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

Phase 3

Completed

Conditions: Pruritus
Prurigo Nodularis

Interventions: Drug: Placebo Tablets
Drug: 5mg Serlopitant Tablets

Registration Number: NCT03546816

Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary: Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with prurigo nodularis

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 285

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo Tablets	Placebo Tablets	-
5 mg Serlopitant Tablets	5mg Serlopitant Tablets	-

Primary Outcome Measures

Name	Time	Method
Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder at Week 10	At Week 10	During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. Subjects were considered responders if they had at least a 4-point reduction from baseline in weekly average WI-NRS at Week 10.

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects With WI-NRS 4-point Responder at Week 2	At Week 2	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
Percent of Subjects With WI-NRS 3-point Responder at Weeks 2, 4, and 10	At Weeks 2, 4, and 10	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. For the 3-point responder rate, subjects were considered responders if they had at least a 3-point reduction between baseline and the corresponding week.
Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4, and 10	At Weeks 2, 4, and 10	The IGA PN-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 (clear) to 4 (severe). Higher scores indicate severe prurigo nodularis.
Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10	At Week 10	Dermatology Life Quality Index (DLQI) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment). The DLQI questions are rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.
Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10	At Weeks 2, 4, 6, and 10	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
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 Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)	35 days (+3 days) after Week 10 or Early Treatment Discontinuation	Adverse events (AEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
Percent of Subjects With WI-NRS 4-point Responder at Week 4	At Week 4	During the study, WI-NRS assessments were reported by the subject via eDiary once daily from screening/mid-screening visit through the follow-up visit. The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects were asked to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.
Change From Baseline in DLQI Question 1 to Week 10	At Week 10	DLQI is a dermatology specific QoL instrument designed to assess the impact of the skin disease on a subject's QoL over the prior week. It is a ten item questionnaire that assesses overall QoL and six aspects that may affect QoL (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) The DLQI question 1 is to measure how itchy, sore, painful or stinging the subject's skin had been. It is rated by the subject as 0 (not at all) to 3 (very much). Scores range from 0 to 30 with higher scores indicating poor QoL.

Trial Locations

Locations (49): Study Site 504
🇺🇸
Birmingham, Alabama, United States
Study Site 533
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Rogers, Arkansas, United States
Study Site 204
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Fremont, California, United States
Study Site 383
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North Hollywood, California, United States
Study Site 356
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San Diego, California, United States
Study Site 514
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Santa Ana, California, United States
Study Site 501
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Aventura, Florida, United States
Study Site 210
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Coral Gables, Florida, United States
Study Site 534
🇺🇸
Fort Lauderdale, Florida, United States
Study Site 531
🇺🇸
Miami, Florida, United States
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Study Site 504
🇺🇸Birmingham, Alabama, United States