Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Moderately to Severely Active Crohn Disease

In brief

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. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

Key facts

Study ID: NCT06456593
Run by: Abivax S.A.
People needed: 212
Starts: 2024-10-30
Expected to finish: 2028-04-01
Last updated by the study team: 2026-04-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Able and willing to comply with study visits and procedures as per protocol.
Confirmed and documented diagnosis of CD based on endoscopy and histology reports.
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).
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)
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.
Subject should be affiliated to a health insurance policy whenever required by a participating country or state.
Subject is able and willing to comply with usual public recommendations for sun protection.

You may not qualify if…

Subjects who meet any of the following exclusion criteria will be excluded from the study:
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.
Current diagnosis of ulcerative colitis (UC) or indeterminate colitis
CD without ileal and/or colonic involvement
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.
Symptomatic bowel stricture and/or stenosis not passable in endoscopy
Related to CD surgery:
Current stoma or ileoanal pouch
More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectum
Combined previous small bowel resections > 100 cm
Surgical bowel resection within the past 3 months prior to baseline
Any other manifestation that might require surgery while enrolled in the study
Related to CD treatments:
Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocol
Subject who has previously received natalizumab (or any other α4β1 integrin agonist)
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
History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)
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)
Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screening
Subject with the following infectious conditions:
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
Herpes zoster reactivation within the last 2 months prior to screening
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)
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.

Where it is running

Tyler Research Institute, LLC — Tyler, Texas, United States (enrolling)
Gastroenterology Consultants of Southwest Virginia. — Roanoke, Virginia, United States (enrolling)
Rapid City Medical Center, LLC — Rapid City, South Dakota, United States (enrolling)
Texas Digestive Specialists — Harlingen, Texas, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Clinical Research Of Brandon, LLC — Brandon, Florida, United States (enrolling)
West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States (enrolling)
Frontier Clinical Research, LLC — Uniontown, Pennsylvania, United States (enrolling)
Novel Research, LLC — Bellaire, Texas, United States (enrolling)
Baylor University Hospital — Dallas, Texas, United States (enrolling)
GI Alliance -Gurnee — Sun City, Arizona, United States (enrolling)
Sarkis Clinical Trials - Parent — Ocala, Florida, United States (enrolling)
Orlando Health, Inc. — Orlando, Florida, United States (enrolling)
GCP Clinical Research, LLC — Tampa, Florida, United States (enrolling)
Theia Clinical Research Centers, LLC — Temple Terrace, Florida, United States (enrolling)
Northwestern University — Evanston, Illinois, United States (enrolling)
Auzmer Research — Lakeland, Florida, United States (enrolling)
Lucida Clinical Trials, LLC — New Bedford, Massachusetts, United States (enrolling)
Research Associates of South Florida, LLC — Miami, Florida, United States (enrolling)
Henry Ford Columbus Center — Detroit, Michigan, United States (enrolling)
United Medical Doctors — Murrieta, California, United States (enrolling)
GI Alliance — Cedar Park, Texas, United States (enrolling)
Advanced Research Institute, Inc. — New Port Richey, Florida, United States (enrolling)
Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
Hopital Universitaire de Bruxelles - Hopital Erasme — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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