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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003284-35-BE

Enrollment

Registered

2017-11-09

Start date

2017-12-19

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.;Primary end point(s): Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this end point from day 0 to EoS.	—

Measure

Time frame

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.;Primary end point(s): Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this end point from day 0 to EoS.

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Secondary

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

Measure

Time frame

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

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Countries

Belgium, Hungary, Poland, Spain

Contacts

Public ContactClinical Operations

Abivax

paul.gineste@abivax.com+33 153830961

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026