2023-507974-42-00招募中2 期
A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Abivax
- 入组人数
- 161
- 试验地点
- 40
- 主要终点
- Number of Adverse Events (AEs) in ABX464 treated subjects.
研究概览
简要总结
The primary objective of the study is to evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Clinical trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies
- •Subjects should be in endoscopic improvement with a rectal bleeding sub-score = 0 point at the end of treatment period in the previous study (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of ≤1 with a rectal bleeding sub-score = 0 point
- •Subjects able and willing to comply with study visits and procedures
- •Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures
- •Women of childbearing potential and men receiving the study treatment and their partners must agree to use highly effective contraceptive method during the study and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. The WOCBP must be willing to perform once a month a urine pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male subjects must not be planning pregnancy during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). In addition, male subjects should use condom during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Male subjects must not donate sperm and female subjects must not donate oocytes as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy
- •Subjects should be affiliated to a social security regimen (for French sites only)
排除标准
- •Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study
- •Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or nvestigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- •Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study
结局指标
主要结局
Number of Adverse Events (AEs) in ABX464 treated subjects.
Number of Adverse Events (AEs) in ABX464 treated subjects.
次要结局
- Percentage of subjects reaching clinical remission at yearly visits.
- Percentage of subjects reaching endoscopic remission at yearly visits.
- Percentage of subjects reaching clinical response at yearly visits.
- Percentage of subjects reaching endoscopic improvement at yearly visits.
- The change from Baseline in CRP and fecal calprotectin levels.
- a. Number and rate of all AEs and causally-related AEs, all Serious Adverse Events (SAEs) and causally-related SAEs, all AEs of Specific Interest (AESIs) and causally-related AESIs, classified by severity; b. Incidence of AEs leading to investigational medicinal product discontinuation; c. The number of clinically-significant laboratory abnormalities
- Change relative to baseline in miRNA-124 expression in total blood at every defined timepoint.
- Echocardiography endpoints: a. Absolute (%) change from baseline echocardiography in left ventricular ejection fraction (LVEF) as measured by 2-dimensional echocardiography; b. Number of subjects with a clinically relevant reduction (change from baseline echocardiography) in LVEF, defined as > 10% reduction (absolute percentage points) to a value < 50%;
- c. Absolute (%) change in left ventricular global longitudinal strain (LVGLS) from baseline echocardiography; d. Number of subjects with a relative percentage reduction in LVGLS by > 15% from the previous value; e. Number of subjects with a reduction of LVEF > 10% (absolute percentage points) to a value ≥ 50% with an accompanying fall in LVGLS > 15%;
- f. Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value ≥ 50%; g, Number of subjects with a reduction from baseline of LVEF > 10% (absolute percentage points) to a value < 50% with an accompanying fall from baseline of LVGLS > 15%;
- h. Changes from baseline echocardiography of other echocardiographic parameters as described in the Statistical Analysis Plan (SAP), including 2-dimensional volumes, right ventricle size and systolic function and valve function.
研究者
Clinical Operations
Scientific
Abivax
研究点 (40)
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