Study on the Effects of Briquilimab in Adults with Chronic Spontaneous Urticaria Unresponsive to Antihistamines

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Chronic Spontaneous Urticaria (CSU), a condition that causes patches of itchy skin. The study is testing a medication called Briquilimab, which is given as a subcutaneous injection, meaning it is injected under the skin. The trial also involves a comparison with a placebo, which looks like the treatment but does not contain the active medication. Additionally, Epinephrine, commonly known as adrenaline, may be used in the study as a safety measure, delivered through an auto-injector device like an EpiPen.

The purpose of the study is to evaluate the safety and tolerability of Briquilimab in adults who continue to experience symptoms of Chronic Spontaneous Urticaria despite treatment with other medications, such as antihistamines or omalizumab. Participants will receive doses of Briquilimab and will be monitored for any side effects or changes in their condition. The study will help determine how well the medication works in reducing the symptoms of itchy skin and hives.

Throughout the study, participants will attend regular visits to track their progress and report any changes in their symptoms. They will also be asked to keep a daily diary of their symptoms and any side effects they experience. The trial aims to provide valuable information on the potential benefits of Briquilimab for those suffering from Chronic Spontaneous Urticaria and to explore its overall safety for future use.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will provide written informed consent, confirming that you understand the trial and agree to participate.

Your medical history will be reviewed, and you will undergo a physical examination. Blood samples will be taken to check your blood counts, including hemoglobin, platelets, leucocytes, and neutrophils.

2 screening period

During the screening period, which lasts for several days, you will be asked to maintain a daily diary. This diary will record your symptoms, including itch and hives, to assess your condition.

You will continue using your current H1-antihistamines at a stable dose, up to four times the approved dose, and this should not change during the first 12 weeks of the trial.

3 treatment phase

If eligible, you will enter the treatment phase. You will receive **briquilimab** through a subcutaneous injection. The dosage and frequency will be determined by the study team based on your response and tolerance.

In case of an allergic reaction, **epinephrine** (also known as adrenaline) may be administered via intramuscular injection as a precautionary measure.

4 follow-up visits

You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and assessments of your symptoms.

Your daily diary entries will be reviewed to evaluate the severity of your urticaria and the effectiveness of the treatment.

5 end of trial

At the end of the trial, a final assessment will be conducted. This will include a comprehensive review of your health, symptoms, and any side effects experienced during the study.

You will be informed about the next steps and any further follow-up that may be required.

Who Can Join the Study?

Provide written informed consent after the trial has been fully explained to you.
Be a male or female aged 18 years or older.
Have a diagnosis of Chronic Spontaneous Urticaria (CSU) that is still causing symptoms despite treatment. This means:
- Having CSU for at least 6 months.
- Experiencing itch and hives for at least 8 consecutive weeks at any time before the trial, even while using H1-antihistamines (medications that reduce allergy symptoms).
- Experiencing itch and hives for at least 8 consecutive weeks at any time before the trial, even after treatment with omalizumab (a medication for allergies) or if you cannot tolerate omalizumab.
- Having a UAS7 score of 16 or more and an ISS7 score of 8 or more during the specified days before the trial. These scores measure the severity of your symptoms.
Be using H1-antihistamines at a stable dose up to four times the approved dose since the start of the trial and not planning to change this during the first 12 weeks of the trial.
Have blood test results at the start of the trial showing:
- Hemoglobin (a protein in red blood cells) of 11 g/dl or more.
- Platelets (cells that help blood clot) of 100,000/mm³ or more.
- Leucocytes (white blood cells) of 3,000/mm³ or more.
- Neutrophils (a type of white blood cell) of 2,000/mm³ or more.
Be willing and able to complete a daily diary for the duration of the trial and attend all scheduled trial visits.

Who Cannot Join the Study?

Patients with 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 similar medications in the past.
Patients currently participating in another clinical trial.
Patients who have used certain medications that might affect the study results.
Patients with a history of substance abuse or alcohol dependency.
Patients with uncontrolled high blood pressure or other heart problems.
Patients with active infections that require treatment.
Patients with autoimmune diseases that are not stable.
Patients who have had a major surgery recently.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Elbe Kliniken Stade-Buxtehude gGmbH	Buxtehude	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Uddklhtcguihiumtwitsp Mkvzuboa Afn	Munster	Germany
Gwmgpaawczogrhlz Zsisvbu Bkeo	Bonn	Germany
Gftpxb Uwbmcjijki Fcvenyqts	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	08.01.2024

Trial locations

Investigated drugs:

Briquilimab

Briquilimab is a medication being studied for its potential to help people with chronic spontaneous urticaria, a condition that causes hives and itching without a known cause. This medication is being tested to see if it is safe and how well it works in people who still have symptoms despite using another treatment called omalizumab, or who cannot tolerate omalizumab. The goal is to find out if briquilimab can reduce the symptoms of urticaria and improve the quality of life for patients.

Investigated diseases:

Chronic spontaneous urticaria

Chronic Spontaneous Urticaria – Chronic Spontaneous Urticaria is a skin condition characterized by the sudden appearance of hives, which are raised, itchy welts on the skin. These hives can vary in size and may appear anywhere on the body. The condition is termed “spontaneous” because the hives occur without an obvious trigger. The hives can last for more than six weeks and may come and go over months or even years. The itching associated with the hives can be intense, leading to discomfort and disruption of daily activities. The exact cause of Chronic Spontaneous Urticaria is often unknown, but it involves the release of histamine and other chemicals from cells in the skin.

Trial ID:

2023-505446-25-00

Protocol code:

JSP-CP-011

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Briquilimab in Adults with Chronic Spontaneous Urticaria Unresponsive to Antihistamines

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?