Clinical trial NCT03677401: Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pruritus
Prurigo Nodularis
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants With Worst Itch Numeric Rating Scale (WI-NRS) 4-point Responder Rate at Week 10
timeFrame: At Week 10
Secondary outcomes:
measure: Percent of Participants With WI-NRS 4-point Responder Rate at Week 4
timeFrame: At Week 4
measure: Percent of Participants With WI-NRS 4-point Responder Rate at Week 2
timeFrame: At Week 2
measure: Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10
timeFrame: At Weeks 2, 4, 6, and 10
measure: Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4, and 10
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10
timeFrame: At Week 10
measure: Change From Baseline in DLQI Question 1 to Week 10
timeFrame: At Week 10
measure: Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Stage (IGA PN-S) to Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4 and 10
measure: Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10
timeFrame: At Weeks 2, 4, and 10
measure: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (SAEs)
timeFrame: 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
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Study Site 649
city: Linz
country: Austria
facility: Study Site 648
city: Vienna
country: Austria
facility: Study Site 650
city: Bad Bentheim
country: Germany
facility: Study Site 623
city: Berlin
country: Germany
facility: Study Site 607
city: Berlin
country: Germany
facility: Study Site 641
city: Bielefeld
country: Germany
facility: Study Site 600
city: Bochum
country: Germany
facility: Study Site 617
city: Bonn
country: Germany
facility: Study Site 608
city: Buxtehude
country: Germany
facility: Study Site 642
city: Dresden
country: Germany
facility: Study Site 606
city: Erlangen
country: Germany
facility: Study Site 621
city: Frankfurt am main
country: Germany
facility: Study Site 602
city: Hamburg
country: Germany
facility: Study Site 639
city: Heidelberg
country: Germany
facility: Study Site 605
city: Leipzig
country: Germany
facility: Study Site 611
city: Mahlow
country: Germany
facility: Study Site 620
city: Mainz
country: Germany
facility: Study Site 614
city: Münster
country: Germany
facility: Study Site 601
city: Osnabrück
country: Germany
facility: Study Site 618
city: Potsdam
country: Germany
facility: Study Site 640
city: Selters
country: Germany
facility: Study Site 615
city: Stuttgart
country: Germany
facility: Study Site 643
city: Bydgoszcz
country: Poland
facility: Study Site 636
city: Iwonicz-Zdrój
country: Poland
facility: Study Site 628
city: Kraków
country: Poland
facility: Study Site 633
city: Kraków
country: Poland
facility: Study Site 624
city: Kraków
country: Poland
facility: Study Site 635
city: Olsztyn
country: Poland
facility: Study Site 631
city: Osielsko
country: Poland
facility: Study Site 625
city: Poznań
country: Poland
facility: Study Site 645
city: Poznań
country: Poland
facility: Study Site 644
city: Rzeszów
country: Poland
facility: Study Site 634
city: Szczecin
country: Poland
facility: Study Site 638
city: Toruń
country: Poland
facility: Study Site 632
city: Warszawa
country: Poland
facility: Study Site 627
city: Wrocław
country: Poland
facility: Study Site 637
city: Wrocław
country: Poland
facility: Study Site 630
city: Wrocław
country: Poland
facility: Study Site 647
city: Łódź
country: Poland
facility: Study Site 629
Study officials:
affiliation: Universitätsklinikum Münster Klinik für Hautkrankheiten Zentrale Studienkoordination für innovative Dermaologie (ZID)
name: Sonja Stander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lukasz Matusiak 4HEALTH
name: Jacek Szepietowski, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Medizinische Universität Graz
name: Franz Josef Legat, MD
role: PRINCIPAL_INVESTIGATOR
References: