Study Evaluating the Long-term Safety and Efficacy of ABX464 in 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.

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: ABX464

Detailed Description

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.

All subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo).

The actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Subjects will be treated with ABX464 for an overall period of 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Department of Gastroenterology - University hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  • Hemoglobin > 9.0 g dL-1;
  • Absolute neutrophil count ≥ 750 mm-3;
  • Platelets ≥ 100,000 mm-3;
  • Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);
  • Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation;
  • Total serum bilirubin < 1.5 x ULN;
  • 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;
• 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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABX464 Treatment arm; All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months.	Drug: ABX464; All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-emergent Adverse Events	Number of treatment-emergent adverse events in ABX464 treated subjects	Through subject study treatment, up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Mayo Score	The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response.	Up to Month 48
Partial Mayo Score	The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9. A higher (in negative) change from baseline shows a better clinical response	Up to Month 48
Number of Subjects With Clinical Response at Month 48	Clinical response was defined as: reduction in Total Mayo Score (TMS) of at least 2 points and >= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of >= 1 point or absolute rectal bleeding sub-score of <= 1 point.	up to 48 months
Number of Subjects With Clinical Remission at Month 48	Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score: rectal bleeding sub-score = 0 central endoscopy sub-score <= 1 stool frequency sub-score <= 1	up to 48 months
Number of Subject With Endoscopic Improvement at Month 48	oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1.	up to 48 Months
Number of Subjects With Endoscopic Remission at Month 48	Endoscopic remission was defined as Mayo central endoscopic sub-score = 0	up to 48 months
Fecal Calprotectin	The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy	Up to Month 48
CRP Levels	The change from Day 0 up to Month 48 in CRP levels	Up to Month 48
Number of Treatment-emergent Serious Adverse Events	The number of incidences of treatment-emergent serious adverse events	Through subject study treatment, up to 48 months
Number of Treatment-emergent Adverse Events of Special Interest	The number of incidences of treatment-emergent adverse events of special interest	Through subject study treatment, up to 48 months
Number of Adverse Events Leading to Investigational Product Discontinuation	The number of incidences of adverse events leading to investigational product discontinuation	Through subject study treatment, up to 48 months
Number of Specific Laboratory Abnormalities	The number of incidences of specific laboratory abnormalities	Through first year of subject study treatment, 12 months
SF-36 Quality of Life Questionnaire (SF-36 Physical Component)	Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement	Up to 24 months
SF-36 Quality of Life Questionnaire (SF-36 Mental Component)	Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement	Up to 24 months
Erythrocyte Sedimentation Rate (ESR) Levels	The change from Day 0 up to Month 48 in ESR levels	up to 48 Months

Collaborators and Investigators

• Sponsor: Abivax S.A.
• Collaborators: Orion Corporation, Orion Pharma
• Investigators: Study Director: Paul GINESTE, Abivax S.A.

Publications and helpful links

Helpful Links

• preliminary results at M24

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; ABX464
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: ABX464-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No