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Long-term study of upadacitinib tablets for adults with Crohn's disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Crohn's Disease, which is a long-term inflammatory condition affecting the digestive system. The study will evaluate a medication called upadacitinib (also known as ABT-494), which is taken as a modified-release tablet by mouth. The purpose is to observe how well this medication works and how safe it is when used for an extended period in people who have already completed a previous study of the same treatment.

The medication will be given as a daily dose of either 15 mg or 30 mg for up to 96 months (8 years). During the study, researchers will monitor how well the treatment controls the symptoms of Crohn's Disease, including improvements in digestive system inflammation, reduction in abdominal pain, and changes in bowel movements. They will also track how many participants are able to stop using steroid medications.

Throughout the study, participants will have regular check-ups to monitor their health and assess how well the treatment is working. The study will look at various aspects of the disease, including quality of life, ability to work, and any hospital visits related to Crohn's Disease. Researchers will also keep track of any side effects that may occur during the long-term use of the medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After completing the previous 52-week study (M13-740), your eligibility for this long-term extension study will be evaluated

    The study medication (upadacitinib) will be provided in the form of modified-release tablets for oral use

  2. Step 2

    Treatment period

    You will continue taking upadacitinib tablets by mouth daily

    The study will monitor your condition for up to 96 months (8 years)

    Regular assessments will occur at months 12, 24, 36, 48, 60, 72, 84, and 96

    Your dose may be adjusted to 30 mg daily if needed

  3. Step 3

    Regular monitoring

    Your Crohn's disease symptoms will be regularly evaluated

    Blood tests will be performed to check inflammation markers

    Stool samples will be collected to measure specific proteins related to gut inflammation

    Gut examinations (endoscopy) will be conducted at specific intervals

    Quality of life questionnaires will need to be completed during visits

  4. Step 4

    Safety assessments

    Regular checks will monitor any side effects or changes in your health

    Your use of other medications, particularly steroids, will be tracked

    Any hospital visits or procedures related to Crohn's disease will be recorded

Who can join the trial?

8 criteria

  • Must have completed the previous study (Study M13-740) through Week 52
  • Must be an adult (18 years or older)
  • Both men and women can participate
  • Female participants must meet one of these conditions:
    • Be postmenopausal (no longer having menstrual periods for at least 12 months naturally)
    • Be surgically sterile (having had surgery that prevents pregnancy)
    • Use an effective method of birth control during the study
    • Must be able and willing to participate in a long-term study testing the medication upadacitinib
    • Must be diagnosed with Crohn's Disease

Who cannot join the trial?

15 criteria

  • Patients who did not complete the previous Study M13-740
  • Patients younger than 18 years old
  • Pregnant or breastfeeding women
  • Patients with active tuberculosis (an infectious bacterial disease affecting the lungs)
  • Patients with serious active infections requiring treatment
  • Patients with history of lymphoma (cancer of the lymphatic system) or other malignancies in the past 5 years
  • Patients with severe liver disease
  • Patients with severe kidney disease requiring dialysis
  • Patients currently taking other biological treatments for Crohn's Disease
  • Patients with a known allergy or hypersensitivity to upadacitinib
  • Patients with uncontrolled high blood pressure
  • Patients with severe heart conditions
  • Patients participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with history of drug or alcohol abuse within the past 6 months
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Investigated drugs

Upadacitinib (also known as ABT-494) is a medication that works by reducing inflammation in the body. It belongs to a class of drugs called JAK inhibitors. This medication helps control the immune system's response and is used to treat Crohn's disease, which is a chronic inflammatory condition affecting the digestive system. The medication is taken orally and helps reduce symptoms such as abdominal pain, diarrhea, and fatigue that are common in people with Crohn's disease.

What is already known about the treatment

Upadacitinib – An oral medication taken in tablet form that belongs to the class of Janus kinase (JAK) inhibitors, specifically targeting JAK1. This drug works by reducing inflammation in the body by blocking specific enzymes involved in the inflammatory response, making it effective for treating Crohn's Disease. It represents a newer generation of targeted therapy that helps manage inflammatory bowel conditions by modulating the immune system's response. The medication has shown promising results in clinical trials for maintaining long-term remission in patients with moderate to severe Crohn's Disease, offering an alternative treatment option for those who may not respond well to conventional therapies.

Investigated diseases

Crohn's Disease - A chronic inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus, but most commonly involves the end of the small intestine and beginning of the colon. The inflammation caused by Crohn's disease often spreads deep into the layers of affected bowel tissue, creating patches of inflamed tissue surrounded by healthy areas. The condition can cause abdominal pain, diarrhea, fatigue, weight loss, and malnutrition. Symptoms typically develop gradually and can range from mild to severe, with periods of active disease followed by periods of remission. The disease can cause changes in the bowel wall that lead to scarring and thickening over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510727-19-00Protocol codeM14-327Estimated enrolment33 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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