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

NCT03677401 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MTI-1062017-004210-25
• Study Type: interventional
• Target: 295
• Locations: 3 countries
• Sites: 40

Brief Summary

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

Conditions

Pruritus; Prurigo Nodularis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percent of Participants With WI-NRS 4-point Responder Rate at Week 4

  At Week 4

• Percent of Participants With WI-NRS 4-point Responder Rate at Week 2

  At Week 2

• Change From Baseline in WI-NRS at Weeks 2, 4, 6, and 10

  At Weeks 2, 4, 6, and 10

• Percent of Participants With WI-NRS 3-point Responder at Weeks 2, 4, and 10

  At Weeks 2, 4, and 10

• Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 10

  At Week 10

Study Arms (2)

5 mg Serlopitant Tablets

EXPERIMENTAL

Drug: 5mg Serlopitant Tablets

Matching Placebo Tablets

PLACEBO COMPARATOR

Drug: Placebo Tablets

Interventions

5mg Serlopitant Tablets DRUG

Serlopitant Tablets

Also known as: VPD-737

5 mg Serlopitant Tablets

Placebo Tablets DRUG

Placebo Tablets

Matching Placebo Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years or older at consent.
• Prurigo nodularis (PN), with at least ten nodules on at least two different body surface areas.
• 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.
• 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.
• Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
• Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
• Willing and able to comply with study visits and study related requirements including providing written informed consent.

You may not qualify if:

• Prior treatment with serlopitant.
• 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).
• Treatment with any of the following therapies within 4 weeks.
• Other neurokinin-1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant).
• Systemic or topical immunosuppressive/immunomodulatory therapies.
• Systemic therapies with recognized anti-pruritic properties.
• Strong cytochrome-P 3A4 inhibitors.
• Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn.
• Treatment with topical anti-pruritic therapies within 2 weeks.
• Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer.
• Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives, whichever is longer.
• Serum creatinine, total bilirubin, alanine aminotransferase or aspartate aminotransferase \> 2.5 times the upper limit of normal during screening.
• Untreated or inadequately treated thyroid adrenal, or pituitary nodules or disease, or history of thyroid malignancy.
• Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (40)

Study Site 649

Graz, 8036, Austria

Location

Study Site 648

Linz, 4020, Austria

Location

Study Site 650

Vienna, 1130, Austria

Location

Study Site 623

Bad Bentheim, 48455, Germany

Location

Study Site 607

Berlin, 10117, Germany

Location

Study Site 641

Berlin, 10783, Germany

Location

Study Site 600

Bielefeld, 33647, Germany

Location

Study Site 617

Bochum, 44793, Germany

Location

Study Site 608

Bonn, 53127, Germany

Location

Study Site 642

Buxtehude, 21614, Germany

Location

Study Site 606

Dresden, 01307, Germany

Location

Study Site 621

Erlangen, 91054, Germany

Location

Study Site 602

Frankfurt am Main, 60590, Germany

Location

Study Site 639

Hamburg, 22391, Germany

Location

Study Site 605

Heidelberg, 69115, Germany

Location

Study Site 611

Leipzig, 04103, Germany

Location

Study Site 620

Mahlow, 15831, Germany

Location

Study Site 614

Mainz, 55131, Germany

Location

Study Site 601

Münster, 48149, Germany

Location

Study Site 618

Osnabrück, 49074, Germany

Location

Study Site 640

Potsdam, 14467, Germany

Location

Study Site 615

Selters, 56242, Germany

Location

Study Site 643

Stuttgart, 70178, Germany

Location

Study Site 636

Bydgoszcz, 85-065, Poland

Location

Study Site 628

Iwonicz-Zdrój, 38-440, Poland

Location

Study Site 633

Krakow, 30-033, Poland

Location

Study Site 624

Krakow, 31-070, Poland

Location

Study Site 635

Krakow, 31-209, Poland

Location

Study Site 629

Lodz, 90-436, Poland

Location

Study Site 631

Olsztyn, 10-900, Poland

Location

Study Site 625

Osielsko, 86-031, Poland

Location

Study Site 645

Poznan, 60-214, Poland

Location

Study Site 644

Poznan, 60-848, Poland

Location

Study Site 634

Rzeszów, 35-055, Poland

Location

Study Site 638

Szczecin, 70-332, Poland

Location

Study Site 632

Torun, 87-100, Poland

Location

Study Site 627

Warsaw, 02-758, Poland

Location

Study Site 637

Wroclaw, 50-566, Poland

Location

Study Site 630

Wroclaw, 53-301, Poland

Location

Study Site 647

Wroclaw, 53-658, Poland

Location

MeSH Terms

Conditions

Pruritus

Interventions

serlopitant

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Iain Stuart
• Organization: Menlo Therapeutics, Inc.

Iain.Stuart@foamix.com

1-800-775-7936

Study Officials

• Sonja Stander, MD

  Universitätsklinikum Münster Klinik für Hautkrankheiten Zentrale Studienkoordination für innovative Dermaologie (ZID)

  PRINCIPAL INVESTIGATOR

• Jacek Szepietowski, MD, Ph.D

  Lukasz Matusiak 4HEALTH

  PRINCIPAL INVESTIGATOR

• Franz Josef Legat, MD

  Medizinische Universität Graz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: August 29, 2018
• Primary Completion: January 9, 2020
• Study Completion: February 6, 2020
• Last Updated: May 20, 2021
• Results First Posted: October 28, 2020

Record last verified: 2021-05

Locations

AU (3); DE (20); PL (17)