Ulcerative ColitisPhase 2NCT03368118
Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
A Phase 2 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ABX464
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2018to 15 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Gastroenterology - University hospitals Leuven
Leuven, 3000
About this study
Official 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.
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- ABX464
- Keywords
- ABX464, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.
| Study group | Role | What they receive |
|---|---|---|
| ABX464 Treatment arm | Experimental | All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. Receives: Drug: ABX464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events
Number of treatment-emergent adverse events in ABX464 treated subjects
Measured: Through subject study treatment, up to 48 months
Secondary outcomes (15)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 48 Months
Number of Subjects With Endoscopic Remission at Month 48
Endoscopic remission was defined as Mayo central endoscopic sub-score = 0
Measured: 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
Measured: Up to Month 48
CRP Levels
The change from Day 0 up to Month 48 in CRP levels
Measured: Up to Month 48
Number of Treatment-emergent Serious Adverse Events
The number of incidences of treatment-emergent serious adverse events
Measured: 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
Measured: 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
Measured: Through subject study treatment, up to 48 months
Number of Specific Laboratory Abnormalities
The number of incidences of specific laboratory abnormalities
Measured: 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
Measured: 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
Measured: Up to 24 months
Erythrocyte Sedimentation Rate (ESR) Levels
The change from Day 0 up to Month 48 in ESR levels
Measured: up to 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start20 Jan 2018
- Primary completion12 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, follow-up study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Paul GINESTE, Study director, Abivax S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368118
- Sponsor's protocol ID
- ABX464-102
- Status last verified
- May 2025
- First submitted
- 13 Nov 2017
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT03368118
- Acronym / sponsor ID
- ABX464-102
- Conditions
- Ulcerative Colitis
- Keywords
- ABX464, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, follow-up study
| Arm | Type | Receives |
|---|---|---|
| ABX464 Treatment arm | Experimental | Drug: ABX464All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Subjects should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures being performed;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX464All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months. | Drug | ABX464 Treatment arm |
Primary outcome
Number of Treatment-emergent Adverse Events
Time frame: Through subject study treatment, up to 48 months
Number of treatment-emergent adverse events in ABX464 treated subjects
15 secondary outcomes
Total Mayo Score
Time frame: Up to Month 48
Partial Mayo Score
Time frame: Up to Month 48
Number of Subjects With Clinical Response at Month 48
Time frame: up to 48 months
Number of Subjects With Clinical Remission at Month 48
Time frame: up to 48 months
Number of Subject With Endoscopic Improvement at Month 48
Time frame: up to 48 Months
Number of Subjects With Endoscopic Remission at Month 48
Time frame: up to 48 months
Fecal Calprotectin
Time frame: Up to Month 48
CRP Levels
Time frame: Up to Month 48
Number of Treatment-emergent Serious Adverse Events
Time frame: Through subject study treatment, up to 48 months
Number of Treatment-emergent Adverse Events of Special Interest
Time frame: Through subject study treatment, up to 48 months
Number of Adverse Events Leading to Investigational Product Discontinuation
Time frame: Through subject study treatment, up to 48 months
Number of Specific Laboratory Abnormalities
Time frame: Through first year of subject study treatment, 12 months
SF-36 Quality of Life Questionnaire (SF-36 Physical Component)
Time frame: Up to 24 months
SF-36 Quality of Life Questionnaire (SF-36 Mental Component)
Time frame: Up to 24 months
Erythrocyte Sedimentation Rate (ESR) Levels
Time frame: up to 48 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- preliminary results at M24Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul GINESTE study director
Abivax S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX464 in people with Ulcerative Colitis, run by Abivax S.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-emergent Adverse Events (time frame: Through subject study treatment, up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.