Pruritus associated with prurigo nodularis (PN), atopic dermatitis (AD), or psoriasis MedDRA version: 20.0 Level: PT Classification code 10037087 Term: Pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Menlo Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.) OR 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 =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are to assess the change in severity of pruritus in subjects with PN, AD, or psoriasis using the worst-itch numeric rating scale (WI-NRS); to assess the change in severity and extent of PN using the Investigator’s Global Assessment of PN Stage (IGA PN-S), for those subjects with PN; and to assess whether serlopitant produces physical dependence.;Primary end point(s): The safety endpoints are as follows: • Incidence of TEAEs and SAEs • Change from baseline in clinical laboratory parameters following study drug exposure • Change from baseline in vital sign and ECG parameters following study drug exposure • Change from baseline in the Hospital Anxiety and Depression Scale (HADS) • Change from baseline in the Epworth Sleepiness Scale (ESS) • Assessment of physical dependence following chronic study drug exposure, in the 5 week post-drug discontinuation period. The efficacy endpoints are as follows: • Change from baseline in WI-NRS to Weeks 4, 8, 20, 28, 36, 44, and 52 • Change from baseline in DLQI (symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment) to Weeks 20, 36 and 52 • Change from baseline in IGA PN-S to Weeks 4, 8, 20, 28, 36, 44, and 52 ;Timepoint(s) of evaluation of this end point: Weeks 4, 8, 20, 28, 36, 44, and 52 ;Main Objective: The primary objective of this study is to assess the long-term safety of serlopitant in adults with pruritus associated with PN, AD, or psoriasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): please see section E.5.1;Timepoint(s) of evaluation of this end point: please see section E.5.1 | — |
Countries
Austria, Germany, Poland, United States
Contacts
Public ContactChief Medical Officer
Menlo Therapeutics Inc.
Outcome results
None listed