EUCTR2018-001219-53-FR进行中（未招募）1 期
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
入选标准
- •1. Individuals diagnosed with PN, defined as the presence of = 20 pruriginous nodules, with predominantly nodular lesions overall.
- •2. Generalized PN, defined as PN lesions with a nodular component involving 2 distinct anatomical areas: for example, either 2 limbs; or a single limb and some axial portion of the body. Individuals with only axial lesions with 2 distinct anatomical areas of involvement, that have no peripheral nervous system overlap, are also eligible: for example, lesions involving a portion of the cranium and a portion of the trunk of the body. For purposes of this study, the axial portion will be defined as any non-appendicular portion of the body.
- •3. WINRS score, recorded daily over the 7 contiguous days prior to the baseline visit via electronic diary, must have at least 5 measurements recorded and all individual measurements must be = 6. The arithmetic mean value of the measurements must be = 7. If necessary, the last WINRS value used in the calculation may be recorded on the day of the baseline visit as long as it occurs prior to dosing.
- •4. Subjects using antidepressant and/or neuroleptic medications must be on a stable dose for a minimum of 8 weeks prior to signing consent and must be willing to remain on their stable dose for the entire duration of the study.
- •5. Subjects who are human immunodeficiency virus (HIV) positive may enroll if they meet the following criteria: (a) currently on a stable (> 6 months stable use) and well tolerated highly active antiretroviral therapy regimen; (b) CD4 count > 500 cells/mL; and (c) HIV ribonucleic acid (RNA) < 50 copies/mL documented for at least 6 months prior to enrollment. If enrolled, these subjects should continue to have their CD4 and HIV RNA monitored by their HIV provider per their standard of care for the duration of the TR11 study, and the data should be reported and documented at the next study visit.
- •6. Males, non-fecund females, or females of childbearing potential using an acceptable method of birth control (if sexually active). All females of childbearing potential must have a negative pregnancy test at the screening and baseline visits.
- •For the purpose of this study, all females are considered to be of childbearing potential unless they are postmenopausal (i.e., at least 1 year since last menses and age > 50 years) or surgically sterile (i.e.,
- •tubal ligation, hysterectomy, and/or bilateral oophorectomy).
- •Sexually active female subjects of childbearing potential are required to use 1 barrier method (e.g., condom, cervical cap, or diaphragm) of contraception in addition to 1 other method (e.g., intrauterine device in place at least 1 month, stable hormonal contraception for at least 3 months, or Essure procedure, or spermicide). For female subjects using a barrier method plus spermicide, that method must be used for at least 14 days prior to screening.
- •Female subjects who are abstinent may participate in the study, however; they must be counseled on the requirement to use appropriate contraception should they become sexually active. This counseling should occur at each study visit and must be documented in source records.
- •7. Age 18 years and older at the time of consent, and a life expectancy of at least 18 months.
- •8. Willing and able to understand and
排除标准
- •1. Pruritus due to localized PN (only 1 body part affected, for example only 1 arm).
- •2. Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic dermatitis, or bullous pemphigoid for example) or other dermatologic conditions that in the opinion of the Investigator could confound the ability to assess PN-related itch.
- •3. Prurigo Nodularis associated with a history of atopic dermatitis is excluded if acute eczematous lesions are present, as characterized by erythematous, active-predominant lichenified plaques with oozing and crusting.
- •4. Major psychiatric disorder, which in the opinion of the Investigator, could interfere with the assessment of anti-pruritic efficacy and/or safety events during the study or with the ability of the subject to cooperate with study requirements.
- •5. Serum bilirubin > 2.5 × upper limit of normal range at screening unless explained by a clinical diagnosis of Gilbert's Syndrome.
- •6. Serum hepatic alanine aminotransferase or aspartate aminotransferase enzymes > 100 U/L at screening.
- •7. Estimated glomerular filtration rate = 44 mL/min/1.73 m^2 at screening.
- •8. Significant medical condition or other factors that in the opinion of the Investigator may interfere with the conduct of the study.
- •9. Subjects who have an active malignancy (either solid tumor or hematologic) are excluded. Subjects who have a past history of malignancy and who have no evidence of active disease, but who continue on therapy to prevent disease recurrence (i.e., tamoxifen for breast cancer, testosterone blockade for prostate cancer, etc.), may be eligible if approved by the Medical Monitor.
- •10. History of substance abuse which as determined by the Investigator may interfere with the conduct of the study.
- •11. Known intolerance of or hypersensitivity or allergy to nalbuphine or vehicle components.
- •12. Pregnant or lactating females.
- •13. Concurrent enrollment in an ongoing clinical trial or anticipated enrollment in a concurrent clinical trial.
- •Medication-related Exclusions:
- •14. Known intolerance (gastrointestinal, central nervous system symptoms) or hypersensitivity/drug allergy to opioids.
- •15. Potential subjects taking monoamine oxidase inhibitors are excluded, as concomitant opiate use may increase the risk for serotonin syndrome.
- •16. Potential subjects taking cyclosporin A are excluded unless they undergo a 6-week washout prior to beginning the screening period.
- •Washout should occur after signing informed consent, if done for study participation purposes, and prior to electronic diary (e-diary) WINRS collection. WINRS collection should not take place prior to 6 weeks after discontinuation of cyclosporin A. Subjects are prohibited from using cyclosporin during the study.
- •17. Potential subjects taking biologics (including monoclonal antibodies), which modify the immune system, are excluded unless they undergo a 3-month washout prior to beginning the screening period.
- •Washout should occur after signing informed consent, if done for study participation purposes, and prior to e-diary WINRS collection.
- •18. Potential subjects who have previously received dupilumab or nemoliz
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