In short
Currently, there are 3 ongoing clinical trials investigating new treatment options for subacute cutaneous lupus erythematosus. These studies are being conducted across multiple European countries and are testing medications called litifilimab and deucravacitinib, primarily for 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
- 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 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 on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
- 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 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 study is evaluating the long-term safety and effectiveness of litifilimab (also known as BIIB059) in adults with active skin lupus who have not responded well to antimalarial medications. The treatment is given as an injection under the skin over a period of up to 128 weeks.
Who can participate:
- Adults who completed a previous study (230LE301) and received treatment through week 48, attending their last assessment at week 52
- Those who can understand the study purpose and risks
- Those who can provide informed consent
- Both men and women are eligible
Who cannot participate:
- People with active infections that are not well controlled
- Those who have had serious allergic reactions to similar medications
- People with other unstable autoimmune diseases
- Those currently using treatments that might interfere with the study medication
- Pregnant or breastfeeding women
- People with a history of substance abuse
- Those with severe, uncontrolled mental health conditions
- Recent participants in other clinical trials
The study's goal: The trial aims to assess how safe and effective litifilimab is over an extended period in reducing the severity of lupus-related skin conditions. Participants will have regular check-ups to monitor their response to treatment and track any side effects. The medication works by targeting specific proteins in the immune system to reduce inflammation and skin damage.
Investigational drug: Litifilimab is an immunomodulatory medication that helps regulate the immune system to prevent it from attacking the body's own tissues.
Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy
This double-blind study is testing BIIB059 (litifilimab) in people with active skin lupus who have not responded to antimalarial treatments. Participants will receive either the active treatment or a placebo injection, with neither participants nor researchers knowing who receives which. The study runs up to 52 weeks.
Who can participate:
- People with a confirmed diagnosis of skin lupus, either past or current
- Those with active skin symptoms meeting study requirements
- A CLASI-A score (a measure of skin condition severity) of 10 or higher
- Those with an active skin lesion despite previous antimalarial treatment
- Both men and women
Who cannot participate:
- People with other serious health conditions that might interfere with the study
- Those taking medications that could affect study results
- People with recent infections or illnesses
- Pregnant or breastfeeding women
- Those with a history of allergic reactions to similar medications
- Recent participants in other clinical trials
- Those unable to follow study procedures or attend visits
The study's goal: Researchers are measuring changes in skin disease activity at weeks 16 and 24 using specialized scoring systems. The primary aim is to see if BIIB059 can significantly reduce skin symptoms and improve quality of life. Participants will be closely monitored for effectiveness and any side effects throughout the study period.
Investigational drug: BIIB059 is an immunomodulatory agent that targets specific immune pathways to decrease inflammation and skin lesions associated with lupus.
Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus
This study is evaluating deucravacitinib, an oral medication taken as a tablet, for people with active discoid lupus and/or skin lupus. The medication is being tested at two different doses (3 mg and 6 mg, both taken twice daily) and compared with placebo over 52 weeks.
Who can participate:
- People diagnosed with discoid and/or skin lupus
- Those with a CLASI-A score of 8 or higher
- Those currently on a stable treatment regimen for skin lupus
- Both men and women within the specified age range
Who cannot participate:
- People with active discoid or skin lupus meeting certain exclusion specifications
The study's goal: The primary focus is on measuring the change in skin symptom severity at week 16. Researchers will assess how well deucravacitinib works in reducing skin rashes and lesions. Throughout the study, participants will have regular check-ups including vital sign monitoring, laboratory tests, and heart function assessments to ensure safety.
Investigational drug: Deucravacitinib is a selective TYK2 inhibitor that works by targeting specific pathways in the immune system involved in inflammation. By blocking the TYK2 enzyme, it aims to reduce symptoms such as skin rashes and lesions caused when the immune system attacks the body's own tissues.
Summary
All three clinical trials focus on finding better treatment options for people with skin lupus, particularly those who have not responded to standard antimalarial medications. Two of the studies are testing litifilimab (BIIB059), while one is investigating deucravacitinib, offering different therapeutic approaches to managing this condition.
The trials are widely distributed across Europe, with the highest concentration in countries like Poland, Germany, France, Spain, Italy, Bulgaria, Slovakia, Sweden, Portugal, and Hungary. This broad geographic distribution increases access for patients in multiple countries to participate in cutting-edge research.
Both medications work by targeting the immune system but through different mechanisms. Litifilimab is an immunomodulatory agent administered by injection, while deucravacitinib is an oral TYK2 inhibitor taken as a tablet. The studies range from 16 weeks to 128 weeks in duration, allowing researchers to assess both short-term and long-term effectiveness and safety.
These trials represent important steps forward in developing new treatment options for people living with these challenging skin conditions, especially for those who have limited success with current therapies.
