What the trial was testing
The ARTEMIS-UC enrolled 178 patients with ulcerative colitis. The study was sponsored by Prometheus Biosciences and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). 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
26% reached clinical remission at 12 weeks vs. 1% in the comparison group.
New England Journal of Medicine · 2024 · NCT04996797
These findings — that clinical remission at 12 weeks on tulisokibart compared with the inactive comparison — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 178 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
Tulisokibart is still in development and not yet FDA-approved. Several ulcerative colitis treatments are FDA-approved and available now, including infliximab, vedolizumab, ustekinumab, upadacitinib, and ozanimod. Ask a gastroenterologist which approved option fits your case, or whether you qualify for ongoing tulisokibart trials.
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
Pregnancy and Inflammatory Bowel Disease
Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases. Diagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).