| 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). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Number | | Percentage of participants | | At Week 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Success | | | | Failure | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | 0.158 | | | | | | | | | | | | | | Superiority | P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation. | |
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| 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). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Number | | percentage of participants | | At Week 4 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Number | | percentage of participants | | At Week 2 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Mean | Standard Deviation | Score on a scale | | At Weeks 2, 4, 6, and 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Number | | Percentage of participants | | At Weeks 2, 4, and 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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.). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Mean | Standard Deviation | Score on a scale | | At Week 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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.). | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Mean | Standard Deviation | Score on a scale | | At Week 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Mean | Standard Deviation | Score on a scale | | At Weeks 2, 4 and 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Intent-to-Treat Population: included all randomized participants who were dispensed study drug. | Posted | | Mean | Standard Deviation | Score on a scale | | At Weeks 2, 4, and 10 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Safety population: included all treated participants with at least one post-baseline assessment or a reported TEAE. | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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