Cure8 trial brief
This trial tests several targeted therapies (including risankizumab) alone and in combination for adults with moderate to severe Crohn's disease, aiming to measure endoscopic remission and safety. Positive findings could expand future treatment options for people who have inadequate responses to current therapies.
Adults with moderate to severe Crohn's disease, patients who have failed or are intolerant to prior biologics/targeted therapies, clinicians managing inflammatory bowel disease, and researchers in IBD drug development.
This is a Phase 2 interventional clinical trial (NCT06548542) run by AbbVie that is recruiting adults with moderate to severe Crohn's disease to evaluate multiple targeted therapies.
The study compares risankizumab, trosunilimab, lutikizumab, and an AbbVie investigational agent (ABBV-8736) as mono- and combination-therapy arms, with endoscopic remission at Week 12 listed as a primary outcome and adverse events tracked through ~96 weeks.
The trial plans to randomize roughly 590 participants across ~300 global sites and includes regular clinic visits, blood tests, endoscopies, and patient-reported questionnaires/diaries.
Eligibility requires documented active Crohn's disease (CDAI ≥220 and SES-CD thresholds) and prior intolerance or inadequate response to conventional therapies/targeted agents.
If you are considering trial participation, note the higher treatment and visit burden compared with standard care and the exclusion of patients with recent bowel resection, ostomy, or intolerance to p19 inhibitors. This entry describes the registered study design and interventions; it does not report results.
This is a trial record (Phase 2, recruiting) listing planned interventions and outcomes; it does not present study results. Risankizumab is a p19/IL-23 pathway agent — participants with prior intolerance to p19 inhibitors are excluded. Participation involves frequent visits, endoscopies, and monitoring.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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