Clinical trial NCT06592768: A Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Allergic Asthma
Keywords: Asthma
Allergy
Chronic Disease
Lung Function
Exacerbation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lead sponsor: Jasper Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a double-blind, placebo-controlled, parallel-group, randomized, study to evaluate the safety and efficacy of briquilimab on allergen-induced asthmatic airway responses.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants
timeFrame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)
measure: To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
timeFrame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
measure: To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR
timeFrame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6
Secondary outcomes:
measure: To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.
timeFrame: 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6
measure: To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.
timeFrame: 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6
measure: Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo
timeFrame: 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6.
measure: Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo.
timeFrame: 24 hours after the allergen challenge compared between briquilimab and placebo at week 6.
measure: Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo.
timeFrame: 7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Quebec City
country: Canada
facility: University of Laval
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Jasper Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: