EUCTR2018-001219-53-AT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
- 360
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. Individuals diagnosed with generalized PN, defined as the presence of = 10 pruriginous nodules, involving at least 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 but involving 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.
- •2. If there is any history of a primary pruritic skin condition other than PN, that condition must have been inactive for at least 6 months prior to screening.
- •3. Subjects with a history of acute secondary dermatoses within the preceding 6 months may enroll only if the dermatosis has resolved completely as follows per medical history or patient self-report and current clinical assessment: (a) Localized contact dermatitis, environmental exposures, superficial burns, or viral exanthems must have been resolved for at least 4 weeks prior to screening. (b) Skin or environmental infestations, such as scabies, lice, or bed bugs, must have been resolved for at least 8 weeks prior to screening.
- •4. Any identified systemic, non-dermatologic disease that could be a potential cause of concomitant pruritus (e.g., thryroid disease, celiac disease, hepatitis C virus [HCV]) must either have resolved, been successfully treated (i.e., HCV RNA negative), or must be successfully managed with stable, optimized treatment (e.g., thyroid replacement, dietary management with resolution of symptoms, respectively) for at least 3 months prior to screening.
- •5. WI-NRS score, recorded daily over the 7 contiguous days prior to and including the days of 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 as confirmed by the Trialogics Eligibility Check report immediately prior to randomization. The last WI-NRS value used in the calculation should be recorded on the day of the baseline visit and prior to dosing.
- •6. Subjects using antidepressant must be on a stable dose for a minimum of 4 weeks prior to screening and must be willing to remain on their stable dose for the entire duration of the study.
- •7. 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.
- •8. Females of childbearing potential must be using an acceptable method of birth control (if sexually active) for 14 days prior to randomization and throughout the study. 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 su
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).
- •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. History of a major psychiatric disorder such as bipolar disorder or schizophrenia is excluded. Subjects with a history of isolated major
- •depression > 3 years previously may be eligible for enrollment if they have access to appropriate psychiatric care. An isolated major depression is defined as a single event of depression that includes recurrent thoughts of death, recurrent suicidal ideation with or without a specific plan, or any history of a suicide attempt. Enrollment must be approved by the Medical Monitor.
- •5. Serum bilirubin > 1.5 × 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, occupational restrictions, and/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 active substance abuse within the past 3 years.
- •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 (other than safety follow-up of a COVID-19 vaccination trial, see protocol for further information).
- •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. Subjects are prohibited from using cyclosporin during the study.
- •17. Potential subjects taking non insulin biologics (including monoclonal antibodies), which modify the immune system, are excluded unless they undergo a 3-month washout.
- •18. Prior exclusion criterion 18 is not applicable to subjects enrolling in Protocol V6 and later.
- •19. Exposure to any investigational medication, including placebo requires a 4-week washout (3 months for non insulin biologics[e.g., monoclonal antibodies]).
- •20. Potential subjects receiving UV-therapy (PUVA, UVA, UVB, Excimer) requires a 4-week washout. Subjects are prohibited from using UV-therapy for the duration of the study.
- •21. Potential subjects who are taking opiates require a 14 - days washout. Subjects are prohibited from using opioids,
- •including naltrexone, for the duration of the study.
- •22. Potential subjects cannot have received g
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