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New combo strategy aims to speed up UC remission without sacrificing safety

NCT ID NCT06095596

Disease control Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a sequential treatment for moderate to severe ulcerative colitis. First, patients take upadacitinib (a fast-acting pill) along with vedolizumab (a slow but safe infusion) for 8 weeks to quickly reduce inflammation. Then, they continue with vedolizumab alone for long-term control. The goal is to combine the speed of upadacitinib with the safety of vedolizumab. The trial will enroll 334 adults and measure how many achieve endoscopic remission at week 8.

What this could mean

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

Active substance
Vedolizumab and upadacitinib
What this could lead to
If successful, this sequential approach could offer a way to quickly bring ulcerative colitis under control and then maintain remission safely with a single drug.
What could go wrong
This is an early-stage study with no phase designation, so results are uncertain. Upadacitinib carries risks like infection and blood clots, and the combination may not prove better than existing treatments.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 334 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Ages

18 years and older

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: * Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis * Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2 * Indications for VDZ or UPA application Exclusion Criteria: * Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy * Evidence of toxic megacolon was found during screening * Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC * Subjects who require surgery due to UC or plan to undergo elective surgery during the study period * There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases * Evidence of active hepatitis B or C infection during screening

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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.

Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • the Sixth Affiliated Hospital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, Guangdong, 501655, China

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