Briquilimab for Allergic Asthma

No longer recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called briquilimab for individuals with allergic asthma. Researchers aim to determine if a single dose of briquilimab can reduce asthma symptoms compared to a placebo (a harmless pill with no effect). This small, early-stage study evaluates the drug's potential effectiveness and safety for this condition. Suitable candidates for this trial include those with stable allergic asthma, who frequently experience wheezing and shortness of breath, and have had asthma symptoms for some time. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that briquilimab is likely to be safe for humans?

Research has shown that briquilimab has been tested in other studies with promising safety results. In one study, all participants who received a 180mg dose of briquilimab experienced good disease control, indicating the treatment worked well without major issues. Another study found that a single dose of briquilimab helped prevent severe allergic reactions, known as anaphylaxis, suggesting the drug is well-tolerated.

Although this trial is in the early stages and primarily focuses on safety, these previous findings offer some reassurance about the treatment's safety in humans. However, early trials are mainly designed to ensure safety before progressing to more extensive testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for allergic asthma?

Unlike the standard treatments for allergic asthma, which typically include inhaled corticosteroids and beta-agonists, Briquilimab stands out due to its novel mechanism of action. It targets specific immune cells involved in the allergic response, potentially offering a more targeted approach to managing asthma symptoms. Researchers are particularly excited about Briquilimab because it could reduce inflammation more effectively and with fewer side effects. This innovative approach may provide better control over asthma symptoms for patients who don't respond well to current therapies.

What evidence suggests that briquilimab might be an effective treatment for allergic asthma?

Studies have shown that briquilimab may help treat allergic conditions. In individuals with chronic spontaneous urticaria, briquilimab significantly reduced hives and itching over 16 weeks. This trial will evaluate briquilimab for its potential to help with allergic asthma. Additionally, research indicates that a single dose can protect against severe allergic reactions (anaphylaxis). These findings suggest that briquilimab could manage symptoms of allergic asthma by calming the immune system's overreaction. Participants in this trial may receive either briquilimab or a placebo to assess its effectiveness in treating allergic asthma. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Jasper Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. ir.jaspertherapeutics.com ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-presents-data-preclinical-briquilimab

News Release Details Results from both studies demonstrated that a single dose of briquilimab protected against anaphylaxis, as measured by significantly higher core ...

2. ir.jaspertx.com ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-announces-health-canada-clearance-clinical

News Release Details Health Canada has cleared the Company's Clinical Trial Application (CTA) for a Phase 1b/2a asthma challenge study evaluating briquilimab in asthma.

3. healio.com healio.com/news/allergy-asthma/20250114/patients-with-chronic-spontaneous-urticaria-see-wellcontrolled-disease-with-briquilimab

Patients with chronic spontaneous urticaria see well- ... Patients with chronic spontaneous urticaria experienced substantial reductions in hives and itch with briquilimab through 16 weeks of treatment.

4. ir.jaspertherapeutics.com ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-announces-first-patient-dosed-phase-1b2a-0

News Release Details The first patient has been dosed in Jasper's Phase 1b/2a clinical challenge study evaluating briquilimab in allergic asthma, called ETESIAN.

5. jacionline.org jacionline.org/article/S0091-6749(23)01959-0/pdf

441 Briquilimab, An Anti-CD117 Antibody, Prevents Outcomes support the Phase 2 clinical development of KN-002 in subjects with moderate to severe asthma not controlled on ICS/LABA treatment. J ALLERGY CLIN ...

6. ir.jaspertx.com ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-reports-positive-data-180mg-cohort-spotlight

Jasper Therapeutics Reports Positive Data from 180mg ... Briquilimab (subcutaneous) administration resulted in deep disease control at 180mg, with 12 of 12 participants (100%) enrolled in the cohort achieving a ...

7. firstwordpharma.com firstwordpharma.com/story/5939051

Jasper Therapeutics Presents Clinical and Preclinical ... Jasper Therapeutics Presents Clinical and Preclinical Briquilimab Data at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual ...

8. veri.larvol.com veri.larvol.com/news/jsp191/drug

News - briquilimab (JSP191) SPOTLIGHT: A Dose Escalation Trial of Safety ... Safety and Efficacy of Briquilimab in Participants With Allergic Asthma (clinicaltrials.gov).

9. jacionline.org jacionline.org/article/S0091-6749(25)00807-3/fulltext

Anti-KIT antibody, briquilimab, induces mast cell apoptosis ... Briquilimab is also being evaluated in a proof-of-concept phase 1b/2a allergic asthma challenge study (NCT06592768). Additionally, briquilimab is being ...