Trial Outcomes & Findings for Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis (NCT NCT03368118)

Results Overview

Number of treatment-emergent adverse events in ABX464 treated subjects

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Through subject study treatment, up to 48 months

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	ABX464 Treatment Arm All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Overall Study STARTED	22
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABX464 Treatment Arm n=22 Participants All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.
Age, Continuous	42.4 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants
Region of Enrollment Poland	10 participants n=5 Participants
Region of Enrollment Hungary	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Through subject study treatment, up to 48 months

Number of treatment-emergent adverse events in ABX464 treated subjects

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Treatment-emergent Adverse Events	145 events

SECONDARY outcome

Timeframe: Up to Month 48

Population: Non responder Imputation (NRI) population

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.

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Total Mayo Score	-3.0 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Up to Month 48

Population: Non responder imputation population

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

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Partial Mayo Score	-2.2 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: up to 48 months

Population: Non responder imputation population

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.

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Subjects With Clinical Response at Month 48	11 Participants

SECONDARY outcome

Timeframe: up to 48 months

Population: non responder imputation population

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

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Subjects With Clinical Remission at Month 48	9 Participants

SECONDARY outcome

Timeframe: up to 48 Months

Population: Non responder imputation population

oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1.

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Subject With Endoscopic Improvement at Month 48	9 Participants

SECONDARY outcome

Timeframe: up to 48 months

Population: non responder imputation population

Endoscopic remission was defined as Mayo central endoscopic sub-score = 0

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Subjects With Endoscopic Remission at Month 48	6 Participants

SECONDARY outcome

Timeframe: Up to Month 48

Population: Non responder imputation population

The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Fecal Calprotectin	-299.69 ug/g Standard Deviation 472.28

SECONDARY outcome

Timeframe: Up to Month 48

Population: Non responder imputation population

The change from Day 0 up to Month 48 in CRP levels

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
CRP Levels	2.29 mg/L Standard Deviation 4.82

SECONDARY outcome

Timeframe: Through subject study treatment, up to 48 months

Population: Observed cases population

The number of incidences of treatment-emergent serious adverse events

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Treatment-emergent Serious Adverse Events	3 events

SECONDARY outcome

Timeframe: Through subject study treatment, up to 48 months

Population: Observed cases population

The number of incidences of treatment-emergent adverse events of special interest

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Treatment-emergent Adverse Events of Special Interest	15 events

SECONDARY outcome

Timeframe: Through subject study treatment, up to 48 months

Population: Observed cases population

The number of incidences of adverse events leading to investigational product discontinuation

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Adverse Events Leading to Investigational Product Discontinuation	1 event

SECONDARY outcome

Timeframe: Through first year of subject study treatment, 12 months

Population: Observed Cases

The number of incidences of specific laboratory abnormalities

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Number of Specific Laboratory Abnormalities	17 events

SECONDARY outcome

Timeframe: Up to 24 months

Population: Non responder imputation population

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

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
SF-36 Quality of Life Questionnaire (SF-36 Physical Component)	4.82 units on a scale Standard Deviation 4.23

SECONDARY outcome

Timeframe: Up to 24 months

Population: Non responder imputation population

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

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
SF-36 Quality of Life Questionnaire (SF-36 Mental Component)	6.38 units on a scale Standard Deviation 3.40

SECONDARY outcome

Timeframe: up to 48 Months

Population: Non responder imputation population

The change from Day 0 up to Month 48 in ESR levels

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Erythrocyte Sedimentation Rate (ESR) Levels	2.90 mm/hour Standard Deviation 8.62

POST_HOC outcome

Timeframe: Up to Month 48

Proportion of subjects with UC worsening based on adverse events

Outcome measures

Outcome measures
Measure	ABX464 Treatment Arm n=22 Participants All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
UC Worsening	7 Participants

Adverse Events

ABX464 Treatment Arm

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABX464 Treatment Arm n=22 participants at risk All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Cardiac disorders Myocardial infarction	4.5% 1/22 • Number of events 1 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Musculoskeletal and connective tissue disorders enteropathic spondylitis	4.5% 1/22 • Number of events 1 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) benign ovarian tumor	4.5% 1/22 • Number of events 1 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)

Other adverse events

Other adverse events
Measure	ABX464 Treatment Arm n=22 participants at risk All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months.
Gastrointestinal disorders Abdominal pain	22.7% 5/22 • Number of events 5 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders Abdominal pain upper	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders colitis ulcerative	31.8% 7/22 • Number of events 11 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders diarrhoea	18.2% 4/22 • Number of events 10 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Number of events 3 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders nausea	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Gastrointestinal disorders vomiting	13.6% 3/22 • Number of events 4 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
General disorders Pyrexia	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Infections and infestations nasopharyngitis	22.7% 5/22 • Number of events 9 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Musculoskeletal and connective tissue disorders arthralgia	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Nervous system disorders headache	13.6% 3/22 • Number of events 7 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	9.1% 2/22 • Number of events 2 • Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)

Additional Information

Vice President Clinical Operations

Abivax

Phone: 01 53 83 08 41

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place