Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a single drug ease Crohn's gut blockages?

NCT ID NCT05387031

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether the drug ustekinumab (Stelara) can help people with moderate-to-severe Crohn's disease who also have bowel strictures (narrowing of the intestine). About 239 participants will receive ustekinumab and be followed for a year. The goal is to see if the drug can reduce symptoms, avoid the need for surgery or balloon dilation, and improve quality of life.

What this could mean

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

Active substance
ustekinumab (Stelara)
What this could lead to
If successful, this could show that ustekinumab helps control Crohn's-related bowel strictures, reducing the need for surgery or dilation.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The drug may not work for all types of strictures, and some patients may still need surgery.

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 239 people

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

Started

Aug 2024

Expected to finish

Aug 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 were adult CD patients treated with their first UST therapy for symptomatic strictures (confirmed on endoscopy or imaging) from centers of IBD at 8 hospitals all over China. This study does not involve the use of vulnerable groups.

Ages

18 to 65 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: * Clinical diagnosis of moderate to severe Crohn's disease * Obstructive symptoms within the last eight weeks * A single or several lumen stricture(s) identified by radiological imaging or endoscopy * For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm * For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing Exclusion Criteria: * Requirement of urgent surgery or endoscopic intervention within 2 months as judged by the clinician * Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions * Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture * Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc. * Unable to eat after using enteral nutrition for more than 2 months * History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months * CT enterograph contraindications, such as allergy to contrast media * Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease * Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy * Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors * Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome * Combination of severe liver and kidney dysfunction * Coexistence of bacterial or viral active infection * Pregnant or breastfeeding * Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Constriction, Pathologic Crohn disease

As listed by the trial registrant

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

Crohn disease Intestinal stricture Stricture; bowel

How to take part

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

  1. The places running it

    8 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

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

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Department of Gastroenterology, Affiliated Hospital of Yangzhou University

    RECRUITING

    Yangzhou, Jiangsu, China

  • Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Department of Gastroenterology, Huai'an First People's Hospital

    RECRUITING

    Huai'an, Jiangsu, China

  • Department of Gastroenterology, Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University

    RECRUITING

    Hangzhou, Zhejiang, China

More trials for these conditions

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