What the trial was testing
The ADVANCE AND MOTIVATE enrolled 931 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 40-45% of patients achieved remission with risankizumab versus 20-25% with placebo.
Lancet (London, England) · 2022 · NCT03105128
These findings — that nearly half of patients saw their Crohn's symptoms go into remission after 12 weeks of treatment. — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 931 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
Risankizumab (brand name Skyrizi) is now FDA-approved for moderate to severe Crohn's disease in adults who haven't responded to other treatments. It works by blocking IL-23, a protein that drives inflammation in the gut. If standard treatments aren't working for you, ask your doctor if this medication might be an option.
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 Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Molecular Inflammation Board at the Center for Personalized Medicine
Molecular Inflammation Board at the Center for Personalized Medicine