Study on the Effectiveness and Safety of Tildrakizumab for Patients with Moderate to Severe Genital Psoriasis

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What is this study about?

This clinical trial is focused on studying moderate to severe genital psoriasis, a skin condition that causes red, scaly patches in the genital area. The study will evaluate the effectiveness and safety of a medication called tildrakizumab, which is given as an injection under the skin. Participants in the study will receive either tildrakizumab or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to assess how well tildrakizumab works in reducing the symptoms of genital psoriasis over a period of 16 weeks. Participants will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The main goal is to see if tildrakizumab can help clear the skin or significantly reduce the severity of the psoriasis compared to the placebo.

Throughout the study, participants will have regular check-ups to monitor their progress and any side effects. The study will last for a total of 52 weeks, allowing researchers to gather comprehensive data on the long-term effects and safety of tildrakizumab. This research aims to provide valuable insights into the treatment of moderate to severe genital psoriasis and potentially improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the purpose and risks of the trial.

You must be at least 18 years old and have a diagnosis of moderate to severe genital psoriasis. This condition should not be well controlled with topical treatments, or you should be intolerant to such treatments.

2 initial assessments

Before starting the treatment, a physical examination will be conducted to ensure your health is within acceptable limits, except for psoriasis.

Women of childbearing potential will undergo a pregnancy test to confirm a negative result before the first dose of the study medication.

3 treatment phase

You will receive **tildrakizumab**, a medication administered through a subcutaneous injection, which means it is injected under the skin.

The study will compare **tildrakizumab** to a placebo, which is a substance with no active medication, over a period of 16 weeks.

4 monitoring and follow-up

Throughout the study, your condition will be monitored regularly to evaluate the effectiveness and safety of the treatment.

The primary goal is to see if there is a significant improvement in your psoriasis condition, measured by a specific scoring system.

5 end of study

At the end of the 16-week period, your progress will be assessed to determine the impact of the treatment.

The study aims to find out if **tildrakizumab** is more effective than the placebo in treating moderate to severe genital psoriasis.

Who Can Join the Study?

Ability to understand the purpose and risks of the trial, willingness and ability to follow the study rules, and provide written consent to participate.
Must be at least 18 years old at the time of giving consent.
Have a diagnosis of moderate to severe genital psoriasis at the start of the study, which means a specific score of 3 or higher on a scale used by doctors.
Have non-genital plaque psoriasis covering at least 1% of the body at the start of the study. Plaque psoriasis is a skin condition that causes red, scaly patches.
Have genital psoriasis that is not well controlled with creams or ointments, or cannot use these treatments due to side effects.
Must have a negative test for tuberculosis (TB) within 4 weeks before starting the study medication. TB is a serious lung infection. If the test is positive, additional checks and treatments must be completed as per local guidelines.
Undergo a physical examination that shows normal or acceptable results before the first dose of the study medication.
For women who can become pregnant, a negative pregnancy test is required at the start of the study and within 24 hours before the first dose of the study medication.
Must be in good health overall, except for psoriasis, as determined by the study doctor based on medical history, physical examination, and lab tests.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the study results.
Patients who have used any other treatments for psoriasis recently that might affect the study results.
Patients with a history of severe allergic reactions to any of the ingredients in the study medication.
Patients who are currently participating in another clinical trial.
Patients with any serious health conditions that might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received any live vaccines recently.
Patients with any infections that are not well controlled.
Patients who have had cancer in the past, except for certain types of skin cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny	Cracow	Poland
Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik	Bialystok	Poland
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.	Malbork	Poland
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Allergo-Derm Bakos Kft.	Szolnok	Hungary
Digcqrbboo Agw Cyjlxtqktt Crkhcj Xmfihzxvrtiy Eprv	Sofia	Bulgaria
Mxjyups Cjjera Rdwggf Lcwc Cjvccd Ltyf	Sofia	Bulgaria
Cwbmcbr Byxil Kloqerqplbr Pkmsnmej Sda z ovcl	Gdansk	Poland
Dbqwrsitpl Sgd z omxx	Wroclaw	Poland
Lttdcdn Seypqzjwnwawewi Gqofwrx Detmmvindwqvvla	Lublin	Poland
Mdvxxsk Cqfuhr Muidktwqae Pldhzn Orz	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.03.2025
Hungary	Not recruiting	01.03.2025
Poland	Not recruiting	01.03.2025

Trial locations

Investigated drugs:

Tildrakizumab

Tildrakizumab is a medication used in this clinical trial to treat moderate to severe genital psoriasis. It is given as an injection under the skin. Tildrakizumab works by targeting a specific protein in the body that causes inflammation and is involved in the development of psoriasis. By blocking this protein, the medication helps to reduce the symptoms of psoriasis, such as redness, scaling, and itching, and can improve the appearance of the skin. This trial aims to evaluate how effective and safe Tildrakizumab is for people with this condition.

Investigated diseases:

Psoriasis

Genital Psoriasis – Genital psoriasis is a chronic skin condition characterized by red, inflamed patches on the skin around the genital area. It is a form of psoriasis that specifically affects the genital region, causing discomfort and irritation. The condition can lead to itching, burning, and soreness, which may be exacerbated by friction or sweating. The skin lesions may appear as smooth, shiny, or scaly patches, differing from the typical thick, scaly plaques seen in other types of psoriasis. The progression of genital psoriasis can vary, with periods of flare-ups and remissions. It is important to note that while genital psoriasis can be uncomfortable, it is not contagious.

Trial ID:

2024-515672-12-00

Protocol code:

TILD-24-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Tildrakizumab for Patients with Moderate to Severe Genital Psoriasis

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