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New hope for Crohn's scarring: risankizumab vs ustekinumab in major trial

NCT ID NCT07177118

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial will test two drugs, risankizumab and ustekinumab, in 260 adults with fibrostenotic Crohn's disease—a form where the bowel becomes scarred and narrow. The study compares how well each drug prevents further scarring over three years. Participants will receive either drug by IV and then injections. The goal is to see if these IL-23 inhibitors can slow disease progression and improve symptoms.

What this could mean

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

Active substance
risankizumab and ustekinumab (IL-23 inhibitors)
What this could lead to
If successful, this could offer a new treatment option for people with fibrostenotic Crohn's disease, potentially slowing or preventing bowel scarring.
What could go wrong
This is an early-stage Phase 3 trial that hasn't started recruiting yet. It's open-label, so both patients and doctors know which drug is given, which can bias results. The drugs may not work for all patients or could have 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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 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

Oct 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.

Ages

18 to 80 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: \- Here's the translation of the provided criteria into English: 1. Age between 18 and 80 years old, with no gender restrictions. 2. Voluntarily sign an informed consent form. 3. Diagnosed with fibrostenosing Crohn's disease by endoscopy and histology, and meet the following criteria: * Presence of symptoms indicating fibrostenosis, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain; * Endoscopic or radiological confirmation of new fibrotic stenosis (not caused by previous dilation/stenting); * The length of stenosis is less than 10 cm, and there are no more than 2 stenoses in a single intestinal segment; 4. Clinical manifestations of intestinal obstruction or sub-obstruction. 5. Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.). 6. Plan to receive treatment with risankizumab or ustekinumab for the first time. 7. Have not previously used risankizumab or ustekinumab; if other biological agents have been used, they have been discontinued for at least the specified washout period (TNF-α inhibitors ≥8 weeks). Exclusion Criteria: * Here is the translation of the exclusion criteria into English: 1. Age less than 18 or greater than 80 years old. 2. Refusal or inability to sign the informed consent form. 3. Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain. 4. Prior stenting and/or dilation treatment for stenosis (within less than 1 year). 5. Pregnancy, lactation, or planning to conceive. 6. Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy. 7. Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment). 8. Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment. 9. Severe coagulation dysfunction (platelet count \< 50,000; INR \> 1.5). 10. Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years. 11. Having received or started treatment with risankizumab or ustekinumab. 12. Investigator determines other conditions that make participation in this clinical study unsuitable.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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More trials for these conditions

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