NIH RePORTER
Cure8 regulatory brief
Why This Matters
This pilot tests whether some patients with acute severe ulcerative colitis could avoid hospitalization by using early oral JAK inhibitor therapy plus steroids with close remote monitoring — a change that could reduce patient burden and healthcare costs if proven feasible and safe.
Who Should Pay Attention
Adults with ulcerative colitis, clinicians treating ASUC, IBD researchers, and health-system planners interested in outpatient care models.
Study Snapshot
Story typeRegulatory
Evidence typeFunded research project
Study statusFunded
Source depthResearch project record
What To Know
This is a funded R03 pilot randomized, double-blind, placebo-controlled trial enrolling 30 outpatients meeting ASUC criteria to receive upadacitinib plus corticosteroids versus corticosteroids alone for 8 weeks. The goals are to assess feasibility, safety under structured remote monitoring, and candidate endpoints to design a larger R01 trial.
The study will use manufacturer-supplied upadacitinib and matching placebo, daily structured monitoring, predefined clinical escalation criteria for hospitalization or rescue therapy, and metrics for protocol fidelity. The pilot is not large enough to establish definitive efficacy or safety but is intended to generate data to power a future definitive trial.
Keep In Mind
This is a funded R03 pilot (no results reported here). The study’s small size (n=30) is intended to inform the design of a larger trial rather than provide definitive evidence about safety or efficacy. Upadacitinib and placebo are provided by the manufacturer.
Source Details
Review the original publication for the complete reporting, methods, and context.
Funded research project
Evidence type derived from source or registry metadata.
PublicationNIH RePORTER
AuthorsJeffrey Berinstein
InstitutionUNIVERSITY OF MICHIGAN AT ANN ARBOR
Study typeFunded Research Project
Indexed viaNIH RePORTER
Source typeFunded research record
PublishedAug 13, 2026, 12:00 AM
Content availableResearch project record
Funding disclosed by the source: National Institute of Diabetes and Digestive and Kidney Diseases - R03DK149488 - $117,000
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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