Clinical Trials for Cold Urticaria
Cold urticaria is a condition where exposure to cold temperatures triggers itchy hives or welts on the skin. Currently, there are 2 ongoing clinical trials testing new treatments for people with this condition who have not found adequate relief from standard antihistamine medications. These studies are evaluating investigational drugs called remibrutinib and barzolvolimab in multiple European countries.
Clinical trial locations
- Bulgaria
- France
- Germany
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Spain
Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines
This trial is testing a medication called remibrutinib (also known as LOU064) in adults who experience chronic inducible urticaria, including cold urticaria, symptomatic dermographism (skin that reacts to scratching), and cholinergic urticaria (triggered by heat or exercise). The study focuses on patients whose symptoms are not adequately controlled by standard H1-antihistamine medications.
Who can participate: Adults aged 18 years or older with a confirmed diagnosis of chronic inducible urticaria for at least 4 months are eligible. Participants must have medical documentation of their condition and show that standard antihistamine doses do not adequately control their symptoms. They must also demonstrate a specific response to provocation tests. For cold urticaria, this means showing a critical threshold temperature of 15°C or higher when tested with TempTest 4.0, and experiencing an itch score of 5 or more after the test.
Who cannot participate: The trial excludes people with other skin conditions that might interfere with study results, those who have had severe allergic reactions to similar medications, individuals currently taking medications that could affect outcomes, people with certain heart conditions or uncontrolled high blood pressure, those with a history of specific cancers, pregnant or breastfeeding individuals, people with a history of substance abuse, those with uncontrolled infections, and anyone who has recently participated in another clinical trial.
What the study involves: Participants will take remibrutinib as a tablet by mouth twice daily (morning and evening) for 52 weeks. The study is double-blind, meaning neither participants nor researchers will know who receives the actual medication versus a placebo. This design helps ensure unbiased results. Participants will be evaluated at Week 2, with a comprehensive assessment at Week 12 to determine if symptoms have significantly improved or resolved. After the initial 52-week period, all participants may have the opportunity to receive the actual medication in an open-label extension phase.
How remibrutinib works: Remibrutinib is a low molecular weight compound that works by inhibiting Bruton’s tyrosine kinase (BTK), a protein involved in activating immune cells that contribute to inflammation and allergic responses. By blocking this pathway, the medication aims to reduce the symptoms experienced by people with chronic inducible urticaria.
Study on the Effectiveness and Safety of Barzolvolimab for Patients with Chronic Inducible Urticaria
This clinical trial is evaluating barzolvolimab (also known as CDX-0159), a different investigational treatment for chronic inducible urticaria. The study specifically focuses on two subtypes: cold urticaria and symptomatic dermographism. The trial aims to determine whether different doses of barzolvolimab can help reduce or eliminate symptoms in patients whose condition is not adequately controlled by antihistamines.
Who can participate: Adults aged 18 years or older who have been diagnosed with cold urticaria or symptomatic dermographism for at least 3 months before screening are eligible. Participants must be on a stable dose of a second-generation non-sedating H1-antihistamine for at least 4 weeks before joining the study, yet still experience symptoms. They must show a positive reaction in provocation tests, developing a wheal (raised, itchy area) within 10 minutes when tested with specific tools at both screening and randomization visits. Blood tests and liver function tests must be within acceptable ranges. Women must use effective birth control or be of non-childbearing potential, and men must also agree to use effective contraception and not donate sperm for at least 150 days after treatment.
Who cannot participate: People with conditions other than chronic inducible urticaria, those outside the specified age range, individuals not part of the designated clinical trial group, and those considered part of vulnerable populations may not be eligible.
What the study involves: This is a randomized, double-blind, placebo-controlled trial, meaning participants will be randomly assigned to receive either barzolvolimab or a placebo, and neither they nor the researchers will know which group they’re in until the study ends. The medication is given as an infusion directly into the bloodstream over a 20-week treatment period. The primary goal is to assess whether participants achieve a negative provocation test at Week 12, meaning they do not develop hives when exposed to their specific triggers. The study is estimated to complete by September 30, 2025.
How barzolvolimab works: Barzolvolimab is a monoclonal antibody, a type of medication designed to target specific proteins in the immune system. It works by modulating immune responses to reduce the symptoms of chronic inducible urticaria. The trial will measure changes in symptoms over time and monitor participants for any side effects to determine both the safety and effectiveness of this treatment approach.
Summary
Both ongoing clinical trials for cold urticaria represent important research efforts to find better treatment options for people whose symptoms are not adequately controlled by standard antihistamine medications. These studies are being conducted across multiple European countries, with particularly strong representation in Germany, Poland, Hungary, and Spain, where both trials are active.
The two trials take different approaches to treatment. The remibrutinib study uses an oral tablet taken twice daily over a longer 52-week period, while the barzolvolimab study administers medication through infusion over a 20-week period. Both medications work through different mechanisms—remibrutinib targets Bruton’s tyrosine kinase, while barzolvolimab is a monoclonal antibody that modulates immune responses.
These trials offer hope for people living with cold urticaria and other forms of chronic inducible urticaria who have struggled to find relief with existing treatments. Participants in these studies will receive careful monitoring and contribute valuable information that may lead to new approved treatment options in the future.
