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Ongoing Clinical Trials for Cutaneous Lupus Erythematosus

This article provides detailed information about 9 ongoing clinical trials investigating new treatments for cutaneous lupus erythematosus, a chronic autoimmune skin condition. These studies are taking place across multiple European countries and are testing several investigational medications including GS-5718, anifrolumab, IMVT-1402, litifilimab, VENT-03, enpatoran, PF-06823859, and deucravacitinib.

Clinical trial locations

Study of GS-5718 for Patients with Cutaneous Lupus Erythematosus (CLE)

This trial is evaluating GS-5718, an oral medication taken as a film-coated tablet, for people with active skin lupus. The study is taking place in Germany, Spain, and Czechia.

Main goal: The study aims to assess how effective and safe GS-5718 is in reducing skin disease activity in people with cutaneous lupus erythematosus, with or without systemic lupus erythematosus. Participants will take the medication for up to 12 weeks, during which they will have regular check-ups to monitor their health and the effects of the treatment.

Investigational drug: GS-5718 is an experimental medication that may help reduce the symptoms of skin lupus and improve quality of life for people affected by this condition.

Who can participate: Adults with confirmed diagnosis of cutaneous or systemic lupus erythematosus who have active skin disease. Participants must have a CLASI-A score of 8 or higher, with an erythema score of 4 or higher. They must have tried standard treatments previously, including topical creams, oral steroids, or other medications such as chloroquine, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, dapsone, or methotrexate. Participants must also be willing to undergo skin biopsies.

Who cannot participate: People with other serious health conditions that might interfere with the study, those currently in another clinical trial, recent surgery patients, pregnant or breastfeeding women, individuals with allergies to similar medications, those who have recently used certain medications, people with substance abuse history, individuals with certain types of cancer, and those with severe mental health conditions.

Study on Anifrolumab for Adults with Chronic or Subacute Cutaneous Lupus Erythematosus Unresponsive to Antimalarial Therapy

This large international trial is testing anifrolumab, given as a subcutaneous injection, in adults with chronic and subacute forms of skin lupus who have not responded well to antimalarial medications. The study is taking place across 13 European countries including Romania, Poland, Slovakia, Greece, Bulgaria, France, Denmark, Italy, Spain, Austria, Netherlands, Portugal, and Germany.

Main goal: The study aims to evaluate the effectiveness and safety of anifrolumab in improving skin conditions associated with cutaneous lupus erythematosus. The trial will be conducted in two stages and will last up to 52 weeks, allowing researchers to monitor long-term effects.

Investigational drug: Anifrolumab is a monoclonal antibody that targets the type I interferon receptor, which plays a role in the inflammatory process associated with lupus. It is designed to reduce skin symptoms in patients who have limited options due to intolerance or inadequate response to existing therapies.

Who can participate: Adults aged 18 to 70 years with confirmed diagnosis of cutaneous lupus erythematosus, documented both clinically and by tissue biopsy. Participants must have a CLASI-A total score of 10 or more, and a CLA-IGA-R erythema score of 3 or more. They must have had inadequate response or intolerance to antimalarial therapy, or if antimalarial treatment was not started for medical reasons, they must have tried alternative treatments. Participants must have no history of tuberculosis and must have negative TB and COVID-19 tests.

Who cannot participate: People with other serious skin conditions, recent infections requiring antibiotics, those taking certain interfering medications, individuals with severe allergic reactions to medications, pregnant or breastfeeding women, those with substance abuse history, people with uncontrolled chronic diseases, recent clinical trial participants, recent vaccination recipients, individuals with certain cancer histories, and those with weakened immune systems.

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

This study is testing IMVT-1402, given as a solution for injection under the skin, for participants with active forms of subacute and chronic cutaneous lupus erythematosus. The trial is taking place in Poland, Spain, Germany, Greece, and Bulgaria.

Main goal: The study evaluates how well IMVT-1402 works in improving the condition of participants with active skin lupus. The trial will last up to 52 weeks, during which participants will have regular check-ups to assess their response to treatment and ensure their safety. The main focus will be on safety and tolerability of IMVT-1402, as well as its effectiveness in reducing the severity of skin symptoms.

Investigational drug: IMVT-1402 is an immunomodulatory medication designed to reduce the activity of the immune system, which may help lessen skin symptoms and related manifestations of lupus.

Who can participate: Adults with documented diagnosis of either subacute cutaneous lupus erythematosus or chronic cutaneous lupus erythematosus confirmed by skin biopsy. Participants must have a CLASI-A score of 10 or higher. They must have active disease despite trying standard treatments like corticosteroids or antimalarial drugs for at least 12 weeks, or must have stopped these treatments due to side effects. Participants must test positive for at least one specific antibody marker including ANA, anti-double-stranded DNA, Anti-Ro/SSA, Anti-La/SSB, Anti-Sm, Anti-RNP70, or have positive direct immunofluorescence test showing IgG in a skin biopsy.

Who cannot participate: People with other serious health conditions, pregnant or breastfeeding women, those who have used certain medications recently, individuals with allergic reactions to similar treatments, current participants in other clinical trials, those with substance abuse history, recent surgery patients, and individuals with unstable mental health conditions.

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

This is an extension study evaluating the long-term safety and effectiveness of BIIB059 (litifilimab), given as a subcutaneous injection, in adults with active subacute or chronic skin lupus who have not responded well to or cannot tolerate antimalarial medications. The study is taking place in Slovakia, Portugal, Italy, Sweden, France, Spain, Hungary, Poland, Germany, and Bulgaria.

Main goal: The study evaluates the long-term safety and effectiveness of litifilimab in reducing skin symptoms over up to 128 weeks. Participants who completed the parent study will continue receiving the medication with regular monitoring to assess for any side effects or adverse reactions.

Investigational drug: Litifilimab is a medication that targets specific proteins in the immune system to reduce inflammation and skin damage. It is being tested in patients who have not had success with standard antimalarial treatments.

Who can participate: Participants must have completed the parent study through Week 48 and attended the last study assessment visit at Week 52. They must be able to understand the purpose and risks of the study, provide informed consent, and authorize use of their confidential health information according to privacy regulations.

Who cannot participate: People with active infections that are not well controlled, those with serious allergic reactions to similar medications in the past, individuals with unstable autoimmune diseases, those using other interfering treatments, pregnant or breastfeeding women, people with substance abuse history, individuals with severe uncontrolled mental health conditions, and recent participants in other clinical trials.

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

This study is testing BIIB059, given as an injection, in people with subacute and chronic forms of skin lupus who have not responded well to antimalarial treatments. The trial is taking place in Poland, Bulgaria, Italy, Slovakia, Germany, France, Spain, Belgium, Sweden, Portugal, and Hungary.

Main goal: The study evaluates how effective and safe BIIB059 is in reducing skin disease activity in participants who have not responded well to antimalarial treatments. The trial is divided into two parts, with participants assessed using specific scores that measure the severity and activity of their skin condition. The study is double-blind, meaning neither participants nor researchers know who is receiving the actual treatment or placebo.

Investigational drug: BIIB059 works by targeting specific immune pathways to decrease inflammation and skin lesions associated with lupus. It is classified as an immunomodulatory agent that helps regulate the immune system’s response.

Who can participate: Adults with confirmed diagnosis of cutaneous lupus erythematosus, either in the past or during the screening period. Participants must have active skin symptoms meeting the study’s specific requirements, with a CLASI-A score of 10 or higher. They must have an active skin lesion even after trying antimalarial treatment.

Who cannot participate: People with other serious health conditions that might interfere with the study, those taking medications that could affect results, individuals with recent infection or illness, pregnant or breastfeeding women, those with history of allergic reactions to similar medications, recent clinical trial participants, and people unable to follow study procedures or attend visits.

Study of VENT-03 tablets in adults with active cutaneous lupus erythematosus with or without systemic lupus erythematosus

This study focuses on evaluating VENT-03, taken as tablets by mouth, for adults with active skin lupus with or without systemic lupus erythematosus. The trial is taking place in Bulgaria, Poland, Hungary, Spain, and France.

Main goal: The research evaluates how well VENT-03 works in reducing the severity of skin symptoms in adults with active cutaneous lupus. After the initial phase, the study continues with an open-label extension where all participants receive the active medication. The study measures how skin symptoms change over time, particularly focusing on improvement in skin lesions.

Investigational drug: VENT-03 is an investigational medication in Phase 2a of clinical development, being evaluated for both safety and effectiveness in treating skin manifestations of lupus.

Who can participate: Adults aged 18 to 70 years with body weight between 40 to 110 kg. Participants must provide written informed consent and must have diagnosed cutaneous lupus at screening. They must be willing and able to follow all study procedures and attend all required visits. Women who can become pregnant must use effective birth control starting at least 30 days before study medication and continuing until 30 days after the last dose. Men who can father children must use effective birth control starting 30 days before medication and continuing until 90 days after the last dose, and must not donate sperm for 90 days after receiving the last dose.

Who cannot participate: People with active or chronic infections including tuberculosis or hepatitis B, those with history of severe allergic reactions to medications, individuals with other autoimmune conditions besides cutaneous lupus, pregnant or breastfeeding women, those using other investigational drugs within 30 days, individuals with significant heart, liver, or kidney problems, active cancer or history of cancer in past 5 years (except successfully treated skin cancer), uncontrolled high blood pressure, major surgery within 8 weeks, substance abuse history within past year, mental health conditions that could interfere with participation, use of interacting medications, blood test results outside acceptable ranges, or inability to follow study procedures or attend scheduled visits.

Study of Enpatoran in Adults with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE)

This Phase 2 study is testing enpatoran, taken as film-coated tablets, in adults with systemic lupus erythematosus and cutaneous lupus erythematosus who are already receiving standard treatments. The trial is taking place in Romania, Bulgaria, Poland, Spain, and Greece.

Main goal: The research evaluates how different doses of enpatoran work in reducing disease activity, particularly focusing on skin symptoms and overall disease control. During the study, participants will receive either enpatoran or placebo in addition to their current lupus medications. The study will track changes in participants’ symptoms and overall health for up to 24 months. The study is double-blind, meaning neither participants nor healthcare providers will know who is receiving enpatoran or placebo.

Investigational drug: Enpatoran is designed to help reduce disease activity and symptoms by targeting specific components of the immune system involved in lupus. It is being studied in combination with standard of care treatments that patients already take as part of their regular treatment plan.

Who can participate: Adults aged 18 years or older with active cutaneous lupus erythematosus with a CLASI-A score of 8 or higher, or active systemic lupus erythematosus with either a CLASI-A score of 8 or higher with moderate disease activity in other organs, severe or moderate disease activity in multiple organs, or a SELENA-SLEDAI score of 6 or higher during screening. Participants must be currently taking at least one stable treatment including immune system modifying medications, oral steroids, or topical steroids.

Who cannot participate: People under 18 or over 75 years, recent participants in other clinical trials, pregnant or breastfeeding women, those with known hypersensitivity to study medication, individuals with active or chronic infections including tuberculosis or hepatitis, cancer history within past 5 years (except successfully treated non-melanoma skin cancer), severe kidney or liver disease, unstable heart conditions or recent heart attack, uncontrolled high blood pressure, history of blood clots, use of interfering medications, mental health conditions that could affect participation, substance abuse within past year, or any condition that makes participation unsafe.

Study of PF-06823859 for Adults with Active Cutaneous or Systemic Lupus Erythematosus with Skin Symptoms

This trial is testing PF-06823859, a humanised IgG1k monoclonal antibody given through intravenous injection, for adults with active cutaneous or systemic lupus erythematosus with skin symptoms. The study is taking place in Spain and Greece.

Main goal: The study aims to see how well PF-06823859 works in reducing the activity of lupus in the skin. This protein is designed to target and block interferon beta, which is thought to play a role in lupus. Participants will be randomly assigned to receive either the treatment or a placebo. The study will last several weeks, with regular check-ups to monitor health and effects of the treatment.

Investigational drug: PF-06823859 is an investigational medication that works by targeting and modulating the type 1 interferon pathway involved in the immune response. It is classified as an immunomodulatory agent.

Who can participate: Men or women aged between 18 and 75 years who are willing to attend all scheduled visits, follow treatment plan, undergo laboratory tests, and follow lifestyle guidelines. Participants must agree not to use skin medications on specific areas that might be used for biopsies until after Week 32. They need suitable veins for IV treatment and blood samples. Participants must have confirmed diagnosis of active cutaneous or systemic lupus erythematosus with skin symptoms, even after using standard treatments for at least 12 weeks, with certain scoring requirements and a past skin biopsy available. Those currently taking stable doses of certain medications are eligible. Participants must weigh more than 40 kg and less than 130 kg, with BMI less than 40 kg/m².

Who cannot participate: The specific exclusion criteria were not fully detailed in the source data, but generally include those with active forms of cutaneous or systemic lupus erythematosus with skin symptoms that meet the study’s definition.

Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

This trial is testing deucravacitinib, taken as film-coated tablets, for individuals with discoid and subacute forms of skin lupus. The medication is being evaluated in two doses: 3 mg and 6 mg, both taken twice daily. The study is taking place in Poland, Germany, and France.

Main goal: The study evaluates how well deucravacitinib works in reducing the severity of skin symptoms in participants with active discoid and subacute cutaneous lupus erythematosus. The study includes comparison with a placebo and will last up to 52 weeks, with regular check-ups to monitor condition and changes in symptoms. The main focus is on change in severity of skin symptoms at Week 16, measured by a specific scoring system.

Investigational drug: Deucravacitinib works by targeting specific pathways in the immune system to reduce symptoms and severity of lupus, such as skin rashes and lesions. It is a selective TYK2 inhibitor that targets pathways involved in inflammation.

Who can participate: Adults with diagnosis of discoid and subacute cutaneous lupus erythematosus with a CLASI-A score of 8 or higher. Participants must currently be receiving stable treatment regimen for their condition.

Who cannot participate: Patients with active discoid or subacute cutaneous lupus erythematosus as defined by the specific study criteria.

Summary

There are currently 9 ongoing clinical trials for cutaneous lupus erythematosus across Europe. The trials are most heavily concentrated in Spain, Poland, Germany, and Bulgaria, which each host multiple studies. France, Italy, and Greece also feature prominently in the trial landscape.

Several investigational medications are being studied multiple times across different trials, particularly litifilimab (BIIB059), which appears in three separate studies including one focused on long-term safety. Anifrolumab is being tested in the largest international trial, spanning 13 countries. Other medications under investigation include GS-5718, IMVT-1402, VENT-03, enpatoran, PF-06823859, and deucravacitinib.

Most trials focus on patients who have not responded well to standard antimalarial therapy or cannot tolerate existing treatments, indicating an important unmet medical need in this patient population. The studies typically measure effectiveness using standardized scoring systems such as CLASI-A to track changes in skin disease activity.

These trials represent important research efforts to develop new treatment options for people living with cutaneous lupus erythematosus, particularly those with limited options due to treatment resistance or intolerance.

Ongoing Clinical Trials on Cutaneous lupus erythematosus

  • A Study of Anifrolumab for Patients with Cutaneous Lupus Erythematosus to Measure Changes in Skin and Blood Inflammation and Clinical Outcomes

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study of VENT-03 tablets in adults with active cutaneous lupus erythematosus with or without systemic lupus erythematosus

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Hungary Poland Spain

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

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Hungary Italy +5

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Hungary Italy +5

  • Comparing lenalidomide and methotrexate for patients with difficult-to-treat cutaneous lupus erythematosus

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Evaluation of Long-term Safety and Efficacy of Enpatoran in Subacute Cutaneous, Discoid, and Systemic Lupus Erythematosus Post-WILLOW Study Completion

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Greece Poland Romania Spain

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Germany Greece Poland Spain

  • Study on Anifrolumab for Adults with Chronic or Subacute Cutaneous Lupus Erythematosus Unresponsive to Antimalarial Therapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Denmark France Germany Greece +7

  • Study of Enpatoran in Adults with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE)

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Greece Poland Romania Spain

  • Study of GS-5718 for Patients with Cutaneous Lupus Erythematosus (CLE)

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Spain

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