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Study on the Effectiveness and Safety of Vedolizumab and Upadacitinib in Adults 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 treatment of Crohn's Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study will evaluate the effectiveness and safety of a combination treatment using two medications: Vedolizumab, which is given through an intravenous infusion, and Upadacitinib, taken as an oral tablet. Vedolizumab is known by the brand name Entyvio, and Upadacitinib is known as Rinvoq. The trial will compare the results of using both medications together against using Vedolizumab with a placebo, which looks like the medication but does not contain the active drug.

The purpose of the study is to see if the combination of Vedolizumab and Upadacitinib can improve the health of people with moderately to severely active Crohn's Disease more effectively than Vedolizumab alone. Participants will receive the treatment for a period of up to 52 weeks. Initially, both medications will be used together for a short period to see if they can quickly improve symptoms and the condition of the digestive tract. After this initial phase, the study will continue with Vedolizumab alone to maintain the improvements.

Throughout the study, participants will be monitored to assess their response to the treatment, focusing on both clinical symptoms and the condition of the digestive tract as seen through medical examinations. The study aims to provide valuable information on whether this dual therapy approach can offer better outcomes for individuals living with Crohn's Disease.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    During the first 12 weeks, the treatment involves two medications: vedolizumab and upadacitinib. Vedolizumab is administered as an intravenous infusion. Upadacitinib is taken orally in the form of a prolonged-release tablet.

    The goal of this phase is to assess improvement in symptoms and intestinal healing. The effectiveness is measured by clinical and endoscopic evaluations.

  2. Step 2

    Maintenance phase

    After the initial 12 weeks, the treatment continues with vedolizumab alone. This phase focuses on maintaining the improvements achieved during the induction phase.

    The treatment is monitored to ensure continued symptom control and intestinal health.

  3. Step 3

    Evaluation points

    At Week 12, the primary evaluation includes checking for clinical remission, defined as a significant reduction in symptoms, and an endoscopic response, which involves a decrease in intestinal inflammation.

    Further evaluations occur at Week 52 to assess long-term outcomes, including symptom control and intestinal healing.

Who can join the trial?

6 criteria

  • The participant must have been diagnosed with Chron's Disease at least 3 months before the start of the study. This diagnosis should be confirmed by medical tests and a report from a tissue examination.
  • The participant must have a confirmed diagnosis of moderately to severely active Chron's Disease. This is measured by a score called CDAI (Chron's Disease Activity Index), which should be between 220 and 450.
  • The participant must show signs of inflammation in the lining of the intestines. This is measured by a score called SES-CD (Simple Endoscopic Score for Chron's Disease). The score should be 6 or higher, or 4 or higher if the disease is only in the last part of the small intestine, as confirmed by a specialist.
  • The participant must have previously tried treatments like corticosteroids, immunomodulators, or biologic therapy and found them not effective, or they could not tolerate these treatments.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations.

Who cannot join the trial?

6 criteria

  • Patients who do not have **Chron's Disease** cannot participate. **Chron's Disease** is a condition that causes inflammation in the digestive tract.
  • Patients who are not in the age range of 18 to 64 years old cannot participate.
  • Patients who are not considered to have moderately to severely active **Chron's Disease** cannot participate. This means the disease is not causing significant symptoms or problems.
  • Patients who are not able to take the study medications, **vedolizumab** and **upadacitinib**, cannot participate. These are specific drugs used in the study.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Vedolizumab

    is a medication given through an intravenous infusion. It is used to treat adults with moderately to severely active Crohn's Disease. Vedolizumab works by targeting specific proteins in the body to reduce inflammation in the gut, helping to manage symptoms and improve the condition of the intestinal lining.

  • Upadacitinib

    is a medication taken orally in the form of a pill. It is used in combination with vedolizumab to enhance the treatment of Crohn's Disease. Upadacitinib works by inhibiting certain enzymes in the body that contribute to inflammation, aiming to improve both clinical symptoms and the appearance of the gut lining when viewed through an endoscope.

What is already known about the treatment

  • Vedolizumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Crohn's Disease. It is already used in medical practice for certain inflammatory bowel diseases. Vedolizumab works by blocking a specific protein that causes inflammation in the gut, helping to reduce symptoms. It is classified as a monoclonal antibody.

  • Upadacitinib

    This medication is taken orally and is being evaluated in clinical trials for its potential benefits in treating Crohn's Disease. It is known for its use in other inflammatory conditions. Upadacitinib functions by inhibiting certain enzymes involved in the inflammatory process, thereby reducing inflammation. It belongs to the class of Janus kinase (JAK) inhibitors.

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 intensity. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can affect any part of the digestive tract from the mouth to the anus, but it most commonly impacts the end of the small intestine. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509391-42-00Protocol codeVedolizumab-3043Estimated enrolment396 patientsSponsorTakeda Development Center Americas Inc.

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