A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma

Launched by JASPER THERAPEUTICS, INC. · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called briquilimab to see how safe and effective it is for people with allergic asthma. The trial is designed to compare briquilimab to a placebo, which is an inactive substance that looks like the treatment but has no effect. Participants will receive a single dose of either briquilimab or the placebo and then undergo tests to see how their asthma responds to allergens, which are substances that can trigger asthma symptoms.

To be eligible for this trial, participants need to be between 18 and 65 years old and have a stable diagnosis of allergic asthma, meaning their asthma is not currently worsening. They should also have had episodes of wheezing and shortness of breath in the past. Additionally, participants must be able to understand the study requirements and provide consent to join. Those interested should know that the study is currently recruiting, and it is important to meet the criteria outlined to participate. Throughout the trial, participants will be monitored closely to ensure their safety and to collect information on how the treatment affects their asthma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women 18 to 65 years of age; stable, allergic asthma; history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline at least 70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form; positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in FEV1 \[PC20\] PC20 ≤ 16 mg/mL or PD20 equivalent to ≤400µg); and positive skin-prick test and positive allergen-induced early and late airway bronchoconstriction to common aeroallergens.
• Exclusion Criteria:
• • Worsening of asthma or respiratory infection in the preceding 6 weeks; lung disease other than allergic asthma; prior treatment with a c-Kit inhibiting therapy; anaphylaxis to any parenterally administered biologics; use of asthma medications (note: intermittent doses of short-acting β2-agonist are allowed once weekly for relief of symptoms but prophylactic use for exercise is allowed as-needed); pregnant or lactating women; and women actively seeking pregnancy or who are not using adequate contraception.