Crohn DiseasePhase 2/3NCT03905109
Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients
A Phase 2/3 study testing ABX464 in people with Crohn Disease, run by Abivax S.A. at 1 site in Belgium.
Trial summary
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- ABX464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Sep 2022to 19 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women age 18-75 years;
- Patients must have a documented diagnosis (endoscopic with histology) of CD for ≥ 3 months before screening;
- Patients must have active moderate to severe ileal, ileocolic, or colonic CD at baseline as defined by 220 ≤ CDAI > 450,
- Patients must have a SES-CD score > 6 (≥4 if isolated ileal disease) at screening, assessed by ileocolonoscopy and confirmed by a central reading.
- Patients must be willing and able to undergo endoscopy during screening after all other inclusion criteria have been met and at the end of Week 16.
- Patients must have had either a documented inadequate response, no response, a loss of response, or an intolerance (defined as the occurrence of at least one Adverse Reaction leading to treatment discontinuation) to either amino-salicylates, immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, biologics (i.e. tumor necrosis factor inhibitors, vedolizumab, ustekinumab), and/or corticosteroid treatment.
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- Patients should be able and willing to comply with study visits and procedures as per protocol;
- Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
- Patients 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.
Who cannot join
- Patients with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or clinical/histologic findings suggestive of ulcerative colitis;
- Patients with colonic dysplasia or neoplasia or adenomatous colonic polyp;
- Patients with presence of fistulae;
- Patients with current symptomatic diverticulitis or diverticulosis;
- Patients with obstructive colonic stricture/stenosis, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period;
- Patients with past medical history of clinically significant short bowel syndrome;
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- Patients requiring parenteral nutrition;
- Patients with past medical history of bowel surgery resulting in an existing or current stoma;
- Patients with active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), cytomegalovirus, tuberculous colitis and recent infectious hospitalization;
- Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
- Acute, chronic or history of immunodeficiency or autoimmune disease;
- History of malignancy excluding patients considered cure (5 years disease free survivors);
- Active malignancy that may require chemotherapy or radiation therapy;
- Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline;
- Pregnant or breast-feeding woman;
- Illicit drug or alcohol abuse or dependence;
- Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer;
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2b/3, Randomized, Double Blind, Placebo Controlled Induction Phase Followed by a Maintenance Phase to Evaluate the Efficacy & Safety of ABX464 in Patients With Moderate to Severe Active Crohn's Disease & to Determine the Optimal Dose
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit
Read the detailed description
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit
Patient eligibility will be determined during a 4 week (28 days) Screening Period. Entry criteria will be based on confirmation of active moderate to severe ileal, ileocolic, or colonic CD. Approximately 930 patients will participate in this study (ABX464 Dose A N = 380, ABX464 Dose B N = 380, placebo N = 170).
On Day 0, eligible patients will be randomized into 2 cohorts:
- Cohort 1: Double blinded Induction Phase according to a 1:1:1 ratio into 3 treatment groups as follows:
- ABX464 - Dose A QD: 170 patients
- ABX464 - Dose B QD: 170 patients
- Matching Placebo: 170 patients
- Cohort 2: Open-label Induction Phase according to a 1:1 ratio into 2 treatment groups as follows:
- ABX464 - Dose A QD: 210 patients
At the end of the 12-week Induction Phase, all patients will be evaluated for the co-primary endpoints, namely induction of clinical remission and endoscopic improvement in addition to the secondary and exploratory endpoints. All patients will also be evaluated for treatment response. The determination of whether patients will be considered treatment responders versus nonresponders, responders being defined as patients with a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 70 points.
Patients will be allocated to the different maintenance treatment regimens according to the following rules:
- Patients who received ABX464 in the Induction Phase (coming from Cohort 1 and 2) and who were responders at Week 12 will be randomized 1:1:1 to receive either ABX464 Dose A QD, ABX464 Dose B QD, or placebo in a double-blinded manner, for an additional 40 weeks. Stratification factors used for re-randomization in the Maintenance Phase are previous failure to biologics and current corticosteroid treatment use.
- Patients who received ABX464 or placebo in the Induction Phase (coming from Cohort 1 and 2) but who were not responders at Week 12 will be allocated to open label ABX464 Dose A QD. They will be evaluated 12 weeks later, and they will continue only if they have achieved clinical response at that timepoint.
- Patients who received placebo (coming from Cohort 1) in the Induction Phase and who were responders at Week 12 will be allocated to receive placebo as part of their double blinded maintenance treatment.
At Week 24, nonresponders who received open label ABX464 Dose A QD in the Maintenance Phase will be assessed for treatment response. If patients have not achieved treatment response at Week 24, patients should discontinue study drug. All patients, including those who have had treatment response in Week 12, can be discontinued due to disease worsening.
Patients will also be evaluated for safety and efficacy throughout the Induction and Maintenance Phases. From Day 0 onwards, all eligible patients will be followed at the investigational site on Week 1, Week 2, Week 4, Week 8, Week 12, and every 4 weeks until Week 52. Ileocolonoscopy will be performed in accordance with the Schedule of Activities.
- Conditions
- Crohn Disease
- Being tested
- ABX464, Placebo
- Keywords
- Inflammatory Bowel Disorders, ABX464
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
ABX464 is a new anti-inflammatory drug. In the treatment arm, patients will receive dose A or Dose B of ABX464 orally once daily for 52 weeks.
PlaceboDrug
In the placebo group, patients will receive dose A or B ABX464-matching-placebo orally once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ABX464 dose A | Experimental | Dose A QD Receives: Drug: ABX464 |
| ABX464 Dose B | Experimental | Dose B QD Receives: Drug: ABX464 |
| Placebo | Placebo comparator | Matching dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss of
Percentage of patients in clinical remission at Week 12, defined as CDAI of ≤ 150
Measured: from baseline, at Week 12
Co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss of
Percentage of patients with endoscopic improvement at Week 12, defined as a decrease from baseline of ≥ 50% in the global SES-CD (SES CD 50)
Measured: from baseline, at Week 12
Secondary outcomes (8)
To evaluate the safety of ABX464
- Number and rate of all adverse events, causally related adverse events, all Serious Adverse Events (SAEs), and causally-related SAEs classified by severity
- Incidence of treatment-emergent SAEs
- Incidence of adverse events leading to investigational medicinal product discontinuation
- The number of clinically-significant laboratory abnormalities
Measured: from baseline, at week 12
To evaluate the effect of ABX464 as measured by Patient-Reported-Outcome-based remission (PRO) at Week 12
Number and rates of patients with the following:
PRO-based remission at Week 12, defined as abdominal pain ≤ 1 and liquid/soft Stool Frequence (SF) score of ≤ 3, averaged over the 7 days prior to visit
Measured: from baseline, at week 12
To evaluate the effect of ABX464 on C reactive protein (CRP) and fecal calprotectin levels
Change from Week 0 to Week 12 in CRP and fecal calprotectin levels
Measured: from baseline, at week 12
To evaluate the effect of ABX464 on patients' quality of life
The scores and changes from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: from baseline to week 12
To evaluate the effect of ABX464 on micro RNA (miR) 124 expression in whole blood and in tissue
Change from Week 0 to Week 12 in microRNA-124 levels in total blood (PAXgene®) and in tissue (RNA later)
Measured: from baseline to week 12
To assess the pharmacokinetics of ABX464 and ABX464-N-Glu
Serum concentration of ABX464 and its main metabolite ABX464-N-Glu levels
Measured: from baseline, at week 12
To evaluate the effect of ABX464 as measured by endoscopic remission at Week 12
Number and rates of patients with the following:
Endoscopic remission at Week 12 defined as SES CD ≤ 4 with at least a 2 point reduction from baseline
Measured: from baseline, at week 12
To evaluate the effect of ABX464 as measured by clinical response at Week 12
Number and rates of patients with the following:
Clinical response at Week 12, defined as a reduction from baseline in CDAI of ≥ 100 points
Measured: from baseline, at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start19 Sep 2022 (estimated)
- Primary completion19 Sep 2022 (estimated)
- Study completion19 Sep 2022 (estimated)
Why it stopped: Study design revised and to be found under new NCT06456593 ABX464-202
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul GINESTE, PharmD, Study director, Abivax S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905109
- Sponsor's protocol ID
- ABX464-201
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b/3, Randomized, Double Blind, Placebo Controlled Induction Phase Followed by a Maintenance Phase to Evaluate the Efficacy & Safety of ABX464 in Patients With Moderate to Severe Active Crohn's Disease & to Determine the Optimal Dose
- ClinicalTrials.gov ID
- NCT03905109
- Acronym / sponsor ID
- ABX464-201
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disorders, ABX464
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design revised and to be found under new NCT06456593 ABX464-202
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (estimated)
- Primary completion
- 19 Sep 2022 (estimated)
- Study completion
- 19 Sep 2022 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit
Detailed description
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe active Crohn's disease (CD) who have inadequate response, loss of response, or intolerance to prior corticosteroid and/or immunosuppressant treatment and/or biologics. This study consists of a 28 day Screening Period, a 52 week Treatment Period; including a 12 week double blinded (Cohort 1) or open label (Cohort 2) Induction Phase and a 40 week double blinded (responders) or open label (nonresponders) Maintenance Phase; and a 4 week Follow up Period, which will consist of an End of Study (EOS) visit
Patient eligibility will be determined during a 4 week (28 days) Screening Period. Entry criteria will be based on confirmation of active moderate to severe ileal, ileocolic, or colonic CD. Approximately 930 patients will participate in this study (ABX464 Dose A N = 380, ABX464 Dose B N = 380, placebo N = 170).
On Day 0, eligible patients will be randomized into 2 cohorts:
- Cohort 1: Double blinded Induction Phase according to a 1:1:1 ratio into 3 treatment groups as follows:
- ABX464 - Dose A QD: 170 patients
- ABX464 - Dose B QD: 170 patients
- Matching Placebo: 170 patients
- Cohort 2: Open-label Induction Phase according to a 1:1 ratio into 2 treatment groups as follows:
- ABX464 - Dose A QD: 210 patients
At the end of the 12-week Induction Phase, all patients will be evaluated for the co-primary endpoints, namely induction of clinical remission and endoscopic improvement in addition to the secondary and exploratory endpoints. All patients will also be evaluated for treatment response. The determination of whether patients will be considered treatment responders versus nonresponders, responders being defined as patients with a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 70 points.
Patients will be allocated to the different maintenance treatment regimens according to the following rules:
- Patients who received ABX464 in the Induction Phase (coming from Cohort 1 and 2) and who were responders at Week 12 will be randomized 1:1:1 to receive either ABX464 Dose A QD, ABX464 Dose B QD, or placebo in a double-blinded manner, for an additional 40 weeks. Stratification factors used for re-randomization in the Maintenance Phase are previous failure to biologics and current corticosteroid treatment use.
- Patients who received ABX464 or placebo in the Induction Phase (coming from Cohort 1 and 2) but who were not responders at Week 12 will be allocated to open label ABX464 Dose A QD. They will be evaluated 12 weeks later, and they will continue only if they have achieved clinical response at that timepoint.
- Patients who received placebo (coming from Cohort 1) in the Induction Phase and who were responders at Week 12 will be allocated to receive placebo as part of their double blinded maintenance treatment.
At Week 24, nonresponders who received open label ABX464 Dose A QD in the Maintenance Phase will be assessed for treatment response. If patients have not achieved treatment response at Week 24, patients should discontinue study drug. All patients, including those who have had treatment response in Week 12, can be discontinued due to disease worsening.
Patients will also be evaluated for safety and efficacy throughout the Induction and Maintenance Phases. From Day 0 onwards, all eligible patients will be followed at the investigational site on Week 1, Week 2, Week 4, Week 8, Week 12, and every 4 weeks until Week 52. Ileocolonoscopy will be performed in accordance with the Schedule of Activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, placebo-controlled, randomized study
| Arm | Type | Receives |
|---|---|---|
| ABX464 dose A | Experimental | Drug: ABX464Dose A QD |
| ABX464 Dose B | Experimental | Drug: ABX464Dose B QD |
| Placebo | Placebo comparator | Drug: PlaceboMatching dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women age 18-75 years;
- Patients must have a documented diagnosis (endoscopic with histology) of CD for ≥ 3 months before screening;
- Patients must have active moderate to severe ileal, ileocolic, or colonic CD at baseline as defined by 220 ≤ CDAI > 450,
- Patients must have a SES-CD score > 6 (≥4 if isolated ileal disease) at screening, assessed by ileocolonoscopy and confirmed by a central reading.
- Patients must be willing and able to undergo endoscopy during screening after all other inclusion criteria have been met and at the end of Week 16.
Key exclusion criteria (18 listed)
- Patients with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or clinical/histologic findings suggestive of ulcerative colitis;
- Patients with colonic dysplasia or neoplasia or adenomatous colonic polyp;
- Patients with presence of fistulae;
- Patients with current symptomatic diverticulitis or diverticulosis;
- Patients with obstructive colonic stricture/stenosis, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period;
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 |
|---|---|---|
| ABX464ABX464 is a new anti-inflammatory drug. In the treatment arm, patients will receive dose A or Dose B of ABX464 orally once daily for 52 weeks. | Drug | ABX464 Dose B, ABX464 dose A |
| PlaceboIn the placebo group, patients will receive dose A or B ABX464-matching-placebo orally once daily for 52 weeks. | Drug | Placebo |
Primary outcome
The co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss of
Time frame: from baseline, at Week 12
Percentage of patients in clinical remission at Week 12, defined as CDAI of ≤ 150
Co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss of
Time frame: from baseline, at Week 12
Percentage of patients with endoscopic improvement at Week 12, defined as a decrease from baseline of ≥ 50% in the global SES-CD (SES CD 50)
8 secondary outcomes
To evaluate the safety of ABX464
Time frame: from baseline, at week 12
To evaluate the effect of ABX464 as measured by Patient-Reported-Outcome-based remission (PRO) at Week 12
Time frame: from baseline, at week 12
To evaluate the effect of ABX464 on C reactive protein (CRP) and fecal calprotectin levels
Time frame: from baseline, at week 12
To evaluate the effect of ABX464 on patients' quality of life
Time frame: from baseline to week 12
To evaluate the effect of ABX464 on micro RNA (miR) 124 expression in whole blood and in tissue
Time frame: from baseline to week 12
To assess the pharmacokinetics of ABX464 and ABX464-N-Glu
Time frame: from baseline, at week 12
To evaluate the effect of ABX464 as measured by endoscopic remission at Week 12
Time frame: from baseline, at week 12
To evaluate the effect of ABX464 as measured by clinical response at Week 12
Time frame: from baseline, at week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- 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, PharmD 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 2/3 study testing ABX464 in people with Crohn Disease, 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 10 inclusion and 18 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: withdrawn, as of the sponsor's last update on 31 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The co-primary objectives of the study are to determine the efficacy of ABX464 in inducing clinical remission and endoscopic improvement after 12 weeks of study treatment in patients with moderate to severe active CD who have inadequate response, loss of (time frame: from baseline, at Week 12). The study lists 2 primary outcomes in all. 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 31 Jul 2024.