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Study on Transmural Healing in Patients with Moderate to Severe Crohn's Disease Using Upadacitinib and Drug Combination

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 treatments for Crohn's disease, 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 effectiveness of achieving a target of healing the intestinal wall, known as transmural healing, without the use of corticosteroids, which are a type of medication often used to reduce inflammation. The study will compare this approach to the traditional goal of achieving clinical remission, where symptoms are reduced or disappear, and biomarker remission, which involves normalizing certain blood tests.

Participants in the study will receive one or more of the following treatments: Upadacitinib (also known as ABT-494), Vedolizumab, Risankizumab (also known as BI 655066 or ABBV-066), Adalimumab (also known as ABP 501), Infliximab (also known as ABP 710), Ustekinumab (also known as Bmab 1200), Prednisone, and Budesonide. These medications are administered in various forms, such as oral tablets or intravenous infusions, and are designed to target different aspects of the immune system to reduce inflammation and promote healing. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study will last for up to 96 weeks, with participants undergoing regular assessments to monitor their health and the effectiveness of the treatment. The main goal is to determine if the new treatment approach leads to better outcomes for patients with Crohn's disease compared to the traditional methods. Participants will be closely monitored for any side effects or complications throughout the study period.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being between 18 to 80 years old, having moderately to severely active Crohn's disease, and meeting specific health markers.

  2. Step 2

    Medication administration

    Participants receive medications such as upadacitinib (oral), prednisone (oral), vedolizumab (intravenous infusion), risankizumab (intravenous or subcutaneous), adalimumab (subcutaneous), infliximab (intravenous infusion), budesonide (oral), and ustekinumab (intravenous or subcutaneous).

    The specific medication, dosage, and frequency depend on individual treatment plans and are determined by the study protocol.

  3. Step 3

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health status and response to treatment. These visits occur at specified intervals, such as weeks 6, 14, 22, 30, 38, and 48.

    During these visits, assessments include clinical evaluations, blood tests, and imaging studies to track disease progression and treatment effectiveness.

  4. Step 4

    Evaluation of treatment targets

    The study aims to achieve specific treatment targets, such as corticosteroid-free remission and biomarker remission, by week 48.

    Progress towards these targets is evaluated through clinical assessments and laboratory tests.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate overall health outcomes and the effectiveness of the treatment strategy.

    This includes a comprehensive review of clinical remission, biomarker levels, and any changes in disease activity.

Who can join the trial?

9 criteria

  • Adults aged 18 to 80 years can participate.
  • Must have **moderately to severely active Crohn's Disease** at the start of the study. This is determined by a **CDAI score** (a measure of Crohn's Disease activity) between 220 and 450, and a **SES-CD** score (a measure of inflammation in the intestines) of 6 or more, or 4 or more for those with disease only in the ileum (part of the small intestine).
  • Must have a **CRP** (a blood test that shows inflammation) level of 5 mg/L or higher, and/or **FCal** (a stool test that shows inflammation) level of 250 micrograms per gram or higher at the start of the study.
  • Must have a **BWT** (a measure of bowel wall thickness) of more than 4.0 mm in the ileum or any part of the colon, except the rectum, as seen on an **IUS** (an ultrasound scan of the intestines).
  • Must not have used more than one advanced treatment (like certain biologic drugs) for Crohn's Disease before. Only 15% to 30% of participants can have used such treatments before.
  • Can continue using a stable dose of **5-ASA** (a medication for Crohn's Disease) if it was started at least 4 weeks before the study begins.
  • Women who can have children must have a negative pregnancy test before starting and must use a highly effective birth control method during the study. Women who cannot have children must have proof of this in their medical records.
  • Must be able to take part in all parts of the clinical trial.
  • Must provide written informed consent, meaning they agree to participate after being told about the study.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had recent surgery related to Crohn's Disease.
  • Patients who are unable to stop using corticosteroids, which are medications that reduce inflammation.
  • Patients who have a history of not responding to treatments for Crohn's Disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an infection that requires treatment with antibiotics.
  • Patients who have a known allergy to the study medication.
  • Patients who have a condition that affects their immune system, which is the body's defense against infections.
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Investigated drugs

  • Corticosteroids

    are medications used to reduce inflammation in the body. In this trial, they are used to help manage symptoms of Crohn's Disease, but the goal is to achieve remission without relying on them.

  • TMH (Transmural Healing)

    is a treatment approach aimed at healing the entire thickness of the bowel wall in patients with Crohn's Disease. This therapy focuses on achieving deep healing beyond just symptom relief.

  • IUS (Intestinal Ultrasound)

    is a non-invasive imaging technique used to monitor the condition of the intestines in patients with Crohn's Disease. It helps in assessing the effectiveness of the treatment by providing real-time images of the bowel.

What is already known about the treatment

Ustekinumab – This medication is administered via injection and is currently used in the treatment of moderately to severely active Crohn's Disease. It is well-documented in medical literature as an effective option for managing this condition. Ustekinumab works by targeting specific proteins in the immune system, helping to reduce inflammation in the gut. It belongs to the pharmacological class of monoclonal antibodies, which are designed to interfere with the pathways that cause inflammation.

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 flares, and periods of remission. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. 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 vary greatly in severity and progression among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509096-16-00Protocol codeTAK01769Estimated enrolment322 patientsSponsorAlimentiv Inc.

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