A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675]

AbbVie GK0 个研究点目标入组 522 人开始时间: 2018年9月28日最近更新: 2023年10月17日

试验速览

阶段: 3 期
状态: 已完成
发起方: AbbVie GK
入组人数: 522

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

Achieved statistically significant improvements in efficacy primary endpoint in UPA vs PBO. The treatment was well tolerated; AEs were consistent with the known safety profile of UPA with no new safety signals identified.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 16age old 至 <= 75age old（—）
性别: All

入选标准

•Diagnosis of Ulcerative Colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
•- Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
•- Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
•- Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
•- If female, participant must meet the contraception recommendation criteria.

排除标准

未提供

研究者

发起方

AbbVie GK

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