Allergic Asthma
Conditions
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
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.
Interventions
DRUGBriquilimab
Subcutaneous Administration
OTHERPlacebo Comparator
Subcutaneous Administration
Sponsors
Jasper Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants | From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months) | Incidence and/or severity of AEs, treatmentemergent adverse events (TEAEs), SAEs, AEIs, and AEs leading to discontinuation. Incidence of clinically significant abnormal laboratory values and vital signs. |
| To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR | 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6 | Allergen-induced LAR will be measured by maximum percentage fall in FEV1 during the period 3-7 hours after the allergen challenge and compared between briquilimab and placebo at week 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo. | 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6 | Allergen-induced EAR will be measured by maximum percentage fall in FEV1 during the period 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6. |
| Comparison of allergen-induced inflammatory mediators at 7h and 24h post allergen, between briquilimab and placebo | 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6. | Changes from pre-allergen challenge sputum inflammatory mediators to 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6. |
| Comparison of the allergen-induced shift in AHR to methacholine at 24 hours after the allergen challenge, between briquilimab and placebo. | 24 hours after the allergen challenge compared between briquilimab and placebo at week 6. | Changes from pre-allergen challenge AHR to 24 hours after the allergen challenge assessed by methacholine PD20, and compared between briquilimab and placebo at week 6. |
| Comparison of the allergen-induced changes in sputum leukocytes at 7h and 24h post allergen challenge, between the briquilimab and placebo. | 7 hours and 24 hours after the allergen challenge, compared between briquilimab at week 6. and placebo. | Changes from pre-allergen challenge sputum leukocytes to 7 hours and 24 hours after the allergen challenge, compared between briquilimab and placebo at week 6. |
Countries
Canada
Outcome results
None listed