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A study to evaluate the effectiveness of barzolvolimab in participants with cold urticaria and symptomatic dermographism

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness of barzolvolimab in people living with Cold Induced Urticaria and Symptomatic Dermographism. Cold Induced Urticaria is a condition where skin reactions, such as hives or itching, occur after exposure to cold temperatures. Symptomatic Dermographism is a condition where skin becomes itchy or raised after being lightly scratched or rubbed. Participants in this study will receive either barzolvolimab or a placebo through subcutaneous injection, which is a method of delivering medication just under the skin. Additionally, epinephrine may be used as a background treatment.

During the study, participants will be assigned to different groups to compare the results of the new medication against the placebo. The process involves monitoring the skin's reaction to specific triggers over several weeks. The study aims to see if the treatment helps reduce the severity of skin reactions when exposed to cold or physical pressure. Information regarding how the body responds to these triggers will be collected at various stages throughout the study period.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, an assignment is made to receive either the test medication, known as barzolvolimab (450 mg administered via subcutaneous injection, which is an injection under the skin), or a placebo (a substance containing no active medication) via subcutaneous injection.
The assignment is double-blind, meaning neither the participant nor the researchers know which substance is being administered.
Step 2
Treatment and monitoring phase
During the treatment period, specific assessments are conducted to monitor the response to the cold-induced urticaria (hives caused by cold) and symptomatic dermographism (skin reactions caused by physical friction or pressure).
At week 4, tests are performed to evaluate the critical temperature threshold (the temperature at which skin reactions occur) and the critical friction threshold (the amount of pressure that triggers a skin reaction).
At week 12, evaluations are conducted to measure the response to the provocation tests, which are controlled tests to trigger skin symptoms, and to record the worst itch-numeric rating scale (a measure of itch intensity) and the worst hives-numeric rating scale (a measure of hive intensity).
At week 24, follow-up assessments are repeated to measure the critical temperature threshold, the critical friction threshold, itch intensity, and hive intensity.

Who can join the trial?

16 criteria

You must be able to read, understand, and sign a consent form, which is a document explaining the study, and provide authorization for your health information to be used.
You must be willing to follow all study rules, attend scheduled visits, and complete a daily symptom diary, which is a personal log used to record how you feel each day.
To be eligible, you must complete your symptom diary for at least 5 out of 7 days immediately before being assigned to a study group.
You must be a man or a woman who is 18 years of age or older at the time of signing the consent form.
You must have been diagnosed with Cold-Induced Urticaria (hives caused by cold temperatures) or Symptomatic Dermographism (skin irritation caused by physical rubbing or pressure) for at least 3 months.
Your condition must be uncontrolled, meaning your symptoms continue even though you are taking a stable dose of a second-generation non-sedating H1AH (a type of antihistamine medication that does not make you sleepy).
You must have experienced itchy wheals (raised, red bumps on the skin) or angioedema (swelling that occurs deep under the skin) for at least 6 weeks.
For those with Cold-Induced Urticaria, a specific provocation test (a test where a trigger is applied to the skin) must show that your skin reacts to temperatures between 10 °C and 37 °C and causes an itch score of 3 or higher.
For those with Symptomatic Dermographism, a friction test (a test involving rubbing the skin) must show a reaction score of 3 or higher and an itch score of 3 or higher.
If you have Cold-Induced Urticaria, you must have a positive ice-cube test, meaning hives appear on the skin where the ice was applied.
Your blood tests must show that your white blood cell count, absolute neutrophil count (a type of white blood cell that fights infection), and platelet count (cells that help blood clot) are at or above the lower limit of normal.
Your hemoglobin (a protein in red blood cells that carries oxygen) must not be more than 1 gram per deciliter below the lower limit of normal.
Your liver function tests, including AST, ALT (enzymes that indicate liver health), and total bilirubin (a yellow substance produced by the liver), must be within a specific range near the upper limit of normal.
Women who are able to have children must agree to use highly effective contraception (methods to prevent pregnancy, such as hormonal methods or an intrauterine device) during the study and for at least 150 days after receiving the treatment.
Women who cannot have children due to surgical sterilization (such as having the uterus or ovaries removed) or who are in menopause (the time after a woman's menstrual periods have permanently stopped) are also eligible.
Men who have female partners able to have children must agree to use a condom or must have had a vasectomy (a medical procedure for male sterilization) and must not donate sperm during the study and for 150 days after treatment.

Who cannot join the trial?

23 criteria

Having diseases that cause similar skin symptoms, such as urticarial vasculitis (inflammation of the blood vessels causing hives), erythema multiforme (a skin reaction), cutaneous mastocytosis (a condition where too many immune cells build up in the skin), Schnitzler Syndrome (a rare inflammatory disorder), or angioedema (deep swelling under the skin).
Having received intravenous immunoglobulin (a treatment using antibodies from donated blood) or plasmapheresis (a process that filters the blood to remove certain substances) within 30 days before the screening.
Planning to use medications or undergo major surgery that is not allowed by the study rules.
Receiving a live vaccine (a vaccine that uses a weakened form of a germ) within 30 days before the screening, such as the nasal spray flu vaccine.
Being pregnant or breastfeeding.
Having severe or uncontrolled long-term illnesses, such as chronic hepatic or renal disease (long-term liver or kidney disease) or diabetes mellitus (high blood sugar), that could make it hard to measure the study's safety or effects.
Having moderate to severe pulmonary (lung) or cardiovascular (heart and blood vessel) diseases.
Having an active infection of hepatitis B, hepatitis C, or HIV.
Having an active infection that requires medicine like antibiotics (to fight bacteria), antivirals (to fight viruses), antifungals (to fight fungus), or antiparasitics (to fight parasites).
Having tuberculosis (TB), a serious bacterial infection, or having a history of it that has not been fully treated.
Having a history of malignancy (cancer) within the last 5 years, except for certain fully treated skin cancers.
Having any other medical or mental health conditions or abnormal laboratory test results that might increase risk or interfere with the study results.
Having active Chronic Spontaneous Urticaria (CSU), which is long-term hives that occur without a specific trigger, at the time of screening.
Having undergone general or epidural anesthesia (medicine used to make you sleep or numb your body for surgery) within 8 weeks before starting treatment, or having minor procedures like dental work within 14 days.
Living in a detention center due to court orders or legal actions.
Being a staff member involved in the study or a family member of the study staff.
Having other types of cold-related hives, such as those caused by heat, sun, pressure, or water, that might make it difficult to study the specific conditions being tested.
Having familial cold urticaria, which is a genetic condition where people get hives from cold.
Having other active skin diseases that cause itching, such as atopic dermatitis (eczema) or psoriasis, which could interfere with the study results.
Using certain skin creams or medicines regularly, such as topical corticosteroids (anti-inflammatory creams), calcineurin inhibitors (immune-modulating creams), or certain antihistamines (allergy medicines), within 1 week before screening.
Using non-biologic systemic medicines (pills or injections) or experimental drugs within 4 weeks before screening.
Having previously received barzolvolimab or other anti-KIT therapy (treatments that target a specific protein in immune cells).
Using immuno-modulatory biologic therapy (medicines that change how the immune system works) or other experimental mAb therapy (monoclonal antibody treatments) within 3 months before screening.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Responsive
Frankfurt, Germany
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
Rzeszow, Poland

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Investigated drugs

Barzolvolimab
is the experimental medication being tested in this study to see if it can help reduce the symptoms of cold-induced hives and skin writing (symptomatic dermographism).
Epinephrine
is a medication used as part of the ongoing background treatment for participants during the study.

What is already known about the treatment

Epinephrine
This medication is an injection given under the skin using a pre-filled pen. It is a well-established medicine used to quickly treat severe allergic reactions by relaxing the muscles in the airways and increasing blood flow. At a molecular level, it works by stimulating specific receptors in the body that help reduce swelling and open up breathing passages.
Barzolvolimab
This is an experimental medication provided as a concentrated liquid for injection under the skin. Currently being studied in clinical trials, it is being tested to treat skin conditions like hives triggered by cold temperatures or skin pressure. It works by targeting and blocking specific parts of the immune system to prevent the body from overreacting and causing skin irritation.

Investigated diseases

Cold-Induced Urticaria
This condition is characterized by the appearance of hives or skin swelling when the skin is exposed to cold temperatures. The reaction typically occurs shortly after contact with cold air, water, or other cold objects. As the skin reacts to the cold stimulus, red, itchy welts may form on the affected areas. The symptoms generally subside once the skin warms up to normal temperature.
Symptomatic Dermographism
This is a skin condition where physical pressure or rubbing on the skin causes raised, itchy welts to appear. The reaction often follows a linear pattern along the path where the skin was stroked or scratched. This process occurs as the skin responds to mechanical stimulation. The localized swelling and redness typically develop quickly after the skin is irritated.