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 Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | At Week 10 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | At Week 2 | 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). |
| 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 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. |
| Percent of Participants 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 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 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). |
| 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 participant'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 participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.). |
| Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | At Week 4 | 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). |
| Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis 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. |
| 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. |
| Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early | 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 DLQI Question 1 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 participant'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 participant as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.). |
Countries
Austria, Germany, Poland
Participant flow
Recruitment details
The study was conducted at 40 sites in US from 29 August 2018 to 06 February 2020. All psrticipants who met the study entry criteria were randomized in a 1:1 ratio to receive daily oral doses of serlopitant 5 mg or placebo.
Pre-assignment details
During the screening period (4 weeks), all participants were evaluated for eligibility and chronic pruritic conditions frequently associated with Prurigo Nodularis. Participants were to complete an electronic diary (eDiary) at the Screening visit.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Randomized participants received daily oral doses of placebo following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period. | 148 |
| Serlopitant 5 mg Randomized participants received daily oral doses of serlopitant 5 mg following an initial 3-tablet loading dose on Day 1. Starting on Day 2, participants took 1 tablet per day until the completion of the 10-week treatment period. | 147 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 14 |
| Overall Study | Lack of Efficacy | 3 | 1 |
| Overall Study | Reason Unspecified | 1 | 0 |
| Overall Study | Sponsor decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Serlopitant 5 mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 15.33 | 58.0 years STANDARD_DEVIATION 14.18 | 58.5 years STANDARD_DEVIATION 12.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 145 Participants | 290 Participants | 145 Participants |
| Sex: Female, Male Female | 98 Participants | 192 Participants | 94 Participants |
| Sex: Female, Male Male | 49 Participants | 103 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 1 / 147 |
| other Total, other adverse events | 33 / 148 | 31 / 147 |
| serious Total, serious adverse events | 2 / 148 | 5 / 147 |
Outcome results
Primary
Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10
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).
Time frame: At Week 10
Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Success | 18.95 Percentage of participants |
| Placebo | Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Failure | 81.05 Percentage of participants |
| Serlopitant 5 mg | Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Success | 25.90 Percentage of participants |
| Serlopitant 5 mg | Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 | Failure | 74.10 Percentage of participants |
Comparison: At Week 10p-value: 0.158Cochran-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 participant'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 participant 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 participants who were dispensed study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | -4.4 Score on a scale | Standard Deviation 5.07 |
| Serlopitant 5 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10 | -4.5 Score on a scale | Standard Deviation 5.14 |
Comparison: At Week 10p-value: 0.797ANCOVA
Secondary
Change From Baseline in DLQI Question 1 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 participant'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 participant 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 participants who were dispensed study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in DLQI Question 1 to Week 10 | -0.6 Score on a scale | Standard Deviation 0.75 |
| Serlopitant 5 mg | Change From Baseline in DLQI Question 1 to Week 10 | -0.6 Score on a scale | Standard Deviation 0.76 |
Comparison: At Week 10p-value: 0.845ANCOVA
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 participants who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 | -0.2 Score on a scale | Standard Deviation 0.49 |
| 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 | -0.5 Score on a scale | Standard Deviation 0.68 |
| 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 | -0.7 Score on a scale | Standard Deviation 0.91 |
| 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 | -0.5 Score on a scale | Standard Deviation 0.68 |
| 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 0.49 |
| 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 0.92 |
Comparison: At Week 2p-value: 0.197ANCOVA
Comparison: At Week 4p-value: 0.694ANCOVA
Comparison: At Week 10p-value: 0.916ANCOVA
Secondary
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis 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 participants who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 2 | -0.2 Score on a scale | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 4 | -0.4 Score on a scale | Standard Deviation 0.64 |
| Placebo | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 10 | -0.5 Score on a scale | Standard Deviation 0.77 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 2 | -0.2 Score on a scale | Standard Deviation 0.43 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 4 | -0.3 Score on a scale | Standard Deviation 0.64 |
| Serlopitant 5 mg | Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10 | Change from Baseline at Week 10 | -0.5 Score on a scale | Standard Deviation 0.78 |
Comparison: At Week 2p-value: 0.385ANCOVA
Comparison: At Week 4p-value: 0.786ANCOVA
Comparison: At Week 10p-value: 0.502ANCOVA
Secondary
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
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.
Time frame: At Weeks 2, 4, 6, and 10
Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 2 | -0.94 Score on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 4 | -1.42 Score on a scale | Standard Deviation 1.908 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 6 | -1.61 Score on a scale | Standard Deviation 2.105 |
| Placebo | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 10 | -1.86 Score on a scale | Standard Deviation 2.334 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 10 | -2.24 Score on a scale | Standard Deviation 2.543 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 2 | -1.25 Score on a scale | Standard Deviation 1.496 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 6 | -1.93 Score on a scale | Standard Deviation 2.182 |
| Serlopitant 5 mg | Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10 | Change from Baseline at Week 4 | -1.60 Score on a scale | Standard Deviation 1.955 |
Comparison: At Week 6p-value: 0.185ANCOVA
Comparison: At Week 10p-value: 0.164ANCOVA
Comparison: At Week 2p-value: 0.06ANCOVA
Comparison: At Week 4p-value: 0.401ANCOVA
Secondary
Number of Participants 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: From screening until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 10 visit or the last dose of study drug for participants who discontinued study drug early
Population: Safety population: included all treated participants with at least one post-baseline assessment or a reported TEAE.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any related TEAE | 24 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any related serious TEAE | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any TEAE | 87 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants who Died | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any serious TEAE | 2 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants who discontinued study drug | 4 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any serious TEAE | 5 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any TEAE | 84 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any related TEAE | 30 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants who discontinued study drug | 13 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants with any related serious TEAE | 0 Participants |
| Serlopitant 5 mg | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) | Participants who Died | 0 Participants |
Secondary
Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10
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 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3).
Time frame: At Weeks 2, 4, and 10
Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 10 | 25.65 Percentage of participants |
| Placebo | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 2 | 8.11 Percentage of participants |
| Placebo | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 4 | 18.24 Percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 10 | 37.58 Percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 2 | 11.89 Percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10 | Percentage of responders at Week 4 | 20.03 Percentage of participants |
Comparison: At Week 10p-value: 0.033Cochran-Mantel-Haenszel
Comparison: At Week 2p-value: 0.283Cochran-Mantel-Haenszel
Comparison: At Week 4p-value: 0.701Cochran-Mantel-Haenszel
Secondary
Percent of Participants With WI-NRS 4-point Responder Rate at Week 2
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).
Time frame: At Week 2
Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Success | 6.76 percentage of participants |
| Placebo | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Failure | 93.24 percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Success | 5.55 percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 | Failure | 94.45 percentage of participants |
Comparison: At Week 2p-value: 0.674Cochran-Mantel-Haenszel
Secondary
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4
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).
Time frame: At Week 4
Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Success | 11.49 percentage of participants |
| Placebo | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Failure | 88.51 percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Success | 12.63 percentage of participants |
| Serlopitant 5 mg | Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 | Failure | 87.37 percentage of participants |
Comparison: At Week 4p-value: 0.75Cochran-Mantel-Haenszel