Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Pruritus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841331
• Other study ID #: MTI-117
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2019
• Est. completion date: January 21, 2020

Study information

• Verified date: May 2021
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: January 21, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion:

• Male or female, age 18 years or older at consent.

• The subject must have ongoing chronic pruritus

• The subject's pruritus is assessed by the investigator to be of unknown origin at baseline.

• Worst-Itch Numeric Rating Scale (WI-NRS) score in the 24-hour period prior to the Screening visit, and average weekly WI-NRS score in each of the 2 weeks prior to Baseline visit indicating an appropriate pruritus level for the study.

• The pruritus must have been unresponsive to prior treatment with emollients.

• The subject's pruritus must be present on multiple segments of the body

• Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study

• All females who are of childbearing potential must be willing to practice highly effective contraception and not be pregnant or nursing

• Willing to comply with study visits and study related requirements including providing written informed consent.

• Adequate cognitive and physical ability, in the investigator's opinion, to comply with study visits and study related requirements including providing written informed consent

Exclusion

• Prior treatment with any NK1-receptor antagonists

• Known dermatologic or systemic condition(s), other than dry skin, that is considered by the investigator to be the primary cause of current pruritus.

• Untreated or inadequately treated thyroid, adrenal, or pituitary disease or nodules, or history of thyroid malignancy.

• Use of an excluded therapy within 3 weeks prior to randomization

• Treatment with any investigational therapy within 3 weeks prior to randomization.

• Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal during screening.

• History of malignancy within 3 years prior to randomization, with the (actinic keratosis, non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma of skin).

• Any known major psychiatric diagnosis that would impact the subject's ability to complete the study

• Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt.

• Known use of recreational drugs.

• Documented history of parasitic infection, including skin parasites such as scabies, within 12 weeks prior to randomization.

• Presence of clinically significant dementia, intellectual impairment, or any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.

• History of hypersensitivity to serlopitant or any of its components.

• Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject's participation in the study.

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• 5 mg Serlopitant Tablets
Serlopitant Tablets
• Matching Placebo Tablets
Placebo Tablets

Locations

Country	Name	City	State
United States	Study Site 365	Austin	Texas
United States	Study Site 811	Aventura	Florida
United States	Study Site 823	Bakersfield	California
United States	Study Site 821	Bellevue	Nebraska
United States	Study Site 808	Brighton	Massachusetts
United States	Study Site 802	Bronx	New York
United States	Study Site 507	Brooklyn	New York
United States	Study Site 820	Centennial	Colorado
United States	Study Site 120	Dallas	Texas
United States	Study Site 804	Denver	Colorado
United States	Study Site 524	Dublin	Ohio
United States	Study Site 819	Fort Worth	Texas
United States	Study Site 204	Fremont	California
United States	Study Site 341	High Point	North Carolina
United States	Study Site 221	Hot Springs	Arkansas
United States	Study Site 814	Indianapolis	Indiana
United States	Study Site 801	Jacksonville	Florida
United States	Study Site 345	Johnston	Rhode Island
United States	Study Site 387	Las Vegas	Nevada
United States	Study Site 813	Las Vegas	Nevada
United States	Study Site 803	Los Angeles	California
United States	Study Site 331	Miami	Florida
United States	Study Site 807	Miami	Florida
United States	Study Site 816	Morristown	New Jersey
United States	Study Site 805	Nashville	Tennessee
United States	Study Site 217	Norfolk	Virginia
United States	Study Site 121	Ocean Township	New Jersey
United States	Study Site 359	Pflugerville	Texas
United States	Study Site 522	Pittsburgh	Pennsylvania
United States	Study Site 116	Portland	Oregon
United States	Study Site 810	Raleigh	North Carolina
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 809	San Antonio	Texas
United States	Study Site 824	Sarasota	Florida
United States	Study Site 349	Savannah	Georgia
United States	Study Site 806	Spokane	Washington
United States	Study Site 812	Walla Walla	Washington
United States	Study Site 815	Warwick	Rhode Island
United States	Study Site 818	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst Itch Numeric Rating Scale 4-point Responder Rate 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).	At Week 10
Primary	WI-NRS 4-point Responder Rate 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).	At Weeks 2, 4, 6, and 8
Primary	WI-NRS 3-point Responder Rate 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.	At Weeks 2, 4, 6, 8, and 10
Primary	Change From Baseline in WI-NRS 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.	At Weeks 2, 4, 6, 8, and 10
Primary	Change From Baseline in Daily WI-NRS Scores Through Week 2	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.	Through 2 weeks
Primary	Change From Baseline in Worst-Itch Visual Analog Scale 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.	At Weeks 2, 4, 6, and 10
Secondary	Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.	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.
Secondary	Plasma Concentrations of Serlopitant and Metabolites	The plasma concentrations of serlopitant and metabolites were combined with the data from other serlopitant clinical studies for population pharmacokinetic analysis.	At Week 10