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

Verified siteRegistered drugNo 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 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.

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.
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.
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.
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.
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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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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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

Medication Name – This medication is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating atopic dermatitis, a skin condition characterized by itchy and inflamed skin. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for this medication is to provide relief for patients with atopic dermatitis who require more advanced treatment options beyond the first line of therapy. At the molecular level, the medication works by targeting specific pathways in the immune system to reduce inflammation and improve skin condition. It is classified pharmacologically as an immunomodulator, which means it helps to regulate the immune system's response.

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.