Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

Conditions

• UC - Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  Upadacitinib is an oral selective Janus kinase 1 (JAK1) inhibitor. In this study, participants will receive upadacitinib 45 mg orally once daily during hospitalization as corticosteroid-free induction therapy for acute severe ulcerative colitis. After discharge, treatment will follow protocol-defined pathways: Participants who are advanced therapy-naïve may transition to an IL-23 inhibitor after 4 weeks. Participants with prior advanced therapy exposure may continue upadacitinib 45 mg for up to 8 weeks, followed by dose reduction to standard maintenance dosing (30 mg or 15 mg once daily) at the discretion of the treating physician. Treatment duration and adjustments may vary based on clinical response and safety.

Study Details

The goal of this clinical trial is to learn if the oral medication upadacitinib can safely and effectively treat acute severe ulcerative colitis (ASUC) in adults who are hospitalized. It will also evaluate whether upadacitinib can be used without corticosteroids during initial treatment. The main questions it aims to answer are: 1. Does upadacitinib reduce treatment failure by Day 14 (defined as need for colectomy or rescue therapy)? 2. What side effects and safety events occur when using upadacitinib in hospitalized patients with ASUC? Researchers will compare outcomes in participants receiving upadacitinib to a historical group of similar patients previously treated with standard therapies, including intravenous corticosteroids and infliximab, to determine if upadacitinib improves outcomes. Participants will: 1. Take oral upadacitinib once daily during hospitalization. 2. Undergo routine clinical monitoring, including blood tests and symptom assessments. 3. Be followed after discharge with clinic visits or phone calls for up to 12 months to assess outcomes such as need for additional treatment, surgery, and safety events

Key Dates

Start date

Jul 1, 2026

Status verified

Apr 2026

Primary completion

Aug 1, 2028

Completion

Aug 1, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Upadacitinib Monotherapy (Corticosteroid-Free Induction)
  Participants hospitalized with acute severe ulcerative colitis will receive oral upadacitinib 45 mg once daily as corticosteroid-free induction therapy during hospitalization, followed by protocol-defined post-discharge management and longitudinal follow-up through 52 weeks.

Primary Outcome Measure

Treatment Failure [ Time Frame: 14 Days ]

Central Contacts

• UCSF Crohn's and Colitis Center Research Coordinator Team
  415-514-4896
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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