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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diamond Clinic Sp. z o.o.	Cracow	Poland
Evimed Sp. z o.o.	Warsaw	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Specderm Poznanska Sp. j.	Bialystok	Poland
Universita’ Politecnica Delle Marche	Ancona	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Allergo-Derm Bakos Kft.	Szolnok	Hungary
Vital Medical Center	Veszprem	Hungary
Mmbbluxqa Ieoebnokgr Cfqxaoaq Swlkrnpk Sde z oozr	Warsaw	Poland
Aeskdox Opymlwjjnfr Uoulvsmmyqmnc Scqtyp	Siena	Italy
Cxuydzo Btyaa Kmezpgmgbas Pdrhseot Sqx z okyf	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	04.08.2023
Italy	Not yet recruiting	04.08.2023
Poland	Not recruiting	04.08.2023

Trial locations

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.

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.

Trial ID:

2022-502888-38-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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