Study on Early Treatment of Plaque Psoriasis with Bimekizumab and Clobetasol Propionate for Patients with Chronic Inflammation

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What is this study about?

This clinical trial is focused on studying the effects of a medication called bimekizumab on a skin condition known as plaque psoriasis. Plaque psoriasis is a common skin disease that causes red, scaly patches on the skin. The study will compare the effectiveness of bimekizumab, which is given as an injection, with a cream containing clobetasol propionate, a type of topical corticosteroid. The purpose of the study is to see if bimekizumab can delay the chronic inflammation associated with plaque psoriasis.

Participants in the study will receive either bimekizumab injections or the clobetasol propionate cream. Some participants may receive a placebo. The study will last for about 12 months, during which participants will have regular check-ups to monitor their skin condition and overall health. The main goal is to assess the activity of the psoriasis at different points in time, specifically at weeks 16 and 24. The study will also look at the quality of life of participants and how the immune system is affected by the treatments.

This trial aims to provide valuable information on whether early intervention with bimekizumab can improve outcomes for people with plaque psoriasis. By comparing it with traditional topical treatments, researchers hope to find better ways to manage this skin condition and improve the quality of life for those affected.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on the study criteria. This includes checking your age, the duration of your psoriasis, and the presence of specific lesions.

For women of child-bearing age, a urine pregnancy test will be conducted. You will also be required to confirm the use of effective contraception.

2 treatment assignment

You will be assigned to one of two treatment groups. One group will receive clobetasol propionate in the form of a cream, known as DERMOVAL 0.05%, for cutaneous use. The other group will receive bimekizumab as a solution for injection, known as Bimzelx 160 mg, administered subcutaneously.

3 treatment period

The treatment period will last for 24 weeks. If you are in the cream group, you will apply the cream as directed by the study team. If you are in the injection group, you will receive injections at specified intervals.

Your psoriasis will be assessed at weeks 16 and 24 to evaluate the effectiveness of the treatment.

4 follow-up assessments

Throughout the study, your psoriasis will be evaluated using specific scales at weeks 16, 24, 48, 72, and 96. These assessments will help determine the clinical activity of your psoriasis and the impact on your quality of life.

Additional assessments will include the analysis of immune cells in your skin at the start and after 24 weeks of treatment.

5 end of study

The study is expected to conclude by March 2028. At the end of the study, a final assessment will be conducted to evaluate the long-term effects of the treatment on your psoriasis.

Who Can Join the Study?

Men and women can participate.
You must be willing and able to attend all study visits.
You need to be between 18 and 45 years old.
You should have plaque psoriasis but not psoriatic arthritis. Plaque psoriasis is a skin condition that causes red, scaly patches.
Your psoriasis should be mild, with a PASI score greater than 2 and less than 6. PASI is a way to measure the severity of psoriasis.
You must have at least one psoriasis lesion on your elbows, knees, or lower back. Having additional lesions in other areas is okay.
Your psoriasis should have lasted for less than 6 months or more than 2 years.
If you are a woman who can have children, you must use effective birth control for more than one month before joining the study. This includes options like the pill, contraceptive implant, IUD, condoms, or having your tubes tied. A urine pregnancy test will be done.
You need to be part of a social security system.
You must sign an informed consent form, which means you agree to participate after understanding the study details.

Who Cannot Join the Study?

Patients who are not diagnosed with psoriasis cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent, cannot participate.

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
Hospital Edouard Herriot	Lyon	France
Du Docteur Ruer S.E.L.A.R.L.	Martigues	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Medipole Hopital Prive	Villeurbanne	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
Ixeiphjm dj Czsidaosbmck Hxehanljpys Umyglsretiows dm Sywsx Eoafkqq (exaohzu	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Bimekizumab is a medication being studied to see if it can help delay the chronic inflammation associated with 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. By blocking these proteins, bimekizumab may help reduce the symptoms of psoriasis and improve the appearance of the skin.

Topical Corticosteroids are creams or ointments that are applied directly to the skin to help reduce inflammation and relieve symptoms of psoriasis. They work by suppressing the immune response in the skin, which can help decrease redness, swelling, and itching. In this study, topical corticosteroids are being used as a comparison to see how effective bimekizumab is in treating psoriasis.

Investigated diseases:

Guttate psoriasis

Psoriasis – Psoriasis 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 called 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 increased symptoms followed by times of remission. The exact cause of psoriasis 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. Psoriasis is not contagious and varies in severity from person to person.

Trial ID:

2024-514647-29-01

Protocol code:

24-PP-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Early Treatment of Plaque Psoriasis with Bimekizumab and Clobetasol Propionate for Patients with Chronic Inflammation

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