Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

Abivax S.A.22 enrolled

Overview

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment. All subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo). The actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018). The enrolment in this follow-up study will be based on 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 an overall period of 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

ABX464DRUG

All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: A subject will be eligible for inclusion in this study only if ALL of the following criteria apply: * Subjects previously enrolled in the ABX464-101 clinical study who have completed the initial 2-month treatment phase; * Subjects able and willing to comply with study visits and procedures; * Subjects with hematological and biochemical laboratory parameters as follows at the D56 visit of the ABX464-101 study: * Hemoglobin \> 9.0 g dL-1; * Absolute neutrophil count ≥ 750 mm-3; * Platelets ≥ 100,000 mm-3; * Total serum creatinine ≤ 1.3 x ULN (upper limit of normal); * Creatinine clearance \> 50 mL min-1 by the Cockcroft-Gault equation; * Total serum bilirubin \< 1.5 x ULN; * Alkaline phosphatase, AST (SGOT) and ALT (SGPT) \< 1.5 x ULN; * Subjects should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures being performed; * Subjects should be affiliated to a social security regimen (for French sites only); * Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 3 months prior to study participation. Women must be either postmenopausal (at least 12 months of amenorrhea), 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), intrauterine hormone-releasing system (IUS), hormonal contraception (estrogen and progestogen or progestogen only) associated with inhibition of ovulation, bilateral tubal occlusion, 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. Exclusion Criteria: The following criterion should be checked at the time of screening. If this exclusion criterion applies, the subject will not be included in the study: ▪ Any condition, which in the opinion of the investigator, could compromise the subject's safety or the adherence to the study protocol.

Locations (1)

Department of Gastroenterology - University hospitals Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Number of Treatment-emergent Adverse Events

Number of treatment-emergent adverse events in ABX464 treated subjects

Time frame: Through subject study treatment, up to 48 months

Secondary Outcomes

Total Mayo Score

The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response.

Time frame: Up to Month 48

Partial Mayo Score

The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9. A higher (in negative) change from baseline shows a better clinical response

Time frame: Up to Month 48

Number of Subjects With Clinical Response at Month 48

Clinical response was defined as: reduction in Total Mayo Score (TMS) of at least 2 points and \>= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of \>= 1 point or absolute rectal bleeding sub-score of \<= 1 point.

Time frame: up to 48 months

Number of Subjects With Clinical Remission at Month 48

Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score: rectal bleeding sub-score = 0 central endoscopy sub-score \<= 1 stool frequency sub-score \<= 1

Data from ClinicalTrials.gov

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