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

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What is this study about?

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.

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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.07.2024

Trial locations

Investigated drugs:

Deucravacitinib

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.

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 ID:

2024-510759-37-00

Protocol code:

IM011-1115

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?