Cure8 trial brief
An LTE Phase 2 study offers longer-term safety monitoring and continued access to investigational long-acting antibody drugs for people who completed or met escape criteria in the parent SKYLINE-UC trial; that can matter to patients weighing continued trial participation or follow-up safety information.
Adults with ulcerative colitis who participated in SKYLINE-UC (SPY123-201), clinicians caring for IBD patients, and researchers interested in long-acting antibody development for IBD.
This LTE enrolls adults with ulcerative colitis from the prior SPY123-201 study and will monitor treatment-emergent adverse events over time, with a primary safety time point at Week 96.
Multiple experimental intervention arms are listed (SPY001, SPY002, SPY003) with different dosing regimens; the record identifies prohibited concomitant immunosuppressive and marketed advanced therapies.
The study is Phase 2 and listed as “ENROLLING_BY_INVITATION,” so participation is limited to eligible completers or escape participants from the parent trial rather than newly diagnosed or treatment-naïve patients.
This is a ClinicalTrials.gov trial record (Phase 2 LTE) and does not report study results. The primary outcome is incidence of adverse events through Week 96. Enrollment is by invitation from the parent study.
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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