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Study of Upadacitinib and Topical Corticosteroids 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 in combination with topical corticosteroids for treating individuals with moderate to severe atopic dermatitis, commonly known as eczema. Atopic dermatitis is a skin condition that causes red, itchy, and inflamed skin. The study aims to evaluate the safety and effectiveness of this treatment combination in adolescents and adults who may need systemic therapy, which involves medication that works throughout the entire body.

Participants in the study will receive either the medication upadacitinib, which is a Janus kinase (Jak) 1 inhibitor, or a placebo, along with topical corticosteroids. Topical corticosteroids are creams or ointments applied directly to the skin to reduce inflammation and itching. The study will last for several weeks, during which the participants' skin condition will be monitored to see if there is an improvement in their eczema symptoms.

The goal of the study is to determine if the combination of upadacitinib and topical corticosteroids can effectively reduce the severity of eczema symptoms and improve the quality of life for those affected by this condition. The study will also assess the long-term safety of using upadacitinib over a period of up to 10 years. Participants will be regularly evaluated to track their progress and any changes in their 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 criteria such as age (12-75 years) and the presence of moderate to severe atopic dermatitis.

    Participants must be candidates 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 using scales like the Eczema Area Severity Index (EASI) and the Investigator's Global Assessment (IGA).

    The severity of itching is also measured using the Worst Pruritus Numerical Rating Scale (NRS).

  3. Step 3

    Treatment phase

    Participants receive upadacitinib in combination with topical corticosteroids. Upadacitinib is administered orally as a modified-release tablet.

    Topical corticosteroids such as pimecrolimus, tacrolimus, triamcinolone, fluocinolone acetonide, and hydrocortisone are applied to the skin.

    The treatment aims to assess the efficacy and safety of the combination over a period of 16 weeks.

  4. Step 4

    Evaluation at week 16

    At week 16, the primary goal is to determine the proportion of participants achieving a significant reduction in symptoms, as measured by the vIGA-AD and EASI 75 scales.

    Secondary outcomes include improvements in itching and further reductions in EASI scores.

  5. Step 5

    Long-term follow-up

    The study includes a long-term follow-up to evaluate the safety and effectiveness of upadacitinib over a period of up to 10 years.

    Participants continue to be monitored for any changes in their condition and response to treatment.

Who can join the trial?

4 criteria

  • Participants must be **male or female** and between **12 to 75 years old**.
  • Participants should 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**. This means they need treatment that affects the whole body, not just the skin, or they have recently needed such treatment for their atopic dermatitis.
  • Participants must be **able to tolerate topical corticosteroids**. These are creams or ointments applied to the skin to reduce inflammation and treat atopic dermatitis lesions.

Who cannot join the trial?

12 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of certain types of cancer.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of certain heart conditions.
  • Patients with liver disease or abnormal liver function tests.
  • Patients with a history of blood disorders.
  • Patients who have received certain vaccines recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have used certain medications recently that might interfere with the study.
  • Patients with any other medical condition that the study doctors think might 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. It is used in combination with topical corticosteroids to help reduce inflammation and improve skin condition in adolescents and adults who need systemic therapy. The study aims to evaluate both the short-term and long-term benefits of using upadacitinib for this skin condition.

  • Topical Corticosteroids

    are creams or ointments applied directly to the skin to reduce inflammation and relieve symptoms of atopic dermatitis, such as itching and redness. In this study, they are used alongside upadacitinib to enhance the treatment's effectiveness for individuals with moderate to severe eczema.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally and is being studied in combination with topical corticosteroids for the treatment of moderate to severe atopic dermatitis. It is currently in Phase 3 clinical trials, which means it is being tested for safety and effectiveness in a larger group of people. The main therapeutic indication for upadacitinib is atopic dermatitis, a condition characterized by inflamed, itchy skin. At the molecular level, upadacitinib works by inhibiting Janus kinase (JAK) enzymes, which play a role in the inflammatory process. It is classified as a JAK inhibitor, a type of medication that helps reduce inflammation by blocking specific pathways in the immune system.

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 tends to flare periodically and then subside, with symptoms varying from mild to severe. Commonly affected areas include the face, neck, and the insides of the elbows, knees, and ankles. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. It is often associated with other allergic conditions like asthma and hay fever.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502937-24-00Protocol codeM16-047Estimated enrolment1 656 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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