A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis - ABX464-107

Abivax0 个研究点目标入组 1,036 人开始时间: 2022年9月22日最近更新: 2024年7月22日

研究概览

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•Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients’ clinical response status must be available., Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1., Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met., Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in the protocol., Subjects must be able and willing to comply with study visits and procedures as per protocol., Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

•Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106)., Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except ulcerative colitis) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study., Subjects who plan to participate in other investigational studies during the maintenance study., Male or female planning a pregnancy within the coming 12 months.

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