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

Fast replyInvestigationalNo 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 long-term effects of a medication called ESK-001 in patients with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The study aims to evaluate the safety, effectiveness, and how well the response to the treatment lasts over time.

Participants in the study will receive ESK-001, which is taken as a tablet by mouth. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The treatment period can last up to 48 weeks, and the study will monitor how patients respond to the medication over this time. The goal is to see if ESK-001 can help reduce the symptoms of plaque psoriasis and maintain these improvements.

The study will also look at the quality of life of participants, assessing changes in their daily living and comfort levels. By the end of the study, researchers hope to gather valuable information on the long-term use of ESK-001 for treating moderate to severe plaque psoriasis, which could help in managing the condition more effectively in the future.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study is an extension to evaluate the long-term safety and effectiveness of ESK-001 for treating moderate to severe plaque psoriasis.

  2. Step 2

    Medication administration

    You will receive the medication ESK-001 in the form of a film-coated tablet. The medication is taken orally. The maximum duration of treatment is 24 weeks.

    The specific dosage and frequency of the medication will be provided by the study team, and it is important to follow their instructions carefully.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments will be conducted to evaluate the safety and effectiveness of the treatment.

    These assessments may include physical examinations, blood tests, and questionnaires about your health and quality of life.

  4. Step 4

    Reporting side effects

    You will be asked to report any side effects or adverse reactions you experience during the study. This information is crucial for assessing the safety of the medication.

    The study team will provide guidance on how to report these effects and will monitor your health closely.

  5. Step 5

    Completion of the study

    At the end of the study period, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    You will receive information about the results and any further steps that may be necessary for your health care.

Who can join the trial?

4 criteria

  • Males or females, age 18 years or older.
  • Must have completed one of the two previous studies of the medication ESK-001 for moderate to severe plaque psoriasis.
  • The safety and tolerability of ESK-001 must have been acceptable in the previous study.
  • Women of childbearing potential (women who can become pregnant) and males who are sexually active with such women must agree to use highly effective methods of contraception (methods to prevent pregnancy) for the entire duration of the study.

Who cannot join the trial?

10 criteria

  • Patients with any other skin conditions that might interfere with the study.
  • Patients who have had a recent infection or are currently experiencing an infection.
  • Patients who have a history of severe allergic reactions.
  • Patients who are currently using other treatments for psoriasis that might interfere with the study medication.
  • Patients with a history of certain heart conditions.
  • Patients with uncontrolled high blood pressure.
  • Patients with liver or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

ESK-001 is a medication being studied for its effects on moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. This trial is focused on understanding how safe and tolerable ESK-001 is when used over a long period. The goal is to see if it can help reduce the symptoms of psoriasis and maintain its effectiveness over time. Patients participating in this study will receive ESK-001 to evaluate its long-term benefits and any potential side effects.

What is already known about the treatment

ESK-001 – ESK-001 is administered to patients in a form that is suitable for treating moderate to severe plaque psoriasis, a condition characterized by red, scaly skin patches. This medication is currently being studied in clinical trials to evaluate its long-term safety and effectiveness. It 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 and improve the quality of life for those affected.

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 larger areas of the body 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 ID2024-511166-36-00Protocol codeESK-001-018Estimated enrolment1 788 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).