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Study on the Effectiveness and Safety of Risankizumab for Patients with Moderate to Severe Crohn's Disease

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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 Crohn's Disease. Crohn's Disease is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study aims to evaluate the safety and effectiveness of Risankizumab as a maintenance therapy for individuals who have already shown improvement after initial treatment with the medication.

Participants in the study will receive either Risankizumab or a placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will last for 52 weeks, during which the participants' health and response to the treatment will be closely monitored. After this period, there is an option for an open-label extension, where all participants can receive Risankizumab to further assess its long-term safety and effectiveness.

The purpose of this study is to gather more information about how well Risankizumab works in maintaining the health of people with Crohn's Disease and to ensure its safety over a longer period. This research could potentially lead to better treatment options for those living with this challenging condition.

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

    Initial phase

    Upon joining the study, participation begins with a randomized, double-blind, placebo-controlled maintenance phase. This phase is designed to evaluate the effectiveness and safety of risankizumab compared to a placebo.

    Participants who have previously responded to intravenous risankizumab treatment in earlier studies are eligible for this phase.

  2. Step 2

    Medication administration

    During the study, risankizumab is administered in two forms: as a solution for infusion and as a solution for injection in a pre-filled syringe.

    The intravenous form is used initially, followed by subcutaneous injections. The specific dosage and frequency are determined based on the study protocol.

  3. Step 3

    Maintenance phase

    The maintenance phase lasts for 52 weeks. Participants receive either risankizumab or a placebo during this period.

    The goal is to assess the proportion of participants achieving clinical remission and endoscopic response by the end of the 52 weeks.

  4. Step 4

    Open-label extension

    After completing the maintenance phase, participants may enter an open-label extension phase. This phase allows for continued treatment with risankizumab to evaluate long-term safety and effectiveness.

    Participants who complete this phase may continue to receive treatment until it becomes commercially available or accessible locally.

  5. Step 5

    Evaluation and follow-up

    Throughout the study, various assessments are conducted to monitor health status, including clinical remission, endoscopic response, and quality of life measures.

    The study aims to ensure the safety and well-being of participants while gathering data on the long-term effects of risankizumab.

Who can join the trial?

4 criteria

  • Participants must have completed Study M16-006, Study M15-991, or another AbbVie study related to **Crohn's Disease**.
  • Participants must have finished Study M16-006 or M15-991 and shown a positive response to the treatment.
  • Participants must be able and willing to provide written consent, which means they agree to join the study and follow its rules.
  • Participants must be able to give themselves injections under the skin (called **subcutaneous injections**) or have a caregiver do it for them, if allowed by local rules.

Who cannot join the trial?

10 criteria

  • Patients who have not responded to the initial treatment with the study medication.
  • Patients with other serious 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 allergic reactions to the study medication or similar drugs.
  • Patients with certain infections that could worsen with the study medication.
  • Patients who are using other medications that might interfere with the study treatment.
  • Patients with a history of substance abuse that could affect their ability to participate.
  • Patients who have had recent surgery or are planning to have surgery during the study.
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Investigated drugs

Risankizumab is a medication being studied for its effectiveness and safety in treating Crohn's Disease, a condition that causes inflammation of the digestive tract. In this clinical trial, risankizumab is used as a maintenance therapy for patients who have already responded to initial treatment with the medication. The trial aims to determine how well risankizumab works over a longer period and to monitor any potential side effects. The study also explores different dosing strategies to find the most effective way to use the medication for maintaining the health of patients with Crohn's Disease.

What is already known about the treatment

Risankizumab – Risankizumab is administered as an intravenous infusion, followed by subcutaneous injections, and is currently being studied for its effectiveness and safety in treating Crohn's Disease. It is in the clinical trial phase, with ongoing research to establish its long-term safety and efficacy. The main therapeutic indication for risankizumab is for individuals with moderately to severely active Crohn's Disease. At the molecular level, risankizumab works by targeting and inhibiting interleukin-23 (IL-23), a protein involved in inflammatory processes. It is classified as a monoclonal antibody, specifically designed to modulate the immune response 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 flare-ups and remission, where symptoms can vary in severity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications such as strictures, fistulas, and malnutrition. The exact cause of Crohn's Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect any part of the gastrointestinal tract from the mouth to the anus, but it most commonly affects the end of the small intestine and the beginning of the colon.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506399-28-00Protocol codeM16-000Estimated enrolment982 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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