Not yet recruiting

Testing GIA632 compared to placebo in adults with moderate to severe atopic dermatitis to measure effectiveness and safety

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. The study is for people who have moderate to severe forms of this condition, meaning their symptoms are more than mild and affect larger areas of their body. People in the study must have had this skin condition for at least one year before joining. The study will test a medication called GIA632, which is given as an injection under the skin. Some people in the study will receive GIA632 while others will receive placebo. The purpose of the study is to see how well GIA632 works compared to placebo at week 16.

The study will last for 16 weeks of treatment. During this time, participants will visit the study site regularly so doctors can check their skin condition and overall health. The doctors will use a scoring system to measure how clear the skin becomes during treatment. They will look for people whose skin becomes clear or almost clear with at least a 2 point improvement from when they started the study. The study will also carefully watch for any unwanted effects that might happen during treatment and after the study ends.

Participants must be adults who are 18 years of age or older. Their atopic dermatitis must be diagnosed according to specific medical criteria and must be at a moderate to severe level at both the first visit and when treatment starts. The study is designed so that neither the participants nor the doctors know who is receiving the actual medication and who is receiving placebo during the treatment period. This helps ensure the results are measured fairly and accurately.

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 treatment assignment
On Day 1, your baseline assessments will be performed before treatment begins.
You will be randomly assigned to receive either GIA632 or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.
Neither you nor your doctor will know which treatment you are receiving during the study.
Step 2
Treatment administration
You will receive your assigned treatment as a subcutaneous injection, which means the medication is injected under the skin.
If you are assigned to the active treatment group, you will receive GIA632 solution for injection at a concentration of 150 mg per mL.
If you are assigned to the placebo group, you will receive an inactive solution that looks identical to GIA632.
The treatment will continue throughout the study period.
Step 3
Treatment period through Week 16
You will continue receiving your assigned treatment according to the schedule provided by your study doctor.
During this period, your skin condition will be regularly assessed.
Your doctor will monitor your response to treatment and any side effects you may experience.
Step 4
Week 16 assessment
At Week 16, a key assessment of your skin condition will be performed.
Your doctor will evaluate your skin using the IGA score, which stands for Investigator's Global Assessment. This is a rating scale that measures the overall severity of your atopic dermatitis.
The assessment will determine whether your skin has improved to a clear or almost clear state with at least a 2-point reduction from your baseline score.
Step 5
Continued monitoring until end of study
After Week 16, you will continue to be monitored until the end of study.
Throughout the entire study period, any treatment-emergent adverse events will be recorded. These are any medical problems or side effects that occur after you start receiving the study treatment.
Your safety and tolerability to the treatment will be continuously assessed.

Who can join the trial?

6 criteria

You must be 18 years of age or older at the time of your first screening visit
You must be diagnosed with atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin, according to specific medical criteria called Hanifin and Rajka criteria from 1980
Your atopic dermatitis must have started at least 1 year before your screening visit
Your atopic dermatitis must be moderate to severe, which means your condition is not mild and affects a significant portion of your skin
You must have an IGA score of 3 or higher at both your screening visit and baseline visit. IGA stands for Investigator Global Assessment, which is a scale doctors use to rate how severe your skin condition is, with higher numbers meaning more severe disease
Both males and females can participate in this study

Who cannot join the trial?

1 criterion

No exclusion criteria have been provided in the available study information

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Verified sites

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

Besancon University Hospital Center
Verified
Besançon, France
Diamond Clinic Sp. z o.o.
Responsive
Cracow, Poland
Not yet recruiting
Fakultni Nemocnice Kralovske Vinohrady
Responsive
Prague, Czechia

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Investigated drugs

GIA632
is an investigational medication being studied for the treatment of moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. This medication is being tested to see if it can help improve the symptoms of atopic dermatitis in adults.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of GIA632 against no treatment, helping researchers determine if GIA632 actually works.

What is already known about the treatment

GIA632 – GIA632 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested as a potential treatment for moderate to severe atopic dermatitis, a chronic skin condition that causes inflammation, itching, and rashes. The exact mechanism of how GIA632 works at the molecular level has not been fully disclosed in available trial information, but it is designed to target the underlying processes that cause skin inflammation in atopic dermatitis. Based on the clinical trial design, the medication's effectiveness and safety are being evaluated to determine if it can reduce symptoms better than placebo treatment over a 16-week period.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition that causes inflammation and irritation of the skin. The disease typically appears as red, itchy patches that can occur anywhere on the body but are most common on the face, hands, feet, and in the folds of the elbows and knees. The skin may become dry, thickened, and scaly over time due to repeated scratching and rubbing. This condition often begins in childhood but can persist into adulthood or develop at any age. The symptoms tend to come and go in cycles, with periods of flare-ups followed by times when the skin improves. During flare-ups, the affected areas may also weep clear fluid and become crusty.