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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003284-35-PL

Enrollment

Registered

2018-03-05

Start date

2018-04-06

Completion date

Unknown

Last updated

2023-09-04

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: - 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

Exclusion criteria

Exclusion criteria: 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. ;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.	—

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. ;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.

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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. •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. ;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. •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. ;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