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

Phase 1TerminatedNCT06592768

Jasper Therapeutics, Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Asthma

Interventions

BriquilimabDRUG

Subcutaneous Administration

Placebo ComparatorOTHER

Subcutaneous Administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

McMaster University

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of briquilimab in mild-to-moderate asthmatic participants

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.

Time frame: From signing the informed consent form (ICF) through end of trial (EOT) visit (up to 4.5 months)

To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR

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.

Time frame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6

To compare the effect of treatment with briquilimab vs placebo on the allergen-induced LAR

Allergen-induced LAR will be measured by area under the FEV1 time-response curve \[AUC\] during the period 3-7 hours after the allergen challenge and compared between briquilimab and placebo at week 6.

Time frame: 3-7 hours after allergen challenge between Briquilimab and Placebo at week 6

Secondary Outcomes

To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.

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.

Time frame: 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6

To compare of the allergen-induced early asthmatic response (EAR) between briquilimab and placebo.

Allergen-induced EAR will be measured by area under the FEV1 time-response curve \[AUC\] during the period 0-2 hours after the allergen challenge and compared briquilimab and placebo at week 6.

Data from ClinicalTrials.gov

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