ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Hospitalized patients with acute severe ulcerative colitis face high risks of colectomy and steroid-related harms. This trial tests whether an oral JAK1 inhibitor (upadacitinib) started in hospital can avoid steroids, act quickly, and reduce early treatment failure requiring surgery or rescue therapy.
Who Should Pay Attention
Adults hospitalized with acute severe ulcerative colitis, IBD clinicians managing inpatient ASUC, researchers studying steroid-sparing inpatient therapies, and patients considering advanced therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment50 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a single-center, open-label Phase IV trial at UCSF testing oral upadacitinib 45 mg once daily as a corticosteroid-free induction strategy for adults hospitalized with acute severe ulcerative colitis (ASUC).
The trial will enroll ~50 participants, treat them with upadacitinib during hospitalization (target 5–7 days), and follow outcomes for 52 weeks. The primary endpoint is treatment failure by Day 14, defined as need for colectomy or rescue therapy with IV corticosteroids or infliximab.
Safety endpoints include serious adverse events, infections, thromboembolic events, and lab abnormalities. The study compares the prospective upadacitinib cohort to a historical UCSF control group treated with infliximab-based regimens, using propensity-score methods to adjust for baseline differences.
Post-discharge management can include transitioning to an IL-23 inhibitor for advanced-therapy–naïve participants or continued upadacitinib with planned dose reductions per protocol and clinician discretion. This trial is listed as Phase 4 and is not yet recruiting.
It aims to generate prospective feasibility, safety, and preliminary effectiveness data on a rapid, oral, steroid-sparing inpatient strategy for ASUC; it is not a randomized controlled trial.
Keep In Mind
This is a single-arm, open-label Phase IV study compared against historical controls, not a randomized trial; that design can suggest feasibility and safety but is less definitive for comparative effectiveness. The registry record does not report trial results; the study is not yet recruiting.
Upadacitinib is already approved for outpatient moderate-to-severe UC, but its safety and effectiveness specifically in hospitalized ASUC patients are the focus here.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorUniversity of California, San Francisco
Trial IDNCT07502339
Study typeInterventional
Trial phasePhase 4
Enrollment50 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 24, 2026, 12:00 AM
Content availableTrial registry record
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.
A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose
This trial tests whether raising the upadacitinib dose to 45 mg can recapture clinical response in people with ulcerative colitis who lost response on the 30 mg maintenance dose. If effective and safe, the approach could...
Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis
This trial tests whether people with UC in deep remission can safely stop JAK inhibitor therapy — potentially reducing long-term exposure and associated safety concerns while preserving disease control and quality of...
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Long-term safety information matters for people with ulcerative colitis considering or already taking filgotinib, because LTE studies track adverse events and lab changes over years. Findings from such a study can...