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: Obefazimod
Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Obefazimod
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg mi
Sponsors
ABIVAX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible to participate in this study if ALL the following criteria are met: ? Patients must have completed the 16-week ( ± 4 days) induction treatment period (ABX464-103); ? Patients are able and willing to comply with study visits and procedures as per protocol; ? Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed; ? Patients should be affiliated to a social security regimen (for French sites only); ? Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause)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 patient. 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 patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment. ? Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score = 2 points and = 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score = 1 point or absolute rectal bleeding sub-score = 1 point. ? Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent. 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 204 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will be excluded from the study: ? Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product; ? Patients 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; ? Patients 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 patient inappropriate for entry into this study; ? Patients 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 assess in all patients the long-term efficacy of ABX464 given at 50 mg QD on clinical remission at week 48 compared to the induction study baseline (ISB).;Secondary Objective: To evaluate: -the clinical remission at week 48 compared to the baseline of the open label study (BOLS) - the proportion of patients with glucocorticoid-free clinical remission at W48 -the effect of ABX464 50 mg QD: ~on Modified Mayo Score at week 48 and W96 and on partial MMS, among patients, at every study visit compared to ISB (Induction study baseline) ~on endoscopic improvement and remission and sustained endoscopic improvement and remission, by segment at W48 compared to ISB and BOLS ~on stool and rectal bleeding frequency at every study visit compared to BOLS ~on fecal calprotectin and CRP levels at W24,48,60,72,84,96 compared to BOLS ~on clinical response at W48 compared to ISB and BOLS ~on RNA later at W48 and 96 and in total blood at W24, 48 and 96 ~on patients’ QoL at W24 and W48 compared to BOLS ~on the rectal/sigmoidal infiltrates at W48 compared to ISB and BOLS ~ on cardiac function through echocardiograms -the long-term safety profile of ABX464 50 mg QD;Primary end point(s): Proportion of patients with clinical remission at week 48 compared to induction study baseline. Clinical remission based on the Mayo Scoring system, is defined as: stool frequency sub-score = 0 or 1 and rectal Bleeding sub-score = 0 and endoscopy sub-score = 0 or 1 (modified to exclude friability).;Timepoint(s) of evaluation of this end point: At week 48 and 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The week 24 and 48 secondary endpoints are: ?Reduction relative to baseline in Modified Mayo Score at week 48 and in partial Modified Mayo Score at every study visit among all patients. ?Proportion of patients with either endoscopic improvement or/and endoscopic remission by segment at week 48 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of =1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0. ?Proportion of patients with sustained endoscopic improvement or/and sustained endoscopic remission at week 48. ?Sustained endoscopic improvement is defined as the number of patients with endoscopic improvement at week 48 among patients who had endoscopic improvement during the Induction study (at week 8 or week 16). Sustained endoscopic remission is defined as the number of patients with endoscopic remission at week 48 among patients who had endoscopic remission during the Induction study (at week 8 or week 16). ?Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48. ?Reduction relative to baseline in stool and rectal bleeding frequency at every study visit. ?Reduction relative to baseline in fecal calprotectin and CRP levels at week 24 and 48. ?Proportion of patients with clinical response at week 48. Clinical response is defined as: a reduction in Modified Mayo Score = 2 points and = 30 % from baseline with an accompanying decrease in rectal bleeding sub-score = 1 point or absolute rectal bleeding sub-score = 1 point. ?Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48. ?Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domains at week 24 and 48. ? Reduction r | — |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinical Operations
ABIVAX
Outcome results
None listed