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: NCT03677401
• Other study ID #: MTI-106
• Secondary ID: 2017-004210-25
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2018
• Est. completion date: February 6, 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: 295
• Est. completion date: February 6, 2020
• Est. primary completion date: January 9, 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
Austria	Study Site 649	Graz
Austria	Study Site 648	Linz
Austria	Study Site 650	Vienna
Germany	Study Site 623	Bad Bentheim
Germany	Study Site 607	Berlin
Germany	Study Site 641	Berlin
Germany	Study Site 600	Bielefeld
Germany	Study Site 617	Bochum
Germany	Study Site 608	Bonn
Germany	Study Site 642	Buxtehude
Germany	Study Site 606	Dresden
Germany	Study Site 621	Erlangen
Germany	Study Site 602	Frankfurt am main
Germany	Study Site 639	Hamburg
Germany	Study Site 605	Heidelberg
Germany	Study Site 611	Leipzig
Germany	Study Site 620	Mahlow
Germany	Study Site 614	Mainz
Germany	Study Site 601	Münster
Germany	Study Site 618	Osnabrück
Germany	Study Site 640	Potsdam
Germany	Study Site 615	Selters
Germany	Study Site 643	Stuttgart
Poland	Study Site 636	Bydgoszcz
Poland	Study Site 628	Iwonicz-Zdrój
Poland	Study Site 624	Kraków
Poland	Study Site 633	Kraków
Poland	Study Site 635	Kraków
Poland	Study Site 629	Lódz
Poland	Study Site 631	Olsztyn
Poland	Study Site 625	Osielsko
Poland	Study Site 644	Poznan
Poland	Study Site 645	Poznan
Poland	Study Site 634	Rzeszów
Poland	Study Site 638	Szczecin
Poland	Study Site 632	Torun
Poland	Study Site 627	Warszawa
Poland	Study Site 630	Wroclaw
Poland	Study Site 637	Wroclaw
Poland	Study Site 647	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate 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).	At Week 10
Secondary	Percent of Participants With WI-NRS 4-point Responder Rate 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).	At Week 4
Secondary	Percent of Participants With WI-NRS 4-point Responder Rate 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).	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 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.	At Weeks 2, 4, 6, and 10
Secondary	Percent of Participants With WI-NRS 3-point Responder 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).	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 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.).	At Week 10
Secondary	Change From Baseline in DLQI Question 1 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 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.).	At Week 10
Secondary	Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis 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 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	Number of Participants 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.	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