Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

NCT03540160 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: MTI-1072017-004211-40
• Study Type: interventional
• Target: 558
• Locations: 4 countries
• Sites: 85

Brief Summary

Study of the long term safety of serlopitant for the treatment of pruritus in adults.

Conditions

Pruritus; Prurigo Nodularis; Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-emergent Adverse Events

  Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.

  From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.

Study Arms (1)

Experimental: 5 mg Serlopitant Tablets

EXPERIMENTAL

Serlopitant Tablets

Drug: 5 mg Serlopitant Tablets

Interventions

5 mg Serlopitant Tablets DRUG

Serlopitant Tablets

Also known as: VPD-737

Experimental: 5 mg Serlopitant 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.
• Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
• 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 comply with study visits and study related requirements including providing written informed consent.

You may not qualify if:

• Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
• Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
• Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
• Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
• Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
• Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
• Currently pregnant or breastfeeding or planning to become pregnant during the study.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (85)

Study Site 504

Birmingham, Alabama, 35233, 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 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 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 343

Spartanburg, South Carolina, 29303, United States

Location

Study Site 511

Knoxville, Tennessee, 37317, 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 226

Webster, Texas, 77598, United States

Location

Study Site 336

Richmond, Virginia, 23220, United States

Location

Study Site 806

Spokane, Washington, 99202, United States

Location

Study Site 532

Morgantown, West Virginia, 26505, United States

Location

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 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; Dermatitis, Atopic; 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, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Limitations and Caveats

Due to a corporate decision to no longer pursue an indication of treatment for pruritus, and further to terminate the development program for serlopitant, the study was terminated prematurely.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 30, 2018
• Study Start: March 15, 2018
• Primary Completion: April 8, 2020
• Study Completion: June 17, 2020
• Last Updated: May 20, 2021
• Results First Posted: November 30, 2020

Record last verified: 2021-05

Locations

US (46); DE (19); PL (17); AU (3)