An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus

Menlo Therapeutics Inc.0 个研究点目标入组 700 人开始时间: 2018年1月12日最近更新: 2020年9月28日

研究概览

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•1. Male or female, age 18 years or older at consent.
•2. Subject reports pruritus in the 24-hour period prior to enrollment and:
•a. Has completed a prior applicable clinical study of serlopitant without an SAE that was assessed as likely related to the study drug (For participants from study TCP-102, the WI-NRS score must be = 7 in the 24-hour period prior to the Baseline visit.)
•b.Has not participated in a prior clinical study of serlopitant and has a clinical diagnosis of PN, AD, or psoriasis, and has a WI-NRS score = 7 in the 24-hour period prior to the Baseline visit, and Sponsor has approved enrollment.
•3. 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, refer to section 7.1.5 for acceptable methods of contraception) from the time of the Baseline visit until 5 weeks after last dose of study drug.
•4. Willing and able (has adequate cognitive ability, in the investigator’s opinion) to comply with study visits and study related requirements including providing written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 350
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 350

•1. Presence of malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
•2. 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.
•3. Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the presence of any medical condition or disability, that, in the investigator’s opinion, could interfere with the assessment of safety in this study or compromise the safety of the subject.
•4. Treatment with any 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 MTI-107.
•5. Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks prior to enrollment.
•6. Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks prior to enrollment (Appendix B).
•7. Currently pregnant or breastfeeding or planning to become pregnant during the study.

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