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Monoclonal Antibodies
Briquilimab for Allergic Asthma
Phase 1
Waitlist Available
Research Sponsored by Jasper Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positive methacholine challenge at baseline (concentration of methacholine causing 20% decrease in FEV1 [PC20] PC20 ≤ 16 mg/mL or PD20 equivalent to ≤400µg)
Men and women 18 to 65 years of age with stable allergic asthma
Must not have
Lung disease other than allergic asthma
Women actively seeking pregnancy or who are not using adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from signing the informed consent form (icf) through end of trial (eot) visit (up to 4.5 months)
Summary
This trial is testing a new drug called briquilimab for allergic asthma using a single dose to see how effective it is compared to a placebo. The study aims to understand the impact of the drug
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this summary doesn't specify side effects, it can be assumed that potential side effects may include typical reactions seen in allergy and immunotherapy trials such as injection site reactions, headaches, fatigue, or respiratory symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a positive reaction to asthma tests.
Select...
I am between 18 and 65 years old with stable allergic asthma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a lung condition that is not allergic asthma.
Select...
I am not trying to get pregnant and am using effective birth control.
Select...
My asthma or lung infection has gotten worse in the last 6 weeks.
Select...
I have been treated with a c-Kit inhibitor before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from signing the informed consent form (icf) through end of trial (eot) visit (up to 4.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from signing the informed consent form (icf) through end of trial (eot) visit (up to 4.5 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants
Secondary study objectives
Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo
Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo.
Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BriquilimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Jasper Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
189 Total Patients Enrolled