JPRN-jRCT2011230021招募中4 期
[M22-000]A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis - A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis
Yamazaki Hayato0 个研究点目标入组 454 人开始时间: 2023年7月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 454
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
- >= 18age old 至 <= 64age old（—）
入选标准
- •Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria.
- •- Eczema Area and Severity Index (EASI) score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area(BSA) of AD involvement at the Baseline Visit.
- •- Baseline weekly average of daily Worst Pruritus NRS >=4.
- •- Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical treatments are otherwise medically inadvisable.
排除标准
- •- Participants with current or past history of infection including:
- •--Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
- •-- One or more episodes of disseminated herpes simplex (including eczema herpeticum);
- •--Human immunodeficiency virus (HIV) infection defined as confirmed positive anti-HIV antibody (HIV Ab) test;
- •-- Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified requirements for TB testing);
- •-- Japan only: Positive result of beta-D-glucan (screening for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;
- •-- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular
- •anti-infectives within 14 days prior to the Baseline Visit;
- •-- Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study;
- •-- COVID-19 infection: In participants who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other
- •symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last).
- •Participants may be rescreened if judged to be in good general health, as determined by the investigator based upon the medical history and physical examination.
- •- Evidence of Hepatitis B virus (HBV) or Hepatitis C virus(HCV).
- •- Any of the following medical diseases or disorders:
- •-- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery;
- •-- History of an organ transplant which requires continued immunosuppression;
- •-- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
- •-- History of gastrointestinal perforation (other than due to appendicitis or mechanical injury), diverticulitis, or
- •significantly increased risk for gastrointestinal perforation per investigator judgment;
- •-- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or
- •gastric bypass surgery; participants with a history of gastric banding/segmentation are not excluded;
- •-- History of malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
研究者
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