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.

jRCT Inquiries IQVIA Contact person0 个研究点目标入组 80 人开始时间: 2023年7月26日最近更新: 2023年10月17日

研究概览

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•1.Subjects must have completed the induction treatment study (ABX464-105 or ABX464 106), and subjects' clinical response status must be available.
•2.Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
•3.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.
•4.Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.4. (Contraception) of this protocol.
•5.Subjects must be able and willing to comply with study visits and procedures as per protocol.

•1.Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
•2.Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) 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.
•3.Subjects who plan to participate in other investigational studies during the maintenance study.
•4.Pregnant or breast-feeding women or male subject of a pregnant partner,
•5.Male or female subjects planning a pregnancy within the coming 12 months.
•6.Subjects who have not adhered to abstinence of prohibited and/or concomitant medications.
•7.Any changes in the laboratory values during the induction period that correspond with the following:
•-Hemoglobin <= 8.0 g dL-1
•-Absolute neutrophil count < 750 mm-3
•-Platelets < 100,000 mm-3
•-Creatinine clearance < 60 mL.min-1 (Cockcroft-Gault formula)
•-Total serum bilirubin > 1.5 x ULN
•-Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x

发起方

jRCT Inquiries IQVIA Contact person