Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
- Conditions
- Pruritus
- Interventions
- Drug: Matching Placebo TabletsDrug: 5 mg Serlopitant Tablets
- Registration Number
- NCT03841331
- Lead Sponsor
- Vyne Therapeutics Inc.
- Brief Summary
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 mg Placebo Tablets Matching Placebo Tablets Placebo Tablets 5 mg Serlopitant Tablets 5 mg Serlopitant Tablets Serlopitant Tablets
- Primary Outcome Measures
Name Time Method Worst Itch Numeric Rating Scale 4-point Responder Rate at Week 10 At Week 10 During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).WI-NRS 4-point Responder Rate at Weeks 2 4, 6, and 8 At Weeks 2, 4, 6, and 8 During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).WI-NRS 3-point Responder Rate at Weeks 2, 4, 6, 8, and 10 At Weeks 2, 4, 6, 8, and 10 During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 subject was a 3-point responder if their change from baseline is ≤ -3 (i.e. a decrease of at least 3). Results presented below is of subjects who were a 3-point responder but not a 4-point responder.Change From Baseline in WI-NRS at Weeks 2, 4, 6, 8, and 10 At Weeks 2, 4, 6, 8, and 10 During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 Daily WI-NRS Scores Through Week 2 Through 2 weeks During the study, Worst Itch Numeric Rating Scale (WI-NRS) assessments was reported by the subject via eDiary. The daily NRS results were summarized. The daily results were averaged to create weekly measures.
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects 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 Worst-Itch Visual Analog Scale at Weeks 2, 4, 6, and 10 At Weeks 2, 4, 6, and 10 The Itch Visual Analog Scale (VAS) is a validated, self-reported instrument for measurement of itch intensity. It used a 24-hour recall period and asked subjects to rate the worst intensity of their itch on a 100-mm horizontal line ranging from 0 mm (no itch) to 100 mm (worst itch imaginable). Higher scores indicated greater itch intensity. The VAS measurement were summarized in centimeters. WI-VAS assessments were reported by the subject via a paper form administered at study visits.
- Secondary Outcome Measures
Name Time Method Number of Subjects With Treatment Emergent Adverse Events (TEAEs) 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 subjects who discontinued study drug early. Adverse events (AEs) were recorded to assess the safety and tolerability of repeated oral doses of serlopitant in adult subjects with chronic pruritus of unknown origin. Adverse events (AEs) and 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.
Plasma Concentrations of Serlopitant and Metabolites At Week 10 The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.
Trial Locations
- Locations (41)
Study Site 807
🇺🇸Miami, Florida, United States
Study Site 121
🇺🇸Ocean Township, New Jersey, United States
Study Site 813
🇺🇸Las Vegas, Nevada, United States
Study Site 387
🇺🇸Las Vegas, Nevada, United States
Study Site 804
🇺🇸Denver, Colorado, United States
Study Site 116
🇺🇸Portland, Oregon, United States
Study Site 823
🇺🇸Bakersfield, California, United States
Study Site 820
🇺🇸Centennial, Colorado, United States
Study Site 221
🇺🇸Hot Springs, Arkansas, United States
Study Site 204
🇺🇸Fremont, California, United States
Study Site 803
🇺🇸Los Angeles, California, United States
Study Site 811
🇺🇸Aventura, Florida, United States
Study Site 801
🇺🇸Jacksonville, Florida, United States
Study Site 331
🇺🇸Miami, Florida, United States
Study Site 824
🇺🇸Sarasota, Florida, United States
Study Site 818
🇺🇸West Palm Beach, Florida, United States
Study Site 349
🇺🇸Savannah, Georgia, United States
Study Site 808
🇺🇸Brighton, Massachusetts, United States
Study Site 814
🇺🇸Indianapolis, Indiana, United States
Study Site 822
🇺🇸Rolla, Missouri, United States
Study Site 371
🇺🇸Saint Joseph, Missouri, United States
Study Site 817
🇺🇸Saint Louis, Missouri, United States
Study Site 821
🇺🇸Bellevue, Nebraska, United States
Study Site 810
🇺🇸Raleigh, North Carolina, United States
Study Site 816
🇺🇸Morristown, New Jersey, United States
Study Site 802
🇺🇸Bronx, New York, United States
Study Site 341
🇺🇸High Point, North Carolina, United States
Study Site 507
🇺🇸Brooklyn, New York, United States
Study Site 345
🇺🇸Johnston, Rhode Island, United States
Study Site 524
🇺🇸Dublin, Ohio, United States
Study Site 120
🇺🇸Dallas, Texas, United States
Study Site 815
🇺🇸Warwick, Rhode Island, United States
Study Site 359
🇺🇸Pflugerville, Texas, United States
Study Site 805
🇺🇸Nashville, Tennessee, United States
Study Site 365
🇺🇸Austin, Texas, United States
Study Site 819
🇺🇸Fort Worth, Texas, United States
Study Site 809
🇺🇸San Antonio, Texas, United States
Study Site 806
🇺🇸Spokane, Washington, United States
Study Site 217
🇺🇸Norfolk, Virginia, United States
Study Site 812
🇺🇸Walla Walla, Washington, United States
Study Site 522
🇺🇸Pittsburgh, Pennsylvania, United States