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Study on the Effectiveness and Safety of Afimetoran for Patients with Active Lupus

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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 effects of a medication called Afimetoran in individuals with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The trial aims to evaluate how effective and safe Afimetoran is compared to a placebo in managing the symptoms of active SLE.

Participants in the study will receive either Afimetoran or a placebo in the form of capsules taken orally. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure unbiased results. The trial will last for a period of time, during which participants will be monitored for changes in their condition and any side effects they may experience.

The main goal of the study is to see if Afimetoran can improve the activity of lupus, as measured by a specific index called the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Participants will be assessed at various points throughout the study to determine the medication's impact on their lupus symptoms and overall health. The study will also track any adverse events or changes in laboratory values to ensure the safety of the participants.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of systemic lupus erythematosus (SLE) made at least 12 weeks prior and testing for specific lupus-related antibodies.

    A score on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is required, with a total score of 6 or more and a clinical score of 4 or more, indicating joint involvement or rash.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either Afimetoran or a placebo. The treatment is administered orally in the form of a capsule.

    The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  3. Step 3

    Treatment phase

    Participants take the assigned capsule daily for a period of 48 weeks. The dosage and specific instructions are provided by the study team.

    Regular monitoring is conducted to assess the efficacy and safety of the treatment, focusing on improvements in lupus activity and any side effects.

  4. Step 4

    Evaluation at week 24

    At week 24, an evaluation is performed to measure the response to treatment. This includes assessing the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) and the SLE Responder Index 4 (SRI[4]).

    Additional assessments include changes in joint counts, skin condition, and overall disease activity.

  5. Step 5

    Evaluation at week 48

    At week 48, a final evaluation is conducted to determine the proportion of participants achieving a significant response, as defined by the SLE Responder Index 4 (SRI[4]).

    Further assessments include changes in disease activity, joint counts, and any adverse events experienced during the trial.

  6. Step 6

    Long-term extension option

    Participants who complete the 48-week treatment phase may be eligible for a long-term extension period if deemed beneficial by the investigator.

    This optional phase allows for continued monitoring and treatment beyond the initial study period.

Who can join the trial?

8 criteria

  • You must have been diagnosed with **Systemic Lupus Erythematosus (SLE)** at least 12 weeks before the screening visit. SLE is a condition where the immune system attacks the body's own tissues.
  • You need to test positive for at least one of the following lupus-related autoantibodies:
    • **Antinuclear antibody** at a level of 1:80 or higher. This is a type of protein made by the immune system that can attack the body's own cells.
    • **Anti-double-stranded deoxyribonucleic acid (dsDNA) antibody**. This is another type of protein that targets the DNA inside cells.
    • **Anti-Smith antibody**. This is a protein that targets specific parts of the cell's nucleus.
    • You should have a total **Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)** score of 6 points or more, and a clinical Hybrid SLEDAI score of 4 points or more, with joint involvement and/or rash. This score measures the activity or severity of lupus symptoms.
    • If you are participating in the long-term extension (LTE) period, you must have completed the study treatment through Week 48, and the investigator should believe that you may benefit from continuing in the optional LTE period.
    • Both **female and male** participants are eligible to join the study.
    • The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

18 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to similar medications.
  • Using certain medications that might interfere with the study treatment.
  • Having a recent history of drug or alcohol abuse.
  • Having an active infection that requires treatment.
  • Having received a live vaccine within a certain period before the study.
  • Having a history of cancer, except for certain types that have been treated and are not active.
  • Having a history of certain blood disorders.
  • Having a history of certain heart conditions.
  • Having a history of certain liver conditions.
  • Having a history of certain kidney conditions.
  • Having a history of certain lung conditions.
  • Having a history of certain neurological conditions.
  • Having a history of certain psychiatric conditions.
  • Having participated in another clinical trial recently.
  • Having a history of non-compliance with medical treatments.
  • Having any condition that, in the opinion of the study doctor, makes participation unsafe.
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Investigated drugs

Afimetoran is a medication being studied for its potential to help people with active Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body's own tissues. The trial aims to see if Afimetoran can reduce the symptoms and activity of lupus, making it easier for patients to manage their condition.

What is already known about the treatment

Afimetoran – Afimetoran is administered orally and is currently being studied in clinical trials for its effectiveness in treating active systemic lupus erythematosus (SLE). It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication for Afimetoran is the treatment of active SLE, a chronic autoimmune disease. At the molecular level, Afimetoran works by modulating the immune response, potentially reducing inflammation and disease activity. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Active Systemic Lupus Erythematosus – This is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues, leading to inflammation and damage in various parts of the body. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever. The disease can have periods of flares, where symptoms worsen, and remissions, where symptoms improve. The progression of the disease varies greatly among individuals, with some experiencing mild symptoms and others having more severe complications. Managing the disease often involves monitoring and addressing the symptoms as they arise.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504320-25-00Protocol codeIM026-024Estimated enrolment550 patients

sourced from the EU Clinical Trials Register and site verification

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