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-PL

Lead Sponsor: ABIVAX

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

- 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;
o 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 protocol-specific procedures being performed;

-Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 3 months prior to
study participation. 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), 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 participants should use condoms and should not donate sperm as
long as contraception is required.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.;Secondary Objective: The secondary objectives are:<br>- To evaluate the long-term effect of ABX464 on clinical and endoscopic remission in subjects with Moderate to Severe Active Ulcerative Colitis assessed by the MCS.<br>- To evaluate the long-term effect of ABX464 on inflammatory markers (CRP, Calprotectin and ESR)<br>- To evaluate the long-term of ABX464 on Quality of Life (QoL) measured by the SF-36 questionnaire in subjects with Moderate to Severe Active Ulcerative Colitis until M24.<br>;Primary end point(s): The primary endpoint of this study is defined as the number of incidences of treatment-emergent adverse events in the ABX464 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 at month 12.<br>•The number of incidences of treatment-emergent serious adverse events.<br>•The number of incidences of treatment-emergent adverse events of special interest.<br>•The number of incidences of adverse events leading to investigational product discontinuation.<br>•The number of incidences of specific laboratory abnormalities.<br>;Timepoint(s) of evaluation of this end point: Time point of evaluation for secondary endpoints are throughout the study.

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