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Study on the Effectiveness and Safety of RO7790121 for Patients with Moderate to Severe Atopic Dermatitis

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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 Moderate to Severe Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed skin. The study will evaluate a treatment called RO7790121, which is administered as a solution for injection or infusion. The purpose of the study is to assess how effective and safe this treatment is for patients with this condition.

Participants in the study will receive either the treatment RO7790121 or a placebo. The study will last for several weeks, during which participants will be monitored to see if there is a significant improvement in their skin condition. The main goal is to see if there is at least a 75% improvement in the severity of the eczema by the 16th week of the study.

Throughout the study, various aspects will be observed, such as changes in the skin's condition, any side effects, and overall quality of life. The study aims to provide valuable information on whether RO7790121 can be a beneficial treatment option for those suffering from moderate to severe atopic dermatitis.

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
Joining the study
Upon joining the study, you will be confirmed to have a diagnosis of moderate to severe atopic dermatitis by a dermatologist. This confirmation is based on specific criteria known as the Hanifin/Rajka criteria, which should have been established at least one year prior to the start of the study.
You will need to have an Eczema Area and Severity Index (EASI) score of 16 or higher and an Investigator Global Assessment (IGA) score of 3 or higher. Additionally, at least 10% of your body surface area should be affected by atopic dermatitis.
Step 2
Baseline visit
During the baseline visit, you will continue using an additive-free, bland emollient at least once daily. This should have been used for at least 7 days prior to this visit and will continue throughout the study.
Your initial health status and the severity of your atopic dermatitis will be assessed to establish a starting point for the study.
Step 3
Treatment phase
You will receive either the study medication RO7790121 or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.
The frequency and dosage of the medication will be determined by the study protocol, and you will be informed of the schedule during the trial.
Step 4
Monitoring and assessments
Throughout the study, your progress will be monitored regularly. This includes checking for any changes in your EASI score and IGA score at specified intervals, such as Week 16 and Week 32.
You will also be assessed for any side effects or adverse events related to the treatment. This is to ensure your safety and the effectiveness of the medication.
Step 5
End of study
At the end of the study, your overall response to the treatment will be evaluated. This includes determining if there has been a significant improvement in your condition, such as achieving an EASI-75 response, which means a 75% improvement from the baseline.
Final assessments will be conducted to gather data on the long-term effects and safety of the treatment.

Who can join the trial?

7 criteria

Must have a confirmed diagnosis of Atopic Dermatitis (AD) by a skin doctor (dermatologist) at least 1 year before joining the study.
Must have moderate to severe Atopic Dermatitis, which means:
- An Eczema Area and Severity Index (EASI) score of 16 or higher at the start of the study. This is a way to measure the severity of eczema.
- An Investigator's Global Assessment (IGA) score of 3 or higher on a 5-point scale at the start of the study. This is another way to measure the severity of eczema.
- Atopic Dermatitis must cover at least 10% of the body surface area at the start of the study.
- Must use a simple, additive-free moisturizer at least once a day for at least 7 days before starting the study and continue using it during the study.
- Open to both male and female participants.
- Participants must be within the specified age range for the study.

Who cannot join the trial?

10 criteria

Patients with any other skin condition that might interfere with the study results.
Patients who have had a serious allergic reaction to any medication in the past.
Patients who are currently participating in another clinical trial.
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 certain medical conditions that could affect their safety or the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received a live vaccine within a certain period before the study.
Patients with a compromised immune system, which means their body's defense against infections is weakened.
Patients who have had a major surgery within a certain period before the study.

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Verified sites

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Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
Rzeszow, Poland

Trial locations

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Investigated drugs

RO7790121 is a medication being tested in this clinical trial for its effectiveness in treating moderate to severe atopic dermatitis, which is a type of eczema. This medication is designed to help reduce the symptoms of eczema, such as redness, itching, and inflammation of the skin. The goal of using RO7790121 in this study is to see if it can improve the condition of the skin by at least 75% over a period of 16 weeks. This improvement is measured using a specific scale called the Eczema Area and Severity Index (EASI). By participating in this trial, patients will help researchers understand if RO7790121 can be a safe and effective treatment option for people suffering from this skin condition.

Ro7790121

What is already known about the treatment

RO7790121 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. The main goal of the study is to see if RO7790121 can significantly improve the skin condition by reducing the severity of eczema symptoms. At the molecular level, RO7790121 works by targeting specific pathways in the immune system that are involved in the inflammation process, helping to reduce the symptoms of atopic dermatitis. It is classified as an immunomodulatory agent, which means it helps to regulate or normalize 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. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen and then improve. The skin may become dry, cracked, and prone to infections due to constant scratching. Over time, affected areas can thicken and become leathery. The condition is influenced by genetic and environmental factors, and it is commonly associated with other allergic conditions such as asthma and hay fever.