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Study on the Effects of Deucravacitinib for Patients with Moderate to Severe Plaque Psoriasis

Verified siteRegistered drugNo placebo
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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 medication called Sotyktu, which contains the active ingredient deucravacitinib, on a skin condition known as plaque psoriasis. Plaque psoriasis is a chronic skin disease that causes red, scaly patches on the skin. The study aims to understand how this medication affects the immune system and the genes involved in causing psoriasis, especially in areas that are difficult to treat, such as the scalp, palms, and soles of the feet.

Participants in the study will take Sotyktu in the form of 6 mg film-coated tablets once a day for a period of 16 weeks. The study will compare the changes in certain genes and immune cells before and after the treatment. This will help researchers learn more about how the medication works in different types of psoriasis plaques, including those that are harder to treat.

The purpose of this study is to assess the changes in the expression of specific genes and the distribution of immune cells in the skin affected by psoriasis. By doing so, the study hopes to provide insights into the effectiveness of Sotyktu in managing moderate to severe plaque psoriasis and improving the quality of life for those affected by this condition. The study is expected to continue until March 2027.

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

    Beginning of treatment

    The treatment involves taking Sotyktu 6 mg film-coated tablets. The medication is taken orally once a day.

    The treatment is prescribed for a duration of 16 weeks.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the baseline condition of the psoriasis plaques.

    This assessment includes examining both classic and hard-to-treat plaques.

  3. Step 3

    Ongoing treatment

    Continue taking the Sotyktu tablets daily as prescribed.

    Regular monitoring of the condition is conducted to observe any changes in the psoriasis plaques.

  4. Step 4

    Final assessment

    At the end of the 16-week treatment period, a final assessment is conducted.

    The assessment focuses on changes in the expression of specific genes related to psoriasis in both classic and hard-to-treat plaques.

Who can join the trial?

11 criteria

  • The patient must have been prescribed the drug Sotyktu as part of their regular medical care, not specifically for the study.
  • The prescription of the drug should be independent of the study.
  • The patient must be willing to participate in the study and sign a document called the informed consent form (ICF), which explains the study and confirms their agreement to join.
  • The patient can be a man or a woman and must be at least 18 years old.
  • The patient must have moderate to severe psoriasis, which is a skin condition. This is defined by certain guidelines and can include:
    • Affected skin covering 10% or more of the body and a score of 10 or higher on a quality of life questionnaire related to skin issues.
    • A score of 10 or higher on a scale that measures the severity of psoriasis and a score of 10 or higher on the same quality of life questionnaire.
    • Severe psoriasis in specific areas like the face, scalp, genitals, palms, or soles of the feet.
    • Psoriasis affecting the nails or causing itching.
    • Psoriasis that does not respond to treatment.
    • The patient must have had psoriasis for at least 6 months.
    • The patient must have psoriasis in at least one difficult-to-treat area, such as the scalp, palms, or other specific areas, with a total affected area of at least 2x2 cm. Smaller patches can add up to this size. It is preferred to take skin samples from the hands rather than the feet.

Who cannot join the trial?

7 criteria

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have used certain medications that could affect the study results.
  • Patients with a history of allergic reactions to similar treatments.
  • Patients with serious health issues that could make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

Deucravacitinib is a medication being studied for its effects on psoriasis, a skin condition that causes red, itchy, and scaly patches. This medication works by blocking a specific enzyme called TYK2, which is involved in the immune system's response. By inhibiting this enzyme, deucravacitinib may help reduce inflammation and improve the appearance of psoriasis plaques, especially in areas that are difficult to treat. The study aims to understand how this medication affects the immune cells and the factors that drive psoriasis.

What is already known about the treatment

Deucravacitinib – This medication is administered orally and is currently being studied for its effects on moderate to severe plaque psoriasis. It is in the clinical trial phase, focusing on its ability to block TYK2, a protein involved in the immune response. The main therapeutic indication is to treat psoriasis by reducing inflammation and altering immune cell activity. Deucravacitinib works at the molecular level by inhibiting the TYK2 enzyme, which plays a role in the signaling pathways that lead to inflammation. It is classified as a selective TYK2 inhibitor, aiming to improve skin condition by targeting specific immune pathways.

Investigated diseases

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition is marked by periods of flare-ups and remission, where symptoms may improve or worsen over time. The plaques can be itchy and sometimes painful, and they may crack and bleed. The severity of plaque psoriasis can vary, with some individuals experiencing only minor patches, while others may have extensive coverage. The exact cause of plaque psoriasis is not fully understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508948-22-00Protocol codeBMS-IM011-1101Estimated enrolment30 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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