Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
- Conditions
- PruritusPrurigo Nodularis
- Interventions
- Drug: Placebo TabletsDrug: 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
Not provided
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 529
🇺🇸Verona, New Jersey, United States
Study Site 533
🇺🇸Rogers, Arkansas, United States
Study Site 501
🇺🇸Aventura, Florida, United States
Study Site 210
🇺🇸Coral Gables, Florida, United States
Study Site 534
🇺🇸Fort Lauderdale, Florida, United States
Study Site 222
🇺🇸North Miami Beach, Florida, United States
Study Site 379
🇺🇸Boston, Massachusetts, United States
Study Site 224
🇺🇸Houston, Texas, United States
Study Site 531
🇺🇸Miami, Florida, United States
Study Site 530
🇺🇸Miami, Florida, United States
Study Site 528
🇺🇸Saint Louis, Missouri, United States
Study Site 356
🇺🇸San Diego, California, United States
Study Site 805
🇺🇸Nashville, Tennessee, United States
Study Site 361
🇺🇸San Antonio, Texas, United States
Study Site 508
🇺🇸Buffalo, New York, United States
Study Site 504
🇺🇸Birmingham, Alabama, United States
Study Site 515
🇺🇸Detroit, Michigan, United States
Study Site 228
🇺🇸Louisville, Kentucky, United States
Study Site 227
🇺🇸Omaha, Nebraska, United States
Study Site 204
🇺🇸Fremont, California, United States
Study Site 383
🇺🇸North Hollywood, California, United States
Study Site 514
🇺🇸Santa Ana, California, United States
Study Site 510
🇺🇸Newnan, Georgia, United States
Study Site 388
🇺🇸Skokie, Illinois, United States
Study Site 525
🇺🇸Glenn Dale, Maryland, United States
Study Site 506
🇺🇸Ann Arbor, Michigan, United States
Study Site 371
🇺🇸Saint Joseph, Missouri, United States
Study Site 201
🇺🇸East Windsor, New Jersey, United States
Study Site 526
🇺🇸Henderson, Nevada, United States
Study Site 507
🇺🇸Brooklyn, New York, United States
Study Site 517
🇺🇸New York, New York, United States
Study Site 500
🇺🇸New York, New York, United States
Study Site 509
🇺🇸Cleveland, Ohio, United States
Study Site 341
🇺🇸High Point, North Carolina, United States
Study Site 516
🇺🇸Bexley, Ohio, United States
Study Site 524
🇺🇸Dublin, Ohio, United States
Study Site 511
🇺🇸Knoxville, Tennessee, United States
Study Site 112
🇺🇸Tulsa, Oklahoma, United States
Study Site 523
🇺🇸Philadelphia, Pennsylvania, United States
Study Site 522
🇺🇸Pittsburgh, Pennsylvania, United States
Study Site 345
🇺🇸Johnston, Rhode Island, United States
Study Site 520
🇺🇸Bellaire, Texas, United States
Study Site 502
🇺🇸Dallas, Texas, United States
Study Site 359
🇺🇸Pflugerville, Texas, United States
Study Site 532
🇺🇸Morgantown, West Virginia, United States
Study Site 226
🇺🇸Webster, Texas, United States
Study Site 806
🇺🇸Spokane, Washington, United States
Study Site 527
🇺🇸New Orleans, Louisiana, United States
Study Site 365
🇺🇸Austin, Texas, United States