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Study Comparing Risankizumab and Ustekinumab for Adults with Moderate to Severe Crohn's Disease After Anti-TNF Therapy Failure

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

This clinical trial is focused on studying the treatment of Crohn's Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study compares two treatments: Risankizumab and Ustekinumab. Both medications are proteins used to reduce inflammation and are administered as injections. Risankizumab is given either as a solution for injection in a pre-filled syringe or as a solution for infusion, while Ustekinumab is available as a solution for injection or infusion as well.

The purpose of the study is to evaluate the effectiveness and safety of Risankizumab compared to Ustekinumab in adults with moderate to severe Crohn's Disease who have not responded well to previous treatments known as anti-TNF therapies. The study is divided into two parts. In the first part, participants will receive either Risankizumab or Ustekinumab for 48 weeks. The second part will focus on the long-term safety of Risankizumab for up to 220 weeks for those who completed the first part. There is also a Continuous Treatment Extension to ensure ongoing care with Risankizumab until it becomes commercially available or participants can access it locally.

Participants will be monitored for clinical remission, which means a significant reduction in symptoms, and endoscopic remission, which involves healing of the digestive tract as seen through a camera. The study aims to determine if Risankizumab is as effective or more effective than Ustekinumab in achieving these outcomes. The trial will also assess the ability to maintain remission without the use of steroids, which are often used to control inflammation. The study is expected to continue until 2027.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Crohn's Disease and ensuring the condition is moderate to severe.

    The assessment involves checking the Crohn's Disease Activity Index (CDAI) score, which should be between 220 and 450, and evaluating symptoms such as stool frequency and abdominal pain.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either risankizumab or ustekinumab. This process is blinded, meaning neither the participant nor the assessor knows which treatment is being administered.

    The purpose of this step is to compare the effectiveness and safety of the two medications over a period of 48 weeks.

  3. Step 3

    Treatment administration

    For those receiving risankizumab, the medication is administered as a solution for injection or infusion. The specific dosage and frequency are determined by the study protocol.

    Participants receiving ustekinumab will receive it either as a subcutaneous injection or an intravenous infusion, depending on the assigned dosage form.

  4. Step 4

    Regular monitoring

    Throughout the 48-week period, regular monitoring is conducted to assess the effectiveness of the treatment. This includes clinical evaluations and endoscopic assessments to check for remission.

    Participants are required to attend scheduled visits for these assessments, which help determine the progress and any side effects of the treatment.

  5. Step 5

    End of part 1 assessment

    At the end of the 48-week period, a comprehensive assessment is conducted to evaluate the primary outcomes, such as clinical and endoscopic remission.

    The results of this assessment help determine the next steps in the study and the participant's eligibility for further treatment.

  6. Step 6

    Long-term safety evaluation

    Participants who received risankizumab and completed the 48-week assessment may continue in the study for a long-term safety evaluation, lasting up to 220 weeks.

    This phase aims to monitor the long-term effects and safety of the treatment, ensuring continuous care and collecting additional data.

  7. Step 7

    Continuous treatment extension

    For those who complete the long-term safety evaluation, a continuous treatment extension may be offered. This ensures uninterrupted access to risankizumab until it becomes commercially available or alternative arrangements are made.

    The extension also allows for ongoing monitoring of safety and effectiveness, contributing to the overall understanding of the treatment's long-term impact.

Who can join the trial?

5 criteria

  • Must be a male or female aged between 18 to 80 years at the start of the study.
  • Must have a confirmed diagnosis of Crohn's Disease for at least 3 months before starting the study.
  • Must have a Crohn's Disease Activity Index (CDAI) score between 220 to 450 at the start of the study. This score is based on symptoms like stool frequency and abdominal pain, as well as results from a procedure called an endoscopy, which looks inside the digestive tract.
  • Must have shown intolerance or inadequate response to one or more treatments known as anti-TNF therapies, which are medications used to reduce inflammation.
  • If female, must follow the study's contraception recommendations to prevent pregnancy during the study.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Crohn's Disease cannot participate.
  • Patients who have not failed anti-TNF therapy cannot participate. Anti-TNF therapy is a treatment that targets a specific protein in the body to reduce inflammation.
  • Patients who are not adults cannot participate. This means individuals under 18 years old are excluded.
  • Patients who have not completed the Week 48 visit in Part 1 of the study cannot participate in Part 2.
  • Patients who are unable to comply with the study requirements or follow-up visits cannot participate.
  • Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
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Investigated drugs

  • Risankizumab

    is a medication used in this clinical trial to treat adults with moderate to severe Crohn's Disease, especially those who have not responded well to other treatments called anti-TNF therapies. It works by targeting a specific part of the immune system that is involved in inflammation, which is a key problem in Crohn's Disease. The goal is to reduce symptoms and improve the quality of life for patients by controlling the inflammation in the gut.

  • Ustekinumab

    is another medication being compared in this trial. It is also used to treat moderate to severe Crohn's Disease in adults. Like risankizumab, ustekinumab works by affecting the immune system to help reduce inflammation. This medication is already used for other conditions like psoriasis and has been found to help some people with Crohn's Disease who have not had success with other treatments. The trial aims to see how well ustekinumab works compared to risankizumab in managing the disease.

What is already known about the treatment

  • Risankizumab

    Risankizumab is administered as an injection under the skin and is currently being studied for its effectiveness and safety in treating moderate to severe Crohn's Disease, particularly in patients who have not responded to anti-TNF therapy. It is a monoclonal antibody that works by targeting a specific protein in the body called interleukin-23 (IL-23), which plays a role in inflammation. This medication is classified as an immunosuppressant, helping to reduce inflammation and manage symptoms of Crohn's Disease over the long term.

  • Ustekinumab

    Ustekinumab is also given as an injection under the skin and is being compared to risankizumab in clinical trials for treating moderate to severe Crohn's Disease in patients who have not had success with anti-TNF therapy. It functions by blocking the activity of certain proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23), which are involved in inflammatory processes. Ustekinumab is classified as a biologic therapy, aiming to control inflammation and alleviate symptoms associated with Crohn's Disease.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can affect different layers of the bowel wall and may lead to complications like strictures or fistulas. The exact cause of Crohn's Disease is unknown, but it involves an abnormal immune response to intestinal bacteria. The disease can vary in severity and may progress differently in each individual.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501645-70-00Protocol codeM20-259Estimated enrolment470 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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