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

Pruritus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546816
• Other study ID #: MTI-105
• Status: Completed
• Phase: Phase 3
• Start date: May 2, 2018
• Est. completion date: February 14, 2020

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: February 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Subjects must meet the following criteria to be randomized into the study:

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

2. Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.

3. Idiopathic PN, or an identified pruritic condition associated with the PN with persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition.

4. The worst pruritus is identified as within the areas of the PN lesions, with a 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.

5. Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.

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

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

Exclusion Criteria (Subjects who meet any of the following criteria are not eligible for participation in the study):

1. Prior treatment with serlopitant.

2. Active pruritic skin disease, other than PN, within 6 months (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks).

3. Treatment with any of the following therapies within 4 weeks.

1. Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).

2. Systemic or topical immunosuppressive/immunomodulatory therapies.

3. Systemic therapies with recognized anti-pruritic properties.

4. Strong cytochrome-P 3A4 inhibitors.

5. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.

4. Treatment with topical anti-pruritic therapies within 2 weeks.

5. Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.

6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.

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

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

9. Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).

10. Relevant major psychiatric diagnosis in the past 3 years, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.

11. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks.

12. Any medical condition or disability that could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject.

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

14. Currently pregnant or breastfeeding or planning to become pregnant during the study.

15. Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments during participation in the study.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis
• Pruritus

Intervention

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

Locations

Country	Name	City	State
United States	Study Site 506	Ann Arbor	Michigan
United States	Study Site 365	Austin	Texas
United States	Study Site 501	Aventura	Florida
United States	Study Site 520	Bellaire	Texas
United States	Study Site 516	Bexley	Ohio
United States	Study Site 504	Birmingham	Alabama
United States	Study Site 379	Boston	Massachusetts
United States	Study Site 507	Brooklyn	New York
United States	Study Site 508	Buffalo	New York
United States	Study Site 509	Cleveland	Ohio
United States	Study Site 210	Coral Gables	Florida
United States	Study Site 502	Dallas	Texas
United States	Study Site 515	Detroit	Michigan
United States	Study Site 524	Dublin	Ohio
United States	Study Site 201	East Windsor	New Jersey
United States	Study Site 534	Fort Lauderdale	Florida
United States	Study Site 204	Fremont	California
United States	Study Site 525	Glenn Dale	Maryland
United States	Study Site 526	Henderson	Nevada
United States	Study Site 341	High Point	North Carolina
United States	Study Site 224	Houston	Texas
United States	Study Site 345	Johnston	Rhode Island
United States	Study Site 511	Knoxville	Tennessee
United States	Study Site 228	Louisville	Kentucky
United States	Study Site 530	Miami	Florida
United States	Study Site 531	Miami	Florida
United States	Study Site 532	Morgantown	West Virginia
United States	Study Site 805	Nashville	Tennessee
United States	Study Site 527	New Orleans	Louisiana
United States	Study Site 500	New York	New York
United States	Study Site 517	New York	New York
United States	Study Site 510	Newnan	Georgia
United States	Study Site 383	North Hollywood	California
United States	Study Site 222	North Miami Beach	Florida
United States	Study Site 227	Omaha	Nebraska
United States	Study Site 359	Pflugerville	Texas
United States	Study Site 523	Philadelphia	Pennsylvania
United States	Study Site 522	Pittsburgh	Pennsylvania
United States	Study Site 533	Rogers	Arkansas
United States	Study Site 371	Saint Joseph	Missouri
United States	Study Site 528	Saint Louis	Missouri
United States	Study Site 361	San Antonio	Texas
United States	Study Site 356	San Diego	California
United States	Study Site 514	Santa Ana	California
United States	Study Site 388	Skokie	Illinois
United States	Study Site 806	Spokane	Washington
United States	Study Site 112	Tulsa	Oklahoma
United States	Study Site 529	Verona	New Jersey
United States	Study Site 226	Webster	Texas

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	Percent of Subjects With Worst-Itch Numeric Rating Scale 4-point Responder 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.	At Week 10
Secondary	Percent of Subjects With WI-NRS 4-point Responder 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.	At Week 4
Secondary	Percent of Subjects With WI-NRS 4-point Responder 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.	At Week 2
Secondary	Change From Baseline in WI-NRS 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.	At Weeks 2, 4, 6, and 10
Secondary	Percent of Subjects With WI-NRS 3-point Responder 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.	At Weeks 2, 4, and 10
Secondary	Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to 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.	At Weeks 2, 4, and 10
Secondary	Change From Baseline in Investigator's Global Assessment of PN Stage (IGA PN-S) to 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.	At Weeks 2, 4, and 10
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) to 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.	At Week 10
Secondary	Change From Baseline in DLQI Question 1 to 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.	At Week 10
Secondary	Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)	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.	35 days (+3 days) after Week 10 or Early Treatment Discontinuation