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Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy

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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 two types of lupus that affect the skin: Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus. These conditions can cause rashes and lesions on the skin, and sometimes they may also involve other parts of the body. The study is testing a new treatment called BIIB059, which is given as an injection. The purpose of the study is to evaluate how effective and safe BIIB059 is in reducing the activity of skin disease in people who have these types of lupus and have not responded well to antimalarial treatments.

Participants in the study will receive either the BIIB059 injection or a placebo, which looks like the treatment but does not contain the active ingredient. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ups to monitor the participants' health and the effects of the treatment.

The trial is divided into two parts, and participants will be assessed using specific scores that measure the severity and activity of their skin condition. These scores help researchers understand how well the treatment is working. The study aims to provide valuable information about the potential benefits of BIIB059 for people with these challenging skin conditions. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

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

    Joining the study

    Upon joining the study, participation is confirmed through a diagnosis of cutaneous lupus erythematosus (CLE) with or without systemic symptoms. Active skin symptoms must meet specific criteria, including a CLASI-A score of 10 or higher.

    Participants must have an active CLE lesion despite previous antimalarial treatment.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of skin disease using the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score.

  3. Step 3

    Treatment administration

    Participants receive either the active drug BIIB059 or a placebo. The medication is administered as a subcutaneous injection.

    The treatment aims to reduce skin disease activity and is given according to the study's schedule.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effectiveness of the treatment. This includes measuring changes in the CLA-IGA-R and CLASI-A scores.

    The primary goal is to achieve a significant reduction in skin disease activity by Week 16 and Week 24.

  5. Step 5

    Long-term evaluation

    The study continues to evaluate participants up to Week 52 to assess long-term effects and safety.

    Secondary outcomes include changes in quality of life scores and the occurrence of any adverse events.

  6. Step 6

    Completion of the study

    The study is expected to conclude by December 2027, with final assessments and data collection completed by this time.

Who can join the trial?

6 criteria

  • You must have a confirmed diagnosis of **Cutaneous Lupus Erythematosus (CLE)**, which is a skin condition, either in the past or during the screening period.
  • You must have active skin symptoms that meet the study's specific requirements.
  • Your **CLASI-A score** must be 10 or higher. This score measures the severity of your skin condition.
  • You must have an active CLE skin lesion even after trying antimalarial treatment, which is a type of medication used to treat lupus.
  • Both males and females can participate in the study.
  • Other specific criteria defined by the study protocol may also apply.

Who cannot join the trial?

7 criteria

  • Participants who have other serious health conditions that might interfere with the study.
  • Individuals who are currently taking medications that could affect the study results.
  • People who have had a recent infection or illness that could impact their participation.
  • Participants who are pregnant or breastfeeding.
  • Individuals who have a history of allergic reactions to similar medications.
  • People who have participated in another clinical trial recently.
  • Participants who are unable to follow the study procedures or attend study visits.
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Investigated drugs

BIIB059 is a medication being studied for its effectiveness in treating skin conditions related to lupus, specifically subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE). This medication is being tested to see if it can help reduce the activity of skin disease in patients who have not responded well to or cannot tolerate antimalarial treatments. The study aims to determine if BIIB059 can improve the condition of the skin by using specific assessment scores to measure changes in disease activity.

What is already known about the treatment

BIIB059 – This medication is administered through an injection and is currently being studied in clinical trials for its effectiveness in treating skin conditions related to lupus, specifically subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. It is in the advanced stages of clinical research, with ongoing studies evaluating its safety and efficacy. The main therapeutic use of BIIB059 is to reduce skin disease activity in patients who have not responded well to traditional antimalarial treatments. At the molecular level, BIIB059 works by targeting specific immune pathways to decrease inflammation and skin lesions associated with lupus. It is classified as an immunomodulatory agent, which means it helps regulate the immune system's response.

Investigated diseases

  • Subacute Cutaneous Lupus Erythematosus

    This is a form of lupus that primarily affects the skin, causing red, scaly patches or ring-shaped lesions, often on sun-exposed areas. The condition can lead to skin sensitivity to sunlight and may result in discolored patches. It typically progresses with periods of flare-ups and remissions. Unlike systemic lupus, it usually does not affect internal organs. The skin lesions can heal without scarring but may leave behind areas of altered pigmentation.

  • Chronic Cutaneous Lupus Erythematosus

    Also known as discoid lupus erythematosus, this condition is characterized by chronic skin lesions that are often red, inflamed, and can lead to scarring. These lesions typically appear on the face, scalp, and ears, and can cause permanent hair loss if they occur on the scalp. The disease progresses slowly, with lesions that can persist for long periods. It primarily affects the skin and rarely involves internal organs. The lesions may heal with scarring and changes in skin color.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505634-94-00Protocol code230LE301Estimated enrolment546 patientsSponsorBiogen Idec Research Limited

sourced from the EU Clinical Trials Register and site verification

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