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Ulcerative ColitisSeptember 2024

What the ARTEMIS-UC Trial Found — Tulisokibart for Ulcerative Colitis

ARTEMIS-UC tested tulisokibart, an IV antibody targeting an inflammatory pathway, in 178 people with moderate-to-severe ulcerative colitis. After 12 weeks, far more on tulisokibart reached clinical remission than on the comparison treatment.

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

RecruitingTesting effectiveness

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis

This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis. This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.

Guangzhou, Guangdong, China
RecruitingObservational study

Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

Children with inflammatory bowel disease (IBD) including both Crohn's disease (CD) and ulcerative colitis (UC) can be at high risk of developing malnutrition due to the nature of their condition. It is also believed that some children with IBD, in need of nutritional care, are not identified quickly by their healthcare professionals. This may negatively affect their nutrition, disease progression and general well-being. Hence, it has been proposed that nutritional screening tools or scores (NSTs) should be used to promptly identify children needing further dietetic review and input. Although there are a few NSTs for generic use in sick children at hospital admission, NSTs or scores to use for children with IBD are currently missing. In this study, we would like to test the performance of an existing tool that is routinely used for all sick children at hospital admission (The Paediatric Yorkhill Malnutrition Score or PYMS)(5) and test whether PYMS can detect children with IBD who are at risk of malnutrition. If PYMS doesn't work well, we will develop a specific tool for children with IBD (The Paediatric IBD Nutrition Score or PIBD-NUTS).

Salzburg, Austria +7 more