Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 skin conditions related to lupus: Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus. These conditions can cause skin rashes and lesions, and sometimes they may be associated with other symptoms throughout the body. The study is testing a treatment called BIIB059, also known as litifilimab, which is given as an injection under the skin. The purpose of the study is to evaluate the long-term safety and effectiveness of this treatment in adults who have these active skin conditions and have not responded well to or cannot tolerate antimalarial medications.

Participants in the study will receive the BIIB059 treatment over a period of time, and their health will be monitored to see how they respond to the medication. The study will look at how well the treatment works in reducing the severity of the skin conditions and any potential side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study will last for up to 128 weeks, during which participants will have regular check-ups to assess their condition and any changes in their symptoms. The goal is to gather information on how safe and effective BIIB059 is for treating these types of lupus-related skin conditions over a long period. This information will help determine if the treatment can be a viable option for people with these conditions in the future.

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, participants will be informed about the purpose and potential risks of the trial. Participants must provide informed consent, which means agreeing to participate after understanding the study details.

    Participants must have completed the previous study, known as the parent study, and attended the last assessment visit at Week 52.

  2. Step 2

    Receiving the medication

    Participants will receive the medication called BIIB059, also known as litifilimab. This medication is administered as an injection under the skin, a method known as subcutaneous injection.

    The frequency and dosage of the medication will be determined by the study protocol and will continue for up to 128 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to evaluate the safety and effectiveness of the medication. This includes checking for any side effects or adverse reactions.

    Participants will have their condition assessed using various measures, such as the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) to track improvements in their condition.

  4. Step 4

    Completion of the study

    The study is expected to last up to 128 weeks. During this time, participants will continue to receive the medication and attend scheduled assessments.

    At the end of the study, participants will have a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

6 criteria

  • Participants must have completed the parent study (230LE301, Part A or Part B) on study treatment. This means they received treatment through Week 48 and attended the last study assessment visit at Week 52.
  • Participants must be able to understand the purpose and risks of the study.
  • Participants must be able to provide informed consent. This means they agree to participate after understanding the study details.
  • Participants must authorize the use of their confidential health information according to national and local privacy regulations.
  • The study is open to both male and female participants.
  • The study includes participants from vulnerable populations. This means people who might need special protection or care.

Who cannot join the trial?

8 criteria

  • Patients with **active infections** that are not well controlled. This means if you have an infection that is not being managed effectively, you cannot participate.
  • Patients who have had a **serious allergic reaction** to similar medications in the past. A serious allergic reaction can include symptoms like difficulty breathing, swelling, or severe rash.
  • Patients with **other autoimmune diseases** that are not stable. Autoimmune diseases are conditions where the immune system attacks the body’s own tissues.
  • Patients who are currently using other treatments that might interfere with the study medication.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients with a history of **substance abuse**. Substance abuse refers to the harmful or hazardous use of substances like alcohol or drugs.
  • Patients with **severe mental health conditions** that are not well controlled. This includes conditions like severe depression or anxiety.
  • Patients who have participated in another clinical trial recently. This is to avoid any interference between different study medications.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

BIIB059 (Litifilimab) is a medication being studied for its potential to help people with certain types of lupus, specifically subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. These are conditions where the immune system mistakenly attacks the skin, causing rashes and other symptoms. This medication is being tested to see if it can safely and effectively reduce these symptoms over a long period. It is particularly aimed at people who have not had success with or cannot tolerate traditional treatments like antimalarial drugs. The goal is to find out if this medication can be a reliable option for managing lupus symptoms without causing significant side effects.

What is already known about the treatment

Litifilimab – Litifilimab is administered as an injection and is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating certain types of lupus, specifically subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. These conditions are characterized by skin rashes and lesions, and the medication is being tested in patients who do not respond well to standard antimalarial treatments. Litifilimab works by targeting specific proteins 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

  • Subacute Cutaneous Lupus Erythematosus

    This is a form of lupus that primarily affects the skin, causing lesions that are often red, scaly, and can appear in sun-exposed areas. The lesions may be ring-shaped or have a papulosquamous appearance, resembling psoriasis. Over time, these lesions can lead to skin discoloration but typically do not cause scarring. The condition can be triggered or worsened by sun exposure. It is often associated with mild systemic symptoms, such as joint pain or fatigue. The disease can fluctuate, with periods of flare-ups and remission.

  • Chronic Cutaneous Lupus Erythematosus

    This form of lupus is characterized by persistent skin lesions that can lead to scarring. The most common type is discoid lupus erythematosus, which presents as round, red, and scaly patches that can thicken and scar over time. These lesions are typically found on the face, scalp, and ears, and can cause hair loss if they occur on the scalp. The condition is chronic, meaning it can last for a long time and may have periods of activity and inactivity. Sun exposure can exacerbate the lesions. Unlike systemic lupus, this form primarily affects the skin and is less likely to involve internal organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504863-17-00Protocol code230LE305Estimated enrolment320 patientsSponsorBiogen Idec Research Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.