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New study tests biologic drug guselkumab for ulcerative colitis in chinese patients

NCT ID NCT07302360

Disease control Sponsor: Xian-Janssen Pharmaceutical Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 5 times

Summary

This study follows 200 Chinese patients with moderate-to-severe ulcerative colitis who have never taken biologic drugs. They will receive guselkumab as part of their normal care. Researchers will measure changes in symptoms and quality of life over 48 weeks to see how well the drug works in everyday practice.

What this could mean

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

Active substance
Guselkumab (a biologic medicine given by injection)
What this could lead to
If successful, this study could show that guselkumab is a safe and effective treatment option for ulcerative colitis in patients who have not used biologics before.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also limited to Chinese patients, so findings may not apply to other populations.

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 200 people

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

Started

Dec 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Eligible Chinese participants with moderate-to-severe UC who are bio-naive will be consecutively enrolled in this study.

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: * Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\>=) 2; c) Mayo rectal bleeding subscore (RBS) \>= 1 at baseline * Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert * Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment * Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements Exclusion criteria: * Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy * Contraindicated to guselkumab per the label * Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab * Participants who will be receiving guselkumab therapy combined with a second advanced therapy * Participants with a history of colectomy and/or pouch

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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.

Colitis ulcerative

How to take part

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

  1. The places running it

    10 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

  • Changzhou No 2 Peoples Hospital

    RECRUITING

    Changzhou, 213003, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, 223800, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100006, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, 100044, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310018, China

  • The First Affiliated Hospital Sun Yat-Sen University

    RECRUITING

    Guangzhou, 510080, China

  • The Second Affiliated Hospital of Zhejiang University

    RECRUITING

    Hangzhou, 310009, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050000, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, 300052, China

More trials for these conditions

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