Ongoing Clinical Trials for Chronic Urticaria
Currently, there are 5 clinical trials investigating new treatments for chronic urticaria, a condition characterized by recurring hives and itchy skin reactions. These studies are testing medications such as remibrutinib, briquilimab, and BLU-808 across several European countries including Germany, Spain, France, Poland, and others. The trials focus on patients whose symptoms are not adequately controlled with standard antihistamine medications, offering potential new treatment options for this persistent condition.
Clinical trial locations
- Denmark
- France
- Germany
- Evaluation of remibrutinib (LOU064) effectiveness and safety in adult patients with chronic urticaria: A 12-week placebo-controlled study
- Study on Long-Term Safety of Briquilimab for Patients with Chronic Urticaria
- Study of BLU-808 tablets compared to placebo in adults with chronic inducible urticaria and chronic spontaneous urticaria
- Study on Briquilimab for Adults with Chronic Inducible Urticaria Unresponsive to H1-Antihistamines
- Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Evaluation of remibrutinib (LOU064) effectiveness and safety in adult patients with chronic urticaria: A 12-week placebo-controlled study
- Study of BLU-808 tablets compared to placebo in adults with chronic inducible urticaria and chronic spontaneous urticaria
- Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines
Evaluation of remibrutinib (LOU064) effectiveness and safety in adult patients with chronic urticaria: A 12-week placebo-controlled study
This study is testing a medication called remibrutinib (also known as LOU064) for adults with chronic urticaria. The trial is being conducted in Spain, Germany, France, and Poland.
Who can participate: You may be eligible if you are 18 years or older and have been diagnosed with chronic inducible urticaria for at least 4 months or chronic spontaneous urticaria for at least 6 months. Your symptoms must not be adequately controlled with standard antihistamine treatment. For inducible urticaria, you must show specific responses to trigger tests such as cold, heat, pressure, or water, and your most bothersome symptom must score at least 3 on a scale from 0 to 10. For spontaneous urticaria, you need to have a weekly urticaria activity score of 16 or higher and a weekly hives severity score of 8 or higher.
Who cannot participate: You cannot join if you have a history of severe allergic reactions or anaphylaxis, active or chronic infections including hepatitis B, hepatitis C, or HIV, current cancer diagnosis or ongoing treatment, severe liver or kidney problems, are pregnant or breastfeeding, or have used other investigational drugs within 30 days before the study. Other exclusions include uncontrolled high blood pressure, recent major surgery, serious heart conditions, certain mental health conditions, or drug and alcohol abuse within the past year.
What the study involves: The study lasts 12 weeks and is designed as a double-blind trial, meaning neither you nor your doctor will know whether you are receiving remibrutinib or placebo. You will take the medication in tablet form and will need to complete a daily symptom diary. The researchers will assess how well the treatment controls your symptoms, particularly focusing on bothersome symptoms like itching, pain, and burning sensations, as well as your quality of life.
Study medication: Remibrutinib works by blocking specific proteins in the body involved in triggering allergic reactions and inflammation. It is designed to help control symptoms and reduce discomfort associated with chronic urticaria. Some participants will receive placebo instead of the active medication for comparison purposes.
Study on Long-Term Safety of Briquilimab for Patients with Chronic Urticaria
This study is investigating the long-term safety of briquilimab, a medication given as an injection under the skin. The trial is taking place in Germany.
Who can participate: You must have previously completed an eligible Jasper-sponsored clinical trial within the last 4 months without experiencing severe allergic reactions to the study treatment. You need to provide informed written consent and have acceptable blood test results including hemoglobin levels of 10 g/dL or higher, platelet count of 100,000/mm³ or higher, and neutrophils of 1,500/mm³ or higher. For those with chronic spontaneous urticaria, you must have a weekly urticaria activity score of 16 or higher after at least 8 weeks of follow-up in the previous study. For chronic inducible urticaria patients, you must have an urticaria control test score of 12 or less. You must also agree not to donate blood during the trial and use appropriate birth control methods if applicable.
Who cannot participate: The trial excludes patients not within the specified age range, those with medical conditions other than chronic urticaria, individuals unable to follow study procedures, pregnant or breastfeeding women, recent participants in other clinical trials, those with a history of severe allergic reactions, and people taking medications that might interfere with the study.
What the study involves: The study monitors long-term safety and effectiveness of briquilimab through regular assessments including physical examinations and laboratory tests. Participants will receive subcutaneous injections according to the study protocol. For those with chronic inducible urticaria, critical temperature and friction thresholds will be measured over time, while chronic spontaneous urticaria patients will have their urticaria activity and control scores assessed. The study is estimated to conclude by December 2029.
Study medication: Briquilimab is a monoclonal antibody administered through injection that targets specific molecules in the immune system to reduce inflammation and allergic reactions. It is being studied to understand its long-term safety profile in managing chronic urticaria symptoms.
Study of BLU-808 tablets compared to placebo in adults with chronic inducible urticaria and chronic spontaneous urticaria
This trial is testing BLU-808, a medication taken as a tablet by mouth, for people with chronic inducible and chronic spontaneous urticaria. The study is being conducted in Germany, Spain, Italy, and Denmark.
Who can participate: You must be between 18 and 64 years old. For chronic inducible urticaria, you need to have been diagnosed for at least 3 months before starting, and for chronic spontaneous urticaria, at least 6 months. In both cases, your condition must not be adequately controlled with standard antihistamine medications. You must be willing and able to comply with all study procedures and meet additional criteria defined in the protocol.
Who cannot participate: You cannot participate if you have a history of serious allergic reactions or anaphylaxis, are currently pregnant or breastfeeding, have active or chronic infections including hepatitis B, C, or HIV, significant heart problems or uncontrolled high blood pressure, or had major surgery within the past 3 months. Other exclusions include current participation in other trials, history of cancer within the past 5 years (except successfully treated skin cancer), severe kidney or liver problems, uncontrolled diabetes, blood clotting disorders, substance abuse or alcohol dependency, mental health conditions interfering with participation, use of medications that could interact with the study drug, or inability to follow study procedures.
What the study involves: The treatment period lasts 12 weeks. You will receive either BLU-808 or placebo tablets. Throughout the study, you will be monitored for side effects and changes in your condition. For cold-induced urticaria, temperature threshold tests will be conducted, and for symptomatic dermographism, skin reaction tests will be performed. At the end of week 12, final assessments will evaluate your response to treatment, including blood samples to measure medication levels in your body.
Study medication: BLU-808 is an experimental medication that works as a KIT inhibitor, targeting a specific protein that plays a role in certain types of urticaria. The study aims to understand how safe it is and how well patients can tolerate it, particularly for those who have not responded to standard treatments.
Study on Briquilimab for Adults with Chronic Inducible Urticaria Unresponsive to H1-Antihistamines
This study is testing briquilimab for adults with chronic inducible urticaria, specifically cold urticaria and symptomatic dermographism. The trial is taking place in Germany.
Who can participate: You must be 18 years or older and have a diagnosis of cold urticaria or symptomatic dermographism for 3 months or more despite using H1-antihistamines. You must have experienced symptoms like wheals and itching or painful sensations for at least 6 consecutive weeks at any time before screening. You need to have a positive cold stimulation test above 4°C for cold urticaria or a positive friction test with 3 or more pins for symptomatic dermographism. You must be using H1-antihistamines at a stable dose (up to four times the approved dose) for at least 4 weeks before screening and not expect to change this during the first 12 weeks. Your blood counts must meet specific requirements including hemoglobin of 11 g/dL or higher, platelets of 100,000/mm³ or higher, leucocytes of 3,000/mm³ or higher, and neutrophils of 2,000/mm³ or higher.
Who cannot participate: The study excludes those with other serious health conditions that could interfere, pregnant or breastfeeding individuals, people who have had severe allergic reactions to medications, current participants in other clinical trials, those who used investigational drugs within the last 30 days, people with a history of drug or alcohol abuse, known infections affecting study results, history of cancer (except certain skin cancers), conditions affecting the immune system, or major surgery within the last 3 months.
What the study involves: The trial evaluates the safety and tolerability of a single dose of briquilimab administered through a subcutaneous injection. You will undergo initial assessments including medical history review and blood tests, followed by specific tests to confirm your diagnosis. Throughout the study, you will be monitored through regular laboratory assessments, ECGs, and vital signs checks. Provocation tests will assess critical temperature or friction thresholds, and you will complete urticaria control tests to evaluate symptom management. The trial concludes with a final assessment of your condition and any symptom changes.
Study medication: Briquilimab is an investigational medication administered as a single injection to see if it can help reduce symptoms of cold urticaria and symptomatic dermographism in patients who still have symptoms despite taking regular allergy medications.
Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines
This comprehensive study is testing remibrutinib (LOU064) for adults with chronic inducible urticaria including symptomatic dermographism, cold urticaria, and cholinergic urticaria. The trial is taking place across multiple countries including Slovakia, Spain, France, Poland, Romania, Netherlands, Hungary, Germany, Portugal, and Italy.
Who can participate: You must be at least 18 years old and have a confirmed diagnosis of chronic inducible urticaria for at least 4 months. Your condition must not be well controlled with standard H1-antihistamine medications. You need to show specific responses to provocation tests: for symptomatic dermographism, a friction score of 3 or more using the FricTest 4.0 and an itchiness score of 5 or more; for cold urticaria, a critical threshold temperature of 15°C or higher using the TempTest 4.0 and an itchiness score of 5 or more; for cholinergic urticaria, a hive severity score of 2 or more using the pulse-controlled ergometry test and an itchiness score of 5 or more.
Who cannot participate: Exclusions include other skin conditions that might interfere with results, history of severe allergic reactions to similar medications, current use of medications affecting study outcomes, certain heart conditions, uncontrolled high blood pressure, history of specific types of cancer, pregnancy or breastfeeding, history of drug or alcohol abuse, uncontrolled infections, and recent participation in other clinical trials.
What the study involves: This is a 52-week double-blind study where participants are randomly assigned to receive either remibrutinib or placebo. The medication is taken orally twice daily as a 25 mg film-coated tablet. Assessments occur at Week 2 and Week 12 to evaluate symptom improvement and treatment response. Throughout the study, regular follow-up visits monitor safety and side effects. After the initial period, participants may enter an open-label extension phase where all receive the active medication. A final assessment evaluates long-term effects and safety.
Study medication: Remibrutinib is a kinase inhibitor that works by blocking Bruton’s tyrosine kinase, a protein involved in activating immune cells that contribute to inflammation and allergic responses. It is taken orally in tablet form twice daily and is being studied for its effectiveness in treating chronic inducible urticaria in patients whose symptoms are not adequately controlled by standard antihistamine treatments.
Summary
The five ongoing clinical trials for chronic urticaria represent a significant research effort to develop new treatment options for patients whose symptoms are not adequately controlled by standard antihistamine medications. The trials are primarily concentrated in Germany, which hosts four of the five studies, followed by Spain with three trials. France, Poland, and Italy each host two trials, while several other European countries including Denmark, Slovakia, Romania, Netherlands, Hungary, and Portugal are also participating.
Three different investigational medications are being tested: remibrutinib, briquilimab, and BLU-808. Remibrutinib appears to be the most extensively studied medication, being tested in two separate trials with different durations and scopes. All medications work by targeting specific pathways in the immune system to reduce inflammation and allergic reactions, though they use different mechanisms of action. The trials vary in duration from 12 weeks to multiple years, with some offering open-label extension phases for continued treatment and monitoring.
The studies focus on two main types of chronic urticaria: chronic inducible urticaria, which is triggered by specific physical factors such as cold, pressure, or friction, and chronic spontaneous urticaria, which occurs without identifiable triggers. All trials use rigorous inclusion and exclusion criteria to ensure participant safety and study validity, with particular attention to previous treatment history, symptom severity, and overall health status.
