Study on the Effects and Safety of Piclidenoson for Patients with Moderate-to-Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Piclidenoson on individuals with plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The study will compare the effects of Piclidenoson, which is taken as a tablet, to a placebo. The purpose of the study is to evaluate how effective and safe Piclidenoson is for people with moderate-to-severe plaque psoriasis.

Participants in the study will take Piclidenoson orally, which means they will swallow the tablets. The study will last for a period of time, during which participants will be monitored to see how their psoriasis responds to the treatment. The main goal is to see if Piclidenoson can help reduce the severity of the psoriasis symptoms and improve the overall condition of the skin. The study will also look at the safety of using Piclidenoson over the course of the treatment.

Throughout the study, participants will have regular check-ups to assess their progress. The effectiveness of the treatment will be measured by looking at improvements in the skin condition, such as the reduction of red, scaly patches. The study aims to provide valuable information on whether Piclidenoson can be a beneficial treatment option for those suffering from moderate-to-severe plaque psoriasis.

1 beginning of the trial

Upon joining the study, you will be randomly assigned to receive either the study medication, piclidenoson, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

2 medication administration

You will take the assigned tablet orally twice a day. If you are in the group receiving piclidenoson, the dosage will be 3 mg per tablet.

This medication schedule will continue for the duration of the study, which is planned to last until January 31, 2028.

3 regular assessments

Throughout the study, you will have regular visits with the study team to monitor your health and the effects of the treatment.

These assessments will include evaluations of your psoriasis using the Psoriasis Area and Severity Index (PASI) and the Static Physician’s Global Assessment (sPGA). These are standard measures used to assess the severity and extent of psoriasis.

4 week 16 evaluation

At week 16, a key evaluation will take place to determine the effectiveness of the treatment. The goal is to see if there is a significant improvement in your psoriasis condition.

The study will assess whether you achieve a PASI 75 response, which means a 75% improvement in your psoriasis, and an sPGA score of 0 or 1, indicating clear or almost clear skin.

5 safety monitoring

Your safety is a priority throughout the study. Regular monitoring will be conducted to identify any side effects or adverse reactions to the treatment.

You will be asked to report any changes in your health or any concerns you may have during the trial.

6 end of trial

Upon completion of the study, you will have a final visit to assess your overall health and the outcomes of the treatment.

The study team will provide information on the next steps and any follow-up care that may be necessary.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must be able to complete the study following the study plan.
Must be able to understand and sign a written consent form to participate.
Must have a diagnosis of moderate-to-severe chronic plaque-type psoriasis with at least 10% of the body surface area affected.
Must have a PASI score of 12 or higher at the initial visits. PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.
Must have a Static PGA score of 3 or higher at the initial visits. Static PGA stands for Static Physician’s Global Assessment, which is a measure of psoriasis severity.
Must be a candidate for systemic treatment or phototherapy for psoriasis. Systemic treatment involves medication that affects the entire body, and phototherapy is a treatment using light.
Must have had psoriasis for at least 12 months.
Females who can become pregnant must have a negative pregnancy test at the start of the study.
Females who can become pregnant must use at least one acceptable method of birth control during the study and for 1 month after the last dose of the study medication.
Male participants must not donate sperm during the study and for at least 1 month after the last dose of the study medication. They must also agree to use condoms during the study and for 1 month after the last dose of the study medication.

Who Cannot Join the Study?

Patients with any other skin conditions that might interfere with the evaluation of plaque psoriasis.
Patients who have used any other treatments for plaque psoriasis within a certain period before the study starts.
Patients with a history of severe allergic reactions to any of the ingredients in the study medication.
Patients with significant medical conditions that could interfere with the study results or pose a risk to the patient.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have had a recent major surgery.
Patients with certain infections that are not well controlled.
Patients with a history of certain types of cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name	City	Country
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak	Grodzisk Mazowiecki	Poland
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz	Bytom	Poland
Mpfwvlt Cxgweb Ebrgv Atwxufskdi Fyi Sbqtysvwkdv Osccycfwhc Mjhaevr Ceey Ovu	Plovdiv	Bulgaria
Drnjtqzfsy Cyqdjstyia Cudaxa 1 Shuexl Eask	Sliven	Bulgaria
Soodsqzijqpsomg Gnnmtvo Dczxrdddcuny Odqzfmo i Ejusnlebwvr	Piaseczno	Poland
Dvbpnvjfk Srt z olqs	Wroclaw	Poland
Mtzlnie Cyhfja Mazkfuszti Pbmuah Obm	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	28.04.2025
Greece	Recruiting	28.04.2025
Poland	Recruiting	28.04.2025

Trial locations

Piclidenoson is a medication being tested for its ability to help people with moderate-to-severe plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches on the skin. This medication is taken by mouth and is being studied to see if it can reduce the severity of these skin patches. The goal is to see if it can help clear up the skin and improve the overall appearance and health of the skin. Researchers are also looking at how safe this medication is for people to use. The study aims to find out if people taking Piclidenoson have better results compared to those who do not take it. This could mean having clearer skin and fewer symptoms of psoriasis.

Plaque psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition results from an overactive immune system that mistakenly attacks healthy skin cells, causing inflammation and accelerated skin cell production. As new skin cells are produced faster than they can be shed, they accumulate on the surface, forming the characteristic plaques. The severity of plaque psoriasis can vary, with some individuals experiencing mild symptoms and others having more extensive and severe outbreaks. The condition tends to follow a pattern of flare-ups and remissions, where symptoms may improve or worsen over time.

Trial ID:

2024-519919-34-00

Protocol code:

CF101-302PS

NCT ID:

NCT06643260

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects and Safety of Piclidenoson for Patients with Moderate-to-Severe Plaque Psoriasis

What is this study about?

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