NCT06456593 · Abivax S.A.
Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
(ENHANCE-CD)
What this study is about
This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase.
View original scientific description
This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
Interventions
DRUG
Obefazimod
Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
OTHER
Placebo
Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).
Primary outcome measures
Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)
Time frame: Week 12 and week 52
Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.
Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)
Time frame: Week 52
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 52 The SES-CD is an endoscopic grading system that consists of a composite score based on 4 components: the size of mucosal ulcers, the extent of the ulcerated surface, the endoscopic extension, and the presence of stenosis (26). Each of the 4 SES-CD components are assessed in the 5 segments of the ileum and colon: ileum, right, transverse, left, and rectum. The SES-CD is the sum of the individual scores of each of the components across the 5 segments. The total score ranges from 0 to 60. Higher scores mean a worse outcome
Maintenance Phase Efficacy - Endoscopic response
Time frame: Week 52
Proportion of subjects with endoscopic response at Week 52
Maintenance Phase Efficacy - SES-CD ulcer subscore > 1
Time frame: Week 52
Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52
Maintenance Phase Efficacy - CDAI clinical remission
Time frame: Week 52
Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52
Maintenance Phase Efficacy - PRO-2 clinical remission
Time frame: Week 52
Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52
Maintenance Phase Efficacy - CDAI clinical response
Time frame: Week 52
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52
Maintenance Phase Efficacy - PRO-2 clinical response
Time frame: Week 52
Proportion of subjects with PRO-2 clinical response (≥ 30% decrease in average daily PRO-2 score (AP + SF) and both no higher than baseline) at Week 52
Maintenance Phase Efficacy - CDAI clinical response and endoscopic response
Time frame: Week 52
Proportion of subjects with CDAI clinical response and endoscopic response at Week 52
Maintenance Phase Efficacy - endoscopic remission
Time frame: Week 52
Proportion of subjects with endoscopic remission at Week 52
Extension Phase Safety- Adverse events
Time frame: Weeks 64, 76, 88,100 and EOS
Incidence of all treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and causally related TEAEs/SAEs Incidence of adverse events (AEs) leading to discontinuation
Extension Phase Safety - Hematology and coagulation
Time frame: Weeks 64, 76, 88,100 and EOS
Number of patients with clinically-significant abnormal laboratory parameters. Hematology: Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, platelet count, red blood cells; white blood cells Coagulation: International normalized ratio, activated partial thromboplastin time, fibrinogen, prothrombin time
Extension Phase Safety - Biochemistry
Time frame: Weeks 64, 76, 88,100 and EOS
Number of patients with clinically-significant abnormal laboratory parameters. Albumin, total protein, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, amylase, creatinine, creatinine clearance, urea, chloride, bicarbonate, sodium, potassium, calcium, phosphate, uric acid, glucose, total cholesterol, LDL cholesterol (direct), HDL cholesterol, triglycerides, creatine phosphokinase (CPK), high sensitivity troponin I and T, N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures 2. Able and willing to comply with study visits and procedures as per protocol. 3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports. 4. Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading). 5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted) 6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requiremen
Where
- Fairhope, Alabama
- Scottsdale, Arizona
- Sun City, Arizona
- Irvine, California
- Murrieta, California
- Colorado Springs, Colorado
- Brandon, Florida
- Clearwater, Florida
- Lakeland, Florida
- Miami, Florida
- Miami Lakes, Florida
- New Port Richey, Florida
And 31 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations