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New study tests if adding a second drug boosts UC treatment

NCT ID NCT07442045

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study looks at whether using two drugs together (upadacitinib and vedolizumab) works better than just one drug (upadacitinib alone) for people with moderate-to-severe ulcerative colitis, a chronic bowel disease. Researchers will review medical records from 150 adults across six hospitals in China to see which approach leads to more symptom relief and fewer side effects during the first 8 weeks of treatment. The goal is to provide real-world evidence to help doctors choose the best treatment plan.

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

About 150 people

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

Started

Jan 2023

Expected to finish

Sep 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.

Who is studied

The study population consisted of consecutive adults aged 18 years or older with an established diagnosis of moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, at six tertiary inflammatory bowel disease referral centers in China between January 2023 and September 2025. The index date was defined as the date of upadacitinib initiation. Treatment was selected by the treating physician as part of routine clinical care.

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: 1. Age 18 years or older at the index date. 2. Established diagnosis of ulcerative colitis for at least 3 months, supported by compatible clinical, endoscopic, and histologic findings. 3. Moderately to severely active ulcerative colitis at baseline, defined as a modified Mayo score of 4 to 9 and a Mayo endoscopic subscore of at least 2. 4. Initiation of upadacitinib induction therapy during the predefined study period. 5. For the combination-therapy group, initiation of vedolizumab concomitantly with upadacitinib at the index date. Exclusion Criteria: 1. Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis. 2. Previous colectomy or colectomy planned at the index date. 3. Previous exposure to upadacitinib or vedolizumab. 4. Initiation of another biologic or small-molecule advanced therapy during the 8-week induction period, except for vedolizumab in the combination-therapy group.

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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

    6 sites. 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

  • Foshan Fosun Chancheng Hospital, Foshan

    RECRUITING

    Foshan, Guangdong, 528000, China

  • The First People's Hospital of Foshan

    RECRUITING

    Foshan, Guangdong, 510260, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510260, China

  • The Sixth Affiliated Hospital, South China University of Technology City: Foshan

    RECRUITING

    Foshan, Guangdong, 528200, China

  • the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)

    RECRUITING

    Shenzhen, Guangdong, 518000, China

  • the Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 501655, China

More trials for these conditions

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