Pruritus in adults with prurigo nodularis (PN) 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. A diagnosis of PN, defined by the presence of at least ten pruriginous nodules secondary to chronic pruritus present on at least two different body surface areas (e.g. both arms, one arm and one leg, one arm and the anterior trunk, or anterior and posterior trunk). 3. The worst pruritus is identified to be within the areas of the PN lesions. 4. Subject has idiopathic PN OR the subject has an identified pruritic condition associated with the PN and has persistent pruritus despite at least 6 weeks of optimized and stable treatment of the underlying condition prior to the Baseline visit, and is willing to continue the treatment during the study. Please refer to Section 5.7.1. 5. WI-NRS score = 7 in the 24-hour period prior to the Screening visit. 6. Average weekly WI-NRS score = 6.5 in each of the 2 weeks (14 days) immediately prior to Baseline visit, as recorded in the eDiary. 7. 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 140
Exclusion criteria
Exclusion criteria: 1. Prior treatment with serlopitant. 2. Active pruritic skin disease, other than PN, within 6 months prior to randomization (with the exception of acute dermatoses such as contact dermatitis, sunburn, viral exanthem, which have been resolved for longer than 4 weeks). 3. Treatment with any of the following therapies within 4 weeks prior to randomization. a. Other NK1-R antagonists (e.g., aprepitant, fosaprepitant, rolapitant). b. Systemic or topical immunosuppressive/immunomodulatory therapies (including but not limited to corticosteroids, phosphodiesterase-4 (PDE-4) inhibitors, cyclosporine, mycophenolate-mofetil, tacrolimus, pimecrolimus, calcipotriene, methotrexate, azathioprine, interferon-gamma, thalidomide, or phototherapy). c. Systemic therapies with recognized anti-pruritic properties (including but not limited to H1 antihistamines, doxepin, gabapentin, pregabalin, cannabinoids, kappa-opioid receptor agonists, and mu-opioid receptor antagonists (e.g. naloxone, naltrexone)). d. Strong CYP3A4 inhibitors e. Use of an indoor tanning facility, or natural sun exposure resulting in significant tanning or sunburn. 4. Treatment with topical anti-pruritic therapies (e.g., menthol, camphor, pramoxine, capsaicin) within 2 weeks prior to randomization 5. Treatment with biologic therapies within 8 weeks or 5 half-lives prior to randomization, whichever is longer. 6. Treatment with any investigational therapy within 4 weeks (8 weeks for investigational biologic therapies) or 5 half-lives prior to randomization, whichever is longer. 7. Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) during screening. 8. Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy. 9. History of malignancy within 5 years prior to randomization, with the exception of actinic keratosis, completely treated and non-metastatic cutaneous basal cell carcinoma or squamous cell carcinoma of the skin. 10. 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 randomization. 11. Suicidal ideation within 3 years prior to randomization, or any history of suicide attempt. 12. Documented history of parasitic infection, including skin parasites such as scabies, within 8 weeks prior to randomization. 13. Presence of any medical condition or disability that, in the investigator’s opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. 14. History of hypersensitivity to serlopitant or any of its components. 15. Currently pregnant or breastfeeding female subject. 16. Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g. extended international travel) during the subject’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy objective of this study is to assess the efficacy of serlopitant for the treatment of pruritus in adults with prurigo nodularis. The safety objective is to assess the safety and tolerability of repeated oral doses of serlopitant in adults with prurigo nodularis.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is the Worst-Itch Numeric Rating Scale (WI-NRS) 4-point responder rate ;Timepoint(s) of evaluation of this end point: week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoints are as follows: • WI-NRS 4-point responder rate at Week 4 • WI-NRS 4-point responder rate at Week 2 Additional secondary efficacy endpoints are as follows: • Change from baseline in WI-NRS to other timepoints • WI-NRS 3-point responder rate at Weeks 2, 4 and 10 • Change from baseline in Dermatology Life Quality Index (DLQI) to Week 10 • Change from baseline in DLQI Question 1 to Week 10 • Change from baseline in Investigator’s Global Assessment of PN Activity (IGA PN-A) to Weeks 2, 4 and 10 • Change from baseline in Investigator’s Global Assessment of PN Stage (IGA PN-S) to Weeks 2, 4 and 10;Timepoint(s) of evaluation of this end point: please see section E.5.2 | — |
Countries
Austria, Germany, Poland
Contacts
Public ContactChief Medical Officer
Menlo Therapeutics Inc.
Outcome results
None listed