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Study of Upadacitinib for Adolescents and Adults with Moderate to Severe Eczema

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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 effects of a medication called Upadacitinib on individuals with moderate to severe Atopic Dermatitis, commonly known as eczema. Eczema is a condition that causes the skin to become itchy, red, and inflamed. The study involves both adolescents and adults who are experiencing significant symptoms of this skin condition. The purpose of the study is to evaluate how effective and safe Upadacitinib is for treating these symptoms. Upadacitinib is a type of medication known as a Janus kinase (Jak) 1 inhibitor, which works by blocking certain enzymes in the body that contribute to inflammation.

Participants in the study will be randomly assigned to receive either Upadacitinib or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a period of time, during which participants will take the medication orally in the form of a modified-release tablet. The goal is to observe any changes in the severity of eczema symptoms and overall skin condition over the course of the study.

Throughout the study, participants will be monitored for any improvements in their eczema symptoms, such as reduced itching and inflammation, as well as any potential side effects. The study aims to provide valuable information on whether Upadacitinib can be an effective treatment option for those suffering from moderate to severe eczema. By participating in this study, researchers hope to gain insights that could lead to better management and treatment options for individuals with this challenging skin 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

    Upon joining the study, eligibility is confirmed based on age (12-75 years) and the presence of moderate to severe atopic dermatitis.

    Candidates must be suitable for systemic therapy or have recently required it for atopic dermatitis.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements for the severity of atopic dermatitis using various scales such as EASI (Eczema Area Severity Index) and IGA (Investigator's Global Assessment).

    Other assessments may include the Worst Pruritus Numerical Rating Scale and the Patient Oriented Eczema Measure.

  3. Step 3

    Treatment phase

    Participants receive either upadacitinib or a placebo. Upadacitinib is administered orally in the form of a modified-release tablet.

    The dosage of upadacitinib is either 15 mg or 30 mg, taken once daily.

    The treatment phase lasts for 16 weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the effectiveness and safety of the treatment.

    Primary outcomes include achieving a significant reduction in atopic dermatitis severity by Week 16, as measured by the vIGA-AD and EASI 75 scales.

    Secondary outcomes involve improvements in pruritus, quality of life, and other related symptoms.

  5. Step 5

    Completion of the study

    At the end of the 16-week treatment period, a final assessment is conducted to evaluate the overall impact of the treatment.

    Participants may be asked to provide feedback on their experience and any changes in their condition.

Who can join the trial?

3 criteria

  • Participants must be male or female and between the ages of 12 and 75.
  • Participants must have active moderate to severe atopic dermatitis. This is a skin condition that causes red, itchy, and inflamed skin. It is measured by specific tools like EASI (Eczema Area and Severity Index), IGA (Investigator's Global Assessment), BSA (Body Surface Area), and pruritus (itchiness).
  • Participants must be candidates for systemic therapy or have recently needed systemic therapy for their atopic dermatitis. Systemic therapy means treatment that affects the entire body, not just the skin.

Who cannot join the trial?

9 criteria

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment.
  • Patients who have a history of certain serious diseases, like cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications recently that might affect the study results.
  • Patients who have participated in another clinical trial recently.
  • Patients with a known allergy to the study medication.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a condition that the study doctor believes would make it unsafe for them to participate.
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Investigated drugs

Upadacitinib is a medication being studied for its effectiveness and safety in treating moderate to severe atopic dermatitis, a type of eczema, in both adolescents and adults. It is intended for patients who may need systemic therapy, which means treatment that affects the entire body rather than just the skin.

What is already known about the treatment

Upadacitinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis. It is in the advanced stages of research, specifically in a Phase 3 trial, which indicates it is close to being considered for approval if proven effective and safe. Upadacitinib is primarily indicated for individuals with atopic dermatitis who require systemic treatment. It works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. This places it in the pharmacological class of JAK inhibitors, which are used to reduce inflammation and immune responses in various conditions.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease progresses with periods of flare-ups, where symptoms worsen, followed by periods of remission. The skin may become thickened and cracked due to persistent scratching. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. It is commonly associated with other allergic conditions such as asthma and hay fever.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502936-38-00Protocol codeM18-891Estimated enrolment918 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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