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Study on SAR444656 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 a skin condition known as atopic dermatitis, which is a type of eczema that causes red, itchy, and inflamed skin. The study is testing a new treatment called SAR444656, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective and safe this treatment is for adults who have moderate to severe atopic dermatitis.

Participants in the study will receive either the new treatment, SAR444656, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of up to 16 weeks, during which participants will take the medication orally and continue using their regular moisturizers.

Throughout the study, researchers will monitor changes in the severity of the atopic dermatitis symptoms, such as the extent of skin affected and the level of itchiness. The goal is to see if SAR444656 can significantly improve these symptoms compared to the placebo. Participants will also be asked to keep an electronic diary to track their symptoms and any side effects they may experience. This information will help researchers understand the potential benefits and risks of the new treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to confirm your eligibility. This involves meeting specific criteria related to your condition, such as having moderate to severe atopic dermatitis for at least one year.

    You will need to have a certain level of skin involvement and a history of inadequate response to topical treatments. Daily use of a moisturizer is required before and during the study.

  2. Step 2

    Baseline assessment

    At the start of the study, a baseline assessment will be conducted. This includes evaluating the severity of your skin condition using specific scoring systems.

    You will also be asked to complete an electronic diary to track your symptoms and treatment progress throughout the study.

  3. Step 3

    Medication administration

    You will be given a medication called SAR444656 in the form of a film-coated tablet. This medication is taken orally.

    The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow the instructions carefully.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor your condition and the effects of the medication.

    These assessments will include checking the severity of your skin condition and any changes in symptoms.

  5. Step 5

    Completion of the study

    At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment.

    You will be asked to return any unused medication and complete any remaining documentation.

Who can join the trial?

9 criteria

  • Participants must have **atopic dermatitis** (a type of skin condition) for at least 1 year before the start of the study.
  • Participants must have an **EASI score** of 12 or higher at the start of the study. EASI is a tool used to measure the severity of eczema.
  • Participants must have a **vIGA score** of 3 or higher at the start of the study. vIGA is a scale from 0 to 4 that measures the severity of skin conditions, where 3 is moderate and 4 is severe.
  • Participants must have **atopic dermatitis affecting at least 10% of their body** at the start of the study.
  • Participants must have a **PP-NRS score** of 4 or higher at the start of the study. PP-NRS is a scale used to measure itchiness.
  • Participants must have a history within the last 6 months of either not responding well to or being unable to use topical medications (creams or ointments applied to the skin).
  • Participants must have used a daily **topical emollient** (a moisturizer) for at least 7 days before the start of the study and should continue using it during the study.
  • Participants must be willing and able to complete an **electronic diary** for the duration of the study.
  • Participants must use **contraception** as required by local regulations if applicable.

Who cannot join the trial?

8 criteria

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have used certain medications that might affect the study results.
  • Patients with a history of severe allergic reactions.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

SAR444656 is a medication being studied for its potential to help people with moderate to severe atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin. This medication is being tested to see if it can reduce the symptoms of atopic dermatitis, such as the size and severity of skin lesions, compared to not using any active treatment. The goal is to find out if SAR444656 can make a noticeable difference in the skin condition of people who have this type of dermatitis.

What is already known about the treatment

SAR444656 – SAR444656 is administered in a form that is not specified in the provided data, but it is being studied for its effects on atopic dermatitis, a skin condition causing itchy and inflamed skin. Currently, SAR444656 is in a phase 2 clinical trial, which means it is being tested for its effectiveness and safety in treating moderate to severe atopic dermatitis in adults. The main therapeutic indication for SAR444656 is to improve skin lesions associated with this condition. While the exact mechanism of action at the molecular level is not detailed in the data, it is being evaluated for its potential to reduce the symptoms of atopic dermatitis. SAR444656 falls under the pharmacological classification of treatments for skin conditions, specifically targeting dermatitis.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen 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 dry, cracked, and prone to infections due to persistent scratching. Over time, affected areas can thicken and develop a leathery texture. The condition is often associated with other allergic disorders, such as asthma and hay fever.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504346-66-00Protocol codeACT17754Estimated enrolment322 patientsSponsorSanofi-Aventis Recherche & Developpement

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