2022-500537-84-00撤回3 期
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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Abivax
- 入组人数
- 339
- 试验地点
- 84
- 主要终点
- Proportion of subjects in clinical remission at Week 44.
研究概览
简要总结
To evaluate the efficacy of ABX464 versus placebo on clinical remission.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of subjects in clinical remission at Week 44.
Proportion of subjects in clinical remission at Week 44.
次要结局
- Proportion of subjects with endoscopic improvement at Week 44
- Proportion of subjects with symptomatic remission at Week 44
- Proportion of subjects with corticosteroid-free clinical remission at Week 44.
- Proportion of subjects with sustained clinical remission at Week 44.
- Proportion of subjects with HEMI per Geboes scoring at Week 44
- Proportion of subjects with endoscopic remission at Week 44.
- Incidence of all treatment-emergent adverse events (TEAEs), causally related adverse events (AEs), all serious adverse events (SAEs) and causally related SAEs classified, by severity
- Incidence of AEs leading to investigational medicinal product discontinuation and study discontinuation.
- Incidence of adverse events of special interest (AESIs).
- Incidence of clinically significant laboratory abnormalities
- Incidence of clinically significant abnormalities regarding vital signs and ECG
研究者
Clinical Operations
Scientific
Abivax
研究点 (84)
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