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

Stopped early · Phase 3

Conditions studied: Pruritus, Prurigo Nodularis, Atopic Dermatitis, Psoriasis

In brief

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

Key facts

Study ID

NCT03540160

Run by

Vyne Therapeutics Inc.

People needed

558

Starts

2018-03-15

Expected to finish

2020-06-17

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study Site 204 — Fremont, California, United States
• Study Site 383 — North Hollywood, California, United States
• Study Site 356 — San Diego, California, United States
• Study Site 514 — Santa Ana, California, United States
• Study Site 501 — Aventura, Florida, United States
• Study Site 210 — Coral Gables, Florida, United States
• Study Site 534 — Fort Lauderdale, Florida, United States
• Study Site 531 — Miami, Florida, United States
• Study Site 222 — North Miami Beach, Florida, United States
• Study Site 510 — Newnan, Georgia, United States
• Study Site 388 — Skokie, Illinois, United States
• Study Site 228 — Louisville, Kentucky, United States
• Study Site 527 — New Orleans, Louisiana, United States
• Study Site 525 — Glenn Dale, Maryland, United States
• Study Site 506 — Ann Arbor, Michigan, United States
• Study Site 515 — Detroit, Michigan, United States
• Study Site 371 — Saint Joseph, Missouri, United States
• Study Site 528 — St Louis, Missouri, United States
• Study Site 227 — Omaha, Nebraska, United States
• Study Site 526 — Henderson, Nevada, United States
• Study Site 201 — East Windsor, New Jersey, United States
• Study Site 529 — Verona, New Jersey, United States
• Study Site 507 — Brooklyn, New York, United States
• Study Site 508 — Buffalo, New York, United States
• Study Site 504 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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