A follow-up study in patients with moderate to severe active ulcerative colitis.

Phase 1

Conditions: Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-003284-35-HU

Lead Sponsor: ABIVAX

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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:
o Hemoglobin > 9.0 g dL-1;
o Absolute neutrophil count = 750 mm-3;
o Platelets = 100,000 mm-3;
o Total serum creatinine = 1.3 x ULN (upper limit of normal);
o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation;
Total serum bilirubin < 1.5 x ULN;
o 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
protocolspecific
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.
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the long-term safety of<br>ABX464 given at 50 mg once daily in subjects with Moderate to Severe<br>Active Ulcerative Colitis.;Secondary Objective: The secondary objectives are to evaluate:<br>• The long-term effect of ABX464 on clinical and endoscopic remission in<br>subjects with Moderate to Severe Active Ulcerative Colitis assessed by<br>the MCS.<br>• The long-term effect of ABX464 on inflammatory markers (CRP,<br>Calprotectin and ESR)<br>• The long-term of ABX464 on Quality of Life (QoL) measured by the SF-<br>36 questionnaire in subjects with Moderate to Severe Active Ulcerative<br>Colitis.;Primary end point(s): Number of incidences of treatment-emergent adverse events in ABX464<br>treated subjects.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this end point from day 0 to EoS.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?The change from Day 0 in Total Mayo Score.<br>? The change from Day 0 in Partial Mayo Score.<br>? The time to UC worsening.<br>? The change from Day 0 in fecal calprotectin, CRP levels and ESR.<br>? The scores and changes from Day 0 in SF-36 Questionnaire scores<br>? The miR-124 expression as month 12 & month 36<br>? The number of incidences of treatment-emergent serious adverse<br>events.<br>? The number of incidences of treatment-emergent adverse events of<br>special interest.<br>?The number of incidences of adverse events leading to investigational<br>product discontinuation.<br>? The number of incidences of specific laboratory abnormalities.;Timepoint(s) of evaluation of this end point: Time point of evaluation for secondary endpoints are throughout the<br>study.

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