Moderate to Severe Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: ABX464
Product Code: [ABX464]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Abivax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies; 2. Subjects should be in endoscopic improvement with a rectal bleedingsub-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 ; 3. Subjects able and willing to comply with study visits and procedures; 4. 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 untilbecoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no mensesfor 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. 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; 2. 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; 3. Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1. To evaluate the long-term effect of ABX464 on clinical remission; 2. To evaluate the long-term effect of ABX464 on endoscopic remission; 3. To evaluate the long-term effect of ABX464 on clinical response; 4. To evaluate the long-term effect of ABX464 on endoscopic improvement; 5. To evaluate the long-term effect of ABX464 on inflammatory markers (C-Reactive Protein (CRP), Calprotectin; 6. To evaluate the safety profile of ABX464; 7. To evaluate the effect of ABX464 on miR-124 expression in total bloodat every timepoint defined in the schedule of assessment. Echocardiography objective: 8. To evaluate the effect of ABX464 on cardiac function as assessed through echocardiograms.;Primary end point(s): Number of adverse events in ABX464 treated subjects.;Timepoint(s) of evaluation of this end point: LSLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1.-4. Yearly visits 5. EOS 6a.-6c. LSLV 7. Yearly visits 8a. EOS 8b. LSLV 8c. EOS 8d.-8f. LSLV 8g. EOS | — |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine
Contacts
Public ContactVice President Clinical Operations
Abivax
Outcome results
None listed