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Evaluating obefazimod for treating active Crohn's disease

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

PHASE2 · Abivax S.A. · NCT06456593

This study is testing a new drug called obefazimod to see if it can help people with active Crohn's disease who haven't found relief with other treatments.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment212 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAbivax S.A. (industry)
Drugs / interventionsnatalizumab
Locations149 sites (Fairhope, Alabama and 148 other locations)
Trial IDNCT06456593 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy and safety of obefazimod in patients with moderately to severely active Crohn's disease who have not responded adequately to conventional or advanced therapies. The study consists of three phases: a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants will receive either obefazimod or a placebo, and the primary focus is on evaluating the drug's safety and tolerability over the extended period. The trial aims to provide insights into a new treatment option for patients struggling with this chronic condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of moderately to severely active Crohn's disease and a history of inadequate response to previous therapies.

Not a fit: Patients who have not been diagnosed with Crohn's disease or those who have not experienced inadequate response to prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with Crohn's disease who have not responded to existing treatments.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new therapies for Crohn's disease.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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 requirements as stated in section 4.5 (contraception) of this protocol.
7. Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
8. Subject is able and willing to comply with usual public recommendations for sun protection.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria will be excluded from the study:

1. WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study; or male subject with WOCBP partner who intends to be pregnant during the study.
2. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
3. CD without ileal and/or colonic involvement
4. Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.
5. Symptomatic bowel stricture and/or stenosis not passable in endoscopy
6. Related to CD surgery:

   1. Current stoma or ileoanal pouch
   2. More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
   3. Combined previous small bowel resections \> 100 cm
   4. Surgical bowel resection within the past 3 months prior to baseline
   5. Any other manifestation that might require surgery while enrolled in the study
7. Related to CD treatments:

   1. Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
   2. Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
   3. Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CD
8. History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)
9. History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not)
10. Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
11. Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening
12. Subject with the following infectious conditions:

    1. Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapy
    2. Herpes zoster reactivation within the last 2 months prior to screening
    3. Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed)
    4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening.
    5. Subject with human immunodeficiency virus (HIV) infection
    6. Acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen \[HbsAg\] or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\], or detectable HBV DNA).
    7. Acute or chronic hepatitis C virus (HCV) infection as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA \[assessed centrally\] are eligible)
    8. Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test)
13. Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failure
14. Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) interval
15. Subject with a history of torsade de pointe (TdP)
16. Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems.
17. Subjects who received live vaccine within 3 months prior to screening and/or subject who is planning to receive such a vaccine during the study duration
18. Acute or chronic pancreatitis
19. Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:

    1. Hemoglobin ≤ 8.0 g/dL1
    2. Absolute neutrophil count \< 750/mm3
    3. Platelets \< 100,000 /mm3
    4. eGFR \< 60 mL/min/1.73 m2
    5. Total serum bilirubin \> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)
    6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 x ULN
20. Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocol
21. Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.
22. Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipients
23. Illicit drug or alcohol abuse or dependence
24. Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
25. Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol

Where this trial is running

Fairhope, Alabama and 148 other locations

+99 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Moderately to Severely Active Crohn Disease, Crohn Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.