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Study on the Effectiveness and Safety of ESK-001 and Apremilast for Patients with Moderate to Severe Plaque Psoriasis

Fast replyRegistered drugNo placebo

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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 effectiveness and safety of a new treatment for Moderate to Severe Plaque Psoriasis, a skin condition that causes red, scaly patches on the skin. The study will test a medication called ESK-001, which is taken as a tablet by mouth. The trial will compare the effects of ESK-001 with a placebo and another medication called Otezla, which contains the active ingredient apremilast.

The purpose of the study is to determine if ESK-001 is more effective than a placebo after 16 weeks of treatment. Participants will be randomly assigned to receive either ESK-001, Otezla, or a placebo. The study will last up to 24 weeks, during which participants will take the medication orally. The trial aims to see improvements in the skin condition by measuring changes in the severity and extent of the psoriasis patches.

Throughout the study, participants will be monitored to assess the safety and effectiveness of the treatments. The trial will help researchers understand if ESK-001 can provide better outcomes for people with moderate to severe plaque psoriasis compared to existing treatments. This study is an important step in finding new and effective ways to manage this chronic skin condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will receive either the study medication, a placebo, or an active comparator. The assignment is random, like flipping a coin, and neither you nor the study team will know which group you are in.
Step 2
Medication administration
If you are assigned to the group receiving Otezla, you will take film-coated tablets orally. The dosage will be 30 mg, and you will take the medication as directed by the study team.
If you are assigned to the group receiving ESK-001, you will take the tablets orally. The dosage and frequency will be provided by the study team.
If you are assigned to the placebo group, you will take a tablet that looks like the study medication but does not contain the active substance. This is to help understand the effect of the study medication compared to no active treatment.
Step 3
Treatment duration
The treatment will last for up to 16 weeks. During this time, you will continue to take the medication as instructed by the study team.
Step 4
Regular check-ups
Throughout the study, you will have regular check-ups with the study team. These visits are important to monitor your health and the effects of the treatment.
During these visits, the study team will assess your condition and may perform tests to evaluate the effectiveness and safety of the treatment.
Step 5
End of treatment evaluation
At the end of the 16-week treatment period, you will have a final evaluation. This will include assessments similar to those conducted during the study to determine the overall impact of the treatment.

Who can join the trial?

6 criteria

Males or females, age 18 years or older.
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.
Patches of psoriasis must cover at least 10% of the body surface area (BSA) at the Screening Visit and on Day 1 of the study.
Must have a PASI score of 12 or higher at the Screening Visit and on Day 1. PASI stands for Psoriasis Area and Severity Index, which measures the severity of psoriasis.
Must have a sPGA score of 3 or higher at the Screening Visit and on Day 1. sPGA stands for Static Physician's Global Assessment, which is a scale used to assess the severity of psoriasis.
Women of childbearing potential and males who are sexually active with women of childbearing potential must agree to use highly effective methods of contraception for the entire duration of the study. This is to prevent pregnancy during the study.

Who cannot join the trial?

10 criteria

Patients with any other skin conditions that might interfere with the study results.
Patients who have used any other treatments for 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 who are currently participating in another clinical trial.
Patients with any significant medical conditions that could affect their safety or the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with certain types of infections.
Patients who have had a recent vaccination.
Patients who have a history of cancer, except for certain types of skin cancer.

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Verified sites

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

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Krakowskie Centrum Medyczne Sp. z o.o.
Cracow, Poland

Trial locations

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Investigated drugs

ESK-001 is a new medication being tested to see if it can help people with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. This medication is being studied to find out if it works better than a placebo, which is a substance with no active ingredients, over a period of 16 weeks. The goal is to see if ESK-001 can reduce the symptoms of psoriasis and improve the skin condition of the patients participating in the trial.

What is already known about the treatment

ESK-001 – ESK-001 is administered as a medication for moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety compared to a placebo. The main goal of the trial is to see if ESK-001 works better than a placebo after 16 weeks of treatment. This medication works by targeting specific molecules in the body that contribute to the inflammation and rapid skin cell growth seen in psoriasis. ESK-001 is classified as a treatment for skin disorders, specifically designed to help manage the symptoms of psoriasis.

Investigated diseases

Moderate to Severe 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 known as plaques. These plaques often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The disease progresses through cycles of flare-ups and remission, where symptoms may improve or worsen over time. In moderate to severe cases, the plaques cover a larger area of the body and can be more inflamed and itchy. The condition is associated with systemic inflammation, which can also affect other parts of the body. The exact cause of plaque psoriasis is not fully understood, but it involves a combination of genetic and environmental factors.