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Study on IMVT-1402 for Patients with Active Cutaneous Lupus Erythematosus

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 a condition known as Cutaneous Lupus Erythematosus (CLE), which affects the skin and can sometimes have other body symptoms. The study will explore the effects of a treatment called IMVT-1402, which is given as a solution for injection under the skin. The trial will compare the effects of IMVT-1402 to a placebo in participants with active forms of CLE, specifically Subacute Cutaneous Lupus Erythematosus (SCLE) and Chronic Cutaneous Lupus Erythematosus (CCLE).

The purpose of the study is to evaluate how well IMVT-1402 works in improving the condition of participants with CLE. Participants will receive either the treatment or a placebo, and the study will monitor changes in their skin condition over time. The trial will last for up to 52 weeks, during which participants will have regular check-ups to assess their response to the treatment.

Throughout the study, the main focus will be on the safety and tolerability of IMVT-1402, as well as its effectiveness in reducing the severity of skin symptoms associated with CLE. The study aims to provide valuable information on whether IMVT-1402 can be a beneficial treatment option for individuals living with this skin condition.

The research process

The trial runs in 4 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 randomly assigned to receive either the investigational medication IMVT-1402 or a placebo. A placebo looks like the investigational medication but does not contain any active ingredients.

  2. Step 2

    Medication administration

    The medication, whether IMVT-1402 or placebo, will be given as a solution for injection under the skin, known as a subcutaneous injection.

    The frequency and dosage of the medication will be determined by the study protocol, and you will be informed of the schedule by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your condition will be monitored regularly. This includes assessments of your skin condition using a scoring system called CLASI-A, which measures the severity of your skin symptoms.

    These assessments will occur at various points, including at the start of the study and at week 12, to evaluate any changes in your condition.

  4. Step 4

    End of study participation

    Your participation in the study will continue until the study's estimated end date, which is April 1, 2027, unless you choose to withdraw earlier.

    At the end of your participation, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

Who can join the trial?

12 criteria

  • Must have a documented diagnosis of either **SCLE** (Subacute Cutaneous Lupus Erythematosus) or **CCLE** (Chronic Cutaneous Lupus Erythematosus) confirmed by a skin biopsy. A biopsy is a small sample of skin taken for testing.
  • Must have a **CLASI-A score** of 10 or higher at the start of the study. The CLASI-A score is a way to measure the severity of skin symptoms in lupus. If the score is between 8 and 10, it should not include hair loss or mouth sores.
  • Must have active **CLE** (Cutaneous Lupus Erythematosus) despite trying standard treatments like corticosteroids or antimalarial drugs for at least 12 weeks, or must have stopped these treatments due to side effects or poor tolerance.
  • Must test positive for at least one of the following at the start of the study:
    • **ANA** (Antinuclear Antibody)
    • Elevated **anti-double-stranded DNA**
    • **Anti-Ro/SSA**
    • **Anti-La/SSB**
    • **Anti-Sm**
    • **Anti-RNP70**
    • Positive direct immunofluorescence test showing **IgG** (a type of antibody) in a skin biopsy
    • Open to both **male** and **female** participants.
    • Participants should not belong to a vulnerable population.

Who cannot join the trial?

8 criteria

  • Participants cannot join the study if they have any other serious health conditions that might interfere with the study.
  • Participants who are pregnant or breastfeeding are not allowed to take part in the study.
  • Participants who have used certain medications recently that might affect the study results cannot participate.
  • Participants with a history of allergic reactions to similar treatments are excluded.
  • Participants who are currently involved in another clinical trial are not eligible.
  • Participants with a history of drug or alcohol abuse may not join the study.
  • Participants who have had a recent major surgery are not allowed to participate.
  • Participants with unstable mental health conditions are excluded from the study.
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Investigated drugs

IMVT-1402 is a medication being studied for its potential to help people with certain types of lupus, specifically subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE). These are conditions where the immune system mistakenly attacks the skin, causing rashes and other skin problems. IMVT-1402 is designed to reduce the activity of the immune system, which may help to lessen the skin symptoms and possibly other related symptoms of lupus. The goal of using IMVT-1402 in this study is to see if it can improve the skin condition of people with lupus compared to those who do not receive the medication.

What is already known about the treatment

IMVT-1402 – IMVT-1402 is administered as an injection, typically under the skin, to treat skin conditions related to lupus, specifically subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE). Currently, it is being studied in clinical trials to determine its safety and effectiveness compared to a placebo. The main goal is to see how well it can improve skin symptoms associated with these types of lupus. At the molecular level, IMVT-1402 works by targeting specific pathways in the immune system to reduce inflammation and skin damage. It is classified as an immunomodulatory drug, which means it helps regulate the immune system to prevent it from attacking the body's own tissues.

Investigated diseases

Cutaneous lupus erythematosus – This is a chronic autoimmune disease that primarily affects the skin, causing inflammation and a variety of skin lesions. The disease can manifest as red, scaly patches or plaques, often on sun-exposed areas such as the face, neck, and arms. Over time, these lesions may lead to scarring and changes in skin pigmentation. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more extensive skin involvement. The progression of the disease can be unpredictable, with periods of flare-ups and remissions. Environmental factors, such as sun exposure, can exacerbate the symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516745-39-00Protocol codeIMVT-1402-2701Estimated enrolment56 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

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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.

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