A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)

Gilead Sciences0 个研究点目标入组 176 人开始时间: 待定最近更新: 2024年7月9日

试验速览

暂无简介。

•UC of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
•Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).
•Previous treatment history of approved UC therapy with at least one of the following advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action:
•a.TNFa inhibitor
•b.IL-12/23 inhibitor
•c.Leukocyte trafficking modulator
•d.Janus kinase inhibitor

•Current diagnosis of CD or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
•Participants with disease limited to the rectum during screening endoscopy.
•Participants who are pregnant, breastfeeding, intend to become pregnant, or are of childbearing potential
•Known hypersensitivity to the study drug, its metabolites, or formulation excipient.

Clinical Response

未报告次要终点

发起方