Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

NCT07502339 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 26-46306
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does upadacitinib reduce treatment failure by Day 14 (defined as need for colectomy or rescue therapy)?
2. 2.What side effects and safety events occur when using upadacitinib in hospitalized patients with ASUC?
3. 3.Take oral upadacitinib once daily during hospitalization.
4. 4.Undergo routine clinical monitoring, including blood tests and symptom assessments.
5. 5.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

Conditions

UC - Ulcerative Colitis

Keywords

ulcerative colitis; inpatient; upadacitinib; corticosteroid-free

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  Proportion of participants experiencing treatment failure by Day 14. Treatment failure is defined as the occurrence of any of the following: Colectomy (total or subtotal colectomy performed for ulcerative colitis), need for rescue therapy with intravenous corticosteroids, or need for rescue therapy with intravenous infliximab

  14 Days

Study Arms (1)

Upadacitinib Monotherapy (Corticosteroid-Free Induction)

EXPERIMENTAL

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.

Drug: Upadacitinib

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.

Upadacitinib Monotherapy (Corticosteroid-Free Induction)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 and ≤75 years of age hospitalized with ASUC (Mayo score \>10 or Truelove and Witts criteria)
• Diagnosis of UC for at least 90 days, confirmed by colonoscopy; appropriate documentation of biopsy results consistent with the diagnosis of UC
• No prior use of upadacitinib
• Capable of providing informed consent
• For women of childbearing potential: negative pregnancy test at screening and agreement to use acceptable contraception throughout study participation

You may not qualify if:

• Current diagnosis of Crohn's disease, indeterminate colitis, fulminant colitis, and/or toxic megacolon
• Disease limited to the rectum during screening endoscopy
• History of colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or was planning bowel surgery
• Infections requiring treatment with IV anti-infectives within 30 days before baseline or oral anti-infectives within 14 days before baseline
• Contraindication to IL-23 agent if advanced therapy-naïve
• Known hypersensitivity to upadacitinib or any excipients
• History of lymphoproliferative disorder, lymphoma, leukemia, or any malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ
• History of venous thromboembolic event (DVT, PE) within past 12 months
• Any condition that, in the investigator's opinion, would compromise the participant's safety or study outcomes
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline.
• Meeting any of the following conditions at Baseline:
• Two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
• One or more prior episodes of disseminated herpes simplex (including eczema herpeticum);
• Human immunodeficiency virus (HIV) infection, defined as confirmed positive anti-HIV antibody (HIV Ab) test or a positive HIV Ab/Ag test
• Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;

Sponsors & Collaborators

• AbbVie: collaborator
• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Sara Lewin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UCSF Crohn's and Colitis Center Research Coordinator Team

CONTACT

415-514-4896; IBD@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)