CTIS2022-503062-72-00招募中1 期
Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria - INCB 54707-207
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 136
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
- •Ability to comprehend and willingness to sign a written ICF for the study., Age 18 to 65 years inclusive at the time of signing the ICF., CSU diagnosis for = 3 months prior to screening., CSU refractory to second-generation H1 antihistamines as defined in section 5.1, line 4 of the protocol., Willingness and ability to comply with the study Protocol and procedures., Willingness and ability to complete daily eDiary for the duration of the study., Agreement to use contraception (as per section 5.1 of the protocol).
排除标准
- •Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening., Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data., Clearly defined predominant or sole trigger of chronic urticaria (chronic inducible urticaria) including urticaria factitial (symptomatic demographism), cold-, heat-, solar-, pressure-, delayed pressure–, aquagenic, cholinergic-, or contact-urticaria., Other cutaneous or systemic diseases with symptoms of urticaria or angioedema., Other skin or systemic diseases associated with chronic itching (eg, AD, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis) that, in the investigator's opinion, might influence the study evaluations and results., Women who are pregnant (or who are considering pregnancy) or breastfeeding., Concurrent conditions or history of other diseases (as per section 5.2 of the protocol)., A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute MI, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff-Parkinson-White syndrome) or criteria associated with Q wave interval (QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities., Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit., History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit., Participants who have any form of dependence on the sponsor, investigator, or study site (including financial) and participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities., History of treatment failure with any systemic or topical JAK inhibitor (eg, abrocitinib, baricitinib, brepocitinib, cerdulatinib, delgocitinib, deucravacitinib, filgotinib, ivarmacitinib, pacritinib, ritlecitinib, ropsacitinib, ruxolitinib, tofacitinib, upadacitinib) for CSU or any other inflammatory condition., Receipt of medical treatment or investigational drugs within the intervals (specified in section 5.2 of the protocol) before the baseline visit (Day 1)., Concurrent enrollment in another clinical study., At the screening visit, any of the laboratory abnormalities defined in Table 6 of section 5.2 of the protocol., Evidence of infection with Mycobacterium tuberculosis (ie, TB)., Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test., Evidence of HBV or HCV infection or risk of reactivation., Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class
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