EUCTR2019-004739-22-DE进行中（未招募）1 期
Efficacy of ruxolitinib cream in Prurigo nodularis patients: A randomized, placebo-controlled pilot study (PRUX)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Subjects will only be included in the study if they meet all of the following criteria:
- •1) Age =18 years
- •2) Written informed consent of the subject for voluntary participation in the study.
- •3) Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •4) Patients with clinically confirmed symptomatic Prurigo nodularis
- •5) Lesions involve body surface area of at least 4.5% up to a maximum of 36% (according to the rule of nine”(1), APPENDIX Figure 1)
- •6) Numeric Rating Scalevalue for average itch (Itch NRS) of at least 4.0 (4.0-10.0) during the past 24 hours before screening
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Subjects will not be included in the study if any of the following criteria applies:
- •1) Patients without legal capacity or unable to understand the nature, scope, significance and consequences of this clinical trial
- •2) Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical trial or may prevent sufficient compliance
- •3) Known or persistent abuse of medication, drugs or alcohol within 365 days prior to screening
- •4) Change in systemic or topical treatment of prurigo nodularis within the last 14 days before screening (care products and topical immunomodulators excluded, topical immunomodulators have to be stopped 7 days before screening )
- •5) Known hypersensitivity to any component of the formulation of the IMP
- •6) Chronic or acute infectious disease (including HIV, Hepatitis B or C infection), disease predisposing for infectious disease or recurring infectious diseases in the history, except for patients with stable chronic Hepatitis B or C as long as their liver values are within normal limits (ULN = 3)
- •7) Patients with a current diagnosis of a solid malignant tumor or a history of a solid malignant tumor within the last 5 years (patients with heaemato-oncological malignancies can be included, patients with basal-cell-carcinoma of the skin can be included, patients with a history of a solid malignant tumor in remission for > 5 years can be included).
- •8) Patients treated within the last 4 weeks before baseline with oral ruxolitinib or any other JAK-specific inhibitor
- •9) Women who are pregnant or breast-feeding
- •10) Patients with reproductive potential who do not accept to use contraception or to adhere to sexual abstinence during the trial and 30 days thereafter
- •11) Prior treatment with an IMP in a different clinical trial either less than 30 days or if not yet reached a minimum of a 5-fold terminal elimination halflife of the respective IMP or one of it's metabolites. The longer of the respective periods shall be applied.
- •12) Neutrophil count less than lower limit of normal, hemoglobin concentration < 10 g/dL, and platelet count < 100 G/l
- •13) Presence of cytopenia (defined as leucocyte count < 3 G/l) - depending on the physician's assessment
- •14) Lymphocyte count < 0.8 G/l - depending on the physician's assessment
研究者
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