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Study on the Effects of Vibozilimod 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 for atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called SCD-044, which is taken in the form of tablets. The active ingredient in these tablets is vibozilimod, a type of medication known as a selective immunosuppressive agent. This means it works by selectively reducing the activity of the immune system, which can help decrease inflammation and other symptoms associated with atopic dermatitis.

The purpose of the study is to determine how effective and safe SCD-044 is in treating moderate to severe cases of atopic dermatitis. Participants in the study will be randomly assigned to receive either the SCD-044 tablets or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for a period of 32 weeks, during which participants will take the tablets orally. The main goal is to see if there is at least a 75% improvement in the severity of the eczema, as measured by a specific index, by the end of the study period.

Throughout the study, participants will be monitored to assess any changes in their condition and to ensure their safety. The study aims to provide valuable information on whether SCD-044 can be an effective treatment option for those suffering from moderate to severe atopic dermatitis. This research could potentially lead to new ways to manage this challenging skin condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and initial assessment

    Upon joining the study, you will be randomly assigned to receive either the investigational medication SCD-044 or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    You will undergo an initial assessment to confirm your eligibility and establish a baseline for your condition. This includes evaluating the severity of your atopic dermatitis.

  2. Step 2

    Medication administration

    You will take the assigned tablets orally once a day. The dosage will be one of the following: 0.1mg, 0.3mg, 0.6mg, or 1.0mg of SCD-044, or a placebo.

    The duration of the medication administration is planned for 16 weeks.

  3. Step 3

    Regular follow-up visits

    Throughout the trial, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the medication.

    During these visits, your skin condition will be assessed, and any side effects or changes in your health will be recorded.

  4. Step 4

    Final assessment

    At the end of the 16-week period, a final assessment will be conducted to evaluate the overall improvement in your condition.

    The primary goal is to determine if there is at least a 75% improvement in your Eczema Area and Severity Index (EASI) score.

Who can join the trial?

4 criteria

  • Aged at least 18 years.
  • Males and non-pregnant, non-lactating females can participate.
  • Must have been diagnosed with chronic atopic dermatitis for at least 1 year at the start of the study. This is based on specific criteria used by doctors to diagnose the condition.
  • Must have moderate to severe atopic dermatitis at the start of the study.

Who cannot join the trial?

8 criteria

  • Patients with any other skin conditions that might interfere with the study results cannot participate.
  • Patients who have used certain medications for atopic dermatitis recently may not be eligible.
  • Patients with a history of severe allergic reactions to any of the study medications are excluded.
  • Patients with significant medical conditions that could affect their safety or the study results cannot join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of drug or alcohol abuse may be excluded.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

SCD-044 is a medication being tested to see if it can help people with moderate to severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. The goal of using SCD-044 in this study is to see if it can improve the skin condition by at least 75% over a period of 16 weeks. This means that researchers want to find out if the medication can significantly reduce the symptoms and make the skin look and feel better for those who are affected by this condition.

What is already known about the treatment

SCD-044 – SCD-044 is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis, a skin condition characterized by itchy and inflamed skin. The medication is not yet widely recognized in medical literature as it is still under investigation. It works by targeting specific pathways in the immune system to reduce inflammation and improve skin condition. SCD-044 is classified as an immunomodulatory agent, which means it helps regulate the immune system's response to reduce symptoms of the disease.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin may become thickened and cracked over time due to persistent scratching and inflammation. It is commonly associated with other atopic conditions such as asthma and allergic rhinitis. The exact cause is unknown, but it involves a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511615-16-00Protocol codeSCD-044-19-16Estimated enrolment250 patientsSponsorSun Pharmaceutical Industries Limited

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