subjects |
| Placebo | Percent of Subjects With WI-NRS 4-point Responder at Week 2 | 4.93 Percentage of subjects |
p-value: 0.236Cochran-Mantel-Haenszel
Secondary
Percent of Subjects With WI-NRS 4-point Responder at Week 4
During the study, 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.
Time frame: At Week 4
Population: Intent-to-Treat Population: included all randomized subjects who were dispensed study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Serlopitant 5 mg | Percent of Subjects With WI-NRS 4-point Responder at Week 4 | 17.66 Percentage of subjects |
| Placebo | Percent of Subjects With WI-NRS 4-point Responder at Week 4 | 7.80 Percentage of subjects |
p-value: 0.013Cochran-Mantel-Haenszel