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Study on the Effectiveness and Safety of ESK-001 and Apremilast for Adults 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 called ESK-001 for patients with moderate to severe 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 ESK-001 with a placebo and an existing medication called Otezla, which contains the active ingredient apremilast. ESK-001 is taken as a tablet by mouth, and the study aims to see if it works better than the placebo after 16 weeks of treatment.

Participants in the study will be randomly assigned to receive either ESK-001, Otezla, or a placebo. The treatment period will last up to 24 weeks, during which participants will take the medication orally. The study will monitor the participants' skin condition and overall health to assess the effectiveness and safety of the treatments. The goal is to determine if ESK-001 can significantly improve the symptoms of plaque psoriasis compared to the placebo and to evaluate its performance against Otezla.

The study is designed to provide valuable information about the potential benefits of ESK-001 for treating moderate to severe plaque psoriasis. By comparing it with a placebo and an existing treatment, researchers hope to understand how well ESK-001 works and its safety profile. This information could help in developing new treatment options for people living with this 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.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as age and the extent of your plaque psoriasis.

    You will be informed about the trial's procedures, and any questions you have will be addressed. Consent will be obtained to ensure you understand and agree to participate.

  2. Step 2

    Randomization

    After the initial visit, you will be randomly assigned to one of the treatment groups. This means you may receive either the new medication ESK-001, a placebo, or an active comparator like Otezla (apremilast).

    The assignment is random to ensure fairness and objectivity in the study results.

  3. Step 3

    Treatment phase

    During the treatment phase, you will take the assigned medication orally. If you are in the ESK-001 group, you will take the medication as a tablet. If you are in the Otezla group, you will take either 10 mg, 20 mg, or 30 mg film-coated tablets.

    The treatment will last for up to 16 weeks. You will be required to take the medication as directed by the study team, which will provide specific instructions on dosage and frequency.

  4. Step 4

    Follow-up visits

    Throughout the trial, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the treatment.

    During these visits, various assessments will be conducted, including physical examinations and questionnaires about your condition and quality of life.

  5. Step 5

    End of treatment evaluation

    At the end of the 16-week treatment period, a final evaluation will be conducted. This will include assessments similar to those during the follow-up visits.

    The purpose of this evaluation is to determine the effectiveness and safety of the treatment you received.

Who can join the trial?

6 criteria

  • Males or females, age 18 years or older
  • Diagnosis of plaque psoriasis for at least 6 months before the Screening Visit
  • Plaques covering at least 10% of the body surface area (BSA) at Screening and Day 1
  • PASI score of 12 or higher at Screening and Day 1 (PASI is a tool used to measure the severity and extent of psoriasis)
  • sPGA score of 3 or higher at Screening and Day 1 (sPGA is a scale used to assess the overall severity of psoriasis)
  • Women who can have children and men who are sexually active with such women must agree to use highly effective birth control methods throughout the study

Who cannot join the trial?

8 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 allergic reactions to similar medications.
  • Patients with any serious medical conditions that could affect their participation in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.
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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 compared to a placebo, which is a substance with no active ingredients, to see if it works better in reducing the symptoms of psoriasis. The study aims to find out if ESK-001 can improve the skin condition of patients more effectively than the placebo over a period of 16 weeks.

What is already known about the treatment

ESK-001 – ESK-001 is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating moderate to severe plaque psoriasis. This medication is in the late stages of research, specifically a Phase 3 trial, which means it has shown promise in earlier studies but is not yet widely available. The main therapeutic use of ESK-001 is to alleviate the symptoms of plaque psoriasis, a skin condition characterized by red, scaly patches. At the molecular level, ESK-001 works by targeting specific pathways in the immune system that are overactive in psoriasis, helping to reduce inflammation and slow down the rapid growth of skin cells. It is classified pharmacologically as an immunomodulator, which means it helps to regulate the immune system's activity.

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 or plaques on the skin. 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. During flare-ups, the affected skin can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate to severe cases involving more extensive skin coverage and more intense symptoms. Environmental factors, stress, and certain medications can trigger or exacerbate the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507193-40-00Protocol codeESK-001-016Estimated enrolment869 patientsSponsorAlumis Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).