What the trial was testing
The U-EXCEL enrolled 526 patients with crohn's disease. The study was sponsored by AbbVie and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. 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
About 50% reached clinical remission at 12 weeks — roughly twice the placebo rate.
New England Journal of Medicine · 2023 · NCT03345849
These findings — that of patients in clinical remission at 12 weeks on upadacitinib vs. placebo — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 526 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 crohn's disease, 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
Upadacitinib (Rinvoq) is FDA-approved for moderately to severely active Crohn's disease in adults who haven't responded to other treatments and available now. It is taken as a once-daily pill — no injections or infusions. Side effects can include increased infection risk and lab changes; regular monitoring is required. Ask your gastroenterologist whether it fits.
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 crohn's disease trials
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living in British Columbia, Canada. The main questions this study seeks to answer are: 1. Can microbiome signatures across different sample types (fecal, intestinal washings, and intestinal epithelial biopsies) predict response to therapy in CD? 2. How do microbiome profiles differ between active and quiescent CD and non-IBD controls? Researchers will compare microbiome signatures in patients with active and inactive CD as well as non-IBD controls to see if there are any microbial signatures that predict response to therapy. Participants will: 1. Provide fecal and blood samples. 2. Undergo intestinal washings and intestinal epithelial biopsy specimens taken during routine colonoscopy. 3. Participate in a longitudinal follow-up over 12 months to monitor clinical, biochemical, and endoscopic responses to therapy.