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

NCT03546816 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MTI-105
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 49

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 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 Outcomes (9)

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

  At Week 4

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

  At Weeks 2, 4, and 10

• Change From Baseline in Investigator's Global Assessment of Prurigo Nodularis Activity (IGA PN-A) to Weeks 2, 4, and 10

  At Weeks 2, 4, and 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 (49)

Study Site 504

Birmingham, Alabama, 35233, United States

Location

Study Site 533

Rogers, Arkansas, 72758, United States

Location

Study Site 204

Fremont, California, 94538, United States

Location

Study Site 383

North Hollywood, California, 91606, United States

Location

Study Site 356

San Diego, California, 92108, United States

Location

Study Site 514

Santa Ana, California, 92701, United States

Location

Study Site 501

Aventura, Florida, 33180, United States

Location

Study Site 210

Coral Gables, Florida, 33134, United States

Location

Study Site 534

Fort Lauderdale, Florida, 33316, United States

Location

Study Site 531

Miami, Florida, 33155, United States

Location

Study Site 530

Miami, Florida, 33165, United States

Location

Study Site 222

North Miami Beach, Florida, 33162, United States

Location

Study Site 510

Newnan, Georgia, 30263, United States

Location

Study Site 388

Skokie, Illinois, 60077, United States

Location

Study Site 228

Louisville, Kentucky, 40202, United States

Location

Study Site 527

New Orleans, Louisiana, 70115, United States

Location

Study Site 525

Glenn Dale, Maryland, 20769, United States

Location

Study Site 379

Boston, Massachusetts, 02114, United States

Location

Study Site 506

Ann Arbor, Michigan, 48103, United States

Location

Study Site 515

Detroit, Michigan, 48202, United States

Location

Study Site 371

Saint Joseph, Missouri, 64506, United States

Location

Study Site 528

St Louis, Missouri, 63110, United States

Location

Study Site 227

Omaha, Nebraska, 68144, United States

Location

Study Site 526

Henderson, Nevada, 89052, United States

Location

Study Site 201

East Windsor, New Jersey, 08520, United States

Location

Study Site 529

Verona, New Jersey, 07044-2946, United States

Location

Study Site 507

Brooklyn, New York, 11203, United States

Location

Study Site 508

Buffalo, New York, 14221, United States

Location

Study Site 500

New York, New York, 10025, United States

Location

Study Site 517

New York, New York, 10075, United States

Location

Study Site 341

High Point, North Carolina, 27262, United States

Location

Study Site 516

Bexley, Ohio, 43209, United States

Location

Study Site 509

Cleveland, Ohio, 44106, United States

Location

Study Site 524

Dublin, Ohio, 43016, United States

Location

Study Site 112

Tulsa, Oklahoma, 74136, United States

Location

Study Site 523

Philadelphia, Pennsylvania, 19104, United States

Location

Study Site 522

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Site 345

Johnston, Rhode Island, 02919, United States

Location

Study Site 511

Knoxville, Tennessee, 37317, United States

Location

Study Site 805

Nashville, Tennessee, 37215, United States

Location

Study Site 365

Austin, Texas, 78745, United States

Location

Study Site 520

Bellaire, Texas, 77401, United States

Location

Study Site 502

Dallas, Texas, 75231, United States

Location

Study Site 224

Houston, Texas, 77004, United States

Location

Study Site 359

Pflugerville, Texas, 78660, United States

Location

Study Site 361

San Antonio, Texas, 78213, United States

Location

Study Site 226

Webster, Texas, 77598, United States

Location

Study Site 806

Spokane, Washington, 99202, United States

Location

Study Site 532

Morgantown, West Virginia, 26505, United States

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, PhD
• Organization: Menlo Therapeutics Inc.

Iain.Stuart@foamix.com

1- 800-775-7936

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: May 23, 2018
• First Posted: June 6, 2018
• Study Start: May 2, 2018
• Primary Completion: January 14, 2020
• Study Completion: February 14, 2020
• Last Updated: May 20, 2021
• Results First Posted: September 7, 2020

Record last verified: 2021-05

Locations

US (49)