Not yet recruiting

Study of LY3454738 for Treating Moderate-to-Severe Atopic Dermatitis in Adults

Verified siteRegistered drug

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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 treatment of Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed skin. The study will evaluate a new treatment called LY3454738, which is a solution for injection. Participants in the study will receive either LY3454738 or a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to assess how effective LY3454738 is in treating adults with moderate-to-severe atopic dermatitis. The study will last for 52 weeks, during which participants will receive regular injections and be monitored for any changes in their condition. The study aims to see if LY3454738 can help reduce the symptoms of atopic dermatitis, such as the extent and severity of the eczema.

Participants will be randomly assigned to receive either the active treatment or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will help determine if LY3454738 is a safe and effective option for people with moderate-to-severe atopic dermatitis who have not had significant improvement with topical treatments.

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 visit
Upon joining the study, you will have an initial visit with the clinical team. During this visit, your medical history will be reviewed, and a physical examination will be conducted to confirm your eligibility for the trial.
You will be asked about your experience with atopic dermatitis and any previous treatments you have tried. This is to ensure that you meet the criteria for participation, such as having active atopic dermatitis for over a year and a specific severity score.
Step 2
First dosing visit
At the first dosing visit, you will receive your initial dose of the study medication. This may be a subcutaneous injection of LY3454738 or a placebo, which is a substance with no active medication.
Your Eczema Area and Severity Index (EASI) score and other assessments will be recorded to track your condition's severity and the percentage of body surface area affected.
Step 3
Ongoing treatment
Throughout the study, you will continue to receive the study medication via subcutaneous injection. The frequency and dosage will be determined by the clinical team and may vary based on your response to the treatment.
Regular follow-up visits will be scheduled to monitor your progress and any side effects. These visits are crucial for assessing the efficacy and safety of the treatment.
Step 4
Topical treatments
In addition to the injections, you may be instructed to use topical treatments, such as soft paraffin and fat products or other emollients, to help manage your skin condition.
These topical treatments are applied directly to the skin and are intended to provide additional relief and protection for your skin.
Step 5
Final assessment
At the end of the study period, which lasts up to 52 weeks, a final assessment will be conducted. This will include a comprehensive evaluation of your skin condition and overall health.
The results of this assessment will help determine the effectiveness of the study medication in treating moderate-to-severe atopic dermatitis.

Who can join the trial?

7 criteria

Must have had active atopic dermatitis for over a year.
Must have an EASI score of 12 or higher at the first dosing visit.
(EASI stands for Eczema Area and Severity Index, a tool used to measure the extent and severity of eczema.)
Must have a vIGA-AD score of 3 or higher at the first dosing visit.
(vIGA-AD stands for Validated Investigator Global Assessment for Atopic Dermatitis, a scale used to assess the overall severity of atopic dermatitis.)
Must have at least 10% of body surface area (BSA) affected by eczema at the first dosing visit.
(BSA refers to the percentage of the body covered by eczema.)
Must have experienced little improvement with topical medicines.
(Topical medicines are treatments applied directly to the skin.)
Open to both male and female participants.
Participants must be within the specified age range.

Who cannot join the trial?

7 criteria

Participants who have used any biologic or small-molecule treatments for atopic dermatitis before. Biologic treatments are medications made from living organisms, and small-molecule treatments are drugs that can easily enter cells to treat diseases.
Participants with any other skin conditions that might interfere with the study results.
Participants who have had a serious infection in the past month.
Participants who are currently pregnant or breastfeeding.
Participants who have a history of allergic reactions to similar medications.
Participants who are currently participating in another clinical trial.
Participants with any medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Verified
Gdansk, Poland
Diamond Clinic Sp. z o.o.
Responsive
Cracow, Poland
Not recruiting

Trial locations

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Investigated drugs

LY3454738 is a medication being tested to see if it can help people with moderate-to-severe atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin. The goal of this medication is to reduce the symptoms of the condition and improve the skin's appearance and comfort. The trial is designed to find out how well this medication works compared to not using it, and to check if it is safe for patients to use over a period of time.

What is already known about the treatment

LY3454738 – LY3454738 is administered orally in the form of a tablet and is currently being studied in clinical trials for its potential use in treating moderate-to-severe atopic dermatitis, a chronic skin condition characterized by inflammation and itching. The medication is in the phase 2 stage of clinical trials, where its effectiveness and safety are being evaluated compared to a placebo. LY3454738 works by targeting specific pathways in the immune system that contribute to inflammation, helping to reduce the symptoms of atopic dermatitis. It is classified as an immunomodulatory agent, which means it helps to regulate the immune system's activity.

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. 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. The severity of symptoms can vary widely among individuals.