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

NCT ID: NCT03677401

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2020-02-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5 mg Serlopitant Tablets

Group Type: EXPERIMENTAL

5mg Serlopitant Tablets

Intervention Type: DRUG

Serlopitant Tablets

Matching Placebo Tablets

Group Type: PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type: DRUG

Placebo Tablets

Interventions

5mg Serlopitant Tablets

Serlopitant Tablets

Intervention Type: DRUG

Placebo Tablets

Placebo Tablets

Intervention Type: DRUG

Other Intervention Names

VPD-737

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonja Stander, MD

Role: PRINCIPAL_INVESTIGATOR

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

Jacek Szepietowski, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Lukasz Matusiak 4HEALTH

Franz Josef Legat, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universität Graz

Locations

Study Site 649

Graz, , Austria

Study Site 648

Linz, , Austria

Study Site 650

Vienna, , Austria

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, , Germany

Study Site 636

Bydgoszcz, , Poland

Study Site 628

Iwonicz-Zdrój, , Poland

Study Site 633

Krakow, , Poland

Study Site 624

Krakow, , Poland

Study Site 635

Krakow, , Poland

Study Site 629

Lodz, , Poland

Study Site 631

Olsztyn, , Poland

Study Site 625

Osielsko, , Poland

Study Site 645

Poznan, , Poland

Study Site 644

Poznan, , Poland

Study Site 634

Rzeszów, , Poland

Study Site 638

Szczecin, , Poland

Study Site 632

Torun, , Poland

Study Site 627

Warsaw, , Poland

Study Site 637

Wroclaw, , Poland

Study Site 630

Wroclaw, , Poland

Study Site 647

Wroclaw, , Poland

Countries

Austria; Germany; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004210-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MTI-106

Identifier Type: -

Identifier Source: org_study_id