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Study on the Long-Term Safety and Effectiveness of Upadacitinib 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 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 trial is testing a medication called Upadacitinib, also known by its code name ABT-494. This medication is taken as a modified-release tablet, which means it is designed to release the drug slowly over time. The study also includes a comparison with a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate the effectiveness and safety of Upadacitinib as a maintenance therapy for people with moderately to severely active Crohn's Disease who have already responded to initial treatment with this medication in previous studies. The study is divided into two parts: the first part is a randomized, double-blind phase where participants will receive either Upadacitinib or a placebo to see how well the medication works in maintaining their health. The second part is a long-term extension to assess the ongoing safety and benefits of using Upadacitinib over a longer period.

Participants in the study will take the medication orally and will be monitored over time to see how their condition responds. The study aims to determine if Upadacitinib can help maintain clinical remission, which means keeping the symptoms of Crohn's Disease under control, and to observe any potential side effects. The trial will also look at the impact of the medication on the need for hospitalizations and surgeries related to Crohn's Disease. The study is expected to continue until 2027, providing valuable information on the long-term use of Upadacitinib for managing this chronic 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

    Joining the study

    Participation begins after completing previous studies M14-431 or M14-433 with a clinical response.

    Eligibility is confirmed based on completion of specific study procedures and achieving a clinical response.

  2. Step 2

    Sub-study 1: maintenance phase

    This phase involves a randomized, double-blind, placebo-controlled study.

    Participants receive either upadacitinib or a placebo. Upadacitinib is administered as a modified-release tablet taken orally.

    The goal is to evaluate the effectiveness and safety of upadacitinib as a maintenance therapy for Crohn's disease.

    The primary focus is on achieving clinical remission and endoscopic response by Week 52.

  3. Step 3

    Sub-study 2: long-term extension

    Participants who complete Sub-study 1 enter the long-term extension phase.

    This phase assesses the long-term safety and effectiveness of upadacitinib.

    The focus is on maintaining clinical remission and monitoring for any hospitalizations or surgeries related to Crohn's disease over time.

  4. Step 4

    Medication details

    Upadacitinib is taken orally as a modified-release tablet.

    The dosage and frequency are determined by the study protocol and are consistent throughout the trial phases.

  5. Step 5

    Study duration

    The estimated end date for the trial is September 3, 2027.

    The study includes multiple assessments to monitor progress and response to treatment.

Who can join the trial?

7 criteria

  • Participants must have **Crohn's Disease**, which is a condition that causes inflammation in the digestive tract.
  • Participants must have taken part in Study M14-431 or Study M14-433 and shown improvement after receiving the study treatment.
  • Participants must have completed the required procedures at Week 12 or Week 24 in Study M14-431 or Study M14-433. If an endoscopy, which is a procedure to look inside the digestive tract, could not be done due to the COVID-19 pandemic, it may be missing.
  • For the long-term extension study, participants must have completed the first part of Study M14-430. The endoscopy at Week 52 may be missing if it could not be done due to the COVID-19 pandemic.
  • Participants must have shown improvement at Week 24 and completed the required procedures in Part 3/Cohort 3 of Study M14-431.
  • Participants can be of any gender.
  • The study includes individuals who may be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

10 criteria

  • Patients who have not responded to the initial treatment with the study medication cannot participate.
  • Individuals with other serious health conditions that might interfere with the study results are excluded.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Participants who are currently involved in another clinical trial are not eligible.
  • People with a history of severe allergic reactions to similar medications are excluded.
  • Individuals with a history of substance abuse or addiction may not participate.
  • Patients with certain infections, like tuberculosis, are not allowed to join.
  • Anyone who has had a recent surgery or plans to have surgery during the study period is excluded.
  • Individuals with a compromised immune system, meaning their body's defense against infections is weakened, cannot participate.
  • Patients who have received certain treatments that might affect the study results are not eligible.
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Investigated drugs

Upadacitinib is a medication being studied for its effectiveness and safety in treating Crohn's disease, a condition that causes inflammation in the digestive tract. In this clinical trial, upadacitinib is being tested as a maintenance therapy for patients who have already shown improvement with this medication in previous studies. The trial aims to see if upadacitinib can help maintain the health of patients with moderate to severe Crohn's disease over a longer period.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating Crohn's Disease. It is in the maintenance and long-term extension phases of clinical trials, specifically for patients who have shown a positive response to initial treatment. The main therapeutic indication for upadacitinib is to manage moderately to severely active Crohn's Disease. At the molecular level, upadacitinib works by inhibiting Janus kinase (JAK) enzymes, which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

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 flare-ups, 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 exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease is unpredictable, with some individuals experiencing mild symptoms and others facing more severe challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504951-29-00Protocol codeM14-430Estimated enrolment902 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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