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Study on Atopic Dermatitis Treatment with Baricitinib, Tralokinumab, Abrocitinib, Upadacitinib, and Dupilumab for Patients Needing Second-Line Systemic Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on the treatment of atopic dermatitis, a common skin condition that causes red, itchy, and inflamed skin. The study aims to optimize treatment for patients who need second-line systemic therapy, which is a type of treatment used when initial treatments do not work. The trial will use several medications, including Olumiant (also known as baricitinib), Adtralza (tralokinumab), Cibinqo (abrocitinib), RINVOQ (upadacitinib), and Dupixent (dupilumab). These medications are designed to help manage the symptoms of atopic dermatitis by targeting specific pathways in the body that contribute to inflammation.

The purpose of the study is to identify genetic, biochemical, and immunological markers that can help predict how well a patient will respond to these treatments. This will allow for a more personalized approach to therapy, ensuring that each patient receives the most effective treatment for their specific condition. The study will involve patients with moderate to severe atopic dermatitis who are either starting or already receiving second-line systemic treatment. Participants will be monitored over a period of time to assess their response to the medication and to gather data on the effectiveness of the treatment.

Throughout the study, researchers will collect information on various factors, including genetic and clinical data, to develop models that can predict treatment outcomes. The study will also evaluate the percentage of patients who achieve significant improvement in their condition, as well as the time it takes for treatment to be effective. By the end of the study, the goal is to have a better understanding of how to tailor treatments for atopic dermatitis, improving the quality of life for those affected by this 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination to ensure the diagnosis of moderate-severe atopic dermatitis.

    Participants must provide written informed consent. For children, a parent or legal guardian must provide consent, and if the child is over 11 years old, they must also give their assent.

  2. Step 2

    Treatment allocation

    Participants are assigned to a treatment group. The treatments include Olumiant (4 mg film-coated tablets), Adtralza (150 mg solution for injection in pre-filled syringe), Cibinqo (200 mg film-coated tablets), RINVOQ (15 mg prolonged-release tablets), and Dupixent (300 mg solution for injection in pre-filled syringe).

    The specific medication, dosage, and route of administration depend on the group assignment.

  3. Step 3

    Treatment phase

    Participants begin the treatment phase, which lasts for 16 weeks. Medications are taken as prescribed, with oral tablets taken daily and injections administered as directed.

    Regular follow-up visits are scheduled to monitor progress and adjust treatment if necessary.

  4. Step 4

    Follow-up assessments

    Throughout the trial, participants undergo regular assessments to evaluate the effectiveness of the treatment. This includes measuring improvement in skin condition using various scales such as EASI (Eczema Area and Severity Index) and SCORAD (Scoring Atopic Dermatitis).

    Additional assessments may include changes in quality of life and any side effects experienced.

  5. Step 5

    Final evaluation

    At the end of the 16-week treatment period, a final evaluation is conducted. This includes a comprehensive review of treatment response and any changes in the condition.

    The primary goal is to determine the percentage of participants achieving significant improvement in their condition.

Who can join the trial?

8 criteria

  • Participants must have been diagnosed with moderate-severe atopic dermatitis. This is a skin condition that causes itchy and inflamed skin.
  • Participants must be either:
    • Going to receive second-line systemic treatment, which means they will start a more advanced treatment that affects the whole body.
    • Already receiving second-line systemic therapy at the time of selection.
    • Participants must be willing and able to provide written informed consent before starting any study procedures. This means they agree to participate after understanding the study details.
    • For children, a parent or legal guardian must provide written informed consent. If the child is older than 11 years, they must also give their agreement, known as assent.
    • Participants must be willing and able to follow the procedures specified in the study protocol.
    • The study is open to both male and female participants.
    • The study includes participants from certain age groups, specifically those who are children, teenagers, and adults.

Who cannot join the trial?

9 criteria

  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions to any medication.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other skin condition that might interfere with the study.
  • Patients who have used certain medications that might affect the study results within a specific time frame before the study starts.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any serious medical condition that might interfere with the study or pose a risk to the patient.
  • Patients who have had a major surgery recently.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • Dupilumab

    is a medication used to treat atopic dermatitis, which is a type of eczema. It works by blocking certain proteins in the body that cause inflammation and itching. This helps to reduce the symptoms of the skin condition, such as redness, swelling, and irritation. In this trial, dupilumab is being studied to see how well it works for people who need more than the usual treatments for their skin condition.

  • Baricitinib

    is a medication that helps to reduce inflammation in the body. It is used to treat conditions like atopic dermatitis by targeting specific pathways that lead to inflammation. By doing this, baricitinib can help to improve the symptoms of the skin condition, making the skin less itchy and red. This trial is looking at how effective baricitinib is for people who need additional treatment options for their atopic dermatitis.

  • Upadacitinib

    is another medication used to treat atopic dermatitis. It works by interfering with certain signals in the body that cause inflammation. This can help to alleviate the symptoms of the skin condition, such as itching and redness. The trial is investigating how well upadacitinib works for patients who require more than the standard treatments for their condition.

  • Tralokinumab

    is a medication that targets specific proteins in the body that are involved in causing inflammation and other symptoms of atopic dermatitis. By blocking these proteins, tralokinumab can help to reduce the severity of the skin condition. This trial is examining the effectiveness of tralokinumab for patients who need additional treatment options for their atopic dermatitis.

What is already known about the treatment

  • Dupilumab

    Dupilumab is an injectable medication administered under the skin (subcutaneously), usually every two weeks, and it is used to treat moderate to severe atopic dermatitis in adults and children when the disease cannot be adequately controlled with standard skin care treatments or when these are not suitable for the patient. The drug belongs to the group of biologic medicines and works at the molecular level by blocking specific proteins (interleukin-4 and interleukin-13) that cause skin inflammation and itching in atopic dermatitis. Dupilumab is widely used in modern medicine and is considered one of the most effective second-line systemic treatment options when first-choice treatments have not produced sufficient results.

  • Ciclosporin

    Ciclosporin is a medication that suppresses the immune system, taken by mouth in the form of capsules or a solution, and it is used to treat severe atopic dermatitis in cases where standard treatments have not been sufficiently effective. The drug works by suppressing the activity of T lymphocytes (a certain type of immune cell) and reducing the production of substances that trigger inflammation, which helps reduce skin inflammation and itching. Ciclosporin belongs to the group of immunosuppressants, that is, medicines that suppress immunity, and it has long been used as a second-line systemic treatment for atopic dermatitis, but its use requires careful monitoring because of possible side effects.

  • Methotrexate

    Methotrexate is a medication taken by mouth in tablet form or injected under the skin or into a muscle, and it is used to treat moderate to severe atopic dermatitis when other treatments have not produced the desired results. The drug belongs to the group of immunosuppressants and anti-inflammatory agents and works at the molecular level by slowing the growth of rapidly dividing cells (including immune cells) and reducing inflammatory reactions in the skin. Methotrexate is a well-known and established second-line systemic treatment option in medicine, considered an effective alternative alongside other forms of systemic therapy.

  • Baricitinib

    Baricitinib is a medication taken by mouth in tablet form, used to treat moderate to severe atopic dermatitis in adults when the disease cannot be adequately controlled with topical treatments or other systemic therapies. The drug belongs to the group of JAK inhibitors and works at the molecular level by blocking certain enzymes (Janus kinases) that take part in transmitting inflammation-causing signals within cells, thereby reducing skin inflammation and itching. Baricitinib is a relatively new treatment option that has come into use in medical practice in recent years as a second-line systemic therapy and is considered an effective alternative to other systemic medications.

Investigated diseases

Atopic dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become dry, cracked, and prone to infections due to scratching. Over time, affected areas can thicken and develop a leathery texture. The condition is associated with a malfunction in the skin barrier and immune system, leading to increased sensitivity to environmental factors. It commonly affects areas such as the face, neck, and the insides of elbows and knees.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506165-62-00Protocol codeDermAtOmics-IISponsorHospital Universitario La Paz

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