Not recruiting

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

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

11 criteria

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 trial?

10 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Ippokratio General Hospital Of Thessaloniki
Verified
Thessaloniki, Greece
Medical Center Medconsult Pleven OOD
Verified
Pleven, Bulgaria

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

PICLIDENOSON

What is already known about the treatment

Piclidenoson – Piclidenoson is an oral medication taken in the form of a pill, designed to treat moderate-to-severe plaque psoriasis. It is currently being studied in clinical trials to assess its effectiveness and safety. The main therapeutic use of Piclidenoson is to help reduce the symptoms of plaque psoriasis, a skin condition that causes red, scaly patches. At the molecular level, Piclidenoson works by targeting specific receptors in the body to help reduce inflammation and slow down the rapid growth of skin cells. It is classified as an anti-inflammatory agent.

Investigated diseases

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.