18424-326: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis - INCB 18424-326

Incyte Corp.0 个研究点目标入组 225 人开始时间: 2024年3月28日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Incyte Corp.
入组人数: 225

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Adults aged = 18 years at screening., Agree to discontinue all agents used to treat AD from screening through the final follow-up visit, except as outlined in Section 6.6.2 and Section 6.6.3 of the protocol., Willingness to avoid pregnancy or fathering children based on the criteria: Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last application of study cream and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first application of study cream on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last application of study cream and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. Female participants not considered to be of childbearing potential are eligible., Ability to comprehend and willingness to sign an ICF., Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria., AD duration of at least 2 years., IGA score of 3 at screening and Day 1., EASI score > 7 at screening and Day 1., Itch NRS score = 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days., %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1., DLQI score > 10 at screening and Day 1., Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs (as stated in Section 6.6.1 in the protocol).

排除标准

•Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1., Removed during Protocol Amendment 1., Known allergy or reaction to any component of the study cream formulation., In the opinion of the investigator, are unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance)., Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities., Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigator or are otherwise dependents of them., The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code., In the EU, participants considered incapacitated (according to CTR Article 31)., Concurrent conditions and history of other diseases as follows: Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome); Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1; Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1; Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety, etc., Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example: Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months before Day 1; New York Heart Association Class III or IV congestive heart failure; or arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless approved by the medical monitor/sponsor; History of malignancy in the 5 years preceding Day 1, except for adequately treated, nonmetastatic, nonmelanoma skin cancer; Current and/or history of arterial or venous thrombosis, including deep venous thrombosis and pulmonary embolism, etc., Any of the following clinical laboratory test results at screening: Hemoglobin < 10 g/dL, Liver function tests: AST or ALT = 2 × ULN, Alkaline phosphatase > 1.5 × ULN, Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) with the exception of Gilbert's disease, etc., Use of any of the following treatments within the indicated washout period before Day 1: 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor; 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate

研究者

发起方

Incyte Corp.

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