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New hope for Crohn's patients: study tests guselkumab after ustekinumab fails

NCT ID NCT07310095

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether guselkumab can help people with Crohn's disease whose current treatment (ustekinumab) has stopped working. Crohn's disease causes severe gut inflammation. About 78 Chinese adults with active Crohn's will receive guselkumab and be followed for 48 weeks to see if their symptoms improve. The goal is to reduce inflammation and achieve remission without needing lifelong medication.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 78 people

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

Started

Dec 2025

Expected to finish

Nov 2027

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.

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 Crohn's disease (CD) * Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 * Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks * Initially responded to UST induction therapy and then lose response to UST * During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic Exclusion Criteria: * Received UST dose optimization or multiple intravenous therapy in maintenance phase * Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months * Is currently enrolled in an interventional clinical study * Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome * Have a current or be suspected to have an abscess

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

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

Crohn disease

How to take part

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

  1. The places running it

    5 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

  • Ruijin Hospital

    RECRUITING

    Shanghai, 200031, 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, 510060, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, 230022, China

  • The Sixth Affiliated Hospital Sun Yat sen University

    RECRUITING

    Guangzhou, 510655, China

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