Ongoing Clinical Trials for Cholinergic Urticaria
There is currently one clinical trial investigating new treatment options for cholinergic urticaria, a condition where the skin develops small, itchy hives in response to increased body temperature from activities like exercise or hot showers. This trial is testing a medication called remibrutinib in adults whose symptoms are not adequately controlled by standard antihistamine treatments, and it is being conducted across multiple European countries.
Clinical trial locations
- France
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Spain
Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines
This clinical trial is investigating a new treatment for people with Chronic Inducible Urticaria, which includes cholinergic urticaria. This condition causes the skin to develop itchy hives or welts in response to specific triggers such as physical activity, hot showers, or other situations that raise body temperature. The study is testing whether a medication called remibrutinib (LOU064) can help people whose symptoms have not been controlled by standard antihistamine treatments.
Inclusion criteria: To participate in this trial, you must be at least 18 years old and have a confirmed diagnosis of Chronic Inducible Urticaria for at least four months. This includes cholinergic urticaria, which is triggered by increased body temperature. Your condition must not be well controlled by standard H1-antihistamines at approved doses. You will need to undergo a specific provocation test at the start of the study. For cholinergic urticaria, this involves a pulse-controlled exercise test where a doctor assesses the severity of your hives with a score of 2 or more, and you report an itchiness score of 5 or more afterward. Medical records or other proof of your condition will be required.
Exclusion criteria: You cannot participate if you have any other skin condition that might interfere with the study results, have had a severe allergic reaction to similar medications, or are currently taking medications that could affect the outcomes. People with a history of certain heart conditions, uncontrolled high blood pressure, certain types of cancer, or poorly controlled infections are excluded. Additionally, if you are pregnant, breastfeeding, have a history of drug or alcohol abuse, or have recently participated in another clinical trial, you will not be eligible for this study.
Focus and goals: The main goal of this trial is to determine whether remibrutinib can help more people achieve a complete response, meaning their symptoms are fully controlled, compared to those taking a placebo. The study is designed as a double-blind trial, which means neither you nor the researchers will know whether you are receiving the actual medication or a placebo. This ensures unbiased results. Participants will take the medication orally, in the form of a 25 mg film-coated tablet, twice daily for 52 weeks. Throughout the study, regular assessments will be conducted to evaluate changes in symptoms and monitor for any side effects. After the initial 52-week period, there is an open-label extension phase where all participants may have the opportunity to receive the active medication.
Investigational drug: The medication being tested is remibrutinib (LOU064), which works by inhibiting a specific enzyme called Bruton’s tyrosine kinase. This protein is involved in activating immune cells that contribute to inflammation and allergic responses. By blocking this enzyme, remibrutinib aims to reduce the skin reactions that occur in people with cholinergic urticaria and other types of chronic inducible urticaria. The drug is taken orally twice daily and is being evaluated for its effectiveness, safety, and tolerability in patients whose symptoms are not adequately controlled by antihistamines.
Summary
Currently, there is one active clinical trial available for people with cholinergic urticaria whose symptoms are not controlled by standard antihistamine treatments. This trial is testing remibrutinib, a new medication that works differently from traditional antihistamines by targeting specific immune system pathways involved in allergic reactions. The trial is being conducted across ten European countries, including France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, and Spain, offering broad access to potential participants across Europe. The study spans 52 weeks with an option for an open-label extension, providing a comprehensive evaluation of the medication’s long-term effects and safety.