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Study on Long-Term Safety and Effectiveness of Upadacitinib for Patients with 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 long-term safety and effectiveness of a medication called Upadacitinib in people with Ulcerative Colitis. Ulcerative Colitis is a chronic condition that causes inflammation and sores in the lining of the large intestine. The medication being tested, Upadacitinib, is a type of drug known as a Janus kinase (Jak) 1 inhibitor, which works by blocking certain enzymes in the body that are involved in the inflammatory process.

The purpose of this study is to evaluate how safe and effective Upadacitinib is over a long period. Participants in the study will take Upadacitinib in the form of a modified-release tablet, which means the medication is designed to be released slowly in the body. The study will also include a placebo group, which means some participants will receive a tablet that does not contain the active medication. This helps researchers compare the effects of the medication against no treatment.

Throughout the study, participants will be monitored regularly to assess any side effects and to see how well the medication is working in managing their Ulcerative Colitis symptoms. The study is designed to last for several years, allowing researchers to gather comprehensive data on the long-term use of Upadacitinib. Participants will have regular check-ups and assessments to ensure their safety and to track the progress of their condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the study requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the study's inclusion criteria. This may involve reviewing your medical history and conducting necessary tests, such as a colonoscopy or sigmoidoscopy, to confirm eligibility.

  3. Step 3

    Medication administration

    You will begin taking the study medication, upadacitinib, in the form of a modified-release tablet. The dosage is 30 mg taken orally once daily. This will continue for the duration of the study unless otherwise directed by the study team.

  4. Step 4

    Regular monitoring

    Throughout the study, you will undergo regular monitoring to assess your health and the medication's effects. This includes physical examinations, vital signs checks, and laboratory tests. These assessments help ensure your safety and the study's integrity.

  5. Step 5

    Dose optimization substudy

    If you are eligible, you may enter a dose optimization substudy. This involves adjusting the medication dosage based on your response and maintaining stable clinical remission. Regular assessments will continue to monitor your condition.

  6. Step 6

    End of study

    At the end of the study, a final assessment will be conducted. This includes a review of your health status and any changes observed during the study. The study team will discuss the next steps and any follow-up care if needed.

Who can join the trial?

13 criteria

  • The study is for people with Ulcerative Colitis, a condition that causes inflammation and sores in the colon.
  • You must have participated in a previous study (Study M14-234) and either not responded to treatment, lost response, or completed the study.
  • If you missed certain medical tests due to the COVID-19 pandemic, you might still be eligible if you showed improvement based on a specific score called the Partial Adapted Mayo Score.
  • You must be in stable condition, meaning you have had no symptoms like frequent bowel movements or bleeding for at least 6 months.
  • A recent medical test called an endoscopy should show mild or no inflammation in your colon.
  • You should not have started any new medication or increased your current medication for Ulcerative Colitis in the past 6 months.
  • Your fecal calprotectin level, a marker of inflammation in the intestines, should be 250 mg/kg or lower.
  • If you are a woman who can have children, you must have a negative pregnancy test at the start of the study and follow specific birth control guidelines.
  • You should be in generally good health as determined by the study doctor based on previous evaluations.
  • You must be able to understand and agree to the study requirements and provide written consent.
  • You should currently be taking a medication called upadacitinib at a dose of 30 mg daily for at least 6 months.
  • You should not have used any corticosteroid treatment for Ulcerative Colitis for at least 90 days before joining the study.
  • The study is open to both men and women.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of Ulcerative Colitis.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a group that is not included in the study.
  • Patients who are part of a vulnerable population that is not selected for the study.
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Investigated drugs

Upadacitinib is a medication being studied for its effects on ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. This medication works by blocking certain enzymes in the body that are involved in the inflammatory process. By doing so, it aims to reduce inflammation and help manage the symptoms of ulcerative colitis, potentially improving the quality of life for those affected by this condition. The study is focused on understanding how safe and effective this medication is when used over a long period.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally in the form of tablets and is currently being studied in clinical trials for its long-term safety and effectiveness in treating ulcerative colitis, a chronic inflammatory condition of the colon. It is a medication that is gaining attention in medical literature for its potential benefits in managing this condition. The main therapeutic indication for upadacitinib is ulcerative colitis, where it works by inhibiting specific enzymes known as Janus kinases (JAKs) at the molecular level, which play a role in the inflammatory process. Upadacitinib is classified pharmacologically as a JAK inhibitor, which helps reduce inflammation and alleviate symptoms associated with 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. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation leads to frequent bowel movements and an urgent need to defecate. Over time, the disease can cause the colon to lose its ability to function properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505699-31-00Protocol codeM14-533Estimated enrolment717 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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