Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
- Conditions
- Prurigo NodularisPruritus
- Interventions
- Drug: Placebo TabletsDrug: 5mg Serlopitant Tablets
- Registration Number
- NCT03677401
- 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
- 295
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 Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10 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).
- Secondary Outcome Measures
Name Time Method 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.
Percent of Participants With WI-NRS 4-point Responder Rate at Week 4 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).
Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis 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.
Percent of Participants 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 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).
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs) 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. 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 Participants With WI-NRS 4-point Responder Rate at Week 2 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).
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 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.
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 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.).
Change From Baseline in DLQI Question 1 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 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.).
Trial Locations
- Locations (40)
Study Site 636
🇵🇱Bydgoszcz, Poland
Study Site 631
🇵🇱Olsztyn, Poland
Study Site 649
🇦🇹Graz, Austria
Study Site 648
🇦🇹Linz, Austria
Study Site 650
🇦🇹Vienna, Austria
Study Site 633
🇵🇱Kraków, Poland
Study Site 624
🇵🇱Kraków, Poland
Study Site 634
🇵🇱Rzeszów, Poland
Study Site 632
🇵🇱Toruń, Poland
Study Site 635
🇵🇱Kraków, Poland
Study Site 625
🇵🇱Osielsko, Poland
Study Site 645
🇵🇱Poznań, Poland
Study Site 644
🇵🇱Poznań, Poland
Study Site 630
🇵🇱Wrocław, Poland
Study Site 641
🇩🇪Berlin, Germany
Study Site 623
🇩🇪Bad Bentheim, Germany
Study Site 607
🇩🇪Berlin, Germany
Study Site 617
🇩🇪Bochum, Germany
Study Site 642
🇩🇪Buxtehude, Germany
Study Site 600
🇩🇪Bielefeld, Germany
Study Site 608
🇩🇪Bonn, Germany
Study Site 606
🇩🇪Dresden, Germany
Study Site 602
🇩🇪Frankfurt am main, Germany
Study Site 621
🇩🇪Erlangen, Germany
Study Site 639
🇩🇪Hamburg, Germany
Study Site 605
🇩🇪Heidelberg, Germany
Study Site 611
🇩🇪Leipzig, Germany
Study Site 601
🇩🇪Münster, Germany
Study Site 620
🇩🇪Mahlow, Germany
Study Site 614
🇩🇪Mainz, Germany
Study Site 640
🇩🇪Potsdam, Germany
Study Site 618
🇩🇪Osnabrück, Germany
Study Site 643
🇩🇪Stuttgart, Germany
Study Site 615
🇩🇪Selters, Germany
Study Site 628
🇵🇱Iwonicz-Zdrój, Poland
Study Site 638
🇵🇱Szczecin, Poland
Study Site 627
🇵🇱Warszawa, Poland
Study Site 637
🇵🇱Wrocław, Poland
Study Site 647
🇵🇱Wrocław, Poland
Study Site 629
🇵🇱Łódź, Poland