Briquilimab for Chronic Hives
(BEACON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of briquilimab (also known as JSP191 or AMG-191) for individuals with chronic hives (chronic spontaneous urticaria) that persist despite standard treatments like antihistamines and omalizumab. The trial will also examine how briquilimab affects certain cells and chemicals in the body related to allergies. Participants should have experienced chronic hives for at least six months and continue to have symptoms such as itchiness and hives despite treatment. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that you continue taking H1-antihistamines at a stable dose, but you must stop using H2 antihistamines, leukotriene receptor antagonists, and tricyclic antidepressants at least 3 days before screening. Other medications like immunosuppressive therapy and certain experimental therapies must be stopped weeks or months before the trial.
Is there any evidence suggesting that briquilimab is likely to be safe for humans?
Research has shown that briquilimab has been safe in previous studies. In one study, participants tolerated briquilimab well, with no serious or severe side effects reported, meaning most people did not experience major negative reactions. Another study found that briquilimab worked quickly and effectively at different doses while remaining safe.
These results suggest that briquilimab might be safe for people with chronic hives who haven't had success with other treatments. While this is encouraging, please remember that the current trial is still in the early stages, so the treatment's safety is still being carefully monitored and evaluated.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for chronic hives, which often include antihistamines and corticosteroids, Briquilimab offers a novel approach by targeting specific immune pathways. Researchers are excited about Briquilimab because it works by inhibiting certain immune cells responsible for inflammation, potentially reducing the frequency and severity of hives more effectively. Additionally, its targeted mechanism may lead to fewer side effects compared to broad-spectrum treatments, providing a more tailored and safer option for patients.
What evidence suggests that briquilimab might be an effective treatment for chronic hives?
Research has shown that briquilimab, which participants in this trial may receive, offers promising results for treating chronic hives, particularly in patients unresponsive to other treatments. In one study, all patients who received a 180mg dose experienced significant symptom control. Another study found that 73% of participants achieved a complete response in just 12 weeks when given 180mg every eight weeks. Additionally, briquilimab demonstrated much better results compared to a placebo, with a noticeable reduction in symptoms. These findings suggest that briquilimab could effectively manage chronic hives.12567
Who Is on the Research Team?
Medical Director
Principal Investigator
Jasper Therapeutics
Are You a Good Fit for This Trial?
Adults over 18 with chronic spontaneous urticaria (CSU) who still have symptoms despite taking H1 antihistamines and omalizumab can join. They must not be pregnant, nursing, or planning pregnancy; should not have other active diseases mimicking CSU; no recent use of certain medications like JAK inhibitors; and willing to use contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of briquilimab to determine safety and tolerability
Randomized Treatment
Participants are randomized to receive either briquilimab or placebo in a double-blinded manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Briquilimab
Briquilimab is already approved in European Union for the following indications:
- Orphan designation for conditioning treatment prior to hematopoietic stem cell transplant in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jasper Therapeutics, Inc.
Lead Sponsor