Cure8 trial brief
A new investigational drug (BI 3032950) is being tested specifically for people with ulcerative colitis who did not do well on prior biologic or targeted treatments. If effective and safe, it could become another option for patients with treatment-resistant disease.
The trial includes regular clinical, laboratory, stool, and endoscopic monitoring, so participants get close medical follow-up while contributing to research.
Adults with moderate-to-severe ulcerative colitis who have had inadequate response or intolerance to biologic/targeted therapies; gastroenterologists and clinical researchers running IBD trials; patients considering trial participation.
This is a Phase 2 interventional trial (NCT06636656) testing BI 3032950 in adults with ulcerative colitis who had inadequate response, loss of response, or intolerance to prior biologic/targeted therapies.
The study has two parts: Part A gives BI 3032950 intravenously every 4 weeks with assessment at 12 weeks; participants then transition to Part B receiving subcutaneous BI 3032950 every 4 weeks and may continue for up to 2 years if they show clinical response.
Regular visits include blood and stool sampling and endoscopy to monitor disease activity and safety. What’s being measured: the registered primary outcome is clinical remission by a modified Mayo Score at up to Week 12. Safety monitoring, lab tests, stool samples, and endoscopic assessment are included.
Practical notes: the trial is recruiting at multiple US sites, plans to enroll about 80 participants, and excludes patients with Crohn’s disease, certain colonic pathologies, or recent abscesses or surgeries. Women of childbearing potential and men must use contraception per protocol.
This entry is a clinicaltrials.gov registry record (Phase 2, recruiting). It describes trial design and planned assessments but does not report results. Participation requires meeting detailed inclusion/exclusion criteria and adherence to study procedures. For individual treatment decisions, discuss options with your clinician.
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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