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Evaluation of Upadacitinib for Reducing Ileal Strictures in Patients with Crohn’s Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Crohn’s disease is a long‑lasting condition that causes inflammation in the digestive tract. In some people the inflammation leads to a narrowing, called a stricturing complication, especially in the part of the small intestine known as the ileum. The narrowing can make it hard for food to pass through and may cause pain or blockage. The study uses the oral medication upadacitinib, which is taken in tablet form at different strengths, to try to reduce these narrow areas.

The purpose of the study is to find out whether upadacitinib can improve the size and shape of the narrowed sections of the small bowel in people with Crohn’s disease. Participants will have a series of visits over about six months. At the start and again after roughly 24 weeks, a special type of scan called MR enterography (a type of MRI that looks closely at the intestines) will be performed to measure changes in the thickness of the bowel wall, the length of the narrowed segment, and the swelling that occurs before the narrowing. The study follows participants through these visits to see if the medication leads to at least a 25 % improvement in these measurements.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After enrollment, an initial evaluation is performed to record the condition of the small bowel and any existing strictures.

    Magnetic resonance imaging (mri) of the abdomen is done to create a reference point for later comparisons.

  2. Step 2

    Start medication

    The study medication, upadacitinib, is prescribed in one of three possible strengths: 15 mg, 30 mg, or 45 mg.

    The medication is taken by mouth (oral) as a single daily dose.

  3. Step 3

    Daily medication intake

    Each day, the assigned dose of upadacitinib is swallowed with water.

    The medication is continued every day for a total period of 24 weeks.

  4. Step 4

    Regular follow‑up visits

    Periodic clinic visits are scheduled to monitor safety, any side effects, and overall health.

    During these visits, the study team may ask about symptoms and check vital signs.

  5. Step 5

    Week 24 mri evaluation

    At week 24, a second mri of the abdomen is performed.

    The images are examined to see if there is at least a 25 % reduction in bowel wall thickness, stricture length, or pre‑stenotic dilation compared with the baseline scan.

Who can join the trial?

6 criteria

  • You must have Crohn’s disease that includes a narrowing (tightening) of the intestine called a stricturing complication.
  • You must sign a voluntary written informed consent form (or have a legal representative do so) before any screening tests are done.
  • You must be an adult aged 18 years or older but younger than 80 years.
  • You must have up to two narrow areas (strictures) in the small intestine that can be reached with an endoscope (a thin tube with a camera).
  • The narrow area must be either a new (naïve) or a surgically joined (anastomotic) part of the small intestine (but not a part that has been repaired with a stricturoplasty), and it must meet two measurements on an MRI scan of the bowel (MRE):
    • The inside space of the intestine (lumen) must be narrowed to half or less of the normal size (normally about 20 mm, so the narrowed part must be 10 mm or smaller). This is called luminal narrowing.
    • The wall of the intestine must be thickened by at least 25% compared with normal (normally 3 mm or less, so the thickened part must be 4 mm or more). This is called bowel wall thickening.

Who cannot join the trial?

15 criteria

  • You have previously not responded, stopped responding, or could not tolerate the drug upadacitinib (a medication being studied).
  • You have any reason that makes a magnetic resonance enterography (MRE) unsafe or unsuitable (this is a special MRI scan of the small intestine).
  • You have a blockage in the small intestine (small bowel obstruction) that is expected to need surgery within the next two weeks.
  • You need a procedure called endoscopic balloon dilation (using a tiny balloon to open the narrowed area) before the study starts.
  • You have internal abnormal connections (fistulas) or fluid collections that are linked to the narrowing seen on the MRE scan.
  • The narrowing (stricture) is suspected to be cancerous (malignant).
  • You have a very short (<1 cm) single narrowing at a surgical connection point (anastomotic stricture).
  • You have any other health problem that the doctor believes could put your safety at risk or make it hard for you to follow the study rules.
  • You are taking or have taken other treatments that could affect your safety or interfere with the study’s results.
  • Any other situation that could threaten your safety or the reliability of the trial (for example, not being able to follow the study schedule).
  • You are currently participating in another clinical trial that uses an experimental drug or device.
  • You have an ostomy (a surgically created opening on the abdomen to allow waste to leave the body).
  • You have a narrowing in the colon (colonic stenosis).
  • You have ulcerative colitis or another type of inflammatory bowel disease that is not classified as Crohn’s disease.
  • You have a medical reason that makes taking a JAK inhibitor (JAK inhibition) unsafe, such as certain infections, blood clot risk, or other warnings listed for the medication.
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Investigated drugs

Upadacitinib is an oral medication that blocks a specific enzyme involved in inflammation. In this study, it is being tested to see if it can reduce the thickening and narrowing (strictures) of the small intestine that can occur in Crohn’s disease. Participants will take the tablet each day, and doctors will use MRI scans after 24 weeks to check whether the medication has helped improve the strictures.

What is already known about the treatment

UPADACITINIB - It is taken as an oral tablet that is swallowed with water once daily. Upadacitinib is already approved for several inflammatory diseases such as rheumatoid arthritis and ulcerative colitis, and it is being studied for Crohn’s disease with stricturing complications. It works by blocking a protein called JAK1, which helps reduce the signals that cause inflammation and tissue scarring. The drug belongs to the class of selective JAK‑1 inhibitors, a type of oral immunomodulator.

Investigated diseases

Crohn’s disease with ileal stricturing complication - Crohn’s disease with ileal stricturing complication is a long‑lasting inflammation that mainly affects the small intestine, especially the ileum. Over time the inflamed tissue can become thickened and form a narrowing, called a stricture, which can block the passage of food. The narrowing may cause abdominal pain, cramping, and changes in bowel movements as it worsens. If the stricture enlarges, it can lead to swelling of the intestine upstream of the blockage.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523038-16-00Protocol codeCLEAR-UPEstimated enrolment56 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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