Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis

Trial details

Who runs it

Abivax

Trial code

EU 2023-507974-42-00

Record updated

2026. szeptember 21.

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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).

Exclusion: 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.

EU CTIS 2023-507974-42-00