Trial Outcomes & Findings for Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis (NCT NCT03677401)

NCT ID: NCT03677401

Last Updated: 2021-05-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 295 participants
• Primary outcome timeframe: At Week 10
• Results posted on: 2021-05-20

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	148	147
Overall Study COMPLETED	138	129
Overall Study NOT COMPLETED	10	18

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	4	14
Overall Study Lack of Efficacy	3	1
Overall Study Withdrawal by Subject	2	2
Overall Study Sponsor decision	0	1
Overall Study Reason Unspecified	1	0

Baseline Characteristics

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

Baseline characteristics by cohort

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.	Total n=295 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 12.97 • n=5 Participants	57.5 years STANDARD_DEVIATION 15.33 • n=7 Participants	58.0 years STANDARD_DEVIATION 14.18 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	98 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	49 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	145 Participants n=5 Participants	145 Participants n=7 Participants	290 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 Success	18.95 Percentage of participants	25.90 Percentage of participants
Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 Failure	81.05 Percentage of participants	74.10 Percentage of participants

SECONDARY outcome

Timeframe: At Week 4

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 Success	11.49 percentage of participants	12.63 percentage of participants
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 Failure	88.51 percentage of participants	87.37 percentage of participants

SECONDARY outcome

Timeframe: At Week 2

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 Success	6.76 percentage of participants	5.55 percentage of participants
Percent of Participants With WI-NRS 4-point Responder Rate at Week 2 Failure	93.24 percentage of participants	94.45 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 6, and 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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.

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
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 1.470	-1.25 Score on a scale Standard Deviation 1.496
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	-1.60 Score on a scale Standard Deviation 1.955
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	-1.93 Score on a scale Standard Deviation 2.182
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	-2.24 Score on a scale Standard Deviation 2.543

SECONDARY outcome

Timeframe: At Weeks 2, 4, and 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
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	11.89 Percentage of participants
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	20.03 Percentage of participants
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	37.58 Percentage of participants

SECONDARY outcome

Timeframe: At Week 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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.).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10	-4.4 Score on a scale Standard Deviation 5.07	-4.5 Score on a scale Standard Deviation 5.14

SECONDARY outcome

Timeframe: At Week 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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.).

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Change From Baseline in DLQI Question 1 to Week 10	-0.6 Score on a scale Standard Deviation 0.75	-0.6 Score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: At Weeks 2, 4 and 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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.

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
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	-0.2 Score on a scale Standard Deviation 0.43
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	-0.3 Score on a scale Standard Deviation 0.64
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	-0.5 Score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: At Weeks 2, 4, and 10

Population: Intent-to-Treat Population: included all randomized participants who were dispensed study drug.

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.

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
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	-0.3 Score on a scale Standard Deviation 0.49
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	-0.5 Score on a scale Standard Deviation 0.68
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	-0.7 Score on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=148 Participants 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.	Serlopitant 5 mg n=147 Participants 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.
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants with any TEAE	87 Participants	84 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants with any related TEAE	24 Participants	30 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants with any serious TEAE	2 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants with any related serious TEAE	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants who Died	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) Participants who discontinued study drug	4 Participants	13 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Serlopitant 5 mg

Serious events: 5 serious events

Other events: 31 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo n=148 participants at risk 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.	Serlopitant 5 mg n=147 participants at risk 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.
Cardiac disorders Coronary artery disease	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Injury, poisoning and procedural complications Wound	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Investigations Hepatic enzyme increased	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.68% 1/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.00% 0/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.68% 1/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.00% 0/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.68% 1/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Vascular disorders Hypertensive crisis	0.68% 1/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	0.00% 0/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.

Other adverse events

Measure	Placebo n=148 participants at risk 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.	Serlopitant 5 mg n=147 participants at risk 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.
General disorders Fatigue	4.1% 6/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	4.8% 7/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Infections and infestations Nasopharyngitis	14.9% 22/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	10.2% 15/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.
Nervous system disorders Headache	3.4% 5/148 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.	6.1% 9/147 • 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. After informed consent was signed, but prior to initiation of study drug, only SAEs considered by the investigator to be caused by a protocol mandated intervention were collected.

Additional Information

Iain Stuart

Menlo Therapeutics, Inc.

Phone: 1-800-775-7936

Email: Iain.Stuart@foamix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60