Ongoing Clinical Trials for Chronic Cutaneous Lupus Erythematosus
There are currently 4 clinical trials investigating new treatments for chronic cutaneous lupus erythematosus, testing medications including litifilimab, daxdilimab, and deucravacitinib. These trials are taking place across multiple European countries and focus on patients who have not responded well to standard antimalarial treatments.
Clinical trial locations
- Belgium
- Bulgaria
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus
- Czechia
- Denmark
- France
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus
- Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
- Germany
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus
- Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
- Greece
- Hungary
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Italy
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Poland
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus
- Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
- Portugal
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Slovakia
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Spain
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Sweden
- Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
- Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
This trial is testing litifilimab, also known as BIIB059, for people with subacute or chronic forms of the condition. The medication is given as an injection under the skin and is being studied for its long-term safety and effectiveness.
Who can join: Adults who have completed a previous study of this medication and attended their final assessment at week 52 are eligible. Participants must be able to understand the study’s purpose and risks, provide informed consent, and allow their health information to be used according to privacy regulations. The study is open to both men and women.
Who cannot join: People with active infections that are not well controlled, those who have had serious allergic reactions to similar medications, individuals with unstable autoimmune diseases, pregnant or breastfeeding women, people with a history of substance abuse, those with severe uncontrolled mental health conditions, and individuals who have recently participated in another clinical trial are excluded from participating.
What the trial involves: The study aims to evaluate how safe and effective litifilimab is over an extended period of up to 128 weeks. Participants will receive regular injections and have their condition monitored using specific scoring systems that measure disease severity. The trial will track improvements in skin condition and watch for any side effects.
About the medication: Litifilimab works by targeting specific proteins in the immune system to reduce inflammation and skin damage. It is an immunomodulatory drug being tested for people who have not responded well to standard antimalarial treatments.
Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
This trial is also studying litifilimab (BIIB059) but focuses on evaluating its effectiveness and safety in a double-blind design, where neither participants nor researchers know who receives the actual medication or placebo.
Who can join: Adults with confirmed diagnosis of the condition and active skin symptoms are eligible. Participants must have a CLASI-A score of 10 or higher, which measures disease severity, and must have active skin lesions despite previous antimalarial treatment. Both men and women can participate.
Who cannot join: People with other serious health conditions that might interfere with the study, those currently taking medications that could affect study results, individuals with recent infections or illnesses, pregnant or breastfeeding women, people with a history of allergic reactions to similar medications, and those who have recently participated in another clinical trial are excluded.
What the trial involves: Participants receive either litifilimab or placebo as injections under the skin. The study lasts up to 52 weeks and includes regular monitoring and assessments at weeks 16 and 24 to measure changes in skin disease activity using the CLASI-A scoring system.
About the medication: Litifilimab is an investigational immunomodulatory drug designed to reduce inflammation and skin lesions by targeting specific immune pathways. It is being tested for people who have not responded to traditional antimalarial treatments.
Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus
This trial is testing daxdilimab, a new injectable medication for people with moderate to severe discoid lupus erythematosus. The study compares daxdilimab with placebo over a 24-week period.
Who can join: Adults aged 18 to 75 years who have had discoid lupus erythematosus for at least 6 months are eligible. Participants must have active disease confirmed by photography and a CLASI-A score of 8 or higher. Those whose condition has not responded to previous treatments or who could not tolerate standard medications may participate. If currently on medications, doses must be stable for specific periods. Women of childbearing age must use effective birth control and have negative pregnancy tests. Men must also use contraception during and after the study.
Who cannot join: People younger than 18 or older than 75, pregnant or breastfeeding women, those with a history of systemic lupus affecting multiple organs, individuals on recent immunosuppressive medications, people with active infections including tuberculosis, hepatitis B, hepatitis C, or HIV, those with cancer history within the past 5 years, individuals with severe kidney or liver disease, uncontrolled high blood pressure, history of severe allergic reactions to medications, recent participation in other trials, mental conditions affecting compliance, substance abuse within the past year, or any condition compromising patient safety are excluded.
What the trial involves: Participants receive either daxdilimab or placebo as injections under the skin throughout the 24-week study period. The trial includes regular skin examinations, digital photographs to document progress, monitoring using the CLASI-A scoring system, and blood tests to measure medication levels. Those already on other medications continue them at the same dose during the study.
About the medication: Daxdilimab is a targeted immunotherapy agent that works by modulating the immune system to reduce inflammation and disease activity in the skin. It represents a new treatment approach for this challenging condition.
Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
This trial is evaluating deucravacitinib, an oral medication taken as a film-coated tablet, for people with discoid and/or subacute forms of the condition. The study tests two different doses: 3 mg and 6 mg, both taken twice daily.
Who can join: Participants must have a confirmed diagnosis of discoid and/or subacute forms of the condition, a CLASI-A score of 8 or higher, and must be on a stable treatment regimen. Both men and women within the specified age range can participate.
Who cannot join: People with active discoid or subacute skin forms cannot participate in this particular trial. The exclusion criteria are specifically focused on ensuring participants have the appropriate disease activity level.
What the trial involves: This is a double-blind, randomized study lasting up to 52 weeks. Participants are randomly assigned to receive either deucravacitinib (at either 3 mg or 6 mg dose) or placebo, taken twice daily for 16 weeks. The main focus is on measuring changes in skin symptom severity at week 16 using the CLASI-A scoring system. Throughout the study, participants undergo regular assessments including vital sign checks, laboratory tests, and heart function monitoring with ECG.
About the medication: Deucravacitinib is a selective TYK2 inhibitor that works by targeting specific pathways in the immune system involved in inflammation. It is taken orally and aims to reduce symptoms such as skin rashes and lesions in people with lupus affecting the skin.
Summary
All four clinical trials focus on developing new treatment options for people whose condition has not responded well to standard antimalarial therapies. Three different investigational medications are being studied: litifilimab, daxdilimab, and deucravacitinib.
The trials show a strong concentration in European countries, with France, Germany, and Poland participating in multiple studies. This suggests these countries have established research infrastructure for lupus-related skin conditions. Bulgaria, Italy, Slovakia, Sweden, Portugal, Hungary, Spain, and Belgium are also active trial locations.
Two of the trials focus on litifilimab, examining both its long-term safety and its effectiveness compared to placebo. The other two trials test different medications: daxdilimab specifically for discoid lupus erythematosus, and deucravacitinib for both discoid and subacute forms. All medications work by modulating the immune system to reduce inflammation and skin symptoms.
The studies use similar assessment tools, particularly the CLASI-A scoring system, to measure disease severity and track improvements. Most trials last between 16 and 52 weeks, with one long-term study extending up to 128 weeks to evaluate safety over an extended period.
