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New study: does starting this pill sooner save colitis patients from surgery?

NCT ID NCT07472309

Disease control Sponsor: Xijing Hospital of Digestive Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked back at medical records of 81 people with severe ulcerative colitis to see if starting upadacitinib early works better than using it after other treatments fail. Researchers checked how many avoided surgery and achieved remission within 12 weeks. The goal is to find the best timing for this medication in real-world care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
upadacitinib (a pill that reduces inflammation)
What this could lead to
If successful, this could show that using upadacitinib early is better than waiting until other treatments fail, potentially reducing the need for surgery.
What could go wrong
This is a small, retrospective study (not a controlled trial), so results may not apply to everyone. Upadacitinib can have side effects like infections or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

81 people

The number who actually took part.

Started

Jun 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a multicenter, retrospective cohort study conducted at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025. A total of 81 patients diagnosed with ASUC according to the modified Truelove and Witts criteria were enrolled. All patients received upadacitinib as first-line or rescue therapy. The study population was categorized into two groups: the first-line therapy group (upadacitinib administered in ASUC patients who had not previously received corticosteroids or biologics during this episode) and the rescue therapy group (including second-line and third-line therapy, defined as upadacitinib initiation after failure of intravenous methylprednisolone or both intravenous methylprednisolone and infliximab).

Ages

16 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients diagnosed with ASUC according to the modified Truelove and Witts criteria; 2. Patients treated with upadacitinib at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025； 3. Patients with complete and available clinical, endoscopic, and follow-up data； 4. Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki. Exclusion Criteria: 1. Patients with hemodynamic instability; 2. Patients with obvious liver and kidney function injury: bilirubin,aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR \< 60ml/min or dialysis patients; 3. Patients allergic to upadacitinib or its excipients; 4. Patients whose primary disease was gastrointestinal malignancy; 5. Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; 6. Female patients during pregnancy and breastfeeding (including patients with reproductive needs)； 7. Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 8. Patients with missing key data for outcome assessment; 9. Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute severe ulcerative colitis Ulcerative colitis (UC) Upadacitinib

Contacts and locations

Locations

  • Xijing Hospital,Fourth Military Medical University

    Xi'an, Shaanxi, 710032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.