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Study on Dose Flexibility of Upadacitinib for Adults with Moderate to Severe Atopic Dermatitis

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 clinical trial is focused on studying Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study is testing a medication called Upadacitinib, which is a type of drug known as a small molecule JAK inhibitor. This medication is taken orally in the form of a modified-release tablet, which means it is designed to release the drug slowly over time.

The purpose of the study is to evaluate how flexible the dosing of Upadacitinib can be for adults with moderate to severe Atopic Dermatitis. Participants will start with a specific dose of the medication, and depending on their response, the dose may be adjusted. The study will explore two main approaches: increasing the dose for those who do not see enough improvement and reducing the dose for those who achieve significant improvement. The study will last for a period of 24 weeks, during which participants will be monitored for changes in their condition.

Throughout the study, the effectiveness and safety of the medication will be assessed by looking at improvements in the severity of the skin condition and the level of itching experienced by participants. The goal is to find the most effective and safe dosing strategy for managing Atopic Dermatitis with Upadacitinib.

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 treatment phase

    Begin taking upadacitinib at a dose of 15 mg once daily. This medication is in the form of a modified-release tablet and is taken orally.

    Continue this dosage for a period of 12 weeks. The goal during this phase is to assess the initial response to the treatment.

  2. Step 2

    Evaluation and adjustment phase

    After 12 weeks, the effectiveness of the treatment is evaluated using the Eczema Area and Severity Index (EASI).

    If the EASI 90 score is not achieved, the dose may be increased to 30 mg once daily. This adjustment aims to improve the treatment response.

    If the EASI 90 score is achieved, the dose may be reduced to 15 mg once daily to maintain the treatment effect while minimizing potential side effects.

  3. Step 3

    Continued treatment and monitoring

    Continue the adjusted dosage for an additional 12 weeks, completing a total of 24 weeks of treatment.

    Throughout this period, regular assessments are conducted to monitor the effectiveness and safety of the treatment.

  4. Step 4

    Final assessment

    At the end of the 24-week period, a final evaluation is performed to determine the overall success of the treatment.

    The primary goal is to achieve an EASI 90 score, indicating a significant reduction in the severity of atopic dermatitis.

Who can join the trial?

3 criteria

  • Participants must be **male or female** and between **18 and 64 years old** at the time of the screening visit.
  • Participants should have **chronic atopic dermatitis (AD)**, which means they have had symptoms for at least **3 years** before the start of the study. They must also meet the **Hanifin and Rajka criteria**, which are specific guidelines used to diagnose atopic dermatitis.
  • Participants must be considered a **candidate for systemic treatment**, which means they may need medication that affects the entire body, not just the skin.

Who cannot join the trial?

18 criteria

  • Patients who have a history of severe allergic reactions to the study medication.
  • Patients with other skin conditions that might interfere with the study results.
  • Patients who are currently participating in another clinical trial.
  • Patients who have used certain medications that could affect the study within a specific time frame before the study starts.
  • Patients with certain medical conditions that the study doctors believe could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have not followed the study instructions in the past.
  • Patients who have certain infections that could affect the study.
  • Patients who have had a recent surgery that could interfere with the study.
  • Patients who have a history of cancer, except for some types of skin cancer.
  • Patients who have a weakened immune system.
  • Patients who have certain blood disorders.
  • Patients who have a history of heart problems.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have liver or kidney problems.
  • Patients who have a history of mental health issues that could affect participation.
  • Patients who are unable to attend all study visits or follow study procedures.
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Investigated drugs

Upadacitinib is a medication used in this clinical trial to treat adults with moderate to severe atopic dermatitis, which is a type of eczema. The study investigates how effective and safe it is to adjust the dose of upadacitinib. In one part of the study, participants who do not see enough improvement with a lower dose of upadacitinib have their dose increased. In another part, participants who respond well to a higher dose have their dose reduced to see if they can maintain their improvement with less medication.

What is already known about the treatment

Upadacitinib – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis, a type of skin inflammation. Upadacitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. By blocking these enzymes, it helps reduce inflammation and symptoms associated with the condition. Upadacitinib is classified as a JAK inhibitor and is being evaluated for its safety and efficacy in dose adjustments to achieve optimal treatment outcomes.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The condition is often associated with other allergic disorders such as asthma and hay fever. It is believed to be caused by a combination of genetic and environmental factors, leading to a compromised skin barrier. Managing the condition involves avoiding triggers and maintaining skin hydration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504869-23-00Protocol codeM22-000Estimated enrolment438 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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