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Neurodermatitis – Trials in Disease

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Clinical Trials for Neurodermatitis

There are currently 9 ongoing clinical trials investigating new treatments for neurodermatitis and related skin conditions. These studies are testing medications including dupilumab, barzolvolimab, povorcitinib, ruxolitinib cream, and nemolizumab across multiple European countries. (Also known as: Lichen Simplex Chronicus, Prurigo Nodularis)

Clinical trial locations

Study on Dupilumab for Itch Relief in Adults with Lichen Simplex Chronicus (Neurodermatitis)

This trial is investigating dupilumab, a medication given as an injection under the skin, for adults with moderate-to-severe Lichen Simplex Chronicus, also known as neurodermatitis. The study aims to determine whether dupilumab can effectively reduce the intense itching associated with this condition.

Inclusion criteria: Participants must be at least 18 years old and have moderate-to-severe LSC for at least 6 months, as confirmed by a doctor’s assessment. They need to have an average worst-itch score of 7 or higher (on a scale of 0 to 10) over 7 days before starting the study. Additionally, participants should have tried a 2-week treatment with medium-to-strong topical corticosteroids without adequate relief, unless these treatments are medically inadvisable.

Exclusion criteria: People with other skin conditions besides neurodermatitis, those under 18 years of age, those whose condition is well-controlled by topical treatments, and those not experiencing moderate-to-severe symptoms or itching related to LSC cannot participate.

Main focus: The study will monitor participants over 24 weeks to see if dupilumab significantly reduces itch severity by 4 or more points on the Worst-Itch Numerical Rating Scale. Secondary evaluations include changes in sleep disturbance, quality of life, and any side effects from the treatment.

Investigational drug: Dupilumab is a monoclonal antibody that works by blocking certain proteins in the body that cause inflammation and itching. It is administered as a subcutaneous injection.

Study on the Effectiveness of Dupilumab Injections for Itch Relief in Adults with Lichen Simplex Chronicus

This trial is testing dupilumab injections for adults with moderate-to-severe Lichen Simplex Chronicus who have not found relief with topical treatments. Like the previous study, it focuses on evaluating both the effectiveness and safety of this medication in reducing itchiness.

Inclusion criteria: Participants must be at least 18 years old and have had LSC for at least 6 months. They need an average worst-itch score of 7 or higher over 7 days before the study begins. Participants should have previously tried topical corticosteroids and possibly topical calcineurin inhibitors without adequate results.

Exclusion criteria: Those with other skin conditions that might interfere with the study, people currently using medications that could affect results, those with severe allergic reactions to study medications, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.

Main focus: The study is randomized and double-blind, lasting 24 weeks. The primary goal is to measure improvement in itch severity. Secondary evaluations include sleep disturbance, quality of life, and the presence of anti-drug antibodies.

Investigational drug: Dupilumab works by inhibiting certain enzymes involved in the inflammatory process, helping reduce itching and skin inflammation. It is classified as a monoclonal antibody and is administered via injection under the skin.

Study on the Effects of Barzolvolimab for Patients with Prurigo Nodularis

This study examines barzolvolimab, a monoclonal antibody given as an injection, for people with Prurigo Nodularis, a condition causing intensely itchy bumps on the skin. The trial aims to assess both the effectiveness and safety of this treatment in reducing itchiness.

Inclusion criteria: Participants must be at least 18 years old and have been diagnosed with Prurigo Nodularis by a skin doctor at least 3 months before the study starts. They need to have at least 20 nodules on both arms, both legs, or both sides of the body. The worst-itch score must be 7 or higher over 7 days before starting the study. Participants should have tried prescription skin medications without success or be unable to use them for safety reasons. Normal blood test results are also required.

Exclusion criteria: Those with medical conditions other than Prurigo Nodularis that could interfere with the study, people not in the specified age range, those unable to comply with study procedures, individuals who have used certain medications recently, those with allergic reactions to similar drugs, and pregnant or breastfeeding women are excluded.

Main focus: The study monitors participants for several weeks with regular check-ups to evaluate changes in itch severity, skin condition, and overall health. The main goal is to determine if barzolvolimab significantly improves the itch response at Week 12.

Investigational drug: Barzolvolimab is a humanized monoclonal antibody that targets specific molecules in the immune system to reduce inflammation and itchiness. It is administered through subcutaneous injection.

Study on the Effects of Povorcitinib for Patients with Prurigo Nodularis

This trial is evaluating povorcitinib, an oral medication taken as a tablet, for people with Prurigo Nodularis. The study aims to see if povorcitinib can reduce itchiness and improve the appearance of skin lesions.

Inclusion criteria: Participants must be between 18 and 75 years old and have a clinical diagnosis of Prurigo Nodularis for at least 3 months. They need an average itch score of 7 or higher during the 7 days before the study starts, along with 20 or more itchy skin bumps on at least 2 different body areas. An IGA-CPG-S score of 3 or higher is required. Participants should have a history of treatment failure, intolerance, or inability to use previous treatments for Prurigo Nodularis.

Exclusion criteria: Those with other skin conditions that might interfere, recent or current infections, pregnant or breastfeeding women, those with severe allergic reactions, those currently using interfering medications, those with serious medical conditions like heart disease or liver problems, recent participation in another trial, and those unable to follow study procedures are excluded.

Main focus: The study lasts for 48 weeks with regular follow-up visits. The main goal is to assess improvement in itchiness and skin lesions by Week 24.

Investigational drug: Povorcitinib is a Janus kinase (JAK) inhibitor that works by inhibiting enzymes involved in the inflammatory process. It is taken orally in tablet form.

Study on the Effects of Povorcitinib for Patients with Prurigo Nodularis

This is another trial testing povorcitinib tablets for Prurigo Nodularis, with similar goals of reducing itchiness and improving skin lesions. The study design and focus mirror the previous povorcitinib trial.

Inclusion criteria: Participants must be between 18 and 75 years old, have a clinical diagnosis of Prurigo Nodularis for at least 3 months, have an average itch score of 7 or higher over 7 days, and have at least 20 itchy skin bumps on at least 2 body areas. An IGA-CPG-S score of 3 or higher is required, along with a history of treatment failure or intolerance.

Exclusion criteria: Those with other skin conditions, recent infections, cancer history (except certain treated skin cancers), severe allergic reactions, current use of interfering medications, drug or alcohol abuse within the past year, pregnant or breastfeeding women, recent trial participation, and those with conditions making participation unsafe are excluded.

Main focus: The study lasts up to 48 weeks with regular monitoring. The primary evaluation occurs at Week 24 to measure improvements in itch and skin lesions.

Investigational drug: Povorcitinib is a JAK inhibitor administered orally that works by inhibiting certain enzymes that play a role in the inflammatory process.

Long-term Safety Study of Oral Povorcitinib in Patients with Hidradenitis Suppurativa, Prurigo Nodularis, or Vitiligo Who Previously Participated in Clinical Trials

This follow-up study focuses on evaluating the long-term safety of povorcitinib in people who have previously participated in other povorcitinib studies for three skin conditions: Hidradenitis Suppurativa, Prurigo Nodularis, and Vitiligo. The study will continue for up to 36 months.

Inclusion criteria: Participants must have completed a previous povorcitinib study without safety concerns and experienced positive results from the treatment. They must have followed all requirements during the previous study and be willing to use appropriate birth control methods. Participants must be at least 12 years old.

Exclusion criteria: Pregnant or breastfeeding women, those under 18 years (for most contexts), people with active infections including tuberculosis, recent cancer history, serious heart conditions, severe liver or kidney disease, current treatment with other investigational drugs, allergic reactions to similar medications, serious mental health conditions, substance abuse, inability to follow procedures, planned major surgery, blood disorders, and immunodeficiency conditions are excluded.

Main focus: The study monitors long-term safety and effectiveness from August 2025 to May 2029. For Prurigo Nodularis patients, itch levels and severity will be assessed at each visit.

Investigational drug: Povorcitinib is a JAK inhibitor taken orally in tablet form that modulates the immune system response by blocking specific signaling pathways involved in inflammation.

Study on the Effectiveness and Safety of Ruxolitinib Cream for Patients with Prurigo Nodularis

This trial tests ruxolitinib cream, a topical medication applied directly to the skin, for people with Prurigo Nodularis. The study aims to determine how well the cream reduces symptoms compared to a vehicle cream without the active ingredient.

Inclusion criteria: Participants must be at least 18 years old and have been diagnosed with Prurigo Nodularis for at least 3 months. They need at least 6 itchy skin lesions on at least 2 different body areas, with the total affected area being 20% or less. An IGA-CPG-S score of 2 or higher and a worst-itch score of 7 or higher at baseline are required. Women of childbearing potential must have a negative pregnancy test.

Exclusion criteria: Those with other skin conditions besides Prurigo Nodularis, people younger than 18 years old, and vulnerable populations who cannot give consent themselves are excluded.

Main focus: The study lasts for 12 weeks with participants applying the cream twice daily. Follow-up assessments occur at Weeks 4 and 12 to measure improvement in itch severity. Secondary evaluations include changes in sleep disturbance and quality of life.

Investigational drug: Ruxolitinib cream is a JAK inhibitor that works by inhibiting enzymes involved in the inflammatory process that contributes to itching and skin inflammation. It is applied topically to the affected skin.

Study on the Effectiveness and Safety of Ruxolitinib Cream for Patients with Prurigo Nodularis

This is another trial evaluating ruxolitinib cream for Prurigo Nodularis, with a similar design and goals to the previous ruxolitinib cream study.

Inclusion criteria: Participants must be at least 18 years old and have had Prurigo Nodularis for at least 3 months. They need at least 6 itchy skin lesions on at least 2 body areas, with total affected area being 20% or less. An IGA-CPG-S score of 2 or higher and a worst-itch score of 7 or higher over a week are required. Women of childbearing potential must test negative for pregnancy.

Exclusion criteria: Those with other skin conditions that might interfere, people currently using other treatments that could affect results, those with allergic reactions to similar creams, pregnant or breastfeeding women, those with serious health conditions affecting safety, recent trial participants, and those unable to follow study procedures are excluded.

Main focus: The 12-week study involves applying the cream twice daily with weekly assessments to monitor progress. The primary evaluation at Week 12 measures improvement in skin condition using a specific scoring system. Secondary evaluations occur at Week 4 and Day 7.

Investigational drug: Ruxolitinib cream is a JAK inhibitor applied topically that helps reduce itching and inflammation by targeting specific pathways in the immune system.

Study on the Long-Term Safety and Effectiveness of Nemolizumab for Patients with Prurigo Nodularis

This study examines the long-term safety of nemolizumab, a medication given as an injection, for people with Prurigo Nodularis. It is designed for participants who have already taken part in previous nemolizumab studies.

Inclusion criteria: Participants must have previously participated in a nemolizumab study for Prurigo Nodularis without safety concerns and experienced positive results. Female participants of childbearing potential must agree to use approved contraception methods throughout the study and for 12 weeks after the last injection. Participants must be willing to follow all study requirements, including using an electronic device to record information weekly, and must sign a consent form.

Exclusion criteria: Those without Prurigo Nodularis, those outside the specified age range (typically adults), and vulnerable populations unable to give informed consent are excluded.

Main focus: The study continues up to Week 184 with regular monitoring for any adverse events and changes in condition. Follow-up visits evaluate skin lesions, quality of life, and long-term treatment effects. The study is estimated to conclude by August 15, 2027.

Investigational drug: Nemolizumab is a monoclonal antibody administered subcutaneously that works by blocking a specific protein involved in the inflammatory process, helping to reduce itching and skin lesions.

Summary

These nine clinical trials represent a comprehensive effort to find better treatments for neurodermatitis and related skin conditions characterized by intense itching and skin lesions. The trials are being conducted across multiple European countries, with Germany, Spain, Italy, Poland, and Belgium appearing most frequently as study locations.

The studies are testing five different types of treatments: dupilumab (two trials), barzolvolimab (one trial), povorcitinib (three trials, including one long-term safety study), ruxolitinib cream (two trials), and nemolizumab (one long-term safety study). Most trials focus on Prurigo Nodularis, while two specifically target Lichen Simplex Chronicus, demonstrating the overlapping nature of these conditions.

The investigational drugs work through different mechanisms: dupilumab and nemolizumab are monoclonal antibodies that block specific inflammatory proteins, povorcitinib is a JAK inhibitor taken orally, barzolvolimab targets immune system molecules, and ruxolitinib is a topical JAK inhibitor cream. Most trials last between 12 and 48 weeks, with two long-term safety studies extending up to 36 months and 184 weeks respectively.

Common inclusion criteria across the trials include minimum age requirements (usually 18 years), confirmed diagnosis for at least 3 months, high itch severity scores (typically 7 or higher on a 0-10 scale), and previous treatment failure with standard therapies. All studies require appropriate contraception measures for participants of childbearing potential.

Ongoing Clinical Trials on Neurodermatitis

  • Study on Dupilumab for Itch Relief in Adults with Lichen Simplex Chronicus (Neurodermatitis)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Germany Greece Hungary Italy +2

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