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Study of deucravacitinib in adults with plaque psoriasis: Effects on immune system cells

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 study focuses on patients with plaque psoriasis, a skin condition that causes red, scaly patches on the skin. The research examines how deucravacitinib (also known as Sotyktu) affects certain immune cells in people who have had psoriasis for less than 5 years. The medication comes in the form of film-coated tablets that are taken by mouth.

The purpose of this research is to understand how this medication works by studying specific immune cells called TRM-like cells (tissue-resident memory-like cells) that play a role in psoriasis. The study will look at changes in these cells and related substances in the body over a 24-week treatment period.

During the study, participants will receive Sotyktu tablets containing 6 milligrams of medication to be taken daily. The research will examine how the treatment affects both the number and activity of certain immune cells, as well as monitoring improvements in psoriasis symptoms.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will begin taking Sotyktu (deucravacitinib) 6 mg tablets once daily by mouth

    The medication comes in the form of film-coated tablets

    This treatment is prescribed for moderate to severe plaque psoriasis

  2. Step 2

    Treatment monitoring - Week 1-24

    You will continue taking Sotyktu 6 mg tablets daily for 24 weeks

    During this period, your response to the treatment will be monitored

    The study will evaluate how the medication affects certain types of immune cells in your body

    The focus will be on observing changes in skin inflammation and specific proteins called interleukins (IL-17, IL-22, IL-23)

  3. Step 3

    Final evaluation - Week 24

    At week 24, a final assessment will be conducted to evaluate your response to the treatment

    The evaluation will measure changes in your skin condition

    The study will analyze how the medication has affected specific immune cells in your body

Who can join the trial?

16 criteria

  • Must be starting treatment with Sotyktu® as part of regular medical care
  • Must have been diagnosed with psoriasis within the last 5 years
  • Must be willing to voluntarily participate in the study
  • Must be able to understand the study information provided
  • Must be able to sign the consent form
  • Open to all genders
  • Must be 18 years or older
  • Must have moderate to severe psoriasis meeting at least one of these conditions:
    • Affected body surface area of 10% or more and a DLQI (quality of life assessment) score of 10 or higher
    • PASI (psoriasis severity score) of 10 or higher and DLQI score of 10 or higher
    • Have any of these conditions:
      • Severe psoriasis in visible areas
      • Severe scalp psoriasis
      • Psoriasis affecting genital areas
      • Psoriasis on palms and soles
      • Separation or deformity of at least 2 fingernails
      • Experiencing itching
      • Psoriasis patches that don't respond to treatment

Who cannot join the trial?

14 criteria

  • Age under 18 years or over 65 years
  • Current pregnancy or breastfeeding
  • History of serious allergic reactions to medications
  • Active or chronic infections, including tuberculosis or hepatitis
  • Significant heart, liver, or kidney disease
  • Current cancer or history of cancer in the past 5 years
  • Use of biologics (specialized medications that affect the immune system) within the past 3 months
  • Use of traditional systemic psoriasis treatments within the past 2 weeks
  • Participation in another clinical trial within the past 30 days
  • Unstable or severe psoriasis requiring immediate treatment
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Inability to comply with study procedures and visits
  • Any condition that, in the investigator's opinion, makes participation unsafe
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Investigated drugs

Deucravacitinib is a medication that works by blocking an enzyme called TYK2 (tyrosine kinase 2) in the body. It is designed to help treat psoriasis by reducing inflammation in the skin. This medication helps control the overactive immune system response that causes the red, scaly patches typical in psoriasis. It works by interrupting signals that trigger inflammation, particularly affecting specific immune cells called T memory cells that play a role in psoriasis.

What is already known about the treatment

Deucravacitinib - An oral medication taken in tablet form that belongs to the class of Tyrosine Kinase 2 (TYK2) inhibitors, specifically developed for treating moderate to severe plaque psoriasis. This novel drug works by selectively blocking TYK2, a signaling protein involved in the inflammatory response pathway, which helps reduce inflammation and skin symptoms associated with psoriasis. Deucravacitinib represents a new generation of targeted immunotherapy that has shown promising results in clinical trials, offering a more selective approach compared to broader immunosuppressive treatments, with the advantage of being administered orally rather than through injection.

Investigated diseases

Plaque Psoriasis - A chronic autoimmune skin condition characterized by red, raised patches of skin covered with silvery-white scales, known as plaques. These patches typically appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition develops when skin cells multiply much faster than normal, causing the rapid buildup of rough, dead skin cells. The patches can be itchy, sore, and sometimes crack and bleed. Plaque psoriasis tends to go through cycles, with periods of flare-ups alternating with periods of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510759-37-00Protocol codeIM011-1115Estimated enrolment15 patientsSponsorCharite Universitaetsmedizin Berlin KöR

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