Cure8 trial brief
Early-phase mechanistic trials test how a new drug affects disease biology and safety; results can help decide whether larger trials should follow.
For people with active Crohn’s disease who have failed or not tolerated prior therapies, such trials can offer access to investigational options while contributing to scientific understanding.
Adults with active Crohn's disease who have inadequate response or intolerance to prior treatments, clinical researchers, and gastroenterologists involved in Crohn's disease trials.
This is a phase 2, single-center mechanistic study testing zasocitinib (TAK-279), an oral investigational therapy, in about 20 adults with active Crohn's disease.
Participants will take zasocitinib once daily for 12 weeks and undergo ileocolonoscopy with intestinal biopsies and blood sampling before and during treatment to study cellular and molecular effects, biomarkers, and safety.
The study’s primary safety assessments include treatment-emergent adverse events and adverse events of special interest collected through a 4-week post-treatment follow-up.
Key eligibility limits people with recent intra-abdominal surgery, active abscesses, J-pouch, or other non-CD bowel inflammation; planned enrollment is small and the study is mechanistic rather than designed to provide definitive efficacy outcomes.
If you’re considering participation, note that this is an early-phase, short-duration investigational study focused on biology and safety rather than established clinical benefit. The trial is recruiting at a single site in Oxford, UK, and additional entry criteria will be reviewed by the study team.
This is a small (≈20 participants), single-center Phase 2 mechanistic study focused on biomarkers and safety over a 12-week treatment period; it is not intended to provide definitive evidence of clinical efficacy. As a clinicaltrials.gov record, this describes study design and planned assessments but does not report results.
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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