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

Abivax S.A.48 个研究点分布在 14 个国家目标入组 203 人2021年12月3日

适应症Ulcerative Colitis

干预措施ABX464

概览

阶段: 2 期
干预措施: ABX464
疾病 / 适应症: Ulcerative Colitis
发起方: Abivax S.A.
入组人数: 203
试验地点: 48
主要终点: Number of adverse events in ABX464 treated subjects
状态: 进行中（未招募）
最后更新: 5天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment.

All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.

注册库

clinicaltrials.gov

开始日期

2021年12月3日

结束日期

2028年4月1日

最后更新

5天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Abivax S.A.

责任方

Sponsor

入排标准

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 ;
•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;
•5\. Women of childbearing potential and men receiving the study treatment and their partners must agree to continue a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. 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. 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. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. 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 6 months post completion of their participation in the trial. In addition, male subjects should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male subjects must not donate sperm 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 postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal 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 investigational 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.

研究组 & 干预措施

ABX464 -25mg

All subjects will receive ABX464 given at 25 mg QD.

干预措施: ABX464

结局指标

主要结局

Number of adverse events in ABX464 treated subjects

时间窗: From Baseline to a maximum period of 54 months

To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.

Number of adverse events in ABX464 treated subjects

时间窗: From Baseline to a maximum period of 78 months

To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.

次要结局

Percentage of subjects reaching endoscopic remission at yearly visits(From Baseline to a maximum period of 54 months)
Percentage of subjects reaching endoscopic improvement at yearly visits(From Baseline to a maximum period of 54 months)
Percentage of subjects reaching clinical remission at yearly visits.(From Baseline to a maximum period of 54 months)
Percentage of subjects reaching clinical response at yearly visits(From Baseline to a maximum period of 54 months)
Percentage of subjects reaching clinical remission at yearly visits.(From Baseline to a maximum period of 78 months)
Percentage of subjects reaching endoscopic remission at yearly visits(From Baseline to a maximum period of 78 months)
Percentage of subjects reaching clinical response at yearly visits(From Baseline to a maximum period of 78 months)
Percentage of subjects reaching endoscopic improvement at yearly visits(From Baseline to a maximum period of 78 months)