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

Phase 3

Terminated

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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Experimental: 5 mg Serlopitant Tablets	5 mg Serlopitant Tablets	Serlopitant Tablets

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-emergent Adverse Events	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.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (85): Study Site 504
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Birmingham, Alabama, United States
Study Site 204
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Fremont, California, United States
Study Site 383
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North Hollywood, California, United States
Study Site 356
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San Diego, California, United States
Study Site 514
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Santa Ana, California, United States
Study Site 501
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Aventura, Florida, United States
Study Site 210
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Coral Gables, Florida, United States
Study Site 534
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Fort Lauderdale, Florida, United States
Study Site 531
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Miami, Florida, United States
Study Site 222
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North Miami Beach, Florida, United States
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Study Site 504
🇺🇸Birmingham, Alabama, United States