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Study on Preventing Crohn's Disease Recurrence After Surgery Using Risankizumab and Drug Combination in Adults at Risk

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What is this trial about?

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

This clinical trial focuses on patients with Crohn's disease, a condition that causes inflammation in the digestive tract. The study aims to prevent the return of the disease after surgery, specifically after a procedure called an ileocolonic resection, where part of the intestine is removed and reconnected. The trial will compare two approaches to starting treatment with biological medications. Biological medications are treatments made from living organisms or their products and are used to reduce inflammation and prevent disease recurrence.

The medications being studied include risankizumab, Infliximab, Adalimumab, Ustekinumab, and vedolizumab. These medications are given as injections or infusions, which means they are administered directly into the body through a needle. The study will compare starting these medications immediately after surgery to starting them only if the disease returns, as seen through an endoscopy, a procedure that uses a camera to look inside the digestive tract.

The purpose of the study is to determine which approach is more effective in preventing the return of Crohn's disease after surgery. Participants will be randomly assigned to one of the two treatment groups and will be monitored over a period of time to assess the recurrence of the disease and any side effects from the medications. The study will help to understand the best timing for starting biological therapy to improve outcomes for patients with Crohn's disease after surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the study procedures and objectives is provided. Consent forms are reviewed and signed.

    A comprehensive medical history is taken, and a physical examination is conducted to ensure eligibility for the trial.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: the systematic biological therapy group or the endoscopy-driven biological therapy group.

    The assignment determines the timing and initiation of the biological therapy.

  3. Step 3

    Treatment initiation

    For those in the systematic biological therapy group, treatment begins immediately after the initial visit. Medications such as risankizumab, infliximab, adalimumab, ustekinumab, or vedolizumab may be administered.

    The method of administration varies: subcutaneous injection or intravenous infusion, depending on the specific medication.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor health status and treatment response. These visits include physical examinations and may involve blood tests or other assessments.

    The frequency of these visits is determined by the study protocol and the specific group assignment.

  5. Step 5

    Endoscopic evaluation

    An endoscopic evaluation is performed at specified intervals to assess the presence of disease recurrence. This procedure involves using a camera to view the inside of the intestines.

    The results of this evaluation may influence the continuation or adjustment of the treatment plan.

  6. Step 6

    Treatment adjustment

    Based on the endoscopic findings and overall health status, adjustments to the treatment regimen may be made. This could involve changing the medication or its dosage.

    Participants in the endoscopy-driven group may start biological therapy if endoscopic recurrence is detected.

  7. Step 7

    Final assessment

    At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of health status and any changes in disease activity.

    The results contribute to the overall findings of the study and help determine the effectiveness of the treatment strategies.

Who can join the trial?

12 criteria

  • Provide voluntary written informed consent, which means you agree to participate after understanding the study details.
  • Have a diagnosis of Crohn's disease, confirmed by tests like X-rays, endoscopy (a camera used to look inside your digestive tract), or tissue samples.
  • Be a male or female aged 18 years or older.
  • Have undergone a specific type of surgery called ileocolonic resection with ileocolonic anastomosis (removal of part of the intestine and reconnection) within 3 to 40 days before the screening visit. If you had a temporary ileostomy (a temporary opening in the belly to pass waste), the surgery should have been done within eight months before the screening, and the reconnection should have been done within 3 to 40 days before the screening.
  • Have an increased risk for the disease coming back after surgery due to reasons like:
    • Having a type of Crohn's disease that causes holes or tunnels in the intestine.
    • Having had a similar surgery within the last ten years.
    • Having had two or more similar surgeries before.
    • Being an active smoker, meaning you smoked at least 7 cigarettes in the past month.
    • Having received advanced treatments, including biological therapy, within 3 months before the surgery.
    • Have had a curative ileocolonic resection, meaning all inflamed parts of the colon were removed. It's okay if you had procedures to widen the small intestine that don't involve the reconnection area.
    • Have previously not responded to at least three months of steroid treatment or three months of immunosuppressive therapy, or if you cannot tolerate these treatments or have a valid reason not to use them.
    • Be able and willing to start and continue biological therapy (a treatment using substances made from living organisms) at the time specified by the study.

Who cannot join the trial?

7 criteria

  • Patients who do not have Crohn's disease.
  • Patients who are not undergoing surgery related to Crohn's disease.
  • Patients who do not have at least one risk factor for the disease coming back after surgery.
  • Patients who are not having a specific type of surgery called ileocolonic resection with ileocolonic anastomosis. This is a surgery where a part of the intestine is removed and then reconnected.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing to follow the study procedures.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • Biological Therapy

    is a type of treatment that uses substances made from living organisms to treat disease. In this trial, biological therapy is used to help prevent the recurrence of Crohn's disease after surgery. It works by targeting specific parts of the immune system to reduce inflammation and prevent the disease from coming back.

  • Endoscopy-Driven Therapy

    is a treatment approach where the use of medication is guided by the results of an endoscopy. An endoscopy is a procedure that allows doctors to look inside the digestive tract. In this trial, endoscopy-driven therapy means that doctors will use the results of an endoscopy to decide if and when to start biological therapy, aiming to prevent the recurrence of Crohn's disease after surgery.

What is already known about the treatment

  • Risankizumab

    Risankizumab is a modern biological medicine given as an injection under the skin, and in Crohn's disease the first doses can also be given into a vein. It is approved for psoriasis, psoriatic arthritis and Crohn's disease. It is a monoclonal antibody that blocks interleukin-23, a messenger protein that drives chronic inflammation in the gut and skin; neutralising it calms the overactive immune response. It belongs to the group of interleukin inhibitors (biological immunosuppressants).

  • Guselkumab

    Guselkumab, sold as Tremfya, is a biological medicine administered as an injection under the skin from a pre-filled syringe, with an infusion form also available. It is approved for psoriasis and psoriatic arthritis and more recently for inflammatory bowel disease. Like risankizumab, it is a monoclonal antibody that binds the p19 part of interleukin-23 and prevents this messenger from switching on inflammatory cells in the intestinal wall. It is classified as an interleukin-23 inhibitor.

  • Adalimumab

    Adalimumab is one of the most widely used biological medicines in the world and is given as an injection under the skin, typically every two weeks after higher starting doses. It is approved for Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and several other inflammatory conditions. It is a fully human monoclonal antibody that captures and neutralises TNF-alpha, a key messenger protein that fuels inflammation in the bowel and joints. It belongs to the group of TNF-alpha inhibitors.

  • Infliximab

    Infliximab is a biological medicine that can be given as an infusion into a vein or, with newer formulations, as an injection under the skin. It has been used for more than two decades in Crohn's disease, ulcerative colitis, rheumatoid arthritis and psoriasis, and it is particularly well studied for preventing the return of Crohn's disease after surgery. It is a monoclonal antibody that binds and blocks TNF-alpha, thereby interrupting the chain of signals that keeps the gut inflamed. It is classified as a TNF-alpha inhibitor.

  • Mirikizumab

    Mirikizumab, sold as Omvoh, is one of the newest biological medicines for inflammatory bowel disease; treatment starts with infusions into a vein, followed by injections under the skin. It is approved for ulcerative colitis and Crohn's disease. It is a monoclonal antibody directed against the p19 subunit of interleukin-23, a central driver of intestinal inflammation, and blocking it helps the bowel lining to heal. It belongs to the interleukin-23 inhibitor class.

  • Ustekinumab

    Ustekinumab is a biological medicine whose first dose in bowel disease is given as an infusion into a vein, followed by injections under the skin every eight to twelve weeks. It is well established for Crohn's disease, ulcerative colitis, psoriasis and psoriatic arthritis. It is a monoclonal antibody that binds the shared p40 part of two messenger proteins, interleukin-12 and interleukin-23, preventing them from activating the immune cells that cause chronic inflammation. It is classified as an interleukin-12/23 inhibitor.

Investigated diseases

Crohn's Disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the ileum and colon. It is characterized by periods of active inflammation and remission. The disease can cause a range of symptoms, including abdominal pain, diarrhea, and weight loss. Over time, inflammation can lead to complications such as strictures, fistulas, and abscesses. The progression of Crohn's disease is unpredictable, with some individuals experiencing mild symptoms and others facing severe complications. The inflammation can affect different layers of the bowel wall, leading to a variety of clinical manifestations.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500311-39-00Protocol codeS62015Estimated enrolment352 patientsSponsorUZ Leuven

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