Study on the Effects of Guselkumab on Memory T-Cells in Psoriasis Patients

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What is this study about?

This clinical trial is focused on studying psoriasis, a skin condition that causes red, scaly patches on the skin. The treatment being investigated is called guselkumab, which is administered as a solution for injection using a pre-filled pen. The purpose of the study is to explore how guselkumab affects certain immune cells in the skin, known as tissue-resident memory T-cells, and the surrounding environment in patients with psoriasis.

Participants in the study will receive guselkumab injections over a period of time. The study will observe changes in the skin, particularly looking at the number and behavior of specific immune cells. These include T-cells, which are a type of white blood cell that plays a role in the immune response. The study will also monitor changes in other types of cells in the skin, such as dendritic cells and macrophages, which are involved in the body’s defense mechanisms.

The study aims to provide insights into how guselkumab can alter the skin’s immune environment in psoriasis, potentially leading to better understanding and management of the condition. The trial is expected to continue until early 2027, with the goal of gathering comprehensive data on the effects of the treatment over time.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to confirm your eligibility. This includes verifying a history of plaque psoriasis and the presence of a target lesion on your body.

Women of childbearing potential will undergo a pregnancy test. If applicable, you must agree to use a highly effective contraceptive method starting at least four weeks before the baseline visit and continue until 12 weeks after the end of treatment.

2 baseline visit

At the baseline visit, a detailed examination of your psoriasis will be conducted. This includes assessing the redness, thickness, and scaliness of your target lesion.

A negative urine pregnancy test is required for women of childbearing potential.

3 treatment administration

You will receive the medication guselkumab, which is provided as Tremfya 100 mg solution for injection in a pre-filled pen. The medication is administered subcutaneously, meaning it is injected under the skin.

The frequency and duration of the administration will be explained to you by the study team.

4 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are designed to monitor your response to the treatment and any changes in your psoriasis.

During these visits, various assessments will be conducted, including changes in specific cells and proteins in your skin.

5 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall changes in your psoriasis and the skin environment.

You will be informed about the results and any further steps, if necessary.

Who Can Join the Study?

Must have a history of plaque psoriasis, which is a common type of psoriasis characterized by raised, red patches covered with a silvery white buildup of dead skin cells.
Must have one target lesion (a specific area of skin affected by psoriasis) that is about 4 cm at its longest point, located on the body (but not on the scalp, face, or areas where skin touches skin, like underarms). This lesion must score at least 1 for redness, thickness, and scaliness.
Women who could become pregnant must agree to use a highly effective birth control method starting at least 4 weeks before the study begins and continue using it until 12 weeks after the study ends. Effective methods include hormonal birth control (like pills, patches, rings, injections, or implants), intrauterine devices (IUDs), or if their partner has had a vasectomy.
Women who are not able to have children include those who are 60 years or older, have had surgery to remove reproductive organs, or are between 40 and 60 years old and have not had a period for at least 12 months with a test confirming they cannot have children, or have not had a period for at least 24 months without a test.
Women who can have children must have a negative pregnancy test at the start of the study and again before the study begins.

Who Cannot Join the Study?

Patients with any other skin conditions besides psoriasis vulgaris cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with a history of severe allergic reactions to medications are excluded.
Patients currently participating in another clinical trial are not allowed to join.
Patients with a compromised immune system, meaning their body’s defense against infections is weakened, cannot take part.
Patients with any serious medical conditions that could interfere with the study are not eligible.
Patients who have used certain medications that might affect the study results are excluded.
Patients with a history of drug or alcohol abuse are not eligible.
Patients who have had a recent major surgery are excluded.
Patients who cannot comply with the study procedures and visits are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	08.05.2023

Trial locations

Investigated drugs:

Guselkumab

Guselkumab is a medication used in this clinical trial to treat psoriasis, a skin condition that causes red, itchy, and scaly patches. It works by targeting a specific protein in the body that is involved in the inflammation process, helping to reduce the symptoms of psoriasis. The study aims to see if guselkumab can change the number of certain immune cells in the skin and alter the environment around these cells, which might help in understanding and improving psoriasis treatment.

Psoriasis vulgaris – Psoriasis vulgaris is a chronic skin condition characterized by the rapid growth of skin cells, leading to 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 times of remission. During flare-ups, the affected skin areas may become itchy, painful, and may crack or bleed. The exact cause of psoriasis vulgaris is not fully understood, but it involves an overactive immune response that accelerates skin cell production. Environmental factors, stress, and certain medications can trigger or worsen the condition.

Trial ID:

2023-503776-25-00

Protocol code:

GUSMEM01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Guselkumab on Memory T-Cells in Psoriasis Patients

What is this study about?

Who Can Join the Study?

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