What the trial was testing
The trial enrolled 217 patients with ulcerative colitis. The study was sponsored by Abivax S.A. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
All three doses of obefazimod significantly improved ulcerative colitis symptoms compared to placebo after 8 weeks.
The lancet. Gastroenterology & hepatology · 2022 · NCT04023396
These findings — that patients taking 50mg obefazimod saw their disease activity scores drop by 3.2 points versus 1.9 with placebo — were published in the The lancet. Gastroenterology & hepatology and represent the headline result of the study.
Researchers tracked outcomes across 217 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with ulcerative colitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was a mid-stage study and obefazimod is not yet FDA-approved for ulcerative colitis. A larger study is ongoing to confirm these results. If you have ulcerative colitis that hasn't responded to standard treatments, ask your doctor about open clinical trials testing obefazimod or other approved biologic options.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open ulcerative colitis trials
Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.
Inflammatory Bowel Disease (IBD) Research Registry
Patients seen at the Center for Inflammatory Bowel Disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their Inflammatory Bowel Disease to be placed in Center's Research Registry for the purpose of facilitating retrospective research studies directed at Inflammatory Bowel Disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving Inflammatory Bowel Disease. Information obtained from the Inflammatory Bowel Disease Registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of IBD and may permit the development of better therapies and the potential for preventive therapies.