EUCTR2017-004210-25-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 1% per year) from the time of the Screening visit until 5 weeks after last dose of study drug. Please refer to Section 7.1.5 for acceptable methods of contraception.
- •8. Willing and able (as demonstrated by a = 70% eDiary completion rate in the two weeks prior to Baseline visit) to complete daily eDiary entries within a consistent timeframe for the duration of the study.
- •9. 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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •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.
研究者
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