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Study on the Safety and Effectiveness of ESK-001 for Adults with Systemic Lupus Erythematosus

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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 disease known as Systemic Lupus Erythematosus (SLE), which is an autoimmune condition where the body's immune system mistakenly attacks its own tissues. The treatment being tested in this study is a medication called ESK-001, which is taken in the form of a tablet. The study will also use a placebo tablet for comparison purposes.

The purpose of the study is to evaluate the safety and effectiveness of different doses of ESK-001 in adults with SLE. Participants will be randomly assigned to receive either the medication or a placebo. The study will be conducted over a period of 48 weeks, during which the effects of the medication on the disease activity will be monitored. The study will also assess how well the medication is tolerated by the participants.

Throughout the study, participants will undergo regular check-ups to monitor their health and any changes in their condition. This will include physical examinations, blood tests, and other assessments to ensure the safety of the participants and to gather data on the medication's impact on SLE. The information collected will help determine the potential benefits and risks of ESK-001 for treating Systemic Lupus Erythematosus.

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 asked to provide written informed consent. This means you agree to participate and understand the study requirements.

    You must be between 18 and 70 years old, have a body mass index between 18 and 40, and weigh more than 40 kg (88 lbs).

    You should have been diagnosed with systemic lupus erythematosus (SLE) at least 6 months before the study and meet specific criteria for this condition.

  2. Step 2

    Initial assessments

    Initial assessments will include a review of your medical history and a physical examination.

    You will undergo tests such as blood tests and possibly an electrocardiogram (ECG) to check your heart's activity.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the study medication, ESK-001, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active substance.

    The medication is taken orally in the form of a tablet. The dosage and frequency will be determined by the study protocol.

  4. Step 4

    Ongoing monitoring

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

    These visits will include physical exams, blood tests, and other assessments to ensure your safety and to evaluate the medication's effectiveness.

  5. Step 5

    Completion of the study

    The study is expected to last until March 31, 2027. Your participation will continue until the study's end or until you decide to withdraw.

    At the end of the study, a final assessment will be conducted to gather comprehensive data on your health and the study's outcomes.

Who can join the trial?

10 criteria

  • Able and willing to provide written informed consent, which means you agree to participate in the study and follow all the study rules.
  • Must be a male or female between the ages of 18 and 70 years old.
  • Have a body mass index (BMI) between 18 and 40 kg/m2 and weigh more than 40 kg (88 lbs).
  • Have good veins for taking blood samples.
  • Diagnosed with systemic lupus erythematosus (SLE) for at least 6 months before joining the study. SLE is a condition where the immune system attacks the body's own tissues.
  • Have a Clinical SLEDAI-2K score of 4 or more points, which is a way to measure the activity of lupus, with skin involvement before starting the study treatment.
  • Currently taking at least one of the following treatments:
    • A stable dose of oral corticosteroid, which is a type of medication used to reduce inflammation.
    • Antimalarial treatment, such as hydroxychloroquine, chloroquine, or quinacrine, which are medications sometimes used to treat lupus.
    • No more than one conventional DMARD, which stands for disease-modifying antirheumatic drug, a type of medication used to treat autoimmune diseases.
    • For women who can have children, a negative pregnancy test is required at the start of the study.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
  • Patients who are currently pregnant or breastfeeding are not eligible for the study.
  • Individuals with a history of drug or alcohol abuse in the past year are excluded.
  • Patients who have received any other investigational drug within the last 30 days cannot join the study.
  • Individuals with any other significant medical condition that might interfere with the study results are not eligible.
  • Patients who have had a major surgery within the last 3 months are excluded.
  • Individuals with active infections that require treatment with antibiotics are not eligible.
  • Patients with a history of cancer, except for certain types of skin cancer, are excluded.
  • Individuals who have been diagnosed with a mental health disorder that is not well controlled are not eligible.
  • Patients who are unable to comply with the study procedures and visits are excluded.
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Investigated drugs

ESK-001 is a medication being studied for its potential to help people with Systemic Lupus Erythematosus, a condition where the immune system attacks the body's own tissues. This medication is being tested to see if it can reduce the activity of the disease, which means it might help lessen the symptoms and improve the quality of life for patients. The study is also looking at how safe the medication is and how well people can tolerate it when they take it. Researchers are trying to find out if ESK-001 can make a significant difference in managing the disease compared to not taking it.

What is already known about the treatment

ESK-001 – ESK-001 is administered in multiple doses and is currently being studied in a clinical trial for its safety, efficacy, and pharmacokinetics in adult patients with systemic lupus erythematosus, a chronic autoimmune disease. The medication is in the Phase 2 stage of clinical trials, which means it is being tested for its effectiveness and side effects. The main therapeutic indication for ESK-001 is to reduce disease activity in patients with systemic lupus erythematosus. At the molecular level, ESK-001 works by modulating the immune system to decrease inflammation and autoimmunity, although the exact mechanism of action is still under investigation. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Systemic lupus erythematosus – Systemic lupus erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. Over time, it can lead to inflammation and damage in the affected organs. The progression of the disease can vary greatly among individuals, with periods of flares and remissions. The exact cause of systemic lupus erythematosus is not fully understood, but it is believed to involve a combination of genetic, environmental, and hormonal factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502105-15-00Protocol codeESK-001-010Estimated enrolment409 patientsSponsorAlumis Inc.

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