Study on How Bimekizumab Affects People with Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called bimekizumab in people with moderate to severe plaque psoriasis and those who also have psoriatic arthritis. Plaque psoriasis is a skin condition that causes red, scaly patches, while psoriatic arthritis is a type of arthritis that affects some people with psoriasis, leading to joint pain and swelling. Bimekizumab is given as a solution for injection using a prefilled pen, which allows for self-administration under the skin.

The purpose of the study is to understand how bimekizumab affects certain biological markers in the body, which are indicators of how the disease is behaving. Participants will receive the treatment over a period of time, and the study will observe changes in these markers at different points, particularly at Week 48. The study will also monitor any side effects that may occur during the treatment period.

Participants will be asked to provide skin samples to help researchers analyze the effects of the medication on gene expression, which is the process by which information from a gene is used to create proteins that affect cell function. This study aims to provide insights into how bimekizumab works in treating these conditions and to gather information on its safety and effectiveness.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, the participant will undergo a series of assessments to confirm eligibility for the study. This includes a review of medical history and a physical examination.

The participant will also provide informed consent, which involves understanding the study’s purpose, procedures, and potential risks and benefits.

2 baseline assessments

Baseline assessments will be conducted to gather initial data. This includes measuring the severity of plaque psoriasis using the Psoriasis Area and Severity Index (PASI) and the Investigator’s Global Assessment (IGA).

A skin biopsy may be taken to analyze gene expression biomarkers. This involves collecting a small sample of skin tissue for laboratory analysis.

3 treatment administration

The participant will begin treatment with bimekizumab, which is administered as a solution for injection under the skin (subcutaneous use).

The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to the participant by the study team.

4 regular follow-up visits

The participant will attend regular follow-up visits throughout the study. These visits are scheduled to monitor the participant’s health and the effects of the treatment.

During these visits, the participant may undergo physical examinations, laboratory tests, and assessments of psoriasis severity.

5 week 48 assessment

At week 48, a comprehensive assessment will be conducted to evaluate the effect of bimekizumab on gene expression biomarkers.

This assessment may include another skin biopsy to compare changes in gene expression from the baseline.

6 safety follow-up

After completing the treatment period, the participant will enter a safety follow-up phase. This phase is designed to monitor any treatment-emergent adverse events (TEAEs) or serious adverse events (TESAEs).

The participant will be asked to report any health changes or concerns during this period.

Who Can Join the Study?

The participant must be at least 18 years old.
The participant must have been diagnosed with plaque psoriasis for at least 6 months before the screening visit. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin.
For certain participants, they must also have a documented diagnosis of psoriatic arthritis for at least 6 months before screening. Psoriatic arthritis is a type of arthritis that affects some people with psoriasis.
The participant must have at least 1 tender joint and 1 swollen joint at screening or within 3 months before screening.
The participant must have a Psoriasis Area and Severity Index (PASI) score of 12 or higher. PASI is a tool used to measure the severity and extent of psoriasis.
The participant must have at least 10% of their body surface area affected by psoriasis.
The participant must have an Investigator’s Global Assessment (IGA) score of 3 or higher on a 5-point scale. IGA is a scale used to assess the severity of psoriasis.
The participant must be a candidate for systemic psoriasis therapy and/or phototherapy. Systemic therapy involves taking medication that affects the entire body, and phototherapy is a treatment using ultraviolet light.
The participant agrees not to change their usual sun exposure during the study and to use ultraviolet A/B sunscreens if unavoidable exposure occurs.
The participant must weigh less than 120 kg (about 265 pounds).
Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.

Who Cannot Join the Study?

Patients with any other serious health conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
Patients who have received any live vaccines within the last 4 weeks.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a known allergy to the study medication or its ingredients.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Sbrgdks Clzqugp Mmioejar Sah z opwt	Poznan	Poland
Pxokcyygo Itxfwnaw Mvfgtger Mimfcoaregdd Sdjcn Wggrezsxlsjq I Aijcbopejotvv	Warsaw	Poland
Govbek Udfantoski Fhgjmsadd	Frankfurt	Germany
Dxqgqgdtqu Sgw z owwj	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.09.2024
Poland	Not recruiting	30.09.2024

Trial locations

Investigated drugs:

Bimekizumab

Bimekizumab is a medication used in this clinical trial to help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. Bimekizumab works by targeting specific proteins in the body that are involved in the inflammation process, which can help reduce the symptoms of psoriasis. In this study, researchers are looking at how bimekizumab affects certain gene expressions in the skin of participants over a period of time. This could help them understand more about how the medication works and how it might benefit people with psoriasis and psoriatic arthritis, which is a related joint condition.

Psoriatic arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can lead to joint damage over time. The disease often progresses with periods of flare-ups and remissions. It can affect any joint in the body, including those in the fingers, toes, and spine. The inflammation can also lead to changes in the nails and cause fatigue. The severity and progression of symptoms can vary widely among individuals.

Moderate to Severe Plaque Psoriasis – Moderate to severe plaque psoriasis is a chronic skin condition characterized by the development of thick, red, scaly patches on the skin. These patches, known as plaques, are often itchy and can be painful. The disease progresses with cycles of flare-ups and periods of remission. It commonly affects areas such as the elbows, knees, scalp, and lower back. The condition results from an overactive immune response that accelerates the growth of skin cells. The severity of the disease can vary, with some individuals experiencing widespread plaques that significantly impact daily life.

Trial ID:

2023-506333-29-00

Protocol code:

PS0039

NCT ID:

NCT06506916

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on How Bimekizumab Affects People with Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

What is this study about?

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