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Study on the Safety and Effects of IMG-007 for Adults 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 the effects of a new treatment called IMG-007 for adults with atopic dermatitis, a condition also known as eczema, which causes the skin to become red, inflamed, and itchy. The study aims to evaluate the safety and effectiveness of IMG-007 in individuals with moderate to severe forms of this skin condition. Participants in the study will receive IMG-007 through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. Some participants may receive a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to assess any side effects that may occur with the use of IMG-007 and to understand how the body processes the medication. The study will also measure changes in the severity of the skin condition over a period of 12 weeks. Participants will be monitored closely by healthcare professionals throughout the study to ensure their safety and to gather important information about the treatment's impact on their condition.

During the study, participants will be required to apply a non-medicated moisturizer regularly to help manage their skin condition. The study will involve regular visits to the clinic for assessments and to receive the treatment. This research is an important step in finding new and effective treatments for people living with 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of atopic dermatitis and ensuring the condition is moderate to severe.
The assessment involves checking the EASI score (a measure of eczema severity) and IGA (Investigator's Global Assessment) to ensure they meet the required levels.
Step 2
Baseline visit
A baseline visit is scheduled to record initial health data and confirm the severity of the condition. This includes measuring the body surface area affected by atopic dermatitis.
Participants are required to apply a stable dose of a non-medicated moisturizer as part of the study protocol.
Step 3
Treatment phase
Participants receive the study medication, IMG-007, administered through intravenous infusion. The frequency and dosage are determined by the study protocol.
A placebo identical in formulation to the drug product minus the active ingredient may also be administered to some participants.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the participant's response to the treatment and any potential side effects.
The primary focus is on the incidence of treatment-emergent adverse events (TEAEs) and changes in the EASI score from baseline to week 12.
Step 5
End of study
The study concludes with a final assessment to evaluate the overall safety and effectiveness of IMG-007.
Participants may be asked to provide feedback on their experience and any changes in their condition.

Who can join the trial?

10 criteria

Must be a male or female aged 18 to 74 years old.
Must have voluntarily signed an informed consent to participate in the study. This means you agree to join the study after understanding what it involves.
Must have been diagnosed with atopic dermatitis (a type of skin condition) for at least 6 months, following specific guidelines from skin experts.
Must have moderate-to-severe atopic dermatitis, which means:
- An EASI score (a way to measure the severity of eczema) of 12 or more at the start and 16 or more at the beginning of the study.
- An IGA score (another way to measure eczema severity) of 3 or more at the start and beginning of the study.
- Affected skin covering 10% or more of the body at the start and beginning of the study.
- Must have a history of not responding well to treatments applied to the skin, or these treatments are not suitable for you.
- Must agree to use a stable amount of a non-medicated emollient (a type of moisturizer).
- Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use a very effective method of birth control or not have sexual activity during the study.
- Male participants must agree not to have sexual activity or use very effective birth control methods with female partners who can have children.

Who cannot join the trial?

8 criteria

Individuals who do not have atopic dermatitis cannot participate. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
Participants must be adults. This means they should be 18 years or older.
People who are not able to understand or follow the study instructions will be excluded.
Individuals with other serious health conditions that might interfere with the study will not be allowed to join.
Pregnant or breastfeeding women cannot participate in the study.
Anyone who has participated in another clinical trial recently may be excluded.
People who have allergies or reactions to the study medication or similar medications will not be included.
Individuals who are unable to attend all required study visits will be excluded.

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Verified sites

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

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Goethe University Frankfurt
Frankfurt, Germany
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Jagiellońskie Centrum Innowacji Sp. z o.o.
Cracow, Poland
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Technische Universitaet Dresden
Dresden, Germany

Trial locations

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Investigated drugs

IMG-007 is a medication being studied for its safety and effectiveness in treating adults with moderate-to-severe atopic dermatitis, a condition that causes itchy and inflamed skin. The trial aims to understand how the body processes this medication and to identify any potential side effects that may occur during its use.

Img-007

What is already known about the treatment

IMG-007 – IMG-007 is administered as a topical treatment, applied directly to the skin. It is currently in the clinical trial phase, specifically a Phase 1b/2a study, to assess its safety, pharmacokinetics, and efficacy in adults with moderate-to-severe atopic dermatitis. The main therapeutic indication for IMG-007 is atopic dermatitis, a chronic skin condition characterized by inflammation and itching. At the molecular level, IMG-007 is designed to modulate specific pathways involved in the inflammatory response, aiming to reduce symptoms associated with the condition. It falls under the pharmacological classification of dermatological agents.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it involves a combination of genetic and environmental factors.