Study on Long-Term Safety of Briquilimab for Patients with Chronic Urticaria

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What is this study about?

This clinical trial is focused on studying the long-term safety and effects of a treatment called Briquilimab for people with Chronic Urticaria. Chronic Urticaria is a condition where the skin develops itchy hives or welts that last for more than six weeks. The treatment being tested, Briquilimab, is given as an injection under the skin and is a type of medication known as a monoclonal antibody, which is a protein designed to target specific parts of the immune system.

The purpose of this study is to evaluate how safe Briquilimab is and how well it works over a longer period. Participants in this study will have previously taken part in other trials sponsored by Jasper Therapeutics, the company behind Briquilimab. During the study, participants will receive regular injections of Briquilimab and will be monitored for any side effects or changes in their condition. The study will help researchers understand how Briquilimab affects the symptoms of Chronic Urticaria over time.

Throughout the study, participants will undergo regular check-ups and assessments to track their progress and any potential side effects. The study aims to provide valuable information on the long-term use of Briquilimab for managing Chronic Urticaria, contributing to the development of effective treatments for this persistent skin condition.

1 joining the study

Upon joining the study, participants must have previously completed an eligible Jasper-sponsored clinical trial within the last 4 months without experiencing any severe allergic reactions related to the investigational product.

Participants must provide informed written consent before proceeding with the study.

2 eligibility confirmation

Eligibility is confirmed by ensuring that laboratory parameters are within acceptable ranges, such as hemoglobin levels, platelet count, and liver function tests.

Participants must agree to abstain from blood donations during the trial period.

3 medication administration

The medication used in this study is briquilimab, administered as a subcutaneous injection.

The frequency and duration of administration will be determined by the study protocol and communicated to participants during the trial.

4 monitoring and assessments

Participants will undergo regular monitoring to evaluate the safety and tolerability of briquilimab.

Assessments will include physical examinations and standard clinical laboratory tests to track any adverse events.

5 evaluation of clinical activity

The study aims to evaluate the long-term clinical activity of briquilimab in managing chronic urticaria.

Participants with chronic inducible urticaria will have their critical temperature and friction thresholds measured over time.

Participants with chronic spontaneous urticaria will have their urticaria activity and control scores assessed over time.

6 completion of the study

The study is estimated to conclude by December 7, 2029.

Participants will be informed of the study’s findings and any relevant follow-up actions upon completion.

Who Can Join the Study?

Participants must provide informed written consent, meaning they agree to join the study after understanding what it involves.
Participants must have previously taken part in and completed an eligible Jasper-sponsored clinical trial in the last 4 months without having any serious allergic reaction related to the study treatment.
For those with Chronic Spontaneous Urticaria (CSU), they must have a UAS7 score of 16 or higher after at least 8 weeks of safety follow-up in the previous study, or they must have completed the previous study regardless of their UAS7 score. UAS7 is a way to measure the severity of urticaria symptoms over a week.
For those with Chronic Inducible Urticaria (CIndU), such as cold contact urticaria or symptomatic dermographism, they must have a UCT score of 12 or less after at least 8 weeks of safety follow-up in the previous study, or they must have completed the previous study regardless of their UCT score. UCT is a way to measure how well urticaria is controlled.
Participants must have certain blood test results within acceptable ranges, including:
- Hemoglobin: 10 grams per deciliter (g/dL) or more. Hemoglobin is a protein in red blood cells that carries oxygen.
- Platelets: 100,000 per cubic millimeter (mm³) or more. Platelets help with blood clotting.
- Neutrophils: 1,500 per cubic millimeter (mm³) or more. Neutrophils are a type of white blood cell important for fighting infections.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): Less than 3 times the upper limit of normal. These are liver enzymes.
- Serum total bilirubin: Less than 2 times the upper limit of normal, unless due to Gilbert’s syndrome, a common and harmless liver condition.
- Estimated creatinine clearance (eCrCl): 30 milliliters per minute (mL/min) or more, which measures kidney function.
Participants must agree not to donate blood while participating in the trial, from the start to the end of the trial.
Male participants who are not surgically sterilized (not had a vasectomy) and are sexually active with women must use highly effective birth control methods and must not donate sperm during the trial and for at least 150 days after the last dose of the study drug. A vasectomy is a surgical procedure for male sterilization.
Female participants who can have children and are sexually active with men must use highly effective birth control methods during the trial and for at least 90 days after the last dose of the study drug. Women who cannot have children must be surgically sterile (had a complete removal of the uterus, ovaries, or fallopian tubes) or be in menopause (no menstrual periods for at least 1 year).

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who have medical conditions other than Chronic Urticaria, which is a condition that causes hives or itchy welts on the skin.
Patients who are not able to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of severe allergic reactions.
Patients who are taking medications that might interfere with the study.
Patients who have any other health issues that the study doctors think might make it unsafe for them to participate.

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
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Uebxrajdajwcfkhpfpnex Mqidvjgr Aby	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.03.2025

Trial locations

Investigated drugs:

Briquilimab

Briquilimab is a medication being studied for its long-term safety and effectiveness in treating chronic urticaria, which is a condition characterized by persistent hives. The trial aims to understand how well patients tolerate this medication over an extended period.

Investigated diseases:

Urticaria chronic

Chronic Urticaria – Chronic urticaria is a condition characterized by the presence of hives, which are red, itchy welts on the skin that can vary in size and appear anywhere on the body. These hives can persist for six weeks or longer and may occur with or without an identifiable trigger. The condition is often divided into two types: chronic spontaneous urticaria, where hives appear without a known cause, and chronic inducible urticaria, where hives are triggered by specific factors such as temperature or pressure. The hives can cause significant discomfort and may be accompanied by swelling, known as angioedema, particularly around the eyes and lips. The severity and frequency of the hives can vary, and they may come and go over time.

Trial ID:

2024-517830-17-00

Protocol code:

JSP-CP-014

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Long-Term Safety of Briquilimab for Patients with Chronic Urticaria

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