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Study on the Effectiveness and Safety of SAR441566 for Adults with Moderate to Severe Plaque Psoriasis

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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 effectiveness and safety of a new treatment for plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The treatment being tested is a medication called SAR441566, which is taken in the form of a tablet. The study aims to determine if SAR441566 is more effective than a placebo in treating adults with moderate to severe plaque psoriasis.

Participants in the study will be randomly assigned to receive either the SAR441566 tablet or a placebo. The study will last for a period of 12 weeks, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their condition and any potential side effects. The main goal is to see if there is a significant improvement in the skin condition of those taking SAR441566 compared to those taking the placebo.

The study will also collect information on the overall safety of SAR441566 by tracking any adverse events or side effects experienced by participants. This information will help researchers understand how well the medication works and its safety profile. The results of this study could provide valuable insights into a new treatment option for people living with plaque psoriasis.

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 randomly assigned to receive either the study medication, SAR441566, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving.

  2. Step 2

    Medication administration

    You will take the assigned tablet orally. The exact dosage and frequency will be provided by the study team. It is important to follow the instructions carefully.

    The duration of the medication administration is planned for 12 weeks.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups will include physical examinations and possibly blood tests.

    The study team will assess your psoriasis condition using specific scores to measure improvement.

  4. Step 4

    End of treatment evaluation

    At the end of the 12-week treatment period, your psoriasis condition will be evaluated to determine the effectiveness of the treatment.

    The primary goal is to see if there is a 75% or greater improvement in your psoriasis condition.

  5. Step 5

    Follow-up

    After the treatment period, there may be additional follow-up visits to monitor any long-term effects and ensure your well-being.

    The study team will provide further instructions regarding these follow-up visits.

Who can join the trial?

9 criteria

  • Participants must have had moderate to severe plaque psoriasis for at least 6 months.
  • Participants must meet the following criteria at the start of the study:
    • PASI score of 12 or more. (PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.)
    • sPGA score of 3 or more. (sPGA stands for Static Physician's Global Assessment, which is a doctor's assessment of psoriasis severity.)
    • BSA score of 10% or more. (BSA stands for Body Surface Area, which indicates the percentage of the body affected by psoriasis.)
    • Participants must be suitable candidates for phototherapy or systemic therapy. (Phototherapy is a treatment using light, and systemic therapy involves medication that affects the entire body.)
    • Participants must weigh at least 50 kg (110 lb).
    • Participants must have a Body Mass Index (BMI) between 18 and 35. (BMI is a measure of body fat based on height and weight.)
    • Participants can be of any gender.
    • Participants must be within the age range of 18 to 65 years old.

Who cannot join the trial?

7 criteria

  • Patients who have a different condition than psoriasis cannot participate.
  • Patients who are not in the age range of 18 to 65 years old cannot participate.
  • Patients who have previously received targeted immunotherapy for psoriasis cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to any medication cannot participate.
  • Patients with any other serious health condition that might interfere with the study cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
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Investigated drugs

SAR441566 is a medication being studied for its potential to help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. This medication is being tested to see if it can reduce the symptoms of psoriasis, such as the redness and scaling, and improve the overall condition of the skin. The study aims to find out if SAR441566 is more effective than a placebo, which is a substance with no active ingredients, in treating this condition. Participants in the trial are those who have not previously received targeted immunotherapy for their psoriasis. The goal is to determine if SAR441566 can provide relief and improve the quality of life for people living with this skin condition.

What is already known about the treatment

SAR441566 – SAR441566 is administered as an injection and is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe plaque psoriasis. This medication is still under investigation and not yet widely available in medical practice. It is designed to help reduce the symptoms of psoriasis, a condition that causes red, scaly patches on the skin. SAR441566 works by targeting specific molecules in the immune system to reduce inflammation and slow down the overproduction of skin cells. It belongs to a class of drugs known as immunomodulators, which help regulate the immune system's activity.

Investigated diseases

Psoriasis – Psoriasis is a chronic autoimmune skin condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, often referred to as plaques, can appear anywhere on the body but are commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of flare-ups followed by remission. During flare-ups, the affected skin areas may become itchy, painful, and may crack or bleed. The severity of psoriasis can vary, with some individuals experiencing only minor patches, while others may have extensive coverage. Environmental factors, stress, and certain medications can trigger or exacerbate the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503911-14-00Protocol codeDRI17849Estimated enrolment490 patientsSponsorSanofi-Aventis Recherche & Developpement

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