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

NCT03343639 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MTI-109
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 39

Brief Summary

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus in adults with plaque psoriasis

Conditions

Pruritus; Psoriasis

Outcome Measures

Primary Outcomes (1)

• WI-NRS 4-point Responder Rate at Week 8

  Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 8.

  8 weeks

Secondary Outcomes (3)

• WI-NRS 4-point Responder Rate at Week 4

  4 weeks

• Change in WI-NRS From Baseline to Day 7

  Change from baseline to day 7

• Change in WI-NRS From Baseline to Day 3

  3 days

Study Arms (2)

5 mg Serlopitant Tablets

EXPERIMENTAL

Serlopitant Tablets

Drug: 5 mg Serlopitant Tablets

Matching Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Matching Placebo Tablets

Interventions

5 mg Serlopitant Tablets DRUG

Serlopitant Tablets

Also known as: VPD-737

5 mg Serlopitant Tablets

Matching Placebo Tablets DRUG

Placebo Tablets

Matching Placebo Tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18-80 years at consent.
• Diagnosis of plaque psoriasis for at least 6 months prior to randomization.
• a. Presence of plaque psoriasis in any anatomic location, covering ≤ 10% BSA in total, at the Screening and Baseline visits.
• Pruritus of at least 4 weeks' duration prior to the initial Screening visit, and throughout the screening period prior to randomization.
• Subjects must be willing to discontinue use of all psoriasis therapies other than the following, for the duration of the study: bland emollients (e.g., Cetaphil, Eucerin, Aquaphor) on any anatomic location; coal tar shampoos, limited to use on scalp.
• WI-NRS initial screening score consistent with severe pruritus.
• WI-NRS scores during the 2 weeks of screening consistent with sever pruritus.
• All female subjects who are of childbearing potential must be willing to practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of \< 1% per year) from the time of the initial Screening visit until 2 weeks after last dose of study drug.
• Weight ≥ 32 kg at the Screening and Baseline visits.
• Willing and able to complete daily eDiary entries within a consistent timeframe for the duration of the study.
• Subjects must have ≥ 80% eDiary completion rate during the two weeks of the screening period immediately prior to randomization.

You may not qualify if:

• Prior treatment with serlopitant.
• a. Prior treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) is not allowed within 1 year prior to randomization.
• Clinical worsening of psoriasis in the opinion of the investigator (e.g., increase in affected BSA or severity requiring use of systemic psoriasis therapies) within 12 weeks prior to randomization.
• Predominance of non-plaque forms of psoriasis (e.g., guttate, drug-induced, pustular, erythrodermic).
• Presence of any concurrent medical condition that provides a clearly defined etiology for pruritus other than psoriasis. These include but are not limited to urticaria, atopic dermatitis or other dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, untreated hyperthyroidism, and infection.
• Treatment with systemic biologic therapies including but not limited to etanercept, infliximab, adalimumab, ustekinumab, secukinumab, or ixekizumab, within 6 months or 5 half-lives (whichever is longer) prior to randomization.
• Treatment with systemic non-biologic psoriasis therapies, including but not limited to systemic corticosteroids, phosphodiesterase-4 inhibitors, Janus kinase inhibitors, cyclosporine, methotrexate, retinoids, hydroxyurea, mycophenolate mofetil, thioguanine, sirolimus, azathioprine, or fumaric acid derivatives, within 12 weeks prior to randomization.
• Treatment with any of the following therapies within 4 weeks prior to randomization:
• i. Non-systemic corticosteroids that do not involve skin application (e.g., inhaled, intranasal, or intra-articular corticosteroids) will be permitted.
• b. Phototherapy, with or without psoralen. c. Use of an indoor tanning facility, or sun exposure likely to result in sunburn.
• d. Systemic therapies with recognized anti-pruritic properties including but not limited to H1 antihistamines, doxepin, mirtazapine, gabapentin, pregabalin, cannabinoids, and kappa opioid receptor agonists.
• e. Any topical anti-pruritic therapies, including but not limited to H1 antihistamines, doxepin, capsaicin, or medicated emollients (e.g., menthol or pramoxine).
• f. Strong CYP3A4 inhibitors.
• Treatment with any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
• Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x the upper limit of normal (ULN) during screening.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (39)

Study Site 221

Bryant, Arkansas, 72022, United States

Location

Study Site 220

Beverly Hills, California, 90212, United States

Location

Study Site 204

Fremont, California, 94538, United States

Location

Study Site 356

San Diego, California, 92108, United States

Location

Study Site 202

San Diego, California, 92123, United States

Location

Study Site 215

San Diego, California, 92123, United States

Location

Study Site 376

Santa Monica, California, 90404, United States

Location

Study Site 212

Clearwater, Florida, 33761, United States

Location

Study Site 210

Coral Gables, Florida, 33134, United States

Location

Study Site 331

Miami, Florida, 33144, United States

Location

Study Site 348

Miami, Florida, 33165, United States

Location

Study Site 222

North Miami Beach, Florida, 33162, United States

Location

Study Site 206

Sanford, Florida, 32771, United States

Location

Study Site 213

Boise, Idaho, 83704, United States

Location

Study Site 360

New Albany, Indiana, 47150, United States

Location

Study Site 207

South Bend, Indiana, 46617, United States

Location

Study Site 228

Louisville, Kentucky, 40202, United States

Location

Study Site 216

Louisville, Kentucky, 40241, United States

Location

Study Site 506

Ann Arbor, Michigan, 48103, United States

Location

Study Site 219

Clinton Township, Michigan, 48038, United States

Location

Study Site 209

Fridley, Minnesota, 55432, United States

Location

Study Site 371

Saint Joseph, Missouri, 64506, United States

Location

Study Site 227

Omaha, Nebraska, 68144, United States

Location

Study Site 201

East Windsor, New Jersey, 08520, United States

Location

Study Site 375

Forest Hills, New York, 11375, United States

Location

Study Site 500

New York, New York, 10023, United States

Location

Study Site 516

Bexley, Ohio, 43209, United States

Location

Study Site 211

Broomall, Pennsylvania, 19008, United States

Location

Study Site 345

Johnston, Rhode Island, 02919, United States

Location

Study Site 205

Murfreesboro, Tennessee, 37130, United States

Location

Study Site 182

College Station, Texas, 77845, United States

Location

Study Site 224

Houston, Texas, 77004, United States

Location

Study Site 359

Pflugerville, Texas, 78660, United States

Location

Study Site 339

Plano, Texas, 75024, United States

Location

Study Site 203

San Antonio, Texas, 78218, United States

Location

Study Site 223

Sugar Land, Texas, 77479, United States

Location

Study Site 226

Webster, Texas, 77598, United States

Location

Study Site 217

Norfolk, Virginia, 23502, United States

Location

Study Site 336

Richmond, Virginia, 23220, United States

Location

Related Publications (1)

• Pariser DM, Bagel J, Lebwohl M, Yosipovitch G, Chien E, Spellman MC. Serlopitant for psoriatic pruritus: A phase 2 randomized, double-blind, placebo-controlled clinical trial. J Am Acad Dermatol. 2020 Jun;82(6):1314-1320. doi: 10.1016/j.jaad.2020.01.056. Epub 2020 Jan 30.

  PMID: 32007513 DERIVED

MeSH Terms

Conditions

Pruritus; Psoriasis

Interventions

serlopitant

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paul Kwon
• Organization: Chief Scientific Officer

pkwon@menlotx.com

650-486-1416

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 10, 2017
• First Posted: November 17, 2017
• Study Start: November 1, 2017
• Primary Completion: October 23, 2018
• Study Completion: November 12, 2018
• Last Updated: May 20, 2021
• Results First Posted: June 12, 2019

Record last verified: 2021-05

Locations

US (39)