A Phase 2, Open-Label, Extension Study to Evaluate Long Term Safety and Clinical Activity of Briquilimab in Participants from Jasper-Sponsored Chronic Urticaria Trials
Chronic urticaria is a skin condition that causes itchy, painful hives or welts lasting for months or years. Some people develop hives for no clear reason, while others get them from triggers like cold, heat, or skin friction. This trial is looking at a study medicine called briquilimab. It is designed for adults who have already completed an earlier study testing the same medicine. Because this is an 'open-label' study, all participants receive the real medicine rather than a dummy drug (placebo). The main aim is to check the long-term safety of briquilimab by monitoring any side effects and checking routine blood tests. Researchers also want to see if the treatment continues to ease skin swelling, reduce itching, and help people manage their hives in day-to-day life.
At a glance
What is this study about?
Chronic urticaria causes raised, itchy patches on the skin, often called hives or nettle rash. These welts can be uncomfortable, painful, and distressing. Some people have 'spontaneous' hives that appear without warning. Others have 'inducible' hives that are set off by physical triggers, such as rubbing, pressure, or changes in temperature. Finding treatments that give lasting relief can be difficult.
This Phase 2 trial is looking at a new medicine called briquilimab. It is an 'extension study', meaning it provides continued treatment for patients who have already taken part in a previous trial of the drug. The aim is to find out what happens when people use briquilimab over an extended period.
During the study, the research team will carefully track your health to see if the medicine causes any unwanted side effects. They will also look at whether the treatment keeps hives and itching under control, helping patients enjoy a better quality of life.
Key takeaways
- This trial looks at the long-term safety and benefits of briquilimab for chronic hives.
- It is only open to people who completed an earlier trial with this medicine.
- Every participant receives the active study drug; there is no placebo.
- Doctors will closely monitor side effects, blood tests, and skin symptoms.
- Taking part is voluntary, and you can withdraw from the study at any time.
Who may be eligible?
This study is only open to adults aged 18 and over who have already taken part in a previous briquilimab clinical trial for chronic urticaria run by Jasper Therapeutics. Both men and women may take part.
Because this is a follow-on study, you cannot join if you have not completed one of the earlier qualifying trials. You will also need to be in suitable general health to continue receiving the study medicine safely.
The study doctor will review your medical records, perform a physical examination, and check your blood tests to confirm whether it is safe and appropriate for you to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have chronic hives (either spontaneous or triggered by things like temperature or friction).
- I have successfully completed an earlier clinical trial of briquilimab.
- I am willing to attend regular hospital or clinic appointments for check-ups and tests.
What does participation involve?
If you join the study, you will receive the study medicine, briquilimab. Because this trial is open-label, there is no dummy drug (placebo), and everyone receives the active treatment. You will need to attend regular clinic appointments for health checks, physical examinations, and routine blood and urine tests. You will also be asked to complete short questionnaires about your hives, itching, and daily comfort. For some participants, doctors may test how your skin reacts to temperature or light friction. The study team will explain the schedule of visits and the total length of the study before you agree to take part.
Potential risks and benefits
Locations (1)
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Common questions
What does an open-label extension study mean?
It means this is a follow-up study where both you and your doctors know you are receiving the active medicine. There is no placebo or dummy drug.
Can I join if I have never used briquilimab before?
No. This study is only open to adults who have already completed a previous clinical trial for briquilimab.
Will I have to pay for the study treatment?
No. The study medicine and all trial-related tests are provided free of charge.
How will the doctors know if the medicine is working?
You will fill out simple symptom diaries tracking your itch and hives. Doctors will also check your skin and may test your reaction to triggers like heat or friction.
Can I leave the study early if I change my mind?
Yes. You are free to stop taking part at any time. Leaving the trial will not change the standard medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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