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Study on Briquilimab for Adults with Chronic Inducible Urticaria Unresponsive to H1-Antihistamines

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Inducible Urticaria, which is a type of skin condition that causes itchy hives or welts. The study is particularly interested in two forms of this condition: Cold Urticaria, where symptoms are triggered by cold temperatures, and Symptomatic Dermographism, where symptoms appear after the skin is scratched or rubbed. The trial is testing a new treatment called Briquilimab, which is given as an injection under the skin. This study aims to evaluate the safety and how well patients tolerate a single dose of Briquilimab, especially for those who continue to have symptoms despite using H1-antihistamines, which are common allergy medications.

Participants in the study will receive either Briquilimab or a placebo. The trial will monitor the participants for any side effects and changes in their condition. The study will also involve various tests to assess the response to the treatment, such as checking the temperature or friction level that triggers symptoms. The goal is to see if Briquilimab can help control the symptoms of Chronic Inducible Urticaria better than current treatments.

The trial will take place over a period of time, with regular visits to monitor the participants’ health and response to the treatment. The study will also measure how long it takes for the symptoms to improve or return after treatment. This research is important for finding new ways to help people with Chronic Inducible Urticaria who do not get enough relief from existing medications.

1 initial visit

Upon joining the trial, the first step involves an initial visit. During this visit, the trial is explained in detail, and written informed consent is obtained. This ensures understanding and agreement to participate in the study.

Eligibility is confirmed through a series of assessments, including a review of medical history and current symptoms. Blood tests are conducted to check hemoglobin, platelets, leucocytes, and neutrophils levels.

2 screening tests

Participants undergo specific tests to confirm the diagnosis of chronic inducible urticaria. For those with cold urticaria, a cold stimulation test is performed. For symptomatic dermographism, a friction test is conducted.

These tests help determine the presence of symptoms such as wheal, itch, or painful sensations.

3 medication administration

The trial involves the administration of a single dose of briquilimab through a subcutaneous injection. This is done to evaluate the safety and tolerability of the medication.

Participants continue their current use of H1-antihistamines at a stable dose, which should not change during the first 12 weeks of the trial.

4 monitoring and follow-up

Participants are monitored for any side effects or changes in their condition. This includes regular laboratory assessments, ECGs, and checks of vital signs.

Specific assessments are conducted to monitor for expected side effects, such as changes in taste or hair color.

5 provocation testing

Provocation tests are performed to assess the critical temperature threshold for cold urticaria and the critical friction threshold for symptomatic dermographism.

These tests help evaluate the effectiveness of the treatment in controlling urticaria symptoms.

6 urticaria control test

Participants complete the urticaria control test to assess the level of symptom control. This test helps determine the proportion of participants who are urticaria-free or well-controlled.

The time taken to achieve complete response or well-controlled disease is also recorded.

7 end of trial

The trial concludes with a final assessment of the participant’s condition and any changes in symptoms.

Participants are informed of the trial results and any further steps, if necessary.

Who Can Join the Study?

  • Provide written informed consent after the trial has been fully explained to you.
  • Be a male or female who is 18 years old or older.
  • Have a diagnosis of Cold Urticaria (ColdU) or Symptomatic Dermographism (SD) despite using H1-antihistamines. This means:
    • You have had ColdU or SD for 3 months or more.
    • You have experienced symptoms like wheal (raised, itchy area of skin) and itch or painful sensation for at least 6 consecutive weeks at any time before the screening, even while using H1-antihistamines.
    • If you have ColdU, you must have a positive cold stimulation test above 4°C using TempTests® during screening.
    • If you have SD, you must have a positive FricTests® with 3 or more pins during screening.
  • Use H1-antihistamines at a stable dose, up to four times the approved dose, for at least 4 weeks before the screening visit and not expect to change this during the first 12 weeks of the trial.
  • If you have chronic spontaneous urticaria (CSU), you can participate if your symptoms are consistent with ColdU or SD, and ColdU or SD is the main type of urticaria you have.
  • Have blood counts at screening with:
    • Hemoglobin (a protein in red blood cells): 11 g/dl or higher
    • Platelets (cells that help with blood clotting): 100,000/mm³ or higher
    • Leucocytes (white blood cells): 3,000/mm³ or higher
    • Neutrophils (a type of white blood cell): 2,000/mm³ or higher
  • Be willing and able to participate and follow the trial visit schedule.

Who Cannot Join the Study?

  • Patients who have any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a severe allergic reaction to any medication in the past.
  • Patients who are currently participating in another clinical trial.
  • Patients who have used any investigational drug within the last 30 days.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a known infection that could affect the study results.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a condition that affects their immune system.
  • Patients who have had a major surgery within the last 3 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Ubuolwobjzvkbdqdbwbzx Mnikptzb Aje Munster Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
08.01.2024

Trial locations

Investigated drugs:

Briquilimab is a medication being tested to see if it can help people with certain types of chronic hives, specifically Cold Urticaria and Symptomatic Dermographism. These are conditions where people get itchy, red welts on their skin when exposed to cold or when their skin is scratched. The trial is looking at how safe and tolerable a single dose of Briquilimab is for patients who still have symptoms even after taking regular allergy medications called H1 antihistamines. The goal is to see if Briquilimab can reduce the symptoms of these skin conditions.

Investigated diseases:

Chronic Inducible Urticaria – Chronic Inducible Urticaria is a condition characterized by the development of hives or welts on the skin in response to specific triggers. These triggers can include physical factors such as pressure, temperature changes, or friction. The hives typically appear within minutes of exposure to the trigger and can last for several hours. The condition is chronic, meaning it persists for an extended period, often for months or years. Symptoms can include itching, redness, and swelling of the affected areas. The severity and frequency of outbreaks can vary among individuals.

Trial ID:
2023-507534-24-00
Protocol code:
JSP-CP-010
Trial Phase:
Human Pharmacology (Phase I) – Other

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