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

• Register: EUCTR
• Last refreshed on: 7 September 2021
• Main ID: EUCTR2017-003284-35-BE
• Date of registration: 09/11/2017
• Prospective Registration: Yes
• Primary sponsor: ABIVAX
• Public title: A follow-up study in patients with moderate to severe active ulcerative colitis.
• Scientific title: A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects
• Date of first enrolment: 19/12/2017
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003284-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Hungary, Poland, Spain

Contacts

• Name: Clinical Operations
• Affiliation: Abivax

• Name: Clinical Operations
• Affiliation: Abivax

Key inclusion & exclusion criteria

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;
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) 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 an 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Code: ABX464
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ABX464
Current Sponsor code: ABX464
Other descriptive name: ABX464
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.

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:
? 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.
? To evaluate the long-term effect of ABX464 on inflammatory markers (CRP, Calprotectin and ESR)
? 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.

The echocardiography objective is:
To evaluate the effect of ABX464 on cardiac function as assessed through echocardiograms.

Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this end point from day 0 to EoS.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Time point of evaluation for secondary endpoints are throughout the study.

Secondary end point(s): The change from Day 0 in Total Mayo Score.
? The change from Day 0 in Partial Mayo Score.
? The time to UC worsening.
? The change from Day 0 in fecal calprotectin, CRP levels and ESR.
? The scores and changes from Day 0 in SF-36 Questionnaire scores
? The miR-124 expression at month 12, month 36 and month 48.
? The number of incidences of treatment-emergent serious adverse events.
? The number of incidences of treatment-emergent adverse events of special interest.
?The number of incidences of adverse events leading to investigational product discontinuation.
? The number of incidences of specific laboratory abnormalities.

The echocardiography secondary endpoints are:
? Absolute (%) change-from-previous echocardiogram of Left ventricle Ejection Fraction (LVEF) as measured by 2- or 3 dimensional echocardiography
? Number of subjects with a clinically relevant reduction (change-from-previous echocardiogram) of LVEF, defined as by > 10% reduction (absolute percentage points) to a value < 50%
? Absolute (%) change in Global Longitudinal Strain (GLS) from-previous echocardiogram
? Number of subjects with a relative percentage reduction in GLS by > 15% from the previous value
? Number of subjects with a reduction of LVEF > 10% (absolute percentage points) to a value = 50% with an accompanying fall in GLS > 15%
? Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value = 50%
? Changes from previous echocardiography of other echocardiographic parameters as described in a standard protocol, including 2- and 3-dimensional volumes, RV size and systolic function and valve function.

Secondary ID(s)

ABX464-102

Source(s) of Monetary Support

Abivax

Ethics review

Status: Approved
Approval date: 19/12/2017
Contact: