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New hope for Crohn's patients when first drug fails

NCT ID NCT07487480

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at whether a drug called guselkumab can help people with moderate to severe Crohn's disease who did not improve or could not tolerate another drug called ustekinumab. About 60 adults will receive guselkumab and be followed for 52 weeks. The main goal is to see how many achieve remission (fewer symptoms) by the end of the study.

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 60 people

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

Started

Feb 2025

Expected to finish

Dec 2028

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

Participants will receive guselkumab according to the following schedule: Induction Phase (Weeks 0-12): Guselkumab 200 mg IV every 4 weeks (3 doses). Maintenance Phase (Weeks 12-52): Guselkumab 100 mg SC every 8 weeks. Adjustments may be made based on clinical response and physician judgment.

Ages

18 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: * Age 18-75 years. * Diagnosis of Crohn's disease for at least 3 months. * Moderate to severe disease activity (CDAI 220-450). * Previous treatment with at least one standard dose of ustekinumab with documented: * Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation. * Willing and able to comply with all study visits and procedures. Exclusion Criteria: * Previous exposure to any anti-IL-23p19 therapy (including guselkumab). * Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (\<8 weeks). * History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection. * Pregnancy, lactation, or planned pregnancy during the study period.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflamatory bowel disease Inflamatory bowel disease (Crohn's and ulcerative colitis)

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

  • Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

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