Briquilimab for Chronic Hives

(BEACON Trial)

Recruiting at 39 trial locations

Overseen By Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jasper Therapeutics, Inc.

Must be taking: H1-antihistamines, Omalizumab

Must not be taking: H2-antihistamines, Tricyclic antidepressants

Disqualifiers: Pregnancy, Chronic urticaria, Anaphylaxis, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

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.

How is the drug Briquilimab different from other treatments for chronic hives?

Briquilimab (JSP191, AMG-191) is unique because it is being studied specifically for chronic hives, whereas other treatments like remibrutinib and omalizumab are used for similar conditions but have different mechanisms or are not specifically focused on chronic hives. Briquilimab's distinctiveness may lie in its specific targeting or administration, which is not detailed in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled. The trial is intended to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment with H1 antihistamines and omalizumab. Additionally, pharmacokinetic (PK) properties of briquilimab, and other pharmacodynamic (PD) parameters (such as effects on mast cells (MC), serum tryptase levels, and on allergic skin reactivity) will be investigated.

Research Team

Medical Director

Principal Investigator

Jasper Therapeutics

Eligibility Criteria

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

Written informed consent after the nature of the trial has been fully explained and before performing any trial related assessments

I have had itch and hives for 8 weeks or more, even with omalizumab treatment or cannot tolerate it.

I have been taking a stable dose of antihistamines since screening.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant during the trial.

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x Upper limit of normal (ULN) at Screening

Serum total bilirubin >1.5 x ULN, unless attributable to Gilbert's syndrome

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of briquilimab to determine safety and tolerability

12 weeks

Multiple visits for dose escalation and monitoring

Randomized Treatment

Participants are randomized to receive either briquilimab or placebo in a double-blinded manner

36 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Briquilimab

Trial Overview The trial is testing Briquilimab's safety, how the body processes it, and its initial effectiveness in treating CSU compared to a placebo. It starts with an open-label phase where everyone gets Briquilimab, followed by a randomized double-blind phase where participants get either Briquilimab or a placebo without knowing which one.

Participant Groups

Group I: Briquilimab Experimental Treatment 1 Intervention

This trial will be performed as a three-part dose escalating clinical trial where Parts 1 is open label and Parts 2 and 3 are randomized, double-blinded, and placebo-controlled.

Group II: Placebo Placebo Group 1 Intervention

Placebo Comparator

Briquilimab is already approved in European Union for the following indications:

Approved in European Union as Briquilimab for:

• 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)

Who Is Running the Clinical Trial?

Jasper Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

310+

Findings from Research

In a phase 2b extension study involving 230 patients with chronic spontaneous urticaria (CSU), remibrutinib showed a favorable safety profile, with most adverse events being mild to moderate and not directly related to the treatment.

Remibrutinib provided significant and sustained efficacy, with 55.8% of patients achieving complete response (UAS7 = 0) and 68.0% achieving well-controlled disease (UAS7 ≤6) after 52 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. Jain, V., Giménez-Arnau, A., Hayama, K., et al.[2023]

In a study of 298 patients with chronic idiopathic urticaria (CIU) treated with omalizumab, about 60% continued therapy beyond 18 months, indicating its long-term efficacy in managing persistent hives.

The use of other medications for CIU, such as corticosteroids and antihistamines, decreased after starting omalizumab, suggesting that it effectively reduces the need for additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States. Ke, X., Kavati, A., Wertz, D., et al.[2023]

In a study involving 104 Israeli patients with chronic idiopathic urticaria (CIU), desloratadine 5 mg daily for 4 weeks significantly improved dermatologic quality of life and reduced symptoms of CIU, including the number and size of hives.

51% of patients reported complete or marked relief from their symptoms, indicating that desloratadine is an effective treatment option for CIU, although mild to moderate adverse events were noted in some participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Desloratadine for chronic idiopathic urticaria]. Rottem, M., Elbirt, D., Sthoeger, Z.[2015]

In a study of 25 patients with chronic idiopathic urticaria, nearly 48% showed improvement when treated with montelukast combined with antihistamines, indicating its potential efficacy for this condition.

Despite the observed responses, the study could not identify specific clinical features or laboratory markers that predicted which patients would benefit from montelukast, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of montelukast as added therapy in patients with chronic idiopathic urticaria. Khan, S., Lynch, N.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States. [2023]

4. Israel pubmed.ncbi.nlm.nih.gov

[Desloratadine for chronic idiopathic urticaria]. [2015]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Efficacy of montelukast as added therapy in patients with chronic idiopathic urticaria. [2021]