A Randomized Placebo-Controlled Study of the Neurokinin-1... | NCT02196324

Label	Type	Description	Intervention Names
serlopitant 5 mg tablets	Active Comparator	serlopitant 5 mg tablets	Drug: serlopitant
Placebo tablets	Placebo Comparator	Placebo tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
serlopitant	Drug	NK1 receptor antagonist	serlopitant 5 mg tablets	VPD-737

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Visual Analog Scale at Baseline	At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.	At Baseline
Average Visual Analog Scale at Week 2	At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.	At Week 2
Average Visual Analog Scale at Week 4	At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.	At Week 4
Average Visual Analog Scale at Week 8	At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.	At Week 8

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus	At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.	At Baseline and Week 8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects meeting all of the following criteria will be eligible for study entry:
1. Males or females who are at least 18 years and no more than 80 years of age at Screening.
2. Must have PN (defined as the presence of pruritic nodules due to chronic pruritus,) of more than 6 weeks duration despite treatment with current therapies such as antihistamines or corticosteroids ("treatment resistant" PN).
3. Must have PN lesions on both arms, both legs, and/or the trunk (ie, the lesions must not be localized).
4. Must have a VAS pruritus score of 70 or greater within 72 hours of Baseline.
5. Males, non-fecund females (ie, surgically sterilized, if procedure was done 12 months before screening or subject is postmenopausal, without menses for 12 months before screening), or females of childbearing potential using an acceptable method of birth control for a period of 35 days before the first dosing, and all females must have a negative pregnancy test at the screening and baseline visits:
  
  Note 1: Acceptable methods of birth control include any one of the following:
  
  abstinence, vasectomized sexual partner, hormonal methods (ie, birth-control pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device [NuvaRing]), intrauterine device (IUD [copper banded coils]), diaphragm, cervical cap, or condom with spermicidal jelly or foam. Subjects using oral contraceptives must also use a reliable backup method of birth control during the study and until the first menses after the last dose of study medication or for 14 days menses after the last dose of study medication.
6. Willing and able to understand and provide written informed consent.
7. Willing and able to comply with study requirements and restrictions including the discontinuation of all current therapies for pruritus.
8. Subjects must be in good health as determined by medical history, physical examination, and results of Electro Cardio Gram (ECG) and clinical laboratory tests (including urinalysis).
9. Agreeing to confidential use and storage of all data and use of all anonymized data for publication including scientific publication.

Exclusion Criteria:

Subjects not eligible for the study are those who:
Have chronic pruritus due conditions other than PN, such as the following conditions:
Lichen simplex chronicus
Lichen amyloidosus
Localized pruritus (e.g., only one arm affected)
Neuropathic and psychogenic pruritus (notalgia paresthetica, brachioradial pruritus, somatoform prurigo, dilusional parasitosis, depression associated prurigo)
Active dermatoses needing immediate therapy such as atopic dermatitis (without PN) or bullous pemphigoid;
Have a history of use (within the specified time periods) of the medications listed below. Prior to randomization, a subject who used any of these medications must undergo a washout period equal to the length of the interval specified below (eg, 2 weeks for antihistamines, 4 weeks for naltrexone, and 4 weeks for cyclosporine A).
Topical or systemic antihistamines, (used ≤2 weeks prior to the baseline visit) [loratindine, or cetirizine may act as rescue medication during treatment];
Topical calcineurin inhibitors, topical capsaicin, menthol, camphor, polidocanol, topical antibiotics, antiseptic baths and cleansing lotions (used ≤2 weeks prior to the baseline visit);
Topical steroids (used ≤2 weeks prior to the baseline visit);
Naltrexone, paroxetine, fluvoxamine, amitriptyline, gabapentin, pregabalin, or UVtherapy (prescribed for the pruritus treatment) (used ≤4 weeks prior to the baseline visit);
Systemic steroids (used ≤4 weeks prior to the baseline visit);
Cyclosporine A and other immunosuppressants (used ≤4 weeks prior to the baseline visit).
Have any medical condition or disability that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
Have any chronic or acute medical condition that, in the opinion of the investigator, might interfere with the study results or place the subject at undue risk.
Have a history of sensitivity to any components of the study material.
Are females of childbearing potential who are unwilling to use adequate contraception or who are breast feeding.
Have chronic renal disease, ie, serum creatinine greater than 2.4 mg/dL.
Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal. Subjects with hepatitis B or C who have normal liver function may be enrolled.
Have a current malignancy (such as Hodgkin's lymphoma, B or T cell lymphoma, or myeloma) or blood cell dyscrasia (eg, polycythemia or myelofibrosis) that might lead to systemic chronic pruritus.
Subjects with untreated hyperthyroidism.
Have pruritus of psychiatric etiology (eg, delusions of parasitosis, obsessive compulsive disorder, or major depression) or neuropathic etiology (eg, due to shingles, spinal cord injury or with neurologic deficit).
Have pruritus due to urticaria, drug allergy, or infection (such as pityriasis rosea or tinea or active human immunodeficiency virus [HIV]). Note: Subjects with HIV who have undetectable viral load, CD 4 counts >200 cells/cc, and stable retroviral therapy may enroll.
Are on medications known to cause pruritus (ie, Erbitux®, opioids, cocaine, amphetamines, and angiotensin converting enzyme [ACE] inhibitors) and are suspected of having drug-induced pruritus.
Have taken investigational medications within 30 days prior to Screening.
Are currently participating in any other clinical study.
Have a history (within the previous 4 weeks) of use of tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRIS), monoamine oxidase (MAO) inhibitors, opioids, immunemodulators (e.g. azathioprine, methotrexate, mycophenolate mofetil, cyclosporine A, antibodies), or neuroactive medications (e.g. pregabalin, gabapentin).
Have a history (within the previous 4 weeks) of use of sedatives or tranquilizers.

Subjects must undergo an appropriate washout period from any sedatives or tranquilizers before enrolling in the study.

Are currently treated with strong CYP3A4 inhibitors (e.g. conazole, ketoconazole, fluconazole, itraconazole, voroconazole etc. or erythromycin). The co-administration of moderate CYP3A4 inhibitors to VPD-737 may be allowed with investigator agreement and appropriate safety monitoring.
Received ultraviolet B (UVB) or psoralen + ultraviolet A (PUVA) treatment within 30 days prior to Screening.
Within the past 12 months, have expressed suicidal ideation with some intent to act.
Started or changed creams, or emollients including over-the-counter (OTC) preparations or bath oil treatment for relief of pruritus within 2 weeks prior to Screening.
Have any social or medical condition (eg, alcoholism, drug dependency, psychotic state) that, in the investigator's opinion, might interfere with the subject's ability to comply with the requirements of the protocol.
Are employees of the study site or of the Sponsor's company.

Name	Affiliation	Role
Sonja Staender, MD	University of Muenster, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Study Site 08		Bonn		53127	Germany
Study Site 06

PubMed Identifier	Type	Citation	Retractions
32936233	Derived	Kimel M, Zeidler C, Kwon P, Revicki D, Stander S. Validation of Psychometric Properties of the Itch Numeric Rating Scale for Pruritus Associated With Prurigo Nodularis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1354-1358. doi: 10.1001/jamadermatol.2020.3071.

ID	Title	Description
FG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
FG001	Serlopitant

ID	Title	Description
BG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
BG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00063 BG00164 BG002127

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Visual Analog Scale at Baseline

At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

The Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Posted

Mean

Standard Deviation

Units on a scale

At Baseline

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts
Participants	OG00063 OG00164

Title

Denominators

Categories

Title	Measurements
	OG0007.92± 1.630 OG0017.88± 1.311

Primary

Average Visual Analog Scale at Week 2

At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Posted

Mean

Standard Deviation

Units on a scale

At Week 2

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Primary

Average Visual Analog Scale at Week 4

At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Posted

Mean

Standard Deviation

Units on a scale

At Week 4

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Primary

Average Visual Analog Scale at Week 8

At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Posted

Mean

Standard Deviation

Units on a scale

At Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Secondary

Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus

At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Count of Participants

Participants

At Baseline and Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Secondary

Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Count of Participants

Participants

At Baseline and Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Secondary

Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Count of Participants

Participants

At Baseline and Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Secondary

Worst Visual Analog Scale (VAS)

At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Mean

Standard Deviation

Units on a scale

At Baseline, Weeks 2, 4, and 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts

Secondary

Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)

The PGA included a question: Did the pruritus improve during the treatment period (yes/no).

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Count of Participants

Participants

At Weeks 2, 4, and 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts
Participants

Secondary

Numeric Rating Scale (NRS)

Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Posted

Mean

Standard Deviation

Units on a scale

At Baseline, Weeks 2, 4, and 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts
Participants

Secondary

Dermatology Life Quality Index (DLQI)

At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16.

The scoring of each question is as follows:

Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3.

The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Interpreting the DLQI Scores:

0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Mean

Standard Deviation

Units on a scale

At Baseline, Weeks 2, 4, and 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001

Secondary

Pruritus-specific Quality of Life (ItchyQoL)

At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus.

Items should be scored for the following answers:

Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.

Posted

Mean

Standard Deviation

Units on a scale

At Baseline, Weeks 2, 4, and 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Secondary

Patient Benefit Index, Version for Patients With Pruritus (PBI-P)

At Visits 2 and 5 (or Early termination) only, participants completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "does/did not apply to me" = 5; and missing value = -9. Higher scores indicated better outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Posted

Mean

Standard Deviation

Units on a scale

At Week 8 / End of Treatment

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001

Secondary

Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)

Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Posted

Count of Participants

Participants

At Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Improvement on Prurigo Activity Score (PAS)

Using the PAS, physicians described, localized, counted, and measured PN lesions.

One of the 7 items was:

Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = > 75%)

a. Prurigo lesions with excoriations/crusts

Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Here, number analyzed in each row signifies only the participants with available data that were analyzed for each day and week.

Posted

Count of Participants

Participants

At Day 1 and Week 8

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units

Secondary

Participants With Rescue Medication Usage

Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.

The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.

Posted

Count of Participants

Participants

Pre-treatment, upto 8 Weeks

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality.

Safety population - participants who received at least one dose of study drug. This population was analyzed based upon the actual treatment received. Participants with dosing errors were assigned to a treatment group based upon the treatment they received most often.

Posted

Count of Participants

Participants

From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)

ID	Title	Description
OG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.
OG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA version 17	Non-systematic Assessment	EG0001 affected63 at risk EG0010 affected64 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 17	Non-systematic Assessment	EG0000 affected63 at risk EG0011 affected64 at risk
Dizziness	Nervous system disorders	MedDRA version 17	Non-systematic Assessment	EG0000 affected63 at risk EG0011 affected64 at risk
Syncope	Nervous system disorders	MedDRA version 17	Non-systematic Assessment	EG0001 affected63 at risk EG0010 affected64 at risk
Depression	Psychiatric disorders	MedDRA version 17	Non-systematic Assessment	EG0000 affected63 at risk EG0011 affected64 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 17	Non-systematic Assessment	EG0001 affected63 at risk EG0010 affected64 at risk
Actinic elastosis	Skin and subcutaneous tissue disorders	MedDRA version 17	Non-systematic Assessment	EG0000 affected63 at risk EG0011 affected64 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA version 17	Non-systematic Assessment	EG0001 affected63 at risk EG0010 affected64 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 17	Non-systematic Assessment	EG0003 affected63 at risk EG0017 affected64 at risk
Fatigue	General disorders	MedDRA version 17	Non-systematic Assessment	EG0004 affected63 at risk EG0016 affected64 at risk
Oedema peripheral	General disorders	MedDRA version 17	Non-systematic Assessment	EG0000 affected63 at risk EG0014 affected64 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 17	Non-systematic Assessment	EG0002 affected63 at risk EG00111 affected64 at risk
Urinary tract infection	Infections and infestations	MedDRA version 17	Non-systematic Assessment	EG0004 affected63 at risk EG0010 affected64 at risk
Dizziness	Nervous system disorders	MedDRA version 17	Non-systematic Assessment	EG0001 affected63 at risk EG0014 affected64 at risk
Headache	Nervous system disorders	MedDRA version 17	Non-systematic Assessment	EG0004 affected63 at risk EG0014 affected64 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 17	Non-systematic Assessment	EG0007 affected63 at risk EG0013 affected64 at risk

ID	Term
D003876	Dermatitis, Atopic
D017512	Lichenoid Eruptions

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D017444	Skin Diseases, Papulosquamous

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Randomized participants took matching placebo tablets for oral administration as 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.	0	63	2	63	20	63
EG001	Serlopitant	Randomized participants took Serlopitant 5 mg tablets for oral administration at a loading dose of 3 tablets at baseline (Day 1) followed by 1 tablet every day at bedtime for 8 weeks.	0	64	3	64	31	64