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Study on the Effectiveness and Safety of Risankizumab for Patients with Moderate to Severe Ulcerative Colitis

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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 effects of a medication called Risankizumab in people with Ulcerative Colitis. Ulcerative Colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The study aims to evaluate how effective and safe Risankizumab is as a maintenance treatment for individuals with moderate to severe Ulcerative Colitis who have previously responded to an initial treatment with Risankizumab.

Participants in the study will receive either Risankizumab or a placebo. The study is divided into several parts. In the first part, the focus is on comparing Risankizumab with a placebo to see how well it works in maintaining the health of participants over a period of time. In the second part, the study will look at two different ways of adjusting the dose of Risankizumab to see which method is more effective. The third part of the study will continue to monitor the long-term safety of Risankizumab in participants who have completed the earlier parts of the study or who were unable to complete the final examination due to external factors like the COVID-19 pandemic or geopolitical issues.

The study will last for a total of 52 weeks, during which participants will be monitored for any changes in their condition. The goal is to see if Risankizumab can help maintain remission, which means the symptoms of Ulcerative Colitis are reduced or disappear. The study will also look at other factors like improvements in the lining of the intestine and overall quality of life. Participants will be closely observed to ensure their safety throughout the study.

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

    Joining the study

    Participation begins after completing Study M16-067, including the final endoscopy. If the final endoscopy was not possible due to specific circumstances, enrollment in Sub-study 3 is allowed if a clinical response was achieved.

  2. Step 2

    Sub-study 1

    This phase evaluates the effectiveness and safety of risankizumab compared to a placebo for maintaining treatment in individuals with moderate to severe ulcerative colitis.

    Participants receive risankizumab or a placebo intravenously as a solution for infusion.

  3. Step 3

    Sub-study 2

    This phase assesses two different dosing strategies for risankizumab as maintenance therapy. The strategies include therapeutic drug monitoring and clinical assessment for dose escalation.

    Participants receive risankizumab intravenously as a solution for infusion.

  4. Step 4

    Sub-study 3

    This phase focuses on the long-term safety of risankizumab for those who completed Sub-study 1 or 2, or those who responded to the initial treatment but could not complete the final endoscopy due to specific circumstances.

    Participants receive risankizumab subcutaneously as a solution for injection in a pre-filled syringe.

  5. Step 5

    Continued treatment extension (CTE)

    This phase provides ongoing treatment with risankizumab for those who completed Sub-study 3, ensuring continuous care until the treatment is commercially available or accessible locally.

    Participants continue to receive risankizumab subcutaneously as a solution for injection in a pre-filled syringe.

Who can join the trial?

4 criteria

  • You must have completed a previous study called Study M16-067. This includes having a final examination of the colon, known as an endoscopy, unless it was missed due to the COVID-19 pandemic or conflicts in certain regions.
  • You must have shown improvement in your condition at the last visit of Study M16-067.
  • Both men and women can participate.
  • Participants should not be from vulnerable populations, which means groups that might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients who have not responded to the initial treatment with the study medication.
  • Patients with other significant health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to the study medication.
  • Patients with active infections that require treatment.
  • Patients with a history of certain types of cancer.
  • Patients who are using medications that could interfere with the study treatment.
  • Patients with a history of substance abuse or alcohol dependency.
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Investigated drugs

Risankizumab is a medication being studied for its effectiveness and safety in treating ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The trial is examining how well this medication works as a long-term treatment for people who have already shown improvement with initial treatment. The study also looks at different ways of adjusting the dosage to maintain the benefits of the medication. Additionally, the trial aims to ensure that patients can continue receiving the medication safely over an extended period.

What is already known about the treatment

Risankizumab – Risankizumab is administered as an intravenous infusion, followed by subcutaneous injections. It is currently being studied in clinical trials for its effectiveness and safety in treating ulcerative colitis, a chronic inflammatory bowel disease. The medication works by targeting and inhibiting a specific protein in the immune system called interleukin-23 (IL-23), which plays a role in inflammation. Risankizumab is classified as a monoclonal antibody and is being evaluated for its potential to maintain remission in patients with moderately to severely active ulcerative colitis.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission, where symptoms may worsen and then improve. Over time, the inflammation can cause the colon to become less effective at absorbing water and nutrients, leading to further complications. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut. Environmental factors, genetics, and an imbalance in gut bacteria may also play a role in its development.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506994-36-00Protocol codeM16-066Estimated enrolment1 155 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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