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New hope for IBD: IL-23 drugs tested in chinese patients

NCT ID NCT07184138

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study will follow 178 Chinese adults with Crohn's disease or ulcerative colitis who are starting treatment with IL-23 inhibitors (guselkumab or risankizumab). Researchers will track how well the drugs control symptoms and heal the gut over 52 weeks, as well as any side effects. The goal is to see if these newer biologics work in real-world Chinese patients, where data is currently limited.

What this could mean

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

Active substance
Interleukin-23 inhibitors (IL-23i) – guselkumab and risankizumab
What this could lead to
If successful, this study could provide real-world evidence that IL-23 inhibitors are effective and safe for Chinese patients with Crohn's disease or ulcerative colitis, potentially improving treatment options.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also early-stage for Chinese populations, and some patients may not respond or may experience side effects.

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 178 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Nov 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

Adult patients in China diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating treatment with an interleukin-23 inhibitor (IL-23i) for the first time in routine clinical practice.

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: Adults aged 18 years or older, any gender. Formally diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). Determined by the treating physician to require initiation of IL-23 inhibitor (IL-23i) therapy for the first time. Exclusion Criteria: Currently enrolled in or planning to participate in any other interventional clinical study. Contraindications to IL-23i treatment as specified in the drug label. Considered by the investigator to be unsuitable for participation in the study for any reason.

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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 (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 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 ↗

  2. 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.

More trials for these conditions

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