Briquilimab for Allergic Asthma

Recruiting at 5 trial locations

Overseen By Jasper

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jasper Therapeutics, Inc.

Must not be taking: Asthma medications

Disqualifiers: Lung disease, Anaphylaxis, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of short-acting β2-agonists once a week for symptom relief and as-needed for exercise. Other asthma medications are not mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Briquilimab for allergic asthma?

While there is no direct data on Briquilimab for allergic asthma, similar drugs like tezepelumab have shown to significantly reduce asthma attacks and improve lung function in patients with severe, uncontrolled asthma. This suggests that treatments targeting similar pathways may be effective for asthma. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Jasper Therapeutics

Eligibility Criteria

This trial is for individuals with allergic asthma. Participants should be healthy enough to undergo an allergen challenge and have a confirmed diagnosis of allergic asthma. Specific details about age, previous treatments, or other health conditions that might affect eligibility are not provided.

Inclusion Criteria

Willing and able to sign an informed consent form

Forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value

I have a positive reaction to asthma tests.

Exclusion Criteria

Pregnant or lactating women

I use asthma medication but only take short-acting relief once a week or as needed for exercise.

I have a lung condition that is not allergic asthma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of briquilimab or placebo and undergo allergen challenge model testing

6 weeks

Multiple visits for allergen challenge and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4.5 months

Treatment Details

Interventions

• Briquilimab

Trial Overview The study tests the safety and effectiveness of Briquilimab compared to a placebo in treating allergic asthma. It's a single-dose study where participants receive either Briquilimab or a placebo without knowing which one they get, to see how well the drug works.

Participant Groups

Group I: Briquilimab Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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

Reslizumab (Cinqair) is an interleukin-5 antagonist specifically designed to treat severe eosinophilic asthma, targeting the underlying inflammation caused by eosinophils.

Clinical studies have demonstrated that reslizumab effectively reduces asthma exacerbations and improves lung function in patients with high eosinophil levels, highlighting its efficacy as a targeted therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reslizumab (Cinqair): An Interleukin-5 Antagonist for Severe Asthma of the Eosinophilic Phenotype. Hom, S., Pisano, M.[2020]

Tezepelumab significantly reduced asthma exacerbations by 60% compared to placebo in a pooled analysis of 1,334 patients from two major trials, demonstrating its efficacy across various subgroups of severe, uncontrolled asthma.

The treatment not only lowered the rate of exacerbations but also decreased related hospitalizations and emergency visits, with a similar safety profile to placebo, indicating it is a safe and effective option for managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Corren, J., Menzies-Gow, A., Chupp, G., et al.[2023]

In the phase 3 NAVIGATOR study involving patients aged 12-80 with severe asthma, tezepelumab significantly improved various lung function parameters, including pre-bronchodilator FEV1 and forced vital capacity (FVC), compared to placebo over 52 weeks.

Improvements in lung function were observed as early as 1-2 weeks and were particularly pronounced in patients with a shorter disease duration and specific baseline lung function characteristics, indicating tezepelumab's efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Menzies-Gow, A., Ambrose, CS., Colice, G., et al.[2023]

Mepolizumab (Nucala) is an effective treatment for patients with severe eosinophilic asthma, targeting and reducing eosinophil levels to help control asthma symptoms.

Clinical studies have shown that mepolizumab significantly decreases asthma exacerbations and improves lung function in patients with high eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab (Nucala) For Severe Eosinophilic Asthma. Choy, MS., Dixit, D., Bridgeman, MB.[2020]

In a study involving 1,051 patients with moderate-to-severe eosinophilic asthma, reslizumab demonstrated favorable long-term safety and sustained efficacy over a treatment period of up to 24 months, with significant improvements in lung function and asthma control.

The most common adverse events were worsening asthma and nasopharyngitis, with serious adverse events occurring in 7% of patients, indicating that while reslizumab is generally safe, monitoring for potential side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma. Murphy, K., Jacobs, J., Bjermer, L., et al.[2018]

References

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

Reslizumab (Cinqair): An Interleukin-5 Antagonist for Severe Asthma of the Eosinophilic Phenotype. [2020]

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

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. [2023]

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

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. [2023]

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

Mepolizumab (Nucala) For Severe Eosinophilic Asthma. [2020]

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

Long-term Safety and Efficacy of Reslizumab in Patients with Eosinophilic Asthma. [2018]